The Food and Drug Administration (FDA) announced its temporary policy regarding requirements under the Prescription Drug Marketing Act (PDMA) and implementing regulations in 21 CFR Part 203 related to the collection of physical signatures upon delivery of drug samples and the ability of licensed health care providers to request that drug samples be delivered to locations other than the provider’s office during the COVID-19 pandemic.
The guidance goes into effect immediately without prior public comment, but it is subject to comment in accordance with FDA’s good guidance practices.
Rationale During the COVID-19 pandemic, manufacturers that use drug samples as part of their marketing programs have been relying more on mail and common carriers rather than sales representatives to deliver drug samples. Manufacturers have sought guidance from FDA relating to the collection of signatures upon receipt of samples and alternate places for delivery of drug samples.
Physical Collection of Signatures Upon Receipt of Drug Samples
Currently, manufacturers are permitted to distribute drug samples to a licensed practitioner or, at the practitioner’s written request, to the pharmacy of a hospital or other health care entity by mail or common carrier, provided that certain conditions are met, including:
- The practitioner submits a written request for drug samples to the manufacturer or authorized distributor of record that contains the name, address, professional title and signature of the practitioner.
- The practitioner signs a receipt for delivery of samples that includes the name, address, professional title and signature of the practitioner or designee.
- If the drug samples are delivered to the pharmacy of a hospital or other health care entity at the request of a practitioner, the receipt must contain the name, address, professional title and signature of the person acknowledging delivery of the drug samples.
FDA acknowledges that the business practices of some manufacturers involve the use of other parties, such as mail delivery or common carriers, to assist in the distribution of their drug samples and that during the COVID-19 pandemic, these delivery services may be using alternate ways of verifying deliveries and receipt of deliveries, including deliveries of drug samples, that would normally require an adult signature.
FDA will not take action against a manufacturer or authorized distributor that accepts alternate ways of verifying delivery and receipt of drug samples instead of obtaining the signature of the person acknowledging delivery, provided, however, the written receipt complies with existing FDA requirements.
Place of Delivery of Prescription Drug Samples
During the COVID-19 pandemic, state or local stay-at-home orders and social distancing recommendations have impacted how practitioners are providing care and consultation. In response to these changes, FDA announced a temporary policy regarding enforcement of the requirement that drug samples 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.
Delivery to Patient’s Home
Many practitioners are not meeting face-to-face with patients during the COVID-19 pandemic and would like to request that a manufacturer or authorized distributor send drug samples directly to a patient’s home. FDA does not intend to take action against a manufacturer or distributor that delivers drug samples by mail or common carrier to a patient’s home during the COVID-19 pandemic, provided that:
- The written request by the practitioner complies with PDMA regulations and is for an identified patient of that practitioner who has been designated to accept delivery of the drug samples as the practitioner’s designee.
- The receipt of the drug samples is documented in accordance with PDMA regulations.
- The record-keeping and other applicable requirements under PDMA regulations are met by the manufacturer or distributor of record.
Delivery to Licensed Practitioner’s Home
FDA recognizes that practitioners may be practicing telemedicine from their homes and believes that neither the PDMA nor its implementing regulations prohibit the delivery of drug samples to the practitioner’s home, provided that the practitioner executes and submits a written request to the manufacturer or distributor for the delivery of the drug samples to their home office and all other applicable provisions in Part 203 are met. This interpretation reflects FDA’s current thinking and is not anticipated to change following termination of the COVID-19 pandemic. FDA intends to address this issue in future guidance, and any changes will be based on comments received on this guidance and FDA’s experience with implementation.
Delivery to Pharmacies
Under the current PDMA and implementing regulations, drug samples cannot be distributed to a retail pharmacy, and the COVID-19 guidance does not change these requirements. A drug sample may be distributed to a pharmacy of a hospital or other health care entity at the written request of a licensed practitioner, however.