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Saturday, June 1, 2013
American Pharmacy Association Comments on Senate Bill (Pharmaceutical Compounding Quality and Accountability Act
June 01, 2013
APhA comments on Senate draft proposal
The Senate Health, Education, Labor, & Pensions (HELP) Committee on May 15 introduced the Pharmaceutical Compounding Quality and Accountability Act (S. 959) following a full committee hearing and comments from stakeholders, such as APhA, on an April 26 draft proposal.
The Senate compounding bill—a manager’s mark, or updated bill, was released May 20—would draw a line between traditional compounders, which would be regulated primarily by state boards of pharmacy, and “compounding manufacturers,” which would be regulated by FDA; compounding manufacturers would be defined as those that make sterile products without or before a prescription and sell those products across state lines. Pharmacies within health systems would remain regulated as traditional compounders. Compounding manufacturers could not be licensed as pharmacies.
Compounding manufacturers would register with FDA, make products under a pharmacist’s oversight and in compliance with Good Manufacturing Practices, and pay an annual establishment fee to defray the cost of FDA oversight such as inspections and a reinspection fee as needed; small businesses would pay reduced fees.
Traditional compounders would be prohibited from compounding marketed FDA-approved drugs not in shortage, variations of marketed FDA-approved drugs unless they fulfill a specific patient need, or products subject to certain Risk Evaluation and Mitigation Strategies unless it is to fulfill a specific patient need and the compounder uses comparable safety controls. The compounding of certain drugs demonstrably difficult to compound, such as complex dosage forms and biologics, could be prohibited through regulatory rulemaking with comments. Wholesale distribution of compounded products would not be permitted. Marketing of compounded drugs could not be false or misleading.
The Senate compounding bill also would encourage communication among FDA and the states as well as among the states themselves. For more information on the bill, visit the HELP Committee website (www.help.senate.gov).
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