News tagged headline

FDA Warns Consumers, Health Care Professionals About Over-the-Counter Drug Products

Topics: Over the counter and Fda

FDA is advising consumers and health care professionals not to use Sit and Slim II, Dermatend Original, and Dermatend Ultra because the drug products are unapproved and could cause harm.

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NABP Issues Policy Statement Supporting the Pharmacist’s Role in Increasing Access to Opioid Overdose Reversal Drug

Topics: Patient safety and Prescription drug abuse

As the opioid overdose epidemic continues to take hundreds of lives each week, the National Association of Boards of Pharmacy® (NABP®) has issued a policy statement promoting an active role for pharmacists in expanding access to the opioid overdose reversal drug, naloxone. 

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NABP Seeks Nominations for 2015 Awards to be Presented at Annual Meeting

NABP invites you to nominate a colleague or board of pharmacy for a 2015 NABP award. 

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Pharmacy Robberies Plague Arizona, Other States, Says DEA

Topics: Diversion, Pharmacies, and Dea

Fueled by the prescription drug abuse epidemic, Arizona experienced the most pharmacy robberies in 2013 with 77 incidents, according to a report compiled by Drug Topics using Drug Enforcement Administration statistics. 

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FDA Orders New Jersey Company to Destroy Unapproved Drug Products

Topics: Fda

Federal authorities have ordered a New Jersey company to destroy its unapproved products and stop further manufacturing and distributing them until the drugs receive Food and Drug Administration (FDA) approval.

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NABP Issues Policy Statement Supporting the Pharmacist’s Role in Increasing Access to Opioid Overdose Reversal Drug

Topics: Pharmacists

As the opioid overdose epidemic continues to take hundreds of lives each week, the National Association of Boards of Pharmacy® (NABP®) has issued a policy statement promoting an active role for pharmacists in expanding access to the opioid overdose reversal drug, naloxone.

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FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA

Topics: Compounding and Fda

Food and Drug Administration (FDA) has issued a question-and-answer draft guidance document to assist industry and state governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug and Cosmetic Act added by Title II of the Drug Quality and Security Act (DQSA). 

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FDA Issues Draft Guidance on Pediatric Acetaminophen Products

Topics: Over the counter, Patient safety, and Fda

FDA has issued draft guidance with new recommendations for manufacturers of acetaminophen products.

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PTCB to Implement Changes in Continuing Education Requirements in 2015

Topics: Pharmacy technicians

The Pharmacy Technician Certification Board (PTCB) will implement two changes in recertification requirements for Certified Pharmacy Technicians (CPhTs) in accordance with its Certification Program changes announced in 2013. 

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FDA Provides Consumer Information on the Effect of OTC Medications on Driving

Topics: Patient safety and Fda

DA is reminding consumers that some over-the-counter (OTC) medications can affect the ability to drive and operate machinery safely in a new Consumer Update.

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Updated NABP Model Act Now Available to Assist Boards of Pharmacy in Developing Laws and Rules to Protect the Public Health

Topics: Pharmacies and Pharmacists

The recently amended NABP Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) is now available to assist the state boards of pharmacy in developing state laws or board rules in their efforts to protect the public health. 

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Rates of Prescription Opioid and Heroin Overdose Deaths Remain High in Many States, CDC Indicates

Topics: Prescription drug abuse

Heroin deaths increased sharply in at least 28 states from 2010 to 2012, and at least twice as many people died from prescription opioid overdoses, new information released by the Centers for Disease Control and Prevention (CDC) indicates.

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Prescription Painkiller Abusers are Rarely Prepared to Respond to Overdoses, Study Finds

Topics: Prescription drug abuse

Most teens and young adults who abuse prescription painkillers are rarely informed about overdose awareness, avoidance, and response strategies, even those with significant overdose experiences.

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New FDA Resource Provides Inspection, Compliance, and Recall Data

Topics: Fda

Food and Drug Administration (FDA) has released a new resource that provides access to comprehensive data on FDA inspections, warning letters, seizures and injunctions, and recall-related statistics.

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Patient Satisfaction Higher With Patient-Pharmacist Communication

Topics: Patient safety and Pharmacists

Patient satisfaction is higher when a pharmacist works with a patient to increase adherence and to thoroughly explain the risks and side effects of medications using multiple communication channels.

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White House Releases National Strategy for Combating Antibiotic-Resistant Bacteria

Topics: Cdc

The White House has released a document detailing a national strategy to curb antibiotic-resistant bacteria. 

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FDA Warns of Growing Network of Rogue Wholesale Drug Distributors

Topics: Counterfeit drugs and Fda

Food and Drug Administration (FDA) is warning pharmacists and other health care providers to watch for counterfeit and unapproved drugs through a new educational program known as Know Your Source.

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CDC Urges Flu Vaccinations for All Americans Over the Age of Six Months

Topics: Vaccinations and Cdc

Because less than half of Americans received flu vaccinations last year, according to a new CDC report, the agency is once again reminding the public that patients and caregivers of patients six months and older should be vaccinated. 

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Reminder: Final DEA Take-Back Day is Saturday, September 27

Topics: Medication collection program disposal and Dea

Consumers will have the opportunity to dispose of unneeded or unwanted medications at the last Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day on Saturday, September 27, 2014.

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Massachusetts Pharmacist Tied to 2012 Fungal Meningitis Outbreak Indicted

Topics: Compounding

A supervising pharmacist who worked for the New England Compounding Center (NECC), the facility linked to the fall 2012 fungal meningitis outbreak that resulted in the deaths of 64 people, has been indicted in US District Court on mail fraud charges related to the outbreak.

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Hospira Recalls One Lot of Heparin Sodium Due to Particulate Matter

Topics: Compounding and Fda

Hospira, Inc, of Lake Forest, IL, has announced a voluntary nationwide recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% sodium chloride injection 500 mL, due to the presence of particulate matter.

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California Passes Bill to Increase Role of Pharmacy Technicians

Topics: Pharmacy technicians

A California bill expanding the role of pharmacy technicians and interns was signed into law by Governor Jerry Brown on September 15, 2014. 

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FDA Issues New Warning Against Using NuVision Pharmacy Products

Topics: Compounding and Fda

Sterile-use drug products produced and distributed by Downing Labs, LLC, of Dallas, TX, doing business as NuVision Pharmacy, may not be safe, and should not be used.

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Pharmacy Creations Recalls Four Lots of Products Due to Sterility Concerns

Topics: Compounding and Fda

Pharmacy Creations of Randolph, NJ, has issued a voluntary recall of four lots of products after testing results found potential for lack of sterility.

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FDA to Host Public Meeting on Development and Regulation of Abuse-Deterrent Opioid Medications

Topics: Controlled substances, Prescription drug abuse, and Fda

FDA will host a public meeting to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications.

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Massive Opioid Diversion Case in New York Hospital Raises Concerns, Report Indicates

Topics: Controlled substances and Diversion

The arrest of the former director of pharmacy services for a large New York City hospital raises the question of how such facilities can ensure they are adequately protecting their controlled substance inventories from diversion.

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NABP Launches .Pharmacy Generic Top-Level Domain to Help Consumers Find Safe Pharmacies Online

Topics: Counterfeit drugs and Buying medicine online

NABP has launched the .pharmacy generic Top-Level Domain (gTLD) to provide consumers around the world a means for identifying safe, legal, and ethical online pharmacies and related resources.

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DEA Finalizes Rule on Controlled Substance Prescription Drug Disposal

Topics: Medication collection program disposal

Drug Enforcement Administration (DEA) has published its Final Rule on Disposal of Controlled Substances, allowing some DEA registrants to modify their registration to become authorized collectors. 

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National Decline in Rates of Prescription Drug Abuse in 2013, SAMHSA Reports

Topics: Prescription drug abuse

The number of people abusing prescription medications decreased from 6.8 million users in 2012, to 6.5 million users in 2013, according to the latest National Survey on Drug Use and Health.

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Martin Avenue Pharmacy Issues Voluntary Recall for All Sterile Compounded Preparations

Topics: Compounding

Martin Avenue Pharmacy, Inc, of Naperville, IL, has issued a voluntary recall for all in-date compounded sterile preparations due to a lack of sterility assurance. 

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Opioid-Related Overdose Deaths Increased from 2010 to 2013 in New York City, Report Indicates

Topics: Controlled substances and Prescription drug abuse

From 2010 to 2013, the rate of unintentional drug overdose deaths increased by 41% in New York City, and in 2013 77% of overdose deaths involved an opioid.

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States with Medical Marijuana Have Fewer Prescription Opioid Overdose Deaths, Study Claims

Topics: Controlled substances and Prescription drug abuse

Annual rates of overdose deaths related to prescription painkillers are an average of 24.8% lower in states with medical marijuana programs.

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DEA Reschedules Hydrocodone Combination Products as Schedule II

Topics: Controlled substances and Dea

Drug Enforcement Administration (DEA) has published its final rule rescheduling hydrocodone combination products from Schedule III to Schedule II in the Federal Register.

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FedEx Indicted on Additional Charges Related to Online Drug Sellers

Topics: Counterfeit drugs and Buying medicine online

FedEx is facing fresh allegations of conspiring to launder money related to the delivery of drugs sold by rogue online drug sellers.

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CDC Report Identifies Link Between Hospital Drug Diversion, Bacterial and Viral Infections

Topics: Patient safety

In 10 years, over 30,000 patients were exposed to pathogens through drugs diverted by infected medical professionals, a Centers for Disease Control and Prevention (CDC) report indicates. 

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Nearly Seventy US Ebola Scares Have Been Reported to CDC, ABC News Reports

Topics: Patient safety

In the United States, hospitals in 27 states have alerted CDC to possible Ebola cases out of an abundance of caution in the wake of the outbreak in western Africa.

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Google Agrees to Create $250 Million Program to Fight Rogue Online Drug Sellers

Topics: Counterfeit drugs, Buying medicine online, and Internet pharmacy

Google will create a $250 million internal program to “disrupt rogue online pharmacies,” as part of a deal to end shareholder litigation over its alleged placement of advertisements offering to sell prescription drugs from outside the United States, Reuters reports.

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Baxter Voluntarily Recalls Two Lots of Peritoneal Dialysis Solution Due to Particulate Matter

Topics: Compounding and Fda

Baxter International, Inc, of Deerfield, IL, has issued a voluntary recall of two lots of DIANEAL® Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level.

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FDA Warns of Additional ‘Supplements’ Containing Hidden Drug Ingredients

Topics: Over the counter

FDA is advising consumers not to purchase or use Herbal Vigor Quick Fix or Arize, two products marketed as dietary supplements for sexual enhancement, because they contain hidden drug ingredients.

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Prescription and OTC Painkillers Should be Used with Caution, Consumer Reports Advises

Topics: Over the counter and Prescriptions

Although medications such as OxyContin®, Percocet®, and Vicodin® can help patients manage pain from surgery, injury, or chronic illness, patients need to know the risks of both prescription and over-the-counter (OTC) medications.

