Recently, the United States Food and Drug Administration (FDA) issued a policy guidance outlining the agency’s enforcement of drug sample distribution requirements during the COVID-19 pandemic.
Under the Prescription Drug Marketing Act of 1987 (PDMA), requirements for distribution of prescription drugs by mail or common carrier are outlined, including requirements for storage, handling, and recordkeeping. Under those rules, a physical signature must usually be captured at the time of delivery by either the licensed practitioner or individual at a hospital or pharmacy, acknowledging receipt of the samples.
However, with the ongoing COVID-19 public health emergency, the FDA has slightly changed policy in the interest of employee and patient safety. In the guidance, the agency indicates that it “does not intend to take action against a manufacturer or authorized distributor of record that accepts alternate ways of verifying delivery and receipt off drug samples instead of obtaining the signature of the person acknowledging delivery.” However, all other requirements under the PDMA and 21 CFR 203.30(c) still need to be followed.
In the guidance, FDA also said that it will temporarily allow for manufacturers and authorized distributors to send drug samples directly to a patient’s home at the request of a licensed medical provider, as long as certain requirements are met (including a written request, documentation, and recordkeeping).
The guidance also notes that medical providers may receive drug samples at their own homes, as “Neither PDMA nor part 203 specifies where a licensed practitioner may receive delivery of requested drug samples,” nor do the laws or regulations specifically prohibit receipt of samples at residences.
Interestingly, in the guidance, FDA notes that this change in interpretation “is not anticipated to change following the termination of the [public health emergency” and that more permanent guidance on the matter will be issued in the coming months.