Timeline of FDA Involvement
Until recently, peptides produced by compounding pharmacies were made available to physicians to be dispensed at a reasonable cost. These pharmacies have come under increased regulation by the FDA to maintain standards in healthcare that protect the public; however, peptides are now being taken away.
Recently, the FDA and Congress have changed the way that peptides are classified so that now many of them are biological substances, which can only be produced and marketed by drug companies. The public is being denied access at a reasonable cost to peptides that have been shown successful results in medical studies and also in treating patients with these banned peptides. If patients cannot obtain these peptides from compounding pharmacies, they are more likely to seek them from unregulated online sources that have been shown to sell fake or fraudulent products.
On September 5, 2019, the FDA issued a regulation on substances (including peptides) that can be compounded. Drugs can be compounded only if they consist of materials appearing in the USP-National Formulary, are a component of an FDA-approved drug or appear on the list of Bulk Drugs Substances (503A). Many peptides that are being restricted by the FDA have been nominated to be on the 503A Bulk Substance List, where they remained for several years.
On Friday September 29th, 2023, without warning or request for comment, the FDA moved a number of peptide raw material substances that had been nominated years ago to the Category 2 Bulk Drug Substance list – meaning compounding pharmacies are no longer able to compound these drugs. Effective immediately, access to these drugs was restricted, and any compounding pharmacy purchasing bulk ingredients that are now listed under Category 2 faces the risk of the FDA “taking action against” that compounding pharmacy, including fines and loss of their license.