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DEA to Hold Next Prescription Drug Take-Back Day on September 27, 2014

Topics: Medication collection program disposal and Dea

Drug Enforcement Administration (DEA) has announced another opportunity for consumers to dispose of unneeded and expired prescription drugs during the ninth DEA National Prescription Drug Take-Back Day.

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Seven Charged For Distributing Anabolic Steroids to High School and Professional Athletes

Topics: Dea

Law enforcement agents have arrested seven Florida residents on charges related to the distribution of anabolic steroids and other performance enhancing drugs from Florida-based Biogenesis of America.

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Hospira Recalls One Lot of 2% Lidocaine HCl Injection

Topics: Compounding and Fda

Hospira, Inc, of Lake Forest, IL, has initiated a voluntary recall of one lot of Lidocaine HCl Injection, USP, 2%, 20 mg per mL, 5mL Single-Dose Vial, due to the presence of visible particulate matter identified as iron oxide. 

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Mississippi Attorney General Targets Illicit Drug Advertisements on Google, Bloomberg Reports

Topics: Buying medicine online

Mississippi Attorney General Jim Hood plans to issue a civil investigative demand for more information from Google to determine whether the search company is profiting from illegal drug advertisements.

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Medication Synchronization Supported by Some Insurance Company Policies

Topics: Medication therapy management

Medication synchronization, programs that allow pharmacists to coordinate a patient’s medications to be refilled at the same time, may be accessible to more patients as insurers adopt policies to support the practice.

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Global Patient Safety Highlighted by NABP, Domestic and International Stakeholders at .Pharmacy Supporter Advisory Committee Meeting

Topics: Counterfeit drugs, Buying medicine online, and Patient safety

The National Association of Boards of Pharmacy® (NABP®) welcomed domestic and international stakeholders last week for a meeting of the .Pharmacy Supporter Advisory Committee.

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FDA Reiterates Warning Against Using NuVision Pharmacy Products

Topics: Compounding and Fda

Health care providers should not use or distribute compounded drugs marketed as sterile produced by Downing Labs, LLC, of Dallas, TX, also known as NuVision Pharmacy.

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Unique Pharmaceuticals Recalls All Sterile Compounded Preparations Due to Lack of Sterility Assurance

Topics: Compounding

Unique Pharmaceuticals, Ltd, of Temple, TX, has announced a voluntary recall of all sterile drug preparations compounded by the outsourcing facility.

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FDA Approves New Abuse-Deterrent Opioid Pain Medication

Topics: Controlled substances and Fda

FDA has approved Targiniq™ ER, an opioid pain reliever designed to be more resistant to abuse.

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NIDA Announces Development of New System to Monitor Drug Abuse Trends

Topics: Prescription drug abuse

Intended to identify information that will help health experts respond quickly to potential outbreaks of illicit drug use and abuse, a new National Drug Early Warning System is under development.

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FedEx Indicted Over Role in Delivering Misbranded Prescription Drugs Ordered from Illegal Online Drug Sellers

FedEx Corporation has been indicted by a federal grand jury in San Francisco, CA,  in connection with its alleged role in trafficking controlled substances (CS) and misbranded prescription drugs for rogue online drug sellers.

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Baxter Recalls Four Lots of IV Solution Due to Particulate Matter

Baxter International Inc, of Deerfield, IL, has recalled four lots of intravenous (IV) solutions due to the presence of particulate matter. 

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Pennsylvania Task Force Releases Voluntary Opioid Prescription Guidelines

Topics: Prescription drug abuse

The Safe and Effective Prescribing Practices and Pain Management task force has created voluntary prescribing guidelines for the treatment of chronic non-cancer pain, under the direction of Governor Tom Corbett. 

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JCPP Releases New Patient-Care Document to Promote Consistency

The Joint Commission of Pharmacy Practitioners (JCPP) has released a resource document aimed at promoting consistency in the pharmacists’ process of patient care service delivery.

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DEA Classifies Tramadol a Controlled Substance

Topics: Controlled substances and Fda

Under a final rule (PDF) published in the Federal Register, the pain reliever tramadol is now classified as a Schedule IV controlled substance (CS). 

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Massachusetts Bill Includes New Requirements for Compounders, Fines for Violations

Topics: Compounding

Aimed to ensure the safety of compounded medications, legislation in Massachusetts includes new inspection requirements and fines for violations, among other provisions. 

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DSCSA Draft Guidance Webinar Available to Assist Small Businesses

Topics: Compounding and Fda

Food and Drug Administration (FDA) Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) hosted a webinar.

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Florida Sees Dramatic Drop in Prescription Drug Overdose Deaths

Topics: Prescription drug abuse and Prescription monitoring program

A number of policy and law enforcement measures helped reduce Florida’s prescription drug overdose death rate by 23% from 2010 to 2012, reports Centers for Disease Control and Prevention (CDC).

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FDA Releases DQSA Compounding Rules and Guidance Documents

Topics: Compounding and Fda

Food and Drug Administration (FDA) has released several policy documents related to compounding as part of the agency’s implementation of the Drug Quality and Security Act (DQSA).

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Counterfeit Antibiotics Contributing to ‘Superbug’ Threat, Bloomberg Reports

Topics: Counterfeit drugs and Buying medicine online

Often distributed by rogue Internet drug outlets, counterfeit medications containing antibiotics are feeding a “global epidemic” of antibiotic-resistant infections.

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Lidocaine Should Not Be Used to Treat Teething Pain in Children, FDA Warns

Topics: Over the counter and Fda

FDA is recommending that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain.

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New York Governor Signs Laws Aimed at Combating Opioid Prescription Drug Abuse Epidemic

Topics: Prescription drug abuse

A legislative package of 11 bills targeting prescription drug and opioid abuse has been approved by New York Governor Andrew Cuomo. 

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Massachusetts Law Will Allow Substitutions of Interchangeable Biologic Medicines

Topics: Fda

Massachusetts Governor Deval Patrick has signed HB 3734 allowing for the substitution of interchangeable biosimilars. 

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NABP Executes Registry Agreement with ICANN for .Pharmacy Domain

Topics: Counterfeit drugs, Buying medicine online, and Patient safety

Consumers Worldwide Will Soon Have New Tool for Finding Safe Internet Pharmacies

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Buyers Should Be Wary of Sites Claiming to be Legitimate Internet Pharmacies from Other Countries, Consumer Reports Advises

Topics: Counterfeit drugs and Buying medicine online

Buying medications online from other countries is dangerous since many websites claiming to be an Internet pharmacy from a particular country are not located in that country and are in fact operating illegally, as reflected in an article from Consumer Reports

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FDA Consumer Update Warns of Hidden Drugs in Bee Pollen ‘Supplements’

Topics: Over the counter, Contamination, and Fda

Noting that more than 50 adverse event reports associated with the use of certain bee pollen products have been submitted to Food and Drug Administration, the Agency has released a Consumer Update warning that such products, marketed as dietary supplements, often contain hidden drug ingredients that can be harmful.

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Illinois PMP Implements New Long-Term Care Initiative

Topics: Prescription monitoring program

With growing concerns regarding substantial use of behavioral health medications among nursing home populations, the Illinois Department of Human Services and the Illinois Department of Public Health have announced the Prescription Monitoring Program Long Term Care initiative.

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NABP Executes Registry Agreement with ICANN for .Pharmacy Domain

Topics: Counterfeit drugs, Buying medicine online, and Patient safety

Consumers Worldwide Will Soon Have New Tool for Finding Safe Internet Pharmacies

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FDA Releases Draft Guidance on Identifying Suspect Drugs Under DSCSA

Topics: Compounding, Diversion, and Fda

Food and Drug Administration (FDA) has published a draft guidance document for prescription drug supply chain stakeholders as part of the agency’s implementation of the Drug Supply Chain Security Act (DSCSA).

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New England Governors Convene for Regional Summit Addressing Opioid Abuse

Topics: Diversion and Prescription drug abuse

Governors of five New England states convened for a regional opioid drug abuse summit on June 17, 2014.

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Michigan Legislature Passes Two Bills in Effort to Reduce Meth Production

Topics: Over the counter and Pseudoephedrine

In Michigan, state lawmakers have passed a package of bills aimed at reducing production of illegal methamphetamine by targeting “smurfs.”

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Cannabis-Based Medication Receives Fast Track Status, May Affect State Medical Marijuana Laws

Topics: Medical marijuana and Fda

Epidiolex®, an “investigational cannabidiol product” developed by GW Pharmaceuticals, has received Fast Track designation from FDA for the treatment of Dravet syndrome.

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Drug Supply Chain Security Act Public Workshop Summary Now Available

Topics: Compounding and Fda

Food and Drug Administration (FDA) held a public workshop on the development of initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements, as required by the Drug Supply Chain Security Act.

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Amazon Accused of Enabling Prescription Drug Diversion

Topics: Counterfeit drugs and Buying medicine online

Amazon, the world’s largest online retailer, is enabling unlawful sales of steroids, muscle relaxants, prescription antibiotics, and other dangerous, often illicit substances, an investigative report from Slate alleges.

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ASHP and ACPE Announce New Commissioners for the Pharmacy Technician Accreditation Commission

Topics: Pharmacists

The American Society of Health-System Pharmacists (ASHP) and the Accreditation Council for Pharmacy Education (ACPE) have announced the first commissioners for the Pharmacy Technician Accreditation Commission (PTAC). 

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Alexion Pharmaceuticals Recalls Soliris Lots Due to Presence of Visible Particles

Topics: Compounding and Fda

Alexion Pharmaceuticals of Cheshire, CT, has initiated a voluntary recall for certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion due to the presence of visible proteinaceous particles detected in one lot during periodic testing. 

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FDA Proposes New Tobacco Rules Affecting Liquid Nicotine Products Used in E-Cigarettes

Topics: Patient safety and Fda

Food and Drug Administration (FDA) has released proposed rules that would place additional tobacco products, including liquid nicotine products and electronic cigarettes, under FDA authority. 

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FDA Lowers Recommended Starting Dose for Lunesta Due to Risk of Morning Impairment

Topics: Patient safety and Fda

FDA has lowered the recommended starting dose of the sleep drug Lunesta®

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New Study Highlights Key Quality Standards for Large-Scale Sterile Compounding

Topics: Compounding

A new study comparing safety measures used by pharmaceutical manufacturing facilities with those used by compounding facilities highlights the quality standards that are needed by all compounding facilities.

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FDA Detains Hundreds of Packages Containing Illegal Prescription Drugs Bound for US Consumers

Topics: Counterfeit drugs, Buying medicine online, and Fda

As part of the seventh annual International Internet Week of Action, FDA and Customs and Border Protection detained and seized 583 packages of illegal prescription drugs.

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Unapproved Drugs Seized by US Marshals at Request of FDA

Topics: Counterfeit drugs and Fda

At the request of FDA and the United States Attorney for the Southern District of Ohio, US Marshals have seized more than $11 million worth of unapproved drugs.

