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DEA Guidance Regarding Information Pharmacists May Provide on CS II Prescriptions
Recognizing that pharmacists are sometimes presented with prescriptions for Schedule II controlled substances that are missing information required by law, Drug Enforcement Administration provides guidance for pharmacists regarding allowed changes or additions to such prescriptions.
Read More →Nominations for 2014 NABP Annual Awards Now Being Accepted
NABP invites you to nominate a colleague or board of pharmacy for a 2014 NABP award.
Read More →FDA Provides New Information About Lack of Sterility Assurance for Drugs Dispensed by The Compounding Shop
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.
Read More →FDA Requires Changes to Fentanyl Pain Patch Warnings
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.
Read More →Florida Sees Continued Decreases in Prescription Drug Related Deaths
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.
Read More →‘Bath Salts’ Linked to Nearly 23,000 Emergency Room Visits in 2011
A group of drugs known as “bath salts” were linked to an estimated 22,904 visits to hospital emergency departments in 2011.
Read More →State Senators Pressure Craigslist to Ban Illegal Prescription Drug Ads
State senators from Nevada and California are calling on Craigslist to remove ads from its site that facilitate illegal distribution and diversion of narcotics.
Read More →Michigan Lawmakers Consider Bill to Strengthen Compounding Regulations
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.
Read More →Threat of Antibiotic-Resistant Bacteria Growing, CDC Warns
A new report from CDC warns that there is a growing threat of antibiotic-resistant strains of infectious diseases.
Read More →FDA Proposes Labeling Changes for ER/LA Opioids to Combat Abuse, Mandates Post-market Research
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.
Read More →Know Your Dose Campaign Offers Acetaminophen Safety Tips Ahead of Cold and Flu Season
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.
Read More →University Compounding Pharmacy Recalls Some Products Due to Lack of Sterility Assurance
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
FDA Drug Info Rounds, a series of online videos, provides important and timely drug information to practicing clinical and community pharmacists.
Read More →Park Pharmacy & Compounding Center Recalls Two Compounded Sterile Preparations
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.
Indiana Medical Board to Adopt Emergency Opioid Prescribing Rules at Request of State Legislature
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.
CVS Aggregates Data to Identify and Cut Off Suspected Pill Mills
In an effort to reduce prescription drug abuse, CVS pharmacists have adopted an analytical system to help identify “pill mill” prescribers.
FDA: Fluoroquinolone Drug Labels Must Provide Better Descriptions of Peripheral Neuropathy
Food and Drug Administration updated its label requirements for the drug labels on fluoroquinolone-based medications.
FDA Reminds Health Care Providers to Not Use NuVision Pharmacy Products
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.
Specialty Compounding, LLC, Clarifies Recall Information
Specialty Compounding, LLC, clarified a recall of all lots of sterile compounded medications produced in its Texas facility.
CHPA Files Petition to Expand Dosing Information on Acetaminophen Products for Young Children
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.
Risks of Buying Prescription Drugs from Illegal Online Sellers Highlighted in NBC Connecticut Report
The risks of ordering medications online and of receiving dangerous counterfeit products are highlighted in a recent NBC Connecticut report.
Illegally Operating Wholesaler in Virginia Posed as Canadian Distributor, Owners Indicted
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.
UPS First Package Delivery Company to Join CSIP in Fight against Rogue Internet Drug Outlets
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.
Specialty Compounding, LLC Recalls All Lots of Unexpired Sterile Products After Reports of Adverse Events
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.
GAO Issues Recommendations for Congress and the Secretary of Health and Human Services for Compounding Pharmacies
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.”
FDA Warns of Rare Skin Reaction in Patients Taking Acetaminophen
FDA has issued a Consumer Update that warns of rare but serious skin reactions that may occur in patients taking acetaminophen.
Three New Alabama Laws Aim to Crack Down on 'Doctor Shopping' and Prescription Drug Abuse
Alabama Governor Robert Bentley has signed into law three bills aimed to reverse the state’s growing prescription drug abuse rate.
