In a Federal Register Notice, FDA explains that ephedrine sulfate and hydroxychloroquine sulfate are not to be included on the bulk drug list for use in compounding by 503B outsourcing facilities (here). As mentioned by the Agency “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under Section 503B of the FD&C Act is that the outsourcing facility may not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of Health and Human Services (the Secretary) identifying bulk drug substances for which there is a clinical need (the 503B Bulks List (List)) or (2) the drug compounded from the bulk drug substance appears on the drug shortage list in effect under Section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing”..
The Notice provides the FDA’s rationale for not including these two substances on the List for each of these ingredients and described the two question the Agency asks when evaluating the criteria that is essential for forming the Agency’s basis for inclusion on the list:
“1. Is there a basis to conclude, for each FDA-approved product that includes the nominated bulk drug substance, that (a) an attribute of the FDA-approved drug product makes it medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation, and (b) the drug product proposed to be compounded is intended to address that attribute?
2. Is there a basis to conclude that the drug product proposed to be compounded must be produced from a bulk drug substance rather than from an FDA-approved drug product?”
The Agency further discusses the relevance of the answers to these two questions and explains why the two drug substances failed to meet the requirements for inclusion on the List. The FDA has other bulk drug substances under evaluation for inclusion on the list and they will provide their decisions in future Federal Register Notices. The current List of bulk drug substances approved for 503B compounding and those that have been considered and found unacceptable for inclusion on the list can be found here. The issue of compounding using a bulk substance in the case of a documented drug shortage where the drug appears on FDA Drug Shortage list is not impacted if appears on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing.
It is interesting to read the FR Notice as it describes how the FDA performs its consideration of each request for a bulk drug substance nominated for the list and the factors the Agency takes into consideration.