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Twenty-Five States’ Prescription Data Now Linked Through NABP PMP InterConnect

Topics: Counterfeit drugs, Diversion, and Prescription drug abuse

Supporting state efforts to fight prescription drug abuse, participation in the National Association of Boards of Pharmacy® (NABP®) PMP InterConnect® program continues to grow with 25 prescription monitoring programs now live.

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NABP 2014-2015 Executive Committee Inaugurated at 110th Annual Meeting in Phoenix, AZ

Delegates to the National Association of Boards of Pharmacy® (NABP®) 110th Annual Meeting, held May 17-20, 2014, in Phoenix, AZ, elected individuals to fill the president-elect, treasurer, and open member positions on the Association’s 2014-2015 Executive Committee.

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Karen M. Ryle, MS, RPh, Assumes Chair of NABP 2014-2015 Executive Committee, Receives President’s Award

Karen M. Ryle, MS, RPh, immediate past president of the National Association of Boards of Pharmacy® (NABP®), assumed the office of chairperson of the Association’s 2014-2015 Executive Committee during the Final Business Session of the NABP 110th Annual Meeting, held May 17-20, 2014, in Phoenix, AZ.

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Delegates Approve Eight Resolutions at the NABP 110th Annual Meeting

Delegates from the member boards of pharmacy adopted eight resolutions during the National Association of Boards of Pharmacy® (NABP®) 110th Annual Meeting, held May 17-20, 2014, in Phoenix, AZ.

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Joseph L. Adams, RPh, Begins Term as NABP President During the Association’s 110th Annual Meeting

Joseph L. Adams, RPh, began his term as president of the National Association of Boards of Pharmacy® (NABP®) during the Final Business Session of the Association’s 110th Annual Meeting, May 17-20, 2014, in Phoenix, AZ.

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Edward G. McGinley, MBA, RPh, Elected NABP President-elect at Association’s 110th Annual Meeting

Edward G. McGinley, MBA, RPh, was elected to serve as the 2014-2015 president-elect of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 110th Annual Meeting, May 17-20, 2014, in Phoenix, AZ. 

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Hal Wand, MBA, RPh, Elected NABP Treasurer at Association’s 110th Annual Meeting

Hal Wand, MBA, RPh, was elected to serve as the 2014-2015 treasurer of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 110th Annual Meeting, May 17-20, 2014, in Phoenix, AZ.

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Jack W. “Jay” Campbell IV, JD, RPh, Elected to Serve as Member of Executive Committee at NABP 110th Annual Meeting

Jack W. “Jay” Campbell IV, JD, RPh, was elected to serve a three-year member term, representing District 3, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 110th Annual Meeting, May 17-20, 2014, in Phoenix, AZ.

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Philip P. Burgess, MBA, DPh, RPh, Elected to Serve as Member of Executive Committee at NABP 110th Annual Meeting

Philip P. Burgess, MBA, DPh, RPh, was elected to serve a three-year member term, representing District 4, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 110th Annual Meeting, May 17-20, 2014, in Phoenix, AZ.

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Richard B. Mazzoni, RPh, Elected to Serve as Member of Executive Committee at NABP 110th Annual Meeting

Richard B. Mazzoni, RPh, was elected to serve a three-year member term, representing District 8, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 110th Annual Meeting, May 17-20, 2014, in Phoenix, AZ.

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New Educational Video for Pharmacists Addresses Prescription Drug Abuse

Topics: Diversion and Prescription drug abuse

The National Association of Boards of Pharmacy® (NABP®) and the Anti-Diversion Industry Working Group, a consortium of pharmaceutical manufacturers and distributors, has released an educational video for pharmacists to help them identify the warning signs of prescription drug abuse and diversion when dispensing controlled substance prescriptions.

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Record Amount of Unwanted Medications Collected During Eighth Prescription Drug Take-Back Day

Topics: Medication collection program disposal

Nearly 800,000 pounds of unneeded prescription medications were properly disposed of during the April 26, 2014, Drug Enforcement Administration National Prescription Drug Take-Back Day.

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Hidden Sibutramine Found in Two Products Marketed for Weight Loss, FDA Warns

Topics: Fda

Due to the presence of undeclared sibutramine, Food and Drug Administration (FDA) is advising consumers not to use Natural Body Solution or Slim Trim U products marketed for weight loss and sold in stores and on websites. 

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Pennsylvania Bill Would Expand the State’s PMP to Include All CS Prescriptions

Topics: Prescription monitoring program

Aimed to help fight prescription drug abuse, proposed legislation in Pennsylvania would establish a comprehensive prescription monitoring program.

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Canadian Drug Seller is Violating State Law, Rules Maine Board of Pharmacy

Topics: Buying medicine online

In a unanimous decision, the Maine Board of Pharmacy directed the state’s attorney general to issue a cease-and-desist letter to Canada Drug Center, a company that has been marketing prescription drugs in Maine.

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Compounding Facilities Invited to Participate in 2014 USP Chapter <797> Compliance Study

Topics: Compounding and Pharmacists

Sterile compounding practices are invited to participate in the 2014 United States Pharmacopeia (USP) <797> Compliance Study. 

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Florida House of Representatives Approves Bill to Increase the Number of Pharmacy Technicians a Pharmacist can Oversee

Topics: Pharmacists and Pharmacy technicians

A bill that would increase the number of pharmacy technicians a pharmacist may supervise has passed the Florida House of Representatives. 

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New Requirements for Some Painkiller Prescriptions Help to Lower Addiction Risk, Massachusetts Insurer Reports

Topics: Controlled substances

After implementing stricter requirements for certain painkiller prescriptions, Blue Cross and Blue Shield of Massachusetts, the state’s largest private health insurer, has released the results of an “18-month checkup.” 

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Super Arthgold ‘Supplement’ Recalled Due to Undeclared Drug Ingredients

Topics: Over the counter and Fda

Nano Well-being Health, Inc, of La Mirada, CA, has issued a voluntary recall of two lots of Super Arthgold, a product promoted and sold as a dietary supplement for joint, muscle, and arthritic pain.

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2014 National Prescription Drug Abuse Summit Presentations Now Available

Topics: Prescription drug abuse

Bringing together clinical experts and representatives from state and federal governments, the 2014 National Rx Drug Abuse Summit took place April 22-24, 2014, in Atlanta, GA.

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Reminder: DEA Take-Back Day Is Saturday, April 26

Topics: Medication collection program disposal and Dea

Consumers will have the opportunity to dispose of unneeded or unwanted medications at a Drug Enforcement Administration National Prescription Drug Take-Back Day collection site on Saturday, April 26, 2014.

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FDA Developing Track and Trace Standards as Part of DSCSA Implementation

Topics: Counterfeit drugs, Buying medicine online, and Fda

To protect consumers from drugs that may be counterfeit, stolen, or tainted, Food and Drug Administration is advancing efforts to implement an advanced track and trace program.

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Prescription Drug Abuse Workgroup Formed in Senate Health Committee

Topics: Federal regulations and Prescription drug abuse

The Senate Committee on Health Education Labor and Pensions is establishing a working group to address the national prescription drug abuse epidemic. 

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Massachusetts Cannot Ban Hydrocodone-Only Medications, Federal Judge Rules

Topics: Controlled substances and Fda

A US District Judge has ruled that Massachusetts may not ban the prescribing and dispensing of hydrocodone-only medication products that have been approved by FDA.

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Canadian Drug Seller Fills Maine Prescriptions in India, Alleges Maine Pharmacy Association President

Topics: Counterfeit drugs and Buying medicine online

A Canadian company is allegedly filling prescriptions in India and other countries for patients in Maine, according to a complaint filed by the president of the Maine Pharmacy Association.

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FDA Warns Consumers Not to Use Lite Fit USA and Infinity ‘Supplements’ Due to Hidden Drug Ingredients

Topics: Patient safety and Fda

Food and Drug Administration is advising consumers not to purchase or use Lite Fit USA and Infinity, two products marketed as dietary supplements for weight loss.

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New FDA Drug Info Rounds Training Video Available

Topics: Pharmacists and Fda

In the latest FDA Drug Info Rounds video, pharmacists discuss how to search the “Electronic Orange Book.”

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Legal Briefs: Court Documents License for Undocumented Licensee

Topics: Federal regulations

The interaction and potential conflict between federal and state law can present interesting issues for regulatory boards that, at times, may be difficult to reconcile.

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DEA Prescription Drug Take-Back Day Collection Site Locator Now Available

Topics: Prescription drug abuse

Now available online, the Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day collection site locator allows consumers to search for a nearby location to dispose of unneeded medications on Saturday, April 26, 2014. 

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NCPDP Recommends Standardized Metric Measurements on Oral Liquid Medication Labels

Topics: Prescription label

The National Council for Prescription Drug Programs (NCPDP) has issued new recommendations and guidance for standardizing the dosing designation used on prescription container labels of oral liquid medications dispensed by community pharmacies in order to reduce dosing errors. 

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Opioid Addiction Epidemic Declared Public Health Emergency in Massachusetts

Topics: Prescription drug abuse

In response to a growing number of opioid-related deaths, Massachusetts Governor Deval Patrick declared a public health emergency. 

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USP Proposes New General Chapter Addressing Compounding of Hazardous Drugs

Topics: Compounding

In an effort to protect health care providers and personnel who handle hazardous drugs, United States Pharmacopeial Convention (USP) has proposed new General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings.

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Countryside Police Department to Implement Cook County’s First Overdose Prevention Program

Topics: Prescription drug abuse

The Countryside Police Department has received approval to implement a new Overdose Prevention Program in partnership with the Chicago Recovery Alliance. 

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Bill Requiring Coverage of Partial Refills to Support Medication Synchronization Efforts Introduced in Missouri

Topics: Medication therapy management

Aimed to promote patient care, a Missouri bill would require that health benefit plans reimburse when pharmacies dispense less than a 30-day supply for the purpose of synchronizing a patient’s chronic medications.

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Shire Recalls Three Lots of VPRIV Due to Particulate Matter

Topics: Patient safety and Fda

Shire Pharmaceuticals has initiated a voluntary recall of three lots of VPRIV® (velaglucerase alfa for infusion) due to the presence of particulate matter, identified as stainless steel and barium sulfate.

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Study Underscores Importance of Multifaceted Strategy to Reduce Opioid Overdoses

Topics: Prescription drug abuse

A group of investigators at Massachusetts General Hospital recently analyzed factors that increased the risk of recurrent opioid overdoses requiring emergency department visits.

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Legal Briefs: JK on the 120 Days

Topics: Pharmacists

To the consumer (and perhaps the legislature), the time it takes to process, investigate, formally charge, and adjudicate an administrative complaint (or negotiate a consent order) can appear to be lengthy.

