Drug samples: FDA issues policy on distribution amid COVID-19

Regulatory NewsRegulatory News | 08 June 2020 |  By 

The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance explaining the agency’s enforcement of drug sample distribution requirements during the coronavirus disease (COVID-19) public health emergency.
The Prescription Drug Marketing Act of 1987 (PDMA) and its implementing regulations found in 21 CFR part 203 set out requirements for the distribution of prescription drugs by mail or common carrier, including requirements for storage, handling and recordkeeping.
Typically, a physical signature must be captured at the time of delivery by the licensed practitioner or individual at a hospital or pharmacy acknowledging receipt of the samples.
However, FDA says that in the interest of employee and patient safety during the public health emergency, 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, FDA says that manufacturers and authorized distributors must still comply with all other requirements under PMDA and 21 CFR 203.30(c).
FDA also says it will temporarily allow manufacturers and authorized distributors to send drug samples directly to a patient’s home at the request of a licensed practitioner, so long as other requirements for the written request, documentation and recordkeeping are met.
Additionally, FDA explains that licensed practitioners may receive drug samples at their homes, as, “Neither PDMA nor part 203 specifies where a licensed practitioner may receive delivery of requested drug samples,” nor do they specifically prohibit doing so.
The agency says this interpretation “is not anticipated to change following the termination of the [public health emergency]” and that it will issue more permanent guidance on the matter in the future.
FDA notes that the temporary policy apply to distributing drug samples to retail pharmacies, a practice prohibited under PDMA and its implementing regulations.


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