Food and Drug Administration (FDA) has issued three additional guidance documents to help compounding entities register as outsourcing facilities. The policy documents also provide guidance for complying with other provisions of the Drug Quality and Security Act (DQSA). The new documents are: Final guidance (PDF) on registration of human drug compounding outsourcing facilities under Section […]

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Beginning November 29, 2014, pharmacies in Pennsylvania may be requested to fill standing orders or prescriptions for the opioid reversal drug naloxone to first responders and friends and family of those at risk. Pennsylvania’s Act 139, signed by Governor Tom Corbett on September 30, 2014, also provides immunity from prosecution for those responding to and […]

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The California Board of Pharmacy is reminding its licensees that licensure as an outsourcing facility under Section 503B of the Food Drug and Cosmetic Act does not exempt or except pharmacies from state licensure requirements. To compound or dispense drug products within or into California, pharmacies must be licensed in California as a resident or […]

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Food and Drug Administration (FDA) has issued a question-and-answer draft guidance document to assist industry and state governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug and Cosmetic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). FDA is issuing this document, “The Effect […]

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A California bill expanding the role of pharmacy technicians and interns was signed into law by Governor Jerry Brown on September 15, 2014. The new law is intended to “make more efficient use of pharmacy personnel,” such as enabling hospital pharmacists to spend more time collaborating with other health care providers, reports the Sacramento Business […]

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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. The Final Rule implements the Secure and Responsible Drug Disposal Act of 2010, which authorized DEA to develop and implement regulations that would allow authorized entities other than law […]

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United States Attorney General Eric Holder is urging federal law enforcement agencies to “identify, train and equip personnel who may interact with a victim of a heroin overdose” to carry naloxone, a medication that can reverse an opioid overdose. In a memorandum, Holder also requests that Congress protect enforcement tools, specifically Immediate Suspension Orders, a […]

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FDA has approved Targiniq™ ER, an opioid pain reliever designed to be more resistant to abuse. The drug is an extended-release/long-acting (ER/LA) opioid analgesic for treating pain severe enough to require around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate. Targiniq ER is the first to combine naloxone hydrochloride, an overdose reversal […]

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Under revisions to the Kansas Pharmacy Practice Act, pharmacists may now collaborate with physicians to manage patients’ medication therapies. Both parties must act under the provisions outlined in a written collaborative practice agreement between the pharmacist and physician, explains the Kansas State Board of Pharmacy. The new provisions codify the informal agreements that many physicians […]

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CVS pharmacies in West Virginia have stopped selling single-ingredient pseudoephedrine cold medications as part of an effort to hinder criminals who use the drug to make illegal methamphetamine, reports the Charleston Gazette. The ban applies to all 50 CVS pharmacies in the state, as well as 40 stores that are within 15 miles of West […]

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