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# FDA Compounding Drug Updated Guidance
- URL: https://www.fdaweb.com/fda-compounding-drug-updated-guidance/
- Published: 2020-04-08T12:00:00.000Z
- Updated: 2026-09-14T16:10:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146518

FDA has posted online updated guidance on drug compounding activities during the Covid-19 pandemic. The [document](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/compounding-activities-covid-19?ref=fdaweb.com) explains four policy clarifications: 

- agency guidance for hospitals and health systems including the “one-mile radius” provision is still in draft and FDA will issue a revision;
- FDA does not plan to enforce the 5% limit in federal law on the interstate distribution of compounded drug products for pharmacy compounders until after the agency has finalized a memorandum of understanding, currently in draft form, and allowed states to sign it;
- FDA does not consider drugs that are on its shortage list or that have been discontinued and are no longer marketed as “commercially available” under the “essentially a copy” provision for pharmacy compounders; and
- FDA does not consider a compounded drug produced by an outsourcing facility as “essentially a copy” if it is identical or nearly identical to an FDA-approved drug that is on the agency’s drug shortage list.