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# FDA Relaxes Drug Sample Enforcement
- URL: https://www.fdaweb.com/fda-relaxes-drug-sample-enforcement/
- Published: 2020-06-08T12:00:00.000Z
- Updated: 2026-09-14T16:17:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146950

FDA has issued a [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-prescription-drug-marketing-act-requirements-distribution-drug-samples-during-covid?ref=fdaweb.com) entitled “Temporary Policy on Prescription Drug Marketing Act (PDMA) Requirements for Distribution of Drug Samples During the Covid-19 Public Health Emergency.” Under the policy, which is effective during the Covid emergency, FDA says it will not take action against a manufacturer or authorized distributor of record that accepts alternate ways of verifying delivery and receipt of drug samples instead of obtaining the signature of the person acknowledging delivery. FDA also is not enforcing its requirement for drug samples to be sent to the requesting health care practitioner licensed to prescribe the drug, or to a designee at the pharmacy of a hospital or other health care entity.

Additionally, FDA says it understands that many practitioners are not meeting face-to-face with patients, and these licensed practitioners would like to be able to request that a manufacturer or authorized distributor of record send drug samples directly to the identified patient’s home. “At this time, FDA does not intend to take action against a manufacturer or authorized distributor of record that delivers drug samples by mail or common carrier directly to the identified patient’s home during the Covid-19 PHE, provided that: **(1)** the written request executed by the licensed practitioner in accordance with 21 CFR 203.30(a)(1), in addition to information required by the regulation, is for an identified patient of that licensed practitioner who has been designated to accept the delivery of the drug samples as the licensed practitioner’s designee; **(2)** the receipt of the drug samples is documented in accordance with 21 CFR 203.30(a)(3) and (4); and **(3)** the recordkeeping and other applicable requirements under PDMA and FDA regulations under part 203 are met by the manufacturer or authorized distributor of record.”