Basic Support for Drug Compounding Guidances
Stakeholders are generally voicing support for two FDA draft guidances on compounded drug products that are essentially copies of a commercially available drug product. The Biotechnology Innovation Organization (BIO) says it strongly believes that the drug compounding provisions of the Drug Quality and Security Act did not change current law on biologics and thus there are no applicable exemptions under the Federal Food, Drug, and Cosmetic Act compounding provisions for entities that compound or repackage biological products. And, it says, due to special manufacturing challenges and heightened patient safety concerns, all drug products with a narrow therapeutic index should not be compounded.
Within that context, BIO says it has “long supported the prohibition on compounding of commercially available FDA-approved products, unless the products are medically necessary to address a unique individual patient need not met by the approved drug, and when supported by a valid prescription.” It praises the agency for incorporating this idea in the draft guidances for both Section 503A and 503B.
The association cautions that FDA must use “its full range of regulatory and enforcement authorities to ensure that compounding does not endanger the public health or the safety of patients that rely on these products. Without adequate regulation (and vigilant oversight and enforcement), compounding under both 503A and 503B may undermine patient safety, and also the integrity of the traditional NDA, sNDA, and ANDA approval processes, by providing a far less regulated alternative pathway.”
Public Citizen says it generally supports the policies expressed in the draft 503A guidance that tightly limit pharmacy compounding of drug products that are essentially copies of a commercially available drug product. “Stringent limits on such pharmacy compounding under Section 503A are critically important to protecting public health” for all the reasons listed by FDA in the draft, Public Citizen says.
A Pew Charitable Trusts comment letter discusses how critical the FDA approval process is to protecting patient safety, and says that compounding copies of approved drugs is only appropriate when the drug is in shortage, or when a modification to the approved product is necessary to meet a patient’s unique needs.
“Because compounded drugs are supposed to be customized to meet a patient need,” Pew says, “they are not subject to the same rigorous safety and quality testing as FDA approved drugs. Without this testing, patients and their providers may not know the risks a compounded drug poses. For example, a compounded formulation of an FDA-approved drug may or may not be absorbed in the body in the same way as the approved product. In addition, quality standards for compounding pharmacies, primarily regulated by states, vary significantly and are not as robust as those applied to pharmaceutical manufacturing and compounding outsourcing facilities. Because of these risks, compounding should not become an alternative to FDA-approved manufacturing.”
Finally, the American Pharmacists Association asks for changes to the guidance to recognize situations that it says require the compounding of commercially available drugs.