Compounding: BIO Comments on FDA Draft Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

 

Dear Sir/Madam:

 

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (Draft Guidance).

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

 

 

BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of the prescription requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). BIO recognizes that access to medically-needed compounded medicines is highly important; but access cannot and should not come at the expense of product quality and patient safety. BIO agrees with the assertion that the prescription requirement is critical in differentiating between compounding by a pharmacist or physician from conventional manufacturing and from compounding by an outsourcing facility. We believe that the Draft Guidance appropriately provides recommendations for compounding in the traditional pharmacy setting either upon receipt of a prescription for an individual patient, or in anticipation of receiving such a prescription but correctly does not allow for distribution of a compounded drug product before receiving a valid patient-specific prescription.

 

Congress recognized that supplies of drugs compounded without patient-specific prescriptions are sometimes needed by providers when an FDA-approved product is not available. However, the need to better ensure the quality of these drugs should not be ignored. If traditional pharmacies under Section 503A are permitted to supply compounded drugs without prescriptions outside of these new quality requirements, they will have little to no incentive to register with the FDA nor to adhere to the more rigorous quality standards that are appropriate for compounding at that scale.

 

As BIO has noted in previous comments to FDA regarding compounding, we strongly believe that the drug compounding provisions of the Drug Quality and Security Act (DQSA) did not alter current law with regard to biologics and that therefore there is still no applicable exemption in the FD&C Act compounding provisions for entities that compound or repackage biological products. We are pleased to see this Draft Guidance contains a footnote (footnote 2) that states this Guidance does not apply to biological products subject to licensure in a biologics license application.

 

More broadly, BIO asks that FDA include a statement in this Guidance, as well as all other applicable FDA regulations and guidance, that compounding of commercially available, FDA-approved products is not allowed. The only exception being when such products are medically necessary to address a unique individual patient need not met by the approved drug, and when supported by a valid prescription. We acknowledge and appreciate FDA’s recent release of the two Draft Guidances on compounded products that are essentially copies of a commercially available drug product but believe it would be helpful for all guidances and relevant compounding documents to include a statement barring the compounding of such products as well as reference to the appropriate guidances. We also believe FDA should articulate penalties for compounding of commercially available, FDA approved drug products.