FDA Issues Temporary Policy On Distribution Of Drug Samples During COVID-19

In response to the ongoing COVID-19 public health emergency, the United States Food and Drug Administration (FDA) issued a temporary policy related to the distribution of drug samples. Recognizing the unique challenges currently facing manufacturers that distribute drug samples as part of marketing efforts and the healthcare providers requesting those samples for patients, the FDA is temporarily easing certain requirements of the Prescription Drug Marketing Act (PDMA).

Physical Collection of Signatures Upon Receipt of Drug Samples

The PDMA and its implementing regulations allow manufacturers (or their authorized distributors of record) to distribute drug samples to a practitioner licensed to prescribe the drug or, at the practitioner's written request, to the pharmacy of a hospital or other healthcare entity, through mail or common carrier. 21 U.S.C. § 353(d)(2)(A) and 21 C.F.R. 203.30(a). When those drug samples are received, the requesting practitioner must