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# FDA Updates Compounder PPE Guidance
- URL: https://www.fdaweb.com/fda-updates-compounder-ppe-guidance/
- Published: 2020-05-14T12:00:00.000Z
- Updated: 2026-09-14T16:14:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146791

FDA says it has updated its [guidance](https://www.fda.gov/media/136841/download?ref=fdaweb.com) for pharmacy compounders who experience shortages due to the Covid-19 public health emergency of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. An agency [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=332976&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=268cd7877d9a409f82ca95eaf896d201&elqaid=12544&elqat=1&ref=fdaweb.com) says the update clarifies that drugs can be compounded under the policy in a segregated compounding area that is not in a clean room when specific beyond-use dates are used.

The dates are up to 12 hours for products stored at room temperature and up to 24 hours for products stored refrigerated. “These beyond-use dates aim to reduce the risk of contamination,” the notice says.

FDA says it adopted the policy to help assure patient access to needed medicines and to reduce the risks of compounding when standard PPE is not available.

“FDA wants to ensure that healthcare professionals are aware of this guidance and the potential for greater contamination risk when compounding drugs are prepared without standard PPE or within segregated compounding areas,” the notice concludes. “FDA encourages healthcare professionals who purchase compounded drugs to engage with compounders to balance these risks and the need for compounded products for patient care.”