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Legislation to Withdraw Approval of New Painkiller Introduced to Congress

Topics: Pain management and Fda

Senator Joe Manchin (D-WV) has introduced Senate Bill 2134 (PDF), which would withdraw Food and Drug Administration (FDA) approval of Zohydro™ ER (hydrocodone bitartrate).

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Internet Drug Outlet Fraudulently Claiming NABP Accreditation

Topics: Buying medicine online

Recently, NABP discovered that the Internet drug outlet, WellnessFitnessNutrition, LLP (WFN), was fraudulently claiming to hold certain NABP certifications. 

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Pain Free by Nature Recalls Reumofan Plus Tablets, Undeclared Drug Ingredients Discovered

Topics: Patient safety and Fda

Pain Free by Nature, LLC, of Woodland Park, CO, is recalling all “Reumofan Plus” tablets purchased through its website because they contain undeclared methocarbamol and diclofenac, making the product an unapproved drug. 

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US Attorney General Urges Increase in Accessibility of Naloxone

Topics: Prescription drug abuse

US Attorney General Eric Holder called the rise in overdose deaths from prescription painkillers and heroin an “urgent public health crisis.”

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Pfizer Pulls Three Lots of Anti-Depressant Medication Over Health, Safety Concerns

Topics: Patient safety

Pfizer, Inc, has voluntarily recalled three lots of its anti-depressant medication, Effexor XR®.

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Prescribers Can Play Important Role in Reducing Painkiller Overdose, CDC Reports

Topics: Controlled substances and Prescription drug abuse

People who frequently abuse opiate painkillers are often at the highest risk of overdosing, and are also likely to obtain the drugs through multiple prescriptions and multiple doctors, a practice known as “doctor shopping.”

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CDC Provides Recommendations for Antibiotic Prescribing Practices

Topics: Patient safety and Practitioner prescriber

CDC has issued new warnings about prescribing practices for antibiotics.

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DEA Announces Temporary Scheduling of 10 Synthetic Cathinones

Topics: Controlled substances and Dea

The administrator of Drug Enforcement Administration (DEA) has issued a final order to temporarily schedule 10 synthetic cathinones into Schedule I of the Controlled Substances Act effective as of March 7, 2014. 

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DEA Publishes Proposed Rulemaking to Reschedule Hydrocodone Products, Invites Public Comment

Topics: Controlled substances, Prescription drug abuse, and Dea

New rules for hydrocodone combination products that would move the controlled substance medications from Schedule III to Schedule II have been proposed by Drug Enforcement Administration.

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FDA Announces Public Hearing on OTC Drug Review Process

Topics: Over the counter and Fda

FDA has announced a public hearing to review the agency’s Over-the-Counter Drug Review process, including strengths and weaknesses of the current process and ideas about modifications or alternatives.

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FDA Develops Drug Supply Chain Security Act Implementation Plan

Topics: Counterfeit drugs, Diversion, and Fda

Food and Drug Administration has developed a 10-year plan for implementation of the Drug Supply Chain Security Act.

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FDA Initiates the Secure Supply Chain Pilot Program to Enhance Security of Imported Drugs

Topics: Counterfeit drugs, Diversion, and Fda

Established to enhance the security of imported drugs, FDA’s Secure Supply Chain Pilot Program will launch with the participation of 13 companies prequalified by the agency.

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GAO Study Finds FDA Actions Have Reduced New Drug Shortages, Recommends Additional Action

Topics: Fda

Steps taken by FDA have successfully reduced the number of new drug shortages, and a new study from the Government Accountability Office urges the agency to take additional steps to reduce the number of overall drug shortages. 

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NABP Moves .Pharmacy Program Closer to Launch, Enters Contracting Phase With ICANN

Topics: Counterfeit drugs, Buying medicine online, and Prescription drug abuse

Moving one step closer to providing consumers worldwide with an easy way to identify safe online pharmacies and resources, the National Association of Boards of Pharmacy® (NABP®) has been deemed eligible to enter contract negotiations with the Internet Corporation for Assigned Names and Numbers (ICANN) to own and operate the .pharmacy domain suffix.

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ACPE Releases Draft Standards for Pharmacy Professional Programs for Public Comment

Topics: Pharmacists and Pharmacy technicians

The Accreditation Council for Pharmacy Education has released the Draft Revised Standards for the Professional Program Leading to the Doctor of Pharmacy Degree and the Guidance Document to Standards 2016 for public review and comment.

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Missouri Legislature Considers Bill to Establish a PMP

Topics: Prescription monitoring program

The Missouri House of Representatives has approved a bill that would establish a prescription monitoring program.

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West Virginia Considering Legislation to Make PSE Prescription-Only

Topics: Over the counter

Aimed to reduce the illegal manufacture and abuse of methamphetamine, a bill that would make pseudoephedrine medications available by prescription only has passed the West Virginia Senate.

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Arth-Q Supplement Should Not Be Used Due to Hidden Ibuprofen, FDA Warns

Topics: Patient safety and Fda

Consumers should not purchase or use Arth-Q, a product promoted and sold as a dietary supplement for joint, muscle, and arthritic pain, Food and Drug Administration warns.

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CVS Caremark Plans to Stop Selling Tobacco Products

Topics: Patient safety

CVS Caremark has announced its plan to stop selling tobacco products in all of its stores by October 1, 2014, in support of patient and customer health. 

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Bill to Restrict DXM Sales to Adults Introduced to House

Topics: Over the counter and Prescription drug abuse

Aimed to reduce the abuse of cough medications, the Preventing Abuse of Cough Treatments of 2014 Act (PACT Act), has been introduced to the United States House of Representatives.

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New York’s Strengthened PMP Helped Cut “Doctor Shopping” by 75%

Topics: Controlled substances and Prescription drug abuse

Since the implementation of New York state’s Internet System for Tracking Over-Prescribing Act (I-STOP) in August 2013, “doctor shopping” – when patients visit multiple doctors to obtain controlled substance medications – has been reduced by 75%.

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Medical Clinic Owner, 23 Others Charged in Alleged Pill Mill Scheme

Topics: Counterfeit drugs and Diversion

Kevin Lowe, former owner and operator of a Bronx, NY medical clinic and 23 others have been arrested on charges related to a massive “pill mill” operation that involved approximately 31,500 medically unnecessary prescriptions for oxycodone with an estimated street value of up to $550 million.

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California Bill Would Allow Pharmacists to Dispense Naloxone Under Approved Protocol

Topics: Pharmacists

In response to the growing rate of opiate overdose fatalities in California, a bill aimed at expanding access to naloxone hydrochloride has been introduced to the state assembly.

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Former Denver Pharmacist Sentenced to 15 Years for Involvement in Oxycodone Trafficking

Topics: Diversion

A former pharmacist, Jeffrey Clawson, has been sentenced to a 15-year term in Adams County Community Corrections for his role in an oxycodone trafficking scheme.

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FDA Prohibits Facility from Producing and Distributing Drug Ingredients for US Market

Topics: Compounding and Fda

A Food and Drug Administration decree has prohibited Ranbaxy Laboratories, Ltd, from manufacturing and distributing active pharmaceutical ingredients from the company’s facility in Toansa, India, for use in FDA-regulated drug products. 

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High Rates of Drug Overdoses in Pennsylvania Prompt Legislative Action

Topics: Prescription drug abuse

In 2011, Pennsylvania had the 14th highest rate of drug overdose deaths in the country, with counties in the southwestern portion of the state experiencing even higher rates of overdose deaths.

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Pharmacist Pleads Guilty to Illegally Dispensing Prescription Painkillers

Topics: Diversion

Leonard “Lenny” Stefanelli, the former pharmacist-in-charge of West Orange Pharmacy, West Orange, NJ, admitted to illegally dispensing hundreds of tablets of OxyContin® and for submitting fraudulent bills to health care benefit providers over the course of two decades.

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ACPE Elects Executive Committee and Board Liaisons for 2014-2015

Topics: Continuing education and Pharmacists

The Accreditation Council for Pharmacy Education has announced the members of the 2014-2015 ACPE Executive Committee.

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USP Posts FAQs to Address Common Questions About USP-NF Chapters <795> and <797>

Topics: Federal regulations

In response to questions concerning United States Pharmacopeia-National Formulary General Chapters <795> and <797>, USP has created a new frequently asked questions page on its website.

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Mentholatum Company Recalls Some Rohto Eye Drops Products Manufactured in Vietnam

Topics: Patient safety and Fda

he Mentholatum Company of Orchard Park, NY, has issued a voluntary recall of some Rohto eye drop products due to a manufacturing review at the production facility in Vietnam involving sterility controls.

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DEA to Hold Next Prescription Drug Take-Back Day on April 26, 2014

Topics: Diversion and Dea

Drug Enforcement Administration has announced another opportunity for consumers to dispose of unneeded and expired prescription drugs.

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FDA Requests that Health Care Providers and Regulators Encourage Outsourcing Facility Registration

Topics: Compounding and Fda

Food and Drug Administration (FDA) Commissioner Margaret Hamburg has encouraged entities that purchase compounded sterile drugs to meet the medical needs of patients that cannot be met by FDA-approved products to consider requiring their providers to register as outsourcing facilities with FDA. 

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Compounding Entities Begin to Register With FDA as Outsourcing Facilities

Topics: Compounding and Fda

Fourteen facilities are the first to be registered as Human Drug Compounding Outsourcing Facilities with Food and Drug Administration (FDA) under the DQSA. 

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Acetaminophen Prescription Combination Drug Products With More Than 325 mg: FDA Statement – Recommendation to Discontinue Prescribing and Dispensing

Topics: Prescriptions and Fda

In light of all the recent news alerts and warnings about the use of acetaminophen and acetaminophen containing products, the FDA issued a recommendation of importance to pharmacists, prescribers, and patients.

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New York State to Permit Limited Medical Marijuana Prescribing

Topics: Medical marijuana

New York Governor Andrew Cuomo plans to announce an executive action that would permit limited prescribing of medical marijuana in up to 20 hospitals within the state. 

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Baxter International Recalls Select Lots of CLINIMIX and CLINIMIX E Due to Complaints of Particulates

Topics: Compounding and Fda

Baxter International Inc, has issued a voluntary recall of two lots of CLINIMIX and one lot of CLINIMIX E Injection parenternal nutrition products to the user level following complaints of particulate matter found in the products. 

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FDA Warns Consumers Not to Use Mass Destruction, a Dietary Supplement Sold Online and in Retail Stores

Topics: Buying medicine online and Fda

Mass Destruction, a product marketed online and in retail stores as a dietary supplement for muscle growth, has been associated with at least one reported serious illness, reports FDA.

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Court Grants Temporary Injunction Against OK Compounding

Topics: Compounding

On August 29, 2013, the District Court of Tulsa County in the state of Oklahoma granted a temporary injunction to enjoin the defendants, including Christopher Parks and OK Compounding, LLC (collectively, OK Compounding), from engaging in certain conduct in connection with plaintiff Rush University Medical Center (Rush). 

