|Footnotes for this article are available at the end of this page.
The novel Coronavirus Disease 2019 (COVID-19) has introduced new social norms into our daily lives and jobs, from stay-at-home orders to having to wear face masks and social distancing, to maybe never shaking someone’s hand again. As the United States tries to find its “new normal” while dealing with the COVID-19 pandemic, the Food and Drug Administration continues to issue temporary policies to allow industry to continue to safely operate during these uncertain times. On June 8, 2020, FDA issued a guidance for industry titled, “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency,” in order to address questions that the agency has received “regarding FDA’s enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency [PHE].1”
While drug manufacturers typically rely on pharmaceutical representatives to distribute drug samples, FDA recognizes that 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.2” The guidance addresses the agency’s current policy regarding the drug sample requirements set forth by PDMA and 21 C.F.R. Part 203 “related to the collection of physical signatures upon delivery of drug samples [by mail or common carrier] and the ability of licensed healthcare providers to request that drug samples be delivered to various locations during the COVID-19 PHE.” It also confirms that drug samples may not be distributed to a retail pharmacy.
We summarize FDA’s guidance with regard to each of these requirements below.
Physical Collection of Signatures upon Receipt of Drug Samples
PDMA and 21 C.F.R. Part 203 allow for prescription drug samples to be distributed by a manufacturer to a practitioner licensed to prescribe the drug that is to be sampled or, at the written request of a licensed practitioner, to the pharmacy of a hospital or other health care entity, by mail or common carrier as long as certain requirements are met.3 Before a drug sample can be delivered, a licensed practitioner must submit a written request to the manufacturer that contains the name, address, professional title, and signature of the practitioner making the request.4 In addition, the recipient of the drug sample must “execute a written receipt of the drug sample upon delivery, and such receipt must be returned to the manufacturer or authorized distributor of record from which the drug sample was received.”5
When a drug manufacturer delivers a drug sample by mail or common carrier to the licensed practitioner who requested it, the mail or common carrier captures the signature of the licensed practitioner or the person designated by the practitioner to sign on their behalf. Similarly, when drug samples are delivered to the pharmacy of a hospital or other health care entity, the mail or common carrier captures the signature of the person acknowledging delivery.
In the guidance, FDA recognizes that, in order to keep both employees and patients safe during the COVID-19 PHE, some mail or common carriers may be using “alternative ways” of verifying deliveries and receipt of deliveries that require an adult signature, including delivery of drug samples. Therefore, the agency does not intend to take action against a manufacturer that “accepts alternative ways of verifying delivery and receipt of drug samples instead of obtaining the signature of the person acknowledging delivery, provided, however, the receipt obtained by the manufacturer or authorized distributor of record complies with all other receipt requirements in PDMA and 21 C.F.R. § 203.30(c).”
Place of Delivery of Prescription Drug Samples
Delivery to Patient’s Home
Given that many licensed practitioners are not meeting face-to-face with patients during the COVID-19 PHE due to social distancing and for the overall protection of patients and health care providers during the pandemic, FDA does not intend to take action against a drug manufacturer that delivers drug samples by mail or common carrier directly to an identified patient’s home provided that:
- the written request executed by the licensed practitioner in accordance with 21 C.F.R. § 203.30(a)(1), in addition to the information requested by the regulation, is for an identified patient of that licensed practitioner who has been designated to accept delivery of the drug samples as the licensed practitioner’s designee;
- the receipt of the drug samples is documented in accordance with 21 C.F.R. § 203.30(a)(3) and (4); and
- the recordkeeping and other applicable requirements under PDMA and FDA regulations under Part 203 are met by the manufacturer or authorized distributor of record.
Delivery to Licensed Practitioner’s Home
FDA notes that neither PDMA nor 21 C.F.R. Part 203 specifies where a licensed practitioner may receive delivery of requested drug samples. Therefore, manufacturers may deliver drug samples to the licensed practitioner’s home, provided that the licensed practitioner executes and submits a written request to the manufacturer or authorized distributor of record for the delivery of the drug samples to their home being used as an office, and all other applicable provisions in 21 C.F.R. Part 203 are met.
This interpretation of PDMA and 21 C.F.R. Part 203 “reflects FDA current thinking” and is not expected to change following the termination of the COVID-19 pandemic. The agency also plans to address this issue in a future guidance after the termination of the PHE.
Delivery to Pharmacies
PDMA and 21 C.F.R. Part 203 do not allow for drug samples to be distributed to retail pharmacies.6 FDA notes that no changes in policy regarding these requirements are being implemented during the COVID-19 PHE. Under 21 C.F.R. § 203.30, a drug sample may be distributed to the pharmacy of a hospital or other health care entity at the written request of a licensed practitioner.
- While FDA is relaxing some of the requirements for the distribution of drug samples, drug manufacturers must still meet strict recordkeeping requirements when delivering drug samples by mail or common carrier.
- FDA recognized that health care practitioners may continue to use telemedicine to meet with patients even after the pandemic is over, and took the opportunity to clarify that PDMA and 21 C.F.R. 203.30 do not prohibit the delivery of drug samples to a doctor’s home office, provided that certain requirements are met. However, the agency noted that it will issue additional guidance on this issue after the COVID-19 PHE is terminated. This could signal that FDA may be considering additional requirements when shipping drug samples to a health care practitioner at an alternate office location.
- Given FDA’s emphasis on recordkeeping, we expect that once FDA resumes normal inspection activities, the agency will be paying close attention to the records for any drug samples distributed during the COVID-19 PHE.
- As with the numerous guidance documents issued by FDA during the pandemic, these policies are being implemented immediately without prior public comment; however, they remain subject to comment in accordance with the Agency’s good guidance practices. The policies, with the exception of the one allowing delivery of drug samples to a practitioner’s home office, will only remain in place for the duration of the PHE.
 The guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-prescription-drug-marketing-act-requirements-distribution-drug-samples-during-covid
 Id. at 3.
 Id. (citing 21 C.F.R. § 203.30(a),(b)).
 Id. at 3-4 (citing 21 C.F.R. § 203.30(a)(3),(4)).
 See FD&C Act § 503(d)(1), (2)(A) (21 U.S.C. § 353(d)(1)); see also 21 C.F.R. § 203.30(a). Pursuant to 21 C.F.R. § 203.30(a), a manufacturer or authorized distributor of record may distribute a drug sample to a practitioner licensed to prescribe the drug that is to be sampled or, at the written request of a licensed practitioner, to the pharmacy of a hospital or other health care entity. Health care entity is defined in 21 C.F.R. § 203.3(q) to mean any person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy or any wholesale distributor.