Investigation
673 hits, 431 documents
The Federal Register is the only public record of what the US government has issued on drug compounding. Searched on the four terms the beat runs on, it returns 673 hits, 431 distinct documents, and 260 that name the FDA. The difference between those three numbers is the story.
Published 13 October 2026Source: federalregister.gov API, retrieved 13 October 2026431 documents
- On 13 October 2026: "compounded drug" 124, 503A 283, "outsourcing facility" 136, "bulk drug substances" 130.
- Summed that is 673. De-duplicated it is 431 documents, because 153 match more than one term.
- Of those 431, 260 list the FDA as an agency. That is the register's compounding footprint as these four terms can see it.
- The weakest term is 503A: 133 of its 283 hits have no FDA involvement, including 33 aviation airworthiness directives and 18 flood-hazard notices.
- Volume is concentrated, not steady: 70 hits in 2015 against 2 in 2011, across a series running 1994 to 2026.
Four terms, and what each one returns
The Federal Register is the published record of what US agencies have actually issued: rules, proposed rules and notices, each with a document number and a permanent link. On 13 October 2026 the four terms the compounding beat runs on returned 673 hits between them.
They are not 673 documents. De-duplicated by document number they are 431, because 153 documents match more than one term. Anyone who sums four term counts and reports the total as a volume of regulatory activity overstates it by roughly a third.
| Search term | Documents | With FDA listed | Share | Years spanned | Document types |
|---|---|---|---|---|---|
| "compounded drug" | 124 | 91 | 73% | 1996 to 2026 | Notice 86, Proposed Rule 21, Rule 17 |
| 503A | 283 | 150 | 53% | 1994 to 2026 | Notice 191, Rule 49, Proposed Rule 37, Correction 3, Uncategorized Document 3 |
| "outsourcing facility" | 136 | 132 | 97% | 2013 to 2026 | Notice 123, Proposed Rule 7, Rule 6 |
| "bulk drug substances" | 130 | 111 | 85% | 1994 to 2026 | Notice 98, Proposed Rule 20, Rule 10, Uncategorized Document 2 |
The term search covers the full text of a document, not its title alone, so a hit may mention the term once in passing. Listing the FDA as an agency is a crude relevance proxy and nothing more; an HHS document without the FDA attached may still concern compounding.
A term count is not a subject count
503A is the clearest illustration. It returns the largest number, 283, and 133 of those are documents with no FDA involvement at all. The top non-FDA agencies behind them are Health and Human Services Department (37), Transportation Department (36), Federal Aviation Administration (33), Federal Emergency Management Agency (18).
The reason is mundane and worth knowing before quoting the number. The string matches aircraft model designations: 33 of the hits are Federal Aviation Administration airworthiness directives about Air Tractor agricultural aeroplanes, the AT-503A among them. Another 18 are Federal Emergency Management Agency flood-hazard determinations, where the string is a map panel reference.
"outsourcing facility" behaves in the opposite way: 132 of its 136 hits list the FDA, a share of 97%, and the term returns no document dated before 2013. A term that did not exist before a date is a useful instrument, because its first appearance is itself a measurement.
Across all four terms, 260 of the 431 distinct documents list the FDA as an agency. That number, not 673, is the size of the register's compounding footprint as these four terms can see it.
The shape over three decades
Counting every hit by year of publication, activity is concentrated rather than steady. The busiest year is 2015 with 70 hits; the quietest in the series is 2011 with 2.
The series is a count of documents, not of regulatory force. A single rule and a single routine information-collection notice are one document each. Reading the rise after 2013 as an increase in regulation would require reading the documents, which this piece has not done.
The most recent FDA documents on the cleanest term
For a reader who wants to start somewhere rather than with 431 documents, these are the five most recent hits on "outsourcing facility" that list the FDA. Titles are the register's own wording.
| Published | Type | Document |
|---|---|---|
| 31 August 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees Document 2026-17676 |
| 30 July 2026 | Notice | Outsourcing Facility Fee Rates for Fiscal Year 2027 Document 2026-15342 |
| 26 May 2026 | Notice | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Document 2026-10372 |
| 1 May 2026 | Notice | List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Document 2026-08552 |
| 23 February 2026 | Notice | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Document 2026-03448 |
Every one of the 673 hits behind this piece is in the dataset with its document number, type, agencies, date and permanent link.
What this cannot show
- No document was read in full. Nothing here describes what any rule requires, what any notice announces, or what the law is.
- A count of documents is not a measure of regulatory activity, burden or enforcement. A routine information-collection notice and a substantive rule count the same.
- Agency attribution comes from the API's own fields. A document concerning compounding that does not list the FDA is counted as non-FDA here, which understates the real footprint.
- Four terms are not the beat. Documents using different vocabulary are invisible to this count, and no attempt was made to find them.
- Counts are a snapshot taken on 13 October 2026 and will not match a later pull.