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Statement of Need: Pharmacy compounding can provide substantial benefits to the public health. It can give to patients, who are allergic to inactive ingredients found in commercially available drug products, versions of those drug products from which the allergenic ingredient has been omitted. Patients who have difficulty taking a commercially available drug product may obtain a compounded version of the drug product in a different dosage form. In certain instances, pharmacy compounding can also enable physicians to access certain drugs that are not commercially available. Just as compounded drugs may present significant benefits to health, they can also present significant risks. Compounded drugs are generally not evaluated by FDA for safety or effectiveness. They are not made according to current good manufacturing practices and have generally not been tested for strength, quality, or purity. Stability testing, to establish the useful shelf life of the products, has generally not been performed on compounded drug products. Compounders have made illicit copies of FDA-approved drug products, threatening the integrity of the drug approval process. FDA is attempting to maximize the public health benefits of pharmacy compounding, while minimizing the potential threat to the public health.

Summary of the Legal Basis: Section 127 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) adds section 503A to the Act. Sections 503A(b)(1)(A)(i)(III) and (d)(2) direct FDA to publish regulations establishing a list of drugs that are suitable for compounding. Section 503A(b)(1)(C) directs FDA to publish in the Federal Register a list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Section 503A(b)(1)(D) directs FDA to define the term "compound regularly or in inordinate amounts" relating to compounding drug products that are essentially copies of a commercially available drug product. Section 503A(b)(3)(A) directs FDA to develop a list of drug products that may not be compounded because they are demonstrably difficult to compound. Efficient enforcement of section 503A would benefit from publication of a substantive rule that interprets and applies the statutory language.

Alternatives: Section 127 of FDAMA directs FDA to develop regulations, so no alternatives to regulations have been considered. FDA has considered a wide range of options and approaches within the framework of a regulation. FDA has convened and consulted the Pharmacy Compounding Advisory Committee, which consists of representatives of the United States Pharmacopoeia, the National Association of Boards of Pharmacy, and a consumer organization, as well as members of the pharmacy and pharmaceutical manufacturing industries, physicians and academics.

Anticipated Costs and Benefits: FDA has not yet quantified the costs and benefits of any regulatory approach. FDA has not been significantly involved in the regulation of pharmacy compounding, and does not have any economic data on the industry at this time. Responses to the NPRM will be important in determining the costs and benefits of any regulation.

Risks: None.