Illinois to Implement Medical Marijuana Pilot Program Under Law Approved by Governor Quinn
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.
Nova Diabetes Care Recalls Up to 62 Million Blood Glucose Test Strips
Nova Diabetes Care and Food and Drug Administration (FDA) officials have announced a voluntary recall of 21 lots of blood glucose test strips.
Kentucky Sees Slight Decline in Drug Overdose Deaths, Including Prescription Drug Overdose
According to a state report released in late July, drug overdose deaths in the state of Kentucky decreased by 19 to 1,004.
Domperidone Not FDA Approved, Should Not be Marketed in the US, FDA Stresses
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.
Healthy Life Chemistry Supplement Product Contains Anabolic Steroids, FDA Warns
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.
FDA Takes Action to Stop Distribution of Illegal, Potentially Harmful Products Claimed to Treat Diabetes
FDA advises consumers not to use, and is taking action to remove from the market, illegal products claiming to treat diabetes.
Proposed Law Calls for Commission to Focus on Prescription Drug Abuse Efforts
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.
Five Individuals Charged With Diversion of Prescription Controlled Substances
Five individuals have been indicted and arrested on charges related to their involvement in a prescription drug diversion scheme.
Montana Man Sentenced for Role in Distribution of Fake Cancer 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.
FDA Raises Awareness About Safe Use of Acetaminophen
FDA is alerting consumers to be mindful of the amount of acetaminophen they take in order to prevent overdose and potential liver damage.
Attorneys General in Nebraska and Oklahoma Call On Google to Remove 'No Prescription Required' Ads from YouTube
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.
State and Federal Regulators Continue to Combat Rogue Internet Drug Sellers, US GAO Reports
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.
Distribution of Counterfeit Drugs to US Residents Via Rogue Internet Sites Continues to Grow, Reports CNN
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.
More Women Dying of Prescription Painkiller Overdoses
Every day, approximately 18 women die from an overdose of prescription pain medication, reports the Centers for Disease Control and Prevention (CDC).
DEA to Hold Next Prescription Drug Take-Back Day on October 26, 2013
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.
FDA Provides New Resources on Importance of Safe Storage and Disposal of Fentanyl Patches
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.
Thousands of Rogue Online Drug Sellers Shut Down During Operation Pangea VI
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.
Consent Decree Prohibits New Jersey Pharmacy from Manufacturing, Distributing Drug Products
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.
AMA Policy Deems 'Inappropriate Queries' From Pharmacies an Interference With Practice of Medicine
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.”
Patient Survey Reveals Poor Adherence to Prescribed Medication Therapy, Explores Adherence Predictors
Many Americans are not adhering to prescribed medication regimens, indicates a new patient survey commissioned by the National Community Pharmacists Association (NCPA).
Rugby Laboratories Enteric Coated Aspirin Recalled Due to Potential Mix-up With Acetaminophen Tablets
One lot of Rugby Laboratories enteric coated aspirin tablets, 81 mg, has been recalled to the user level.
ISMP to Launch Safety Alert Newsletter Providing Medication Error Prevention Information Tailored to LTCFs
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.
FDA Confirms Presence of Microbial Growth in Main Street Family Pharmacy Products
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.
'Plan B' Morning After Pill to Be Available OTC Without Age Restrictions, According to Federal Judge’s Ruling
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.
Bills to Safeguard Medications Through National Tracking System Under Consideration in Congress
A bill aimed to ensure the security of pharmaceuticals in the drug supply chain has passed the United States House of Representatives.
FDA Announces Opportunity for Expansion of ‘Script Your Future’ Medication Adherence Program
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.
FDA Allows Import of Injectable Nutritional Drugs Due to Product Shortage
FDA will allow the import of injectable drugs used in total parenteral nutrition (TPN) due to a critical shortage of the products.
Sandoz Recalls Two Lots of Methotrexate Sodium, USP Due to Particulate Matter
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.
NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing
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.
Illinois Legislature Passes Medical Marijuana Bill
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.
Three Additional Synthetic Cannabinoids Classified as Schedule I Drugs
DEA has issued a final order temporarily placing three synthetic cannabinoids into Schedule I of the Controlled Substances Act (CSA).
NABP Expresses Support of Federal Legislation That Distinguishes Compounding From Manufacturing and Clarifies Regulatory Oversight
National Association of Boards of Pharmacy ® (NABP®) has expressed its support for the Pharmaceutical Compounding Quality and Accountability Act.
NABP’s .PHARMACY Proposal Passes Initial ICANN Evaluation
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.
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.
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.
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.
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.
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.
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.
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.
NABP Supports Federal Legislation Creating New Category of Manufacturer Under FDA Oversight, While Maintaining Board of Pharmacy Authority Over Compounding Pharmacies
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.
Products Produced by The Compounding Shop Should Be Quarantined Due to Lack of Sterility Assurance, Warns FDA
Medications produced and distributed by The Compounding Shop of St Petersburg, FL, should not be administered to patients and should be quarantined, warns FDA.
US Senate Committee Proposes Legislation to Create Compounding Manufacturer Category to Be Under FDA Regulation
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).
NABP Updates VAWD Criteria, Continuing Efforts to Help Secure the Integrity of US Drug Supply Chain for the Protection of Public Health
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.
Illegal Online Sellers Fuel Global Spread of Fake and Substandard Medications, International Collaboration Key in Response, Reports NABP
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.
Two Compounding Pharmacies Recall Sterile Products Over Sterility Assurance Concerns
Two pharmacies have voluntarily recalled their sterile compounded products because of concerns associated with quality control processes and a lack of sterility assurance.
Reminder: Next DEA Prescription Drug Take-Back Day is April 27
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.
House Committee Members Examine FDA’s Responsibilities Relative to the Meningitis Outbreak
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.
FDA Reports Unsanitary Conditions at Compounding Facilities, Calls for More Regulatory Authority
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.
Dallas Drug Makers Issue Voluntary Recall for Sterile Products
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.
Tennessee Bill Would Allow Non-Patient-Specific Compounding During Drug Shortages
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.
Congressional Report Highlights State Challenges in Regulating Compounding Pharmacies
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.
Nevada Pharmacy Recalls All Sterile Compounded Products
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.
FSMB Live Webcast to Explore Multi-State Licensure
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.
Rx Open Web Site to Provide Pharmacy Status Information During Public Health Emergencies
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.
Fentanyl Patches Should Be Stored and Disposed of Properly to Avoid Accidental Poisonings in Children
Fentanyl patches should be securely stored out of the sight and reach of children and disposed of properly, advises Food and Drug Administration (FDA).
UPS Forfeits Shipping Profits from Illegal Online Drug Sellers
United Parcel Service (UPS) agreed to forfeit $40 million in payments received from online entities illegally selling and distributing prescription drug products.
FDA Calls for Legislation to Allow Federal Oversight of Entities Compounding Non-Patient-Specific Drugs
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.
Legislation to Reschedule Products Containing Hydrocodone as Schedule II Drugs Introduced to Congress
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.
New Jersey Compounding Pharmacy Recalls All Compounded Products Due to Mold Contamination
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.
Georgia Compounding Pharmacy Recalls All Sterile Products After Eye Infections Reported
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.
FDA Releases New Consumer Video on Acetaminophen 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.
NABP Comments on FDA Drug Shortages Strategic Plan Stress Ensuring Safety When Non-Approved Drugs Are Used
To protect the public health, Food and Drug Administration (FDA) should carefully consider using the exercise of enforcement discretion during drug shortages, urges NABP.
Legislation to Allow Foreign Mail-Order Pharmacies to Dispense to Patients in Maine Poses Danger to Public Health, Warns NABP
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.
Former NECC Employees Reveal Compounding Facility's Conditions During 60 Minutes Segment
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.