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Abrams Royal Compounding Pharmacy Recalls All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance

Topics: Compounding and Fda

Abrams Royal Compounding Pharmacy of Dallas, TX, and Food and Drug Administration (FDA) have announced a voluntary recall of all unexpired lots of sterile products after a report of an adverse event involving mineral IV injection, Lot Number 11142013@74. 

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Hospira, Inc, Initiates Recall of One Lot of 2% Lidocaine HCl Injection

Topics: Compounding and Fda

Hospira, Inc, of Lake Forest, IL, has initiated a voluntary recall for one lot of Lidocaine HCl Injection, USP 2%, 5 mL Single-Dose Vial, National Drug Code 0409-4276-01, Lot 32-135-DD due to the presence of particulate matter.

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Teen Prescription Drug Abuse Remains Steady in 2013, Monitoring the Future Survey Finds

Topics: Prescription drug abuse

Results of the 2013 Monitoring the Future survey (PDF) show abuse of most types of prescription drugs among teens remained relatively stable in 2013. 

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Rx Formulations Recalls Some Sterile Products Due to Observed Floating Matter

Topics: Compounding and Fda

Rx Formulations of Mesa, AZ, and Food and Drug Administration (FDA) have announced a voluntary recall of some compounded sterile products after 2 to 3 millimeter, irregularly shaped floating matter was observed in an intact, unused vial of calcium gluconate injection produced at the facility.

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USP Adopts Labeling Standards for Ferrules and Cap Overseals to Protect Patient Safety

Topics: Patient safety, Prescription label, and Adverse drug events

United States Pharmacopeial Convention (USP) labeling standards for ferrules and cap overseals that require warning messages with vital information aimed to prevent imminent life-threatening situations became official on December 1, 2013.

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Event Registration for NIDA's Drug Facts Week for Teens Now Open

Topics: Education and Patient safety

In preparation for National Drug Facts Week (NDFW), community organizations are invited to register drug abuse awareness events online. 

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Study Finds Medication Synchronization Programs Improve Adherence Rates

Topics: Medication therapy management

Appointment-based medication synchronization programs improve patient adherence by 3.4 to 6.1 times, a study published in the November/December 2013 issue of the Journal of the American Pharmacists Association reports. 

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Voluntary Recall of HYDRAVAX Dietary Supplement Issued Due to Possible Undeclared Ingredient

Topics: Compounding and Fda

IQ Formulations of Sunrise, FL, is initiating a voluntary nationwide recall on all lots of its 45-capsule bottles of HYDRAVAX due to potential inclusion of an unlisted ingredient.

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National Influenza Vaccination Week Resources for Health Care Providers Available

Topics: Vaccinations

Centers for Disease Control and Prevention is encouraging health care providers to remind patients and caregivers of patients six months and older that it is not too late to get a flu vaccine.

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Baxter International Inc, Recalls One Lot of Nitroglycerin in 5% Dextrose Injection

Topics: Compounding and Fda

FDA and Baxter International, Inc, have issued a voluntary recall of one lot of nitroglycerin in 5% dextrose injection due to the presence of particulate matter found in one vial.

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Hospital Pharmacies Frequently Contacted by Opportunistic Vendors

Topics: Diversion and Pharmacies

Of 125 hospital pharmacy directors in Texas, more than 85% reported that they have been contacted by gray market vendors offering to sell drugs in short supply.

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Twitter Offers Insight into College Students’ Medication Misuse

Topics: Controlled substances and Prescription drug abuse

College students are taking to Twitter to talk about prescription drugs, often revealing how they misuse medications, according to two recent studies. 

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Prescription Drug Abuse Fastest Growing Drug Threat, Reports DEA

Topics: Prescription drug abuse

Prescription drug abuse continues to be the nation’s fastest growing drug problem, and abuse of controlled substance prescription drugs poses a significant drug threat to the United States, stresses the Drug Enforcement Administration (DEA) in 2013 National Drug Threat Assessment Summary. 

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Michigan Pharmacy Owner and Eight Employees Indicted for Misbranding and Reselling Returned Drugs

Topics: Diversion

A Michigan pharmacy owner and eight staff members have been indicted on charges of conspiracy to misbrand drugs.

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FDA Launches Responsive Design Web site for Easier Mobile Viewing

Topics: Fda

To better address the needs of its Web site users, Food and Drug Administration (FDA) has upgraded its Web site for improved viewing on tablets, smart phones, and other mobile devices. 

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Unapproved Male Enhancement Dietary Supplements Could Cause Dangerous Low Blood Pressure Levels, FDA Warns

Topics: Counterfeit drugs, Over the counter, and Fda

Food and Drug Administration is warning consumers about male lifestyle dietary supplements containing undeclared ingredients.

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Michigan Senate Bill Would Allow Medical Marijuana to Be Dispensed by Pharmacies

Topics: Medical marijuana

A Michigan law passed by the state’s Senate would allow patients to purchase medical marijuana from licensed pharmacies as a Schedule II controlled substance.

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New FDA Drug Info Rounds Training Videos Available

Topics: Education and Fda

FDA has published new Drug Info Rounds videos.

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DEA Reports Strong Turnout for Seventh Prescription Drug Take-Back Day

Topics: Diversion, Medication collection program disposal, and Dea

Drug Enforcement Administration reports that nearly 650,000 pounds of unneeded prescription medications were properly disposed of during the October 26, 2013 National Prescription Drug Take-Back Day.

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FDA Actions Aim to Reduce Drug Shortages

Topics: Federal regulations and Fda

In an ongoing effort to reduce drug shortages, Food and Drug Administration has released a strategic plan and has also proposed a new early notice rule for manufacturers. 

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2013 USP Chapter <797> Compliance Survey Shows Compliance Trends Unchanged From 2012

Topics: Compounding and Federal regulations

The 2013 United States Pharmacopoeia (USP) Chapter <797> Compliance Survey, the third annual report released since 2011, shows that the overall compliance rate of 77.2% remains nearly unchanged from the 2012 rate.

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One in 10 Teens Visiting Emergency Departments Reported Past Year Non-Medical Use of Prescription Drugs, Study Reports

Topics: Prescription drug abuse

As many as one in 10 teenagers who visited an emergency department (ED) reported abuse of prescription painkillers or sedatives within the last year, University of Michigan researchers report in a study published in Pediatrics.

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Pharmacy Owners, Pharmacists Indicted for Illegal Mail-Order Prescription Painkiller Scheme

Topics: Counterfeit drugs

Nine defendants, including three licensed pharmacists, face federal charges related to their alleged roles in operating a prescription painkiller ring on the East Coast, NBC News reports. 

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FDA to Recommend Reclassification of Hydrocodone Combination Products as Schedule II Controlled Substances

Topics: Controlled substances and Fda

Food and Drug Administration (FDA) plans to submit a formal recommendation to reclassify hydrocodone combination products as Schedule II controlled substances. 

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Consumers Encouraged to Ensure Online Pharmacies are Licensed, Legitimate in New FDA Video

Topics: Buying medicine online

Tip-offs that an Internet drug seller may be fraudulent include offering prescription drugs without requiring a valid prescription and too-good-to-be-true prices, warns a new FDA consumer video.

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Reminder: DEA Prescription Drug Take-Back Day Is Saturday, October 26

Topics: Medication collection program disposal and Dea

Americans throughout the country will have the opportunity to dispose of unneeded or unwanted medications at a Drug Enforcement Administration National Prescription Drug Take-Back Day collection site on Saturday.

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Massachusetts House Unanimously Approves Compounding Oversight Bill

Topics: Compounding

The Massachusetts House has passed a bill that would make random unannounced inspections of compounding pharmacies a permanent requirement.

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Pharmacy Owner Pleads Guilty to Illegally Selling Narcotics to Patients Without a Prescription

Topics: Counterfeit drugs and Diversion

Peter Riccio, owner of pharmacies in Hellertown and Palmer, PA, pleaded guilty to charges of illegal distribution of the drug butalbital, a Schedule II narcotic.

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Legal Briefs: 132,265 Bye Byes

Topics: Diversion and Pharmacists

On occasion, civil and criminal judicial decisions maintain relevance to the regulatory community and are of interest to boards of pharmacy. 

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Maine Law Allowing International Drug Imports Raises Safety Concerns

Topics: Counterfeit drugs, Buying medicine online, and Federal regulations

A Maine law allowing for the direct purchase of mail-order prescription drugs from foreign entities is facing legal challenges.

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Reminder: The Next DEA Prescription Drug Take-Back Day is Saturday, October 26, 2013

Topics: Medication collection program disposal and Dea

The next opportunity to dispose of any unneeded or unwanted medications at a Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day collection site will be Saturday, October 26, 2013. 

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Hospira, Inc, Recalls One Lot of 1% Lidocaine HCI Injection After Report of Particulate Matter

Topics: Compounding and Fda

Food and Drug Administration (FDA) and Hospira, Inc, of Lake Forest, IL, have issued a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 2 mL Multiple-dose Fliptop Vial, National Drug Code 0409-4276-01, Lot 25-090-DK. 

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California Enacts Two Laws Aimed to Reduce Prescription Drug Abuse

Topics: Prescription drug abuse and Prescription monitoring program

Governor Brown signed two bills into law that aim to reduce prescription drug abuse by enhancing the state’s prescription monitoring program and by making it easier for the medical board to investigate patient records after a suspicious death.

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FDA Provides New Information About Lack of Sterility Assurance for Drugs Dispensed by The Compounding Shop

Topics: Compounding, Adverse drug events, and Fda

Food and Drug Administration (FDA) is warning patients and health care providers that budesonide solution (for nasal irrigation), dispensed by The Compounding Shop of St Petersburg, FL, may be contaminated and should not be used or administered to patients. 

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FDA Requires Changes to Fentanyl Pain Patch Warnings

Topics: Adverse drug events and Fda

To reduce the risk of accidental exposure, FDA has announced new requirements that change the appearance of fentanyl pain patch warnings to make them more visible. 

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Florida Sees Continued Decreases in Prescription Drug Related Deaths

Topics: Prescription drug abuse

In Florida, deaths tied to prescription drugs dropped by 17.7% and deaths caused by oxycodone plunged by 41%, state officials announced in a recent report.

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‘Bath Salts’ Linked to Nearly 23,000 Emergency Room Visits in 2011

Topics: Patient safety

A group of drugs known as “bath salts” were linked to an estimated 22,904 visits to hospital emergency departments in 2011.

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State Senators Pressure Craigslist to Ban Illegal Prescription Drug Ads

Topics: Buying medicine online and Diversion

State senators from Nevada and California are calling on Craigslist to remove ads from its site that facilitate illegal distribution and diversion of narcotics.

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Michigan Lawmakers Consider Bill to Strengthen Compounding Regulations

Topics: Compounding

A series of bills have been introduced to the Michigan Legislature that would include several provisions intended to strengthen the regulation of compounding in the state.

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Threat of Antibiotic-Resistant Bacteria Growing, CDC Warns

Topics: Vaccinations

A new report from CDC warns that there is a growing threat of antibiotic-resistant strains of infectious diseases. 

