An Overview of 2012 and 2013 Federal Legislation Regulating Pharmacy Compounding

Last month, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved the “Pharmaceutical Compounding Quality and Accountability Act,” a bipartisan bill introduced by Senator Tom Harkin (D-Iowa) and other members of the HELP Committee. The bill will likely serve as the primary Senate vehicle to address pharmaceutical compounding and delineate compounding oversight responsibility between states and the U.S. Food and Drug Administration (FDA). The bill represents one of Congress’s latest responses to last year’s tragic New England Compounding Company (NECC) meningitis outbreak, but it has not been its only attempt. This article compares past and current legislation in the House and Senate related to pharmacy compounding.

2012 House Actions

After the meningitis outbreak came to light, the House introduced two bills in 2012 that died last year in Congress: “The Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012,” and “The Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act of 2012.” While both bills would have strengthened federal oversight of compounding pharmacies, the VALID Compounding Act of 2012 had several key elements:

1. Provided that new drug approval requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) did not apply to a compounded product under certain circumstances, such as when drugs are made for an identified individual patient based on a prescription.

2. Specified drugs that should not be compounded.

3. Preserved state authority regulating traditional small compounding pharmacy activities.

4. Ensured that compounding pharmacies operating as drug manufacturers were regulated by FDA as drug manufacturers.

5. Permitted some compounding pharmacies to request waivers to enable them to compound drugs before the receipt of a valid prescription.

6. Allowed FDA to waive the requirement to compound drugs only if the compounded drugs are not copies of commercially-available drugs if doing so is necessary to protect public health or well-being.

7. Increased transparency regarding compounded drugs.

While both House bills required compounding pharmacies to register their facilities with the FDA and comply with certain labeling requirements, the SAFE Compounded Drugs Act of 2012 also would have:

1. Required the practitioner writing the prescription, pharmacist dispensing the product, and health care provider providing services to follow certain procedures related to informing the patient for whom the prescription is being written that a compounded drug is being prescribed and provide the patient with a document containing safety, availability, and production information.

2. Established an FDA database of compounding pharmacies and an advisory committee on the database to ensure states and FDA shared information.

3. Established another FDA advisory committee to advise on the appropriate label content and format for compounded drugs.

4. Required the FDA to set minimum production standards for compounded drugs.

5. Established a registration process for compounding pharmacies.

6. Directed the FDA to offer training opportunities for state regulators.

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