News tagged headline

USP Prescription Container Labeling Chapter is Now the Official Standard

Topics: Prescription label

The United States Pharmacopeia (USP) General Chapter <17> Prescription Container Labeling, published in the USP 36–NF 31, became an official standard on May 1, 2013.

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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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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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Sixth DEA Take-Back Day Collects Over 740,000 Pounds of Unneeded Medication, Helping to Prevent Diversion and Abuse

Topics: Medication collection program disposal and Dea

The Drug Enforcement Administration's (DEA) sixth National Prescription Drug Take-Back Day on April 27, 2013, collected twice the amount of unneeded and expired medications for safe disposal than the previous DEA take-back event six months ago.

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New Jersey State Board of Pharmacy and State’s Attorney General Partner to Provide Pharmacies With Security Best Practice Guidelines

Topics: Diversion and Pharmacies

Best practices for pharmacy security guidelines have been developed by the New Jersey State Board of Pharmacy and the state’s Attorney General to assist pharmacies in preventing drug theft and diversion. 

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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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