Food and Drug Administration (FDA) is alerting compounders of the conditions that need to be met to qualify for the exceptions under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
“Under section 503A: The drug product is compounded for an individual patient based on receipt of a prescription. The compounder does not compound, regularly or in inordinate amounts, any that are essentially copies of a commercially available drug product,” as stated by FDA.
Furthermore, FDA has stated it does not intend, at this time, to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month.
FDA states that outsourcing facilities may not use bulk drug substances (or active pharmaceutical ingredients) for compounded drugs unless: “the bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need, which is referred to as the 503B bulks list, or the drug compounded from the bulk drug substance is on FDA’s drug shortage list at the time of compounding, distribution and dispensing.”
FDA is reminding compounders that tirzepatide and semaglutide are not currently on FDA’s drug shortage list or on the 503B bulks list. Additional information about compounding medications is available on the FDA website.