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 intends to launch the .PHARMACY gTLD by the end of 2013, and […]
Read More ›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. The Senate Health, Education, Labor, and Pensions (HELP) committee’s proposed legislation distinguishes between pharmacies engaged in […]
Read More ›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). 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 […]
Read More ›USP Prescription Container Labeling Chapter is Now the Official Standard
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 […]
Read More ›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. Revisions to the criteria will allow virtual manufacturers and virtual wholesale distributors – a growing segment of the pharmaceutical wholesale industry – […]
Read More ›Bill to Strengthen Regulation of Compounding Introduced in Maine Legislature
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 […]
Read More ›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®) 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, […]
Read More ›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. 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 […]
Read More ›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. 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 […]
Read More ›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. 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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