How a drug’s place on FDA’s shortage list changes the compounding rules
When FDA lists a drug as in shortage, some federal limits on compounding copies of that drug stop applying; when FDA resolves the shortage, they return. Here is how that works for 503A pharmacies and 503B outsourcing facilities.
The signal
A drug on FDA’s drug shortage list is not treated as commercially available for the section 503A copies limit, and outsourcing facilities may compound copies of an approved drug while it is on the list — flexibilities that end when FDA removes the drug from the list.
Why this matters
Shortage status can open and close the legal room for compounding. Pharmacies, outsourcing facilities and prescribers need to know where a drug stands on FDA’s list, and what happens to orders when a shortage ends.
The 2-minute brief
FDA keeps a public database of drug shortages. That list matters for compounding because federal law restricts making copies of approved drugs — and relaxes some of those restrictions while a drug is in shortage.
For 503A pharmacies, FDA does not treat a drug on the shortage list as commercially available, so the limit on compounding essentially copies does not apply while the shortage lasts. For 503B outsourcing facilities, copies of an approved drug on the list are allowed, including from bulk drug substances.
When FDA resolves a shortage the flexibilities end. FDA has said it may act against outsourcing facilities that keep filling new orders after removal, or existing orders more than 60 days after removal.
What changed
- FDA’s Drug Shortages database lists current and resolved drug shortages and discontinuations and can be searched by generic name or active ingredient.[1, 2]
- Shortages can occur for many reasons, including manufacturing and quality problems, delays and discontinuations.[1]
- Section 503A compounders may not compound regularly or in inordinate amounts drugs that are essentially copies of a commercially available drug product.[5, 6]
- FDA does not consider a drug commercially available while it is on FDA’s drug shortages list, so the 503A essentially-copies limit does not apply in those circumstances; the section’s other conditions still apply.[3, 6]
- Outsourcing facilities generally may not compound drugs that are essentially copies of an approved drug, but that limitation does not apply to copies of an approved drug that is on FDA’s drug shortages list.[3]
- Outsourcing facilities may compound from a bulk drug substance only if it is on FDA’s 503B bulks list or the drug compounded from it is on FDA’s drug shortage list at the time of compounding, distribution and dispensing.[4]
- FDA has said it may take action if an outsourcing facility keeps filling new orders after the approved drug is removed from the shortage list, or fills existing orders more than 60 days after removal.[3]
- FDA has determined that the shortages of tirzepatide injection and semaglutide injection products are resolved.[5]
Who this affects
- 503A compounders
- 503B outsourcing facilities
- Pharmacies
- Prescribers
- Weight-management clinics
What to watch next
Status changes in FDA’s Drug Shortages database for drugs you compound, prescribe or dispense.[2]
FDA statements describing how it will handle the transition when a shortage is resolved.[5]
Full analysis
What the shortage list is
FDA’s Drug Shortages database records current and resolved shortages and discontinuations. Shortages can result from manufacturing and quality problems, delays and discontinuations. It is the authoritative place to confirm a drug’s status.
What changes for 503A pharmacies
Section 503A bars compounding, regularly or in inordinate amounts, drugs that are essentially copies of a commercially available drug product. FDA’s guidance treats a drug on its shortage list as not commercially available, so that limit does not apply while the drug is listed. Every other condition of section 503A — including patient-specific prescriptions — still applies.
What changes for 503B outsourcing facilities
Outsourcing facilities may not compound essentially copies of approved drugs unless the approved drug is on the shortage list, and may compound from a bulk drug substance only if it is on the 503B bulks list or the drug is on the shortage list at the time of compounding, distribution and dispensing.
When a shortage is resolved
The flexibilities end when the drug leaves the list. FDA has said it may take action against an outsourcing facility that keeps filling new orders after removal, or that fills existing orders more than 60 days after removal. FDA has determined that the tirzepatide and semaglutide injection shortages are resolved.
A practical checklist
- Check the drug’s status in FDA’s database and record the date you checked.
- Know which pathway — 503A or 503B — applies to the product.
- Plan for the end of a shortage before it happens.
NPHLA takeaway
Shortage-based flexibility is temporary by design. Build a documented check of FDA’s shortage database into compounding and purchasing decisions, and expect the ordinary limits to return when FDA resolves a shortage. General information, not legal advice.
Source file
- [1]
- [2]
- [3]
- [4]
- [5]
- [6]
Drafted with AI assistance from the sources listed in the Source File, then reviewed and approved by an NPHLA editor before publication. NPHLA links to sources and does not republish their text. Professional information only — not medical, legal or regulatory advice for any individual situation. Our standards.