FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA

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Food and Drug Administration (FDA) has issued a question-and-answer draft guidance document to assist industry and state governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug and Cosmetic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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California Passes Bill to Increase Role of Pharmacy Technicians

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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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DEA Finalizes Rule on Controlled Substance Prescription Drug Disposal

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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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Attorney General Holder Urges Actions by Federal Agencies, Congress to Fight Opioid Abuse and Overdose

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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 Approves New Abuse-Deterrent Opioid Pain Medication

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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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White House Targets Opioids in 2014 Drug Control Strategy

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Setting out a four-part science-based strategy for reducing illicit drug use, the White House 2014 National Drug Control Strategy (PDF) includes a focus on reducing heroin and prescription painkiller abuse and overdose, which have spiked dramatically in recent years. Released annually, the Office of National Drug Control Policy (ONDCP) strategy document serves as a national […]

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New Kansas Law Allows Collaborative Practice Agreements Between Pharmacists, Physicians

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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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FDA Releases DQSA Compounding Rules and Guidance Documents

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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). The documents include: Draft interim guidance (PDF) describing FDA’s expectations for compliance with current good manufacturing practice requirements for compounding facilities registered as outsourcing facilities with FDA A […]

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