FDA Continues Inspections of Facilities Compounding Sterile Injectable Drugs
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.
Pennsylvania Legislators Consider Bill to Establish Expanded State PMP
Aimed to reduce prescription drug abuse and diversion, legislation that would establish an expanded PMP in Pennsylvania is under consideration by state lawmakers.
Legal Briefs: Administrative Order Not Subject to Stay
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.
Bill to Expand Pharmacists' Authorization to Vaccinate Passes Wyoming Senate
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.
New York Doctor Pleads Guilty to Federal Charges of Illegally Distributing Oxycodone
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.
Prescription Drug Misuse Contributes to Continued Increase in Overdose Death Rate
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).
Federal Legislation to Prevent Prescription Drug Abuse Introduced to Senate
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.
Institute of Medicine Recommends Actions for Fighting Substandard Drugs in the US and Globally
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).
April 2013 DEA Prescription Drug Take-Back Day Offers Consumers Another Opportunity for Convenient Medication Disposal
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.
FDA Reexamines Its Exercise of Enforcement Discretion Regarding Valid, Patient-Specific Prescriptions and Compounding Pharmacies
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.
Surprise Inspections in Massachusetts Result in Cease and Desist Orders to 11 Compounding Pharmacies
Partial or complete cease and desist orders were issued to 11 compounding pharmacies by the Massachusetts Department of Public Health (DPH).
Another Counterfeit Cancer Medication Distributed in US, FDA Warns
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.
Progress Made in Implementing Recommendations Intended to Prevent Acetaminophen Overdose
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).
ISMP Publishes Survey Results on Compounding Practices
A majority of respondents to a survey on compounding practices indicated that pharmacy technicians who work in sterile compounding should be certified or licensed.
New York Pharmacists’ Authority to Administer Flu Vaccinations Expanded Under Emergency Order
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.
FDA Committee Recommends Schedule II Classification for Drugs Containing Hydrocodone
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.
Providers Should Ensure Only Diluted Forms of Acetic Acid are Used, ISMP Warns
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.
USP Seeks Candidates for Expert Panel on General Chapter <797> Pharmaceutical Compounding – Sterile Preparations
USP is seeking qualified candidates to serve on the Pharmaceutical Compounding–Sterile Preparations Expert Panel.
Canadian Citizen Sentenced to Four Years for Role in Internet Drug Outlet Operation
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.
Rx Response Offers Support for Areas Affected By Flu Outbreak
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.
FDA Issues New Guidelines for Sleep Aids Containing Zolpidem
FDA has issued new dosing recommendations for sleep aids containing zolpidem.
ISMP Launches Program to Track Vaccine Errors With Aim to Protect Patient Safety
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.
Minnesota Board Implements Plan to Strengthen Regulation of Compounding Pharmacies
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.
California Board of Pharmacy Sponsors Legislation Authorizing Inspection of Nonresident Compounding Pharmacies
The California State Board of Pharmacy will sponsor a bill that would allow inspectors to make unannounced on-site inspections of certain nonresident pharmacies.
Massachusetts Governor Patrick Files Bill to Strengthen State’s Regulation of Compounding Pharmacies
Massachusetts Governor Deval Patrick will file a bill that would strengthen the state’s regulation of compounding pharmacies.
ASOP and Google Help Warn Consumers About Online Dangers; European Partners Join ASOP Efforts
Google has begun running search-based advertising aimed to help educate US consumers about illegal online drug sellers.
FDA Warns Doctors About Unapproved Drug Products, Including Botox, Purchased from Foreign Suppliers
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.
FDA to Hold Public Hearing on Use of Opioid Pain Medications
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.
House Bill Would Tighten Federal Regulations of Compounding Pharmacies
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.
NECC and Ameridose Closures Intensify Drug Shortages
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.
NABP Leads the Charge as States Tighten Ranks Around Compounding Pharmacies
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...
Read More →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,...
Read More →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...
Read More →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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