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FDA Proposes Labeling Changes for ER/LA Opioids to Combat Abuse, Mandates Post-market Research

Topics: Pain management and Fda

To combat the misuse and abuse of extended-release and long-acting (ER/LA) opioids, Food and Drug Administration (FDA) is announcing class-wide label changes to ER/LA opioids, including a statement indicating the medications should be prescribed when the patient requires constant treatment of severe pain and when alternative methods are inadequate.

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Know Your Dose Campaign Offers Acetaminophen Safety Tips Ahead of Cold and Flu Season

Topics: Over the counter and Patient safety

With flu shots now available across the country, and consumers stocking home medicine cabinets ahead of the coming cold and flu season, the Acetaminophen Awareness Coalition has issued a consumer message to “Double Check, Don’t Double Up” on acetaminophen when treating winter illnesses.

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University Compounding Pharmacy Recalls Some Products Due to Lack of Sterility Assurance

Topics: Compounding and Fda

Food and Drug Administration (FDA) and University Compounding Pharmacy of San Diego, CA, have issued a voluntary recall of several products.

Read More →

New FDA Drug Info Rounds Training Video

Topics: Continuing education, Pharmacists, and Fda

FDA Drug Info Rounds, a series of online videos, provides important and timely drug information to practicing clinical and community pharmacists.

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Park Pharmacy & Compounding Center Recalls Two Compounded Sterile Preparations

Topics: Compounding

Food and Drug Administration (FDA) and Park Pharmacy & Compounding Center of Irvine, CA, have announced a voluntary recall of two lots of products that were dispensed to patients and distributed to physician offices by prescription in June and July 2013 in California, Florida, New Mexico, and Indiana.

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Indiana Medical Board to Adopt Emergency Opioid Prescribing Rules at Request of State Legislature

Topics: Diversion and Prescription drug abuse

The Medical Licensing Board of Indiana is considering emergency rules related to opioid prescribing as mandated by the state’s “pill mill bill” (SB 246), which was signed into law by Governor Mike Pence in May 2013. 

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CVS Aggregates Data to Identify and Cut Off Suspected Pill Mills

Topics: Controlled substances and Diversion

In an effort to reduce prescription drug abuse, CVS pharmacists have adopted an analytical system to help identify “pill mill” prescribers.

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FDA: Fluoroquinolone Drug Labels Must Provide Better Descriptions of Peripheral Neuropathy

Topics: Patient safety and Fda

Food and Drug Administration updated its label requirements for the drug labels on fluoroquinolone-based medications.

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FDA Reminds Health Care Providers to Not Use NuVision Pharmacy Products

Topics: Fda

After NuVision Pharmacy refused FDA’s most recent request to recall all of its sterile products, FDA is reminding health care providers not to use NuVision sterile products.

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Specialty Compounding, LLC, Clarifies Recall Information

Topics: Compounding

Specialty Compounding, LLC, clarified a recall of all lots of sterile compounded medications produced in its Texas facility.

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CHPA Files Petition to Expand Dosing Information on Acetaminophen Products for Young Children

Topics: Over the counter and Fda

The Consumer Healthcare Products Association (CHPA) has filed a citizen petition to FDA that asks the agency to provide convenient and accurate access to dosing information for children ages six months to two years.

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Risks of Buying Prescription Drugs from Illegal Online Sellers Highlighted in NBC Connecticut Report

Topics: Counterfeit drugs and Buying medicine online

The risks of ordering medications online and of receiving dangerous counterfeit products are highlighted in a recent NBC Connecticut report.

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Illegally Operating Wholesaler in Virginia Posed as Canadian Distributor, Owners Indicted

Topics: Counterfeit drugs and Diversion

US Department of Justice (DOJ) officials indicted 11 people on 17 different charges related to the illegal importation and distribution of non-Food and Drug Administration (FDA)-approved drugs into the US.

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UPS First Package Delivery Company to Join CSIP in Fight against Rogue Internet Drug Outlets

Topics: Buying medicine online

United Parcel Service (UPS) has become the first global package delivery organization to join the Center for Safe Internet Pharmacies (CSIP) as a strategic partner and board member.

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Specialty Compounding, LLC Recalls All Lots of Unexpired Sterile Products After Reports of Adverse Events

Topics: Compounding

Food and Drug Administration (FDA) has announced a voluntary recall of all lots of unexpired sterile products produced by Specialty Compounding, LLC, in Cedar Park, TX.

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GAO Issues Recommendations for Congress and the Secretary of Health and Human Services for Compounding Pharmacies

Topics: Compounding

In a July 2013 report, the United States Government Accountability Office (GAO) recommends that “Congress should consider clarifying FDA’s authority to oversee certain entities that compound drugs.”

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FDA Warns of Rare Skin Reaction in Patients Taking Acetaminophen

Topics: Over the counter and Patient safety

FDA has issued a Consumer Update that warns of rare but serious skin reactions that may occur in patients taking acetaminophen.

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Three New Alabama Laws Aim to Crack Down on 'Doctor Shopping' and Prescription Drug Abuse

Topics: Prescription drug abuse and Prescription monitoring program

Alabama Governor Robert Bentley has signed into law three bills aimed to reverse the state’s growing prescription drug abuse rate. 

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Illinois to Implement Medical Marijuana Pilot Program Under Law Approved by Governor Quinn

Topics: Medical marijuana

On August 1, 2013, Illinois Governor Pat Quinn signed into law the Compassionate Use of Medical Cannabis Pilot Program Act, making Illinois the 21st state to legalize some form of medical marijuana. 

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Nova Diabetes Care Recalls Up to 62 Million Blood Glucose Test Strips

Topics: Patient safety

Nova Diabetes Care and Food and Drug Administration (FDA) officials have announced a voluntary recall of 21 lots of blood glucose test strips.

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Kentucky Sees Slight Decline in Drug Overdose Deaths, Including Prescription Drug Overdose

Topics: Prescription drug abuse

According to a state report released in late July, drug overdose deaths in the state of Kentucky decreased by 19 to 1,004. 

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Domperidone Not FDA Approved, Should Not be Marketed in the US, FDA Stresses

Topics: Compounding and Patient safety

Food and Drug Administration (FDA) stresses that domperidone is not an FDA-approved drug, and that it may not be legally marketed in the US. 

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Healthy Life Chemistry Supplement Product Contains Anabolic Steroids, FDA Warns

Topics: Patient safety

FDA is warning consumers not to use a product marketed as a Vitamin B dietary supplement due to the presence of potentially harmful anabolic steroids. 

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FDA Takes Action to Stop Distribution of Illegal, Potentially Harmful Products Claimed to Treat Diabetes

Topics: Counterfeit drugs and Patient safety

FDA advises consumers not to use, and is taking action to remove from the market, illegal products claiming to treat diabetes.

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Proposed Law Calls for Commission to Focus on Prescription Drug Abuse Efforts

Topics: Prescription drug abuse

A bill calling for a 30-member commission to coordinate law enforcement and health agency efforts to combat prescription drug abuse was introduced to the United States Senate. 

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Five Individuals Charged With Diversion of Prescription Controlled Substances

Topics: Diversion and Dea

Five individuals have been indicted and arrested on charges related to their involvement in a prescription drug diversion scheme. 

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Montana Man Sentenced for Role in Distribution of Fake Cancer Drugs

Topics: Counterfeit drugs

Paul Bottomley of Montana forfeited nearly $6 million in cash and property and was sentenced to five years probation for his role in the scheme that imported fake cancer drugs into US clinics, ultimately reaching patients.

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FDA Raises Awareness About Safe Use of Acetaminophen

Topics: Over the counter

FDA is alerting consumers to be mindful of the amount of acetaminophen they take in order to prevent overdose and potential liver damage. 

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Attorneys General in Nebraska and Oklahoma Call On Google to Remove 'No Prescription Required' Ads from YouTube

Topics: Counterfeit drugs and Buying medicine online

Attorneys General are calling on Google to remove video ads from YouTube that promote rogue Internet sites marketing medications, including controlled substances, as “no prescription required” products.

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State and Federal Regulators Continue to Combat Rogue Internet Drug Sellers, US GAO Reports

Topics: Buying medicine online

While facing the challenges of investigating and prosecuting complex, global operations, federal agencies in the United States continue to take action against Web sites illegally distributing prescription drugs to US consumers.

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Distribution of Counterfeit Drugs to US Residents Via Rogue Internet Sites Continues to Grow, Reports CNN

Topics: Counterfeit drugs

The problem of counterfeit drugs distributed into the US via rogue Internet drug sellers is growing, FDA consumer safety officers told CNN’s Sanjay Gupta, MD, as part of a special report.

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More Women Dying of Prescription Painkiller Overdoses

Topics: Prescription drug abuse

Every day, approximately 18 women die from an overdose of prescription pain medication, reports the Centers for Disease Control and Prevention (CDC).

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DEA to Hold Next Prescription Drug Take-Back Day on October 26, 2013

Topics: Controlled substances and Dea

Drug Enforcement Administration (DEA) will provide another opportunity for consumers to dispose of unneeded and expired prescription drugs during the 7th DEA National Prescription Drug Take-Back Day, October 26, 2013.

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FDA Provides New Resources on Importance of Safe Storage and Disposal of Fentanyl Patches

Topics: Medication errors

As part of its efforts to prevent accidental exposure to fentanyl patches, FDA is providing new resources about safe storage and safe disposal of the patches.

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Thousands of Rogue Online Drug Sellers Shut Down During Operation Pangea VI

Topics: Counterfeit drugs and Buying medicine online

As part of the sixth annual International Internet Week of Action (IIWA), Food and Drug Administration (FDA) took action against more than 9,600 Web sites illegally selling drugs that included counterfeit, substandard, and other potentially dangerous products. 

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Consent Decree Prohibits New Jersey Pharmacy from Manufacturing, Distributing Drug Products

Topics: Compounding

Med Prep Consulting, Inc, has been prohibited from manufacturing, holding, and distributing drug products under a consent decree of permanent injunction entered against the pharmacy by a federal court. 

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AMA Policy Deems 'Inappropriate Queries' From Pharmacies an Interference With Practice of Medicine

Topics: Pharmacies, Pharmacists, and Prescription drug abuse

The American Medical Association (AMA) has adopted a resolution stating that the organization deems certain pharmacy inquiries relating to the verification of prescriptions to be “an interference with the practice of medicine and unwarranted.” 

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Patient Survey Reveals Poor Adherence to Prescribed Medication Therapy, Explores Adherence Predictors

Topics: Medication therapy management

Many Americans are not adhering to prescribed medication regimens, indicates a new patient survey commissioned by the National Community Pharmacists Association (NCPA). 

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Rugby Laboratories Enteric Coated Aspirin Recalled Due to Potential Mix-up With Acetaminophen Tablets

Topics: Over the counter

One lot of Rugby Laboratories enteric coated aspirin tablets, 81 mg, has been recalled to the user level. 

