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. The Senate Health, Education, Labor, and Pensions (HELP) committee’s proposed legislation distinguishes between pharmacies engaged in […]

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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). Traditional compounding pharmacies that prepare patient-specific medications pursuant to an individual prescription would continue to be licensed and regulated by the state boards of pharmacy, under the proposed law. Entities […]

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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. The standards, which provide a universal approach to the format, appearance, content, and language of instructions for medicines in containers dispensed by pharmacists, was published in General Chapter <17> in […]

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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. Revisions to the criteria will allow virtual manufacturers and virtual wholesale distributors – a growing segment of the pharmaceutical wholesale industry – […]

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A bill (LD1315) to strengthen the regulation of compounding pharmacies in Maine was introduced to the state’s legislature. The proposed law would require pharmacies compounding medications to obtain a special license, and would require that all pharmacies dispensing compounded drugs to patients in Maine be licensed by the state. The bill also proposes to change […]

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The National Association of Boards of Pharmacy® (NABP®) today issued a report emphasizing that the global distribution of counterfeit and substandard medications, fueled by illegal online sellers, demands an international response. As detailed in the Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: April 2013, NABP has partnered with regulatory authorities, […]

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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. Some of the conditions they witnessed included black particles floating in vials of supposedly sterile medicine, rust and mold in clean rooms, and technicians handling […]

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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. Representative Markey is a proponent of granting FDA authority to establish standards and regulate compounding pharmacies. The report findings were the subject of a House Energy and Commerce […]

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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. The bill, sponsored by Senator Ferrell Haile (R) and Representative David Shepard (D), has already passed the state’s Senate and is still being debated in the […]

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United Parcel Service (UPS) agreed to forfeit $40 million in payments received from online entities illegally selling and distributing prescription drug products. UPS and the United States Attorney’s Office for the Northern District of California entered a non-prosecution agreement that also included the company’s commitment to develop a compliance program to ensure that illegal online […]

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