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ISMP to Launch Safety Alert Newsletter Providing Medication Error Prevention Information Tailored to LTCFs

Topics: Medication errors

With Institute for Safe Medication Practices (ISMP) Medication Safety Alert! publications making a significant impact on preventing medication errors, the organization will soon be providing a new resource tailored to long-term care facilities.

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FDA Confirms Presence of Microbial Growth in Main Street Family Pharmacy Products

Topics: Compounding

As a result of an investigation initiated in May 2013, FDA has identified bacterial and fungal growth in products compounded by Main Street Family Pharmacy of Newbern, TN. 

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'Plan B' Morning After Pill to Be Available OTC Without Age Restrictions, According to Federal Judge’s Ruling

Topics: Over the counter and Emergency contraception

A ruling by Judge Edward R. Korman, Eastern District Court of New York, will effectively make the Plan B® One-Step, or “morning after” contraceptive pill, available as an over-the-counter product with no age restrictions.

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Bills to Safeguard Medications Through National Tracking System Under Consideration in Congress

Topics: Compounding, Counterfeit drugs, and Patient safety

A bill aimed to ensure the security of pharmaceuticals in the drug supply chain has passed the United States House of Representatives. 

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FDA Announces Opportunity for Expansion of ‘Script Your Future’ Medication Adherence Program

Topics: Education

FDA has announced the availability of grant funds intended to support the National Consumers League (NCL) in expanding efforts to educate the public about medication adherence.

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FDA Allows Import of Injectable Nutritional Drugs Due to Product Shortage

Topics: Federal regulations

FDA will allow the import of injectable drugs used in total parenteral nutrition (TPN) due to a critical shortage of the products.

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Sandoz Recalls Two Lots of Methotrexate Sodium, USP Due to Particulate Matter

Topics: Patient safety

Sandoz US is voluntarily recalling two lots of methotrexate sodium, USP, 25 mg/mL, 40 mL vial injectable product because of particulate matter found during a routine test of samples. 

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NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing

Topics: Compounding

NABP expressed its support for federal legislation that would distinguish between compounding and manufacturing, in testimony presented at a United States House subcommittee hearing on May 23, 2013. 

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Illinois Legislature Passes Medical Marijuana Bill

Topics: Medical marijuana

Illinois would establish a four-year medical marijuana pilot program under a bill passed by the state’s Legislature and under review by Illinois Governor Pat Quinn.

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Three Additional Synthetic Cannabinoids Classified as Schedule I Drugs

Topics: Controlled substances and Dea

DEA has issued a final order temporarily placing three synthetic cannabinoids into Schedule I of the Controlled Substances Act (CSA). 

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NABP Expresses Support of Federal Legislation That Distinguishes Compounding From Manufacturing and Clarifies Regulatory Oversight

Topics: Compounding

National Association of Boards of Pharmacy ® (NABP®) has expressed its support for the Pharmaceutical Compounding Quality and Accountability Act.

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NABP’s .PHARMACY Proposal Passes Initial ICANN Evaluation

Topics: Buying medicine online and Internet pharmacy

Reaching a critical milestone in the generic Top-Level Domain (gTLD) approval process, the National Association of Boards of Pharmacy® (NABP®) application to own and operate the .PHARMACY domain suffix has passed the Internet Corporation for Assigned Names and Numbers (ICANN) initial evaluation.

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NABP 2013-2014 Executive Committee Inaugurated at 109th Annual Meeting in St Louis, MO

Delegates to the National Association of Boards of Pharmacy® (NABP®) 109th Annual Meeting, held May 18-21, 2013, in St Louis, MO, elected individuals to fill the president-elect, treasurer, and open member positions on the Association’s 2013-2014 Executive Committee.

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Karen M. Ryle, MS, RPh, Begins Term as NABP President During the Association’s 109th Annual Meeting

Karen M. Ryle, MS, RPh, began her term as president of the National Association of Boards of Pharmacy® (NABP® ) during the Final Business Session of the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO. 

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Joseph L. Adams, RPh, Elected NABP President-elect at Association’s 109th Annual Meeting

Joseph L. Adams, RPh, was elected to serve as the 2013-2014 president-elect of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO. 

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Edward G. McGinley, MBA, RPh, Elected NABP Treasurer at Association’s 109th Annual Meeting

Edward G. McGinley, MBA, RPh, was elected to serve as the 2013-2014 treasurer of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO. 

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NABP Reelects James T. DeVita, RPh, to Serve as Member of Executive Committee at Association’s 109th Annual Meeting

James T. DeVita, RPh, was reelected to serve a second three-year member term, representing District 1, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO.

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Susan Ksiazek, RPh, Elected to Serve as Member of Executive Committee at Association’s 109th Annual Meeting

Susan Ksiazek, RPh, was elected to serve a three-year member term, representing District 2, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO.

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Gary Dewhirst, RPh, Elected to Serve as Member of Executive Committee at Association’s 109th Annual Meeting

Gary Dewhirst, RPh, was elected to serve a three-year member term, representing District 5, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO. 

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NABP Supports Federal Legislation Creating New Category of Manufacturer Under FDA Oversight, While Maintaining Board of Pharmacy Authority Over Compounding Pharmacies

Topics: Compounding

In testimony presented at a United States Senate Committee Hearing, NABP expressed its support of draft legislation that would create a new category of manufacturer to include entities that engage in large-scale production of sterile non-patient-specific drugs for distribution. 

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Products Produced by The Compounding Shop Should Be Quarantined Due to Lack of Sterility Assurance, Warns FDA

Topics: Compounding

Medications produced and distributed by The Compounding Shop of St Petersburg, FL, should not be administered to patients and should be quarantined, warns FDA. 

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US Senate Committee Proposes Legislation to Create Compounding Manufacturer Category to Be Under FDA Regulation

Topics: Compounding

Federal lawmakers have drafted legislation that would create a new category of drug compounders, “compounding manufacturers,” to be regulated by Food and Drug Administration (FDA). 

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NABP Updates VAWD Criteria, Continuing Efforts to Help Secure the Integrity of US Drug Supply Chain for the Protection of Public Health

Topics: Counterfeit drugs and Patient safety

To further protect the integrity of the United States drug supply chain, the National Association of Boards of Pharmacy® (NABP®) has updated the criteria for the Association’s Verified-Accredited Wholesale Distributors® (VAWD®) accreditation program. 

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Illegal Online Sellers Fuel Global Spread of Fake and Substandard Medications, International Collaboration Key in Response, Reports NABP

Topics: Buying medicine online and Internet pharmacy

The National Association of Boards of Pharmacy® (NABP®) recently issued a report emphasizing that the global distribution of counterfeit and substandard medications, fueled by illegal online sellers, demands an international response.

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Two Compounding Pharmacies Recall Sterile Products Over Sterility Assurance Concerns

Topics: Compounding

Two pharmacies have voluntarily recalled their sterile compounded products because of concerns associated with quality control processes and a lack of sterility assurance. 

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Reminder: Next DEA Prescription Drug Take-Back Day is April 27

Topics: Medication collection program disposal

The next opportunity to dispose of any unneeded or unwanted medications at a Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day collection site will be Saturday, April 27, 2013.

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House Committee Members Examine FDA’s Responsibilities Relative to the Meningitis Outbreak

Topics: Compounding

In a meeting last week, members of a House Energy and Commerce subcommittee stressed that Food and Drug Administration (FDA) could have done more to prevent the fungal meningitis outbreak that killed 53 people and sickened hundreds in late 2012.

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FDA Reports Unsanitary Conditions at Compounding Facilities, Calls for More Regulatory Authority

Topics: Compounding

FDA Commissioner Margaret A. Hamburg, MD, reported in a recent FDA blog article that agency inspectors encountered “objectionable conditions” at 30 of the 31 sterile compounding pharmacies they recently examined.

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Dallas Drug Makers Issue Voluntary Recall for Sterile Products

Topics: Compounding

FDA is warning health care providers to quarantine and cease use of sterile drug products from ApotheCure, Inc, and NuVision Pharmacy, two Dallas, TX, facilities.

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Tennessee Bill Would Allow Non-Patient-Specific Compounding During Drug Shortages

Topics: Compounding

Tennessee lawmakers are considering legislation that would enable compounding pharmacies to create medicines without patient-specific prescriptions during drug shortages and other times when a product is not commercially available.

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Congressional Report Highlights State Challenges in Regulating Compounding Pharmacies

Topics: Compounding

A report released by US Representative Ed Markey (D-MA) highlights the challenges states face in regulating compounding pharmacies and examines how the pharmacies are tracked and inspected.

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Nevada Pharmacy Recalls All Sterile Compounded Products

Topics: Compounding and Patient safety

Nevada-based Green Valley Drugs has issued a voluntary recall of all lots of all its compounded, repackaged drugs because of a lack of sterility assurance. 

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FSMB Live Webcast to Explore Multi-State Licensure

Topics: Pharmacist license

The Federation of State Medical Boards (FSMB) will provide a free, live Webcast Thursday, April 18, 2013, from its Annual Meeting in Boston, MA, of a panel discussion on current trends in multi-state licensure in health care. 

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Rx Open Web Site to Provide Pharmacy Status Information During Public Health Emergencies

Topics: Patient safety

The emergency pharmacy status reporting tool operated by Rx Response now goes by an easy-to-remember name, Rx Open, with a matching URL, www.RxOpen.org.

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Fentanyl Patches Should Be Stored and Disposed of Properly to Avoid Accidental Poisonings in Children

Topics: Patient safety and Adverse drug events

Fentanyl patches should be securely stored out of the sight and reach of children and disposed of properly, advises Food and Drug Administration (FDA).

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UPS Forfeits Shipping Profits from Illegal Online Drug Sellers

Topics: Diversion and Dea

United Parcel Service (UPS) agreed to forfeit $40 million in payments received from online entities illegally selling and distributing prescription drug products.

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FDA Calls for Legislation to Allow Federal Oversight of Entities Compounding Non-Patient-Specific Drugs

Topics: Compounding and Federal regulations

US Food and Drug Administration (FDA) has called for the development of legislation to establish appropriate, minimum federal standards for entities engaged in the compounding of non-patient-specific sterile drugs for interstate distribution, states FDA Commissioner Margaret Hamburg, MD.

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Legislation to Reschedule Products Containing Hydrocodone as Schedule II Drugs Introduced to Congress

Topics: Controlled substances and Prescription drug abuse

With the aim of curbing prescription drug abuse, bipartisan legislation that would reclassify drug products containing hydrocodone as Schedule II controlled substances (CS) was introduced to Congress on March 20, 2013.

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New Jersey Compounding Pharmacy Recalls All Compounded Products Due to Mold Contamination

Topics: Compounding

Med Prep Consulting, Inc, a New Jersey-based compounding pharmacy, voluntarily recalled all lots of all its compounded products after a Connecticut hospital discovered mold particles in five bags of an intravenous solution.

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Georgia Compounding Pharmacy Recalls All Sterile Products After Eye Infections Reported

Topics: Compounding

FDA is alerting health care providers and patients of a voluntary recall of all sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, GA. 

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FDA Releases New Consumer Video on Acetaminophen Safety

Topics: Education, Over the counter, and Patient safety

With the arrival of allergy season, FDA has a released a new video to help educate patients about safe use of medications containing acetaminophen.

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NABP Comments on FDA Drug Shortages Strategic Plan Stress Ensuring Safety When Non-Approved Drugs Are Used

Topics: Federal regulations

To protect the public health, Food and Drug Administration (FDA) should carefully consider using the exercise of enforcement discretion during drug shortages, urges NABP. 

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Legislation to Allow Foreign Mail-Order Pharmacies to Dispense to Patients in Maine Poses Danger to Public Health, Warns NABP

Topics: Counterfeit drugs and Patient safety

Stressing the potential danger to patients, NABP expressed its opposition to legislation introduced in Maine that would allow the dispensing of drugs from mail-order pharmacies located around the world.

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Former NECC Employees Reveal Compounding Facility's Conditions During 60 Minutes Segment

Topics: Compounding and Patient safety

Former New England Compounding Center (NECC) employees reveal how workload and facility conditions contributed to the tragic meningitis outbreak linked to the company’s contaminated drugs in a 60 Minutes segment.

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FDA Continues Inspections of Facilities Compounding Sterile Injectable Drugs

Topics: Compounding and Patient safety

Inspections of 30 entities engaged in compounding are underway by Food and Drug Administration (FDA) inspectors as part of the agency’s response to the 2012 meningitis outbreak linked to contaminated compounded injectable drugs.

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Pennsylvania Legislators Consider Bill to Establish Expanded State PMP

Topics: Diversion and Prescription drug abuse

Aimed to reduce prescription drug abuse and diversion, legislation that would establish an expanded PMP in Pennsylvania is under consideration by state lawmakers. 

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Legal Briefs: Administrative Order Not Subject to Stay

Topics: Pharmacists and Pharmacist license

The NABP membership consists of the regulatory boards regulating the profession of pharmacy. These boards are statutorily created and empowered and act in the interest of protecting the public. 

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Bill to Expand Pharmacists' Authorization to Vaccinate Passes Wyoming Senate

Topics: Pharmacists and Vaccinations

Pharmacists’ authority to vaccinate may be expanded in Wyoming under a bill that would allow pharmacists to prescribe and administer immunizations for individuals age seven and older.

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New York Doctor Pleads Guilty to Federal Charges of Illegally Distributing Oxycodone

Topics: Controlled substances, Diversion, and Dea

New York physician Felix Rodriguez pled guilty to the distribution of more than 1,000 oxycodone pills to individuals without legitimate medical need for the drug.

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Prescription Drug Misuse Contributes to Continued Increase in Overdose Death Rate

Topics: Prescription drug abuse

Prescription drugs were involved in 60% of drug overdose deaths, which increased for the 11th consecutive year, reports Centers for Disease Control and Prevention (CDC).

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Federal Legislation to Prevent Prescription Drug Abuse Introduced to Senate

Topics: Controlled substances and Prescription drug abuse

Aimed to address prescription drug misuse, addiction, and overdose deaths, the Prescription Drug Abuse Prevention and Treatment Act (SB 348) was reintroduced in the United States Senate.

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Institute of Medicine Recommends Actions for Fighting Substandard Drugs in the US and Globally

Topics: Buying medicine online, Diversion, and Vipps vet vipps

Cooperation among international pharmacy regulatory agencies and tightening the United States drug distribution chain would help protect global public health from substandard and falsified drugs, indicates a new report from the Institute of Medicine (IOM).

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April 2013 DEA Prescription Drug Take-Back Day Offers Consumers Another Opportunity for Convenient Medication Disposal

Topics: Medication collection program disposal and Dea

Consumers across the country will have another opportunity to help prevent abuse and misuse of prescription drugs by disposing of any unneeded or unwanted medications during the sixth Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day.

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FDA Reexamines Its Exercise of Enforcement Discretion Regarding Valid, Patient-Specific Prescriptions and Compounding Pharmacies

Topics: Compounding

In a letter (PDF) to PharMEDium Services LLC, Food and Drug Administration (FDA) Center for Drug Evaluation and Research indicates that it will no longer exercise enforcement discretion that allowed the company to produce non-patient specific drug products for distribution to hospitals across the country. 

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Surprise Inspections in Massachusetts Result in Cease and Desist Orders to 11 Compounding Pharmacies

Topics: Compounding

Partial or complete cease and desist orders were issued to 11 compounding pharmacies by the Massachusetts Department of Public Health (DPH).

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Another Counterfeit Cancer Medication Distributed in US, FDA Warns

Topics: Counterfeit drugs

FDA is alerting health care providers that an unapproved cancer medicine distributed by a United States company, Medical Device King (also known as Pharmalogical), is counterfeit.

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Progress Made in Implementing Recommendations Intended to Prevent Acetaminophen Overdose

Topics: Patient safety and Medication errors

Compelling progress has been made by stakeholders seeking to address the public health issue of acetaminophen overdose, indicates a white paper published by the National Council for Prescription Drug Programs (NCPDP).

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ISMP Publishes Survey Results on Compounding Practices

Topics: Compounding

A majority of respondents to a survey on compounding practices indicated that pharmacy technicians who work in sterile compounding should be certified or licensed. 

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New York Pharmacists’ Authority to Administer Flu Vaccinations Expanded Under Emergency Order

Topics: Vaccinations

Responding to epidemic proportions of flu in New York State, Governor Andrew Cuomo has passed emergency orders expanding pharmacists’ authority to vaccinate individuals against the illness. 

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FDA Committee Recommends Schedule II Classification for Drugs Containing Hydrocodone

Topics: Controlled substances and Prescription drug abuse

The Food and Drug Administration (FDA) Drug Safety and Risk Management Advisory Committee recommended reclassifying hydrocodone combination products as Schedule II controlled substances after a two-day meeting.

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Providers Should Ensure Only Diluted Forms of Acetic Acid are Used, ISMP Warns

Topics: Patient safety and Medication errors

The Institute for Safe Medication Practices (ISMP) has issued a National Alert Network (NAN) notice (PDF) advising that health care organizations should take immediate steps to ensure that only diluted acetic acid solutions are used in patient care.

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USP Seeks Candidates for Expert Panel on General Chapter <797> Pharmaceutical Compounding – Sterile Preparations

Topics: Pharmacists

USP is seeking qualified candidates to serve on the Pharmaceutical Compounding–Sterile Preparations Expert Panel.

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Canadian Citizen Sentenced to Four Years for Role in Internet Drug Outlet Operation

Topics: Diversion

Andrew J. Strempler, a Canadian citizen, was sentenced to four years in prison for charges related to the operation of a Web site illegally marketing and distributing prescription drugs to US residents. 

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Rx Response Offers Support for Areas Affected By Flu Outbreak

Topics: Patient safety

A spike in flu activity and limited supplies of vaccine and Tamiflu® doses across the country have prompted Rx Response to move its operations to Alert status.

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FDA Issues New Guidelines for Sleep Aids Containing Zolpidem

Topics: Adverse drug events

FDA has issued new dosing recommendations for sleep aids containing zolpidem.

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ISMP Launches Program to Track Vaccine Errors With Aim to Protect Patient Safety

Topics: Patient safety and Vaccinations

The Institute for Safe Medication Practices (ISMP) has launched a National Vaccine Error Reporting Program (VERP) that allows health care providers to confidentially report vaccine administration errors and near misses.

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Minnesota Board Implements Plan to Strengthen Regulation of Compounding Pharmacies

Topics: Compounding

The Minnesota Board of Pharmacy, which already has strong compounding regulations and requirements in place, is in the process of considering additional requirements, some of which will require the passage of new legislation. 

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California Board of Pharmacy Sponsors Legislation Authorizing Inspection of Nonresident Compounding Pharmacies

Topics: Compounding

The California State Board of Pharmacy will sponsor a bill that would allow inspectors to make unannounced on-site inspections of certain nonresident pharmacies.

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Massachusetts Governor Patrick Files Bill to Strengthen State’s Regulation of Compounding Pharmacies

Topics: Compounding

Massachusetts Governor Deval Patrick will file a bill that would strengthen the state’s regulation of compounding pharmacies. 

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ASOP and Google Help Warn Consumers About Online Dangers; European Partners Join ASOP Efforts

Topics: Buying medicine online and Internet pharmacy

Google has begun running search-based advertising aimed to help educate US consumers about illegal online drug sellers.

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FDA Warns Doctors About Unapproved Drug Products, Including Botox, Purchased from Foreign Suppliers

Topics: Patient safety and Prescription

Emphasizing risks to patient safety, Food and Drug Administration (FDA) has alerted more than 350 medical practices (PDF) across the country that they may have received unapproved medications.

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FDA to Hold Public Hearing on Use of Opioid Pain Medications

Topics: Patient safety and Prescription drug abuse

As FDA continues to seek a balance between minimizing opioid drug abuse and enabling the appropriate treatment of pain, the agency will hold a two-day public hearing to obtain information.

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House Bill Would Tighten Federal Regulations of Compounding Pharmacies

Topics: Compounding and Patient safety

In an attempt to tighten federal oversight of compounding pharmacies in the wake of the meningitis outbreak, the S.A.F.E. Compounded Drugs Act of 2012 (HR 6638) was introduced in Congress.

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NECC and Ameridose Closures Intensify Drug Shortages

Topics: Compounding and Patient safety

Hospitals and medical centers that relied upon the NECC and its sister company, Ameridose LLC, are suffering shortages of antibiotics, pain medications, and other drugs.

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NABP Leads the Charge as States Tighten Ranks Around Compounding Pharmacies

Topics: Compounding, Patient safety, and Pharmacists

Supporting state board of pharmacy efforts to enforce compounding regulations, the National Association of Boards of Pharmacy® (NABP®) is implementing a four-part action plan centered around inspection of nonresident compounding pharmacies and creating an information sharing network of regulatory details...

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Microbial Contamination Found in Additional NECC Products

Additional microbial contamination has been identified in three drug products at NECC. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) continue investigating NECC and have discovered bacteria and fungal species in unopened vials of betamethasone,...

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Grand Jury Begins Investigating NECC and Fungal Meningitis Outbreak

A federal grand jury is collecting information and evidence from people who worked with the New England Compounding Center (NECC), the pharmacy that produced contaminated steroid injections leading to a multistate outbreak of fungal meningitis affecting over 540 people. The...

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Massachusetts Department of Public Health Finds Storage and Preparation Problems at Three Compounding Pharmacies

The Massachusetts Department of Public Health has sent cease and desist orders to three compounding pharmacies for drug preparation and storage problems that were discovered during surprise inspections. The Boston Globe reports that the issues found at the facilities –...

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