The FDA issued an immediately effective guidance today titled Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency (here).  This guidance (which will stay in effect until the public health emergency [PHE] is over) will provide additional flexibility for healthcare providers and distributors of record for the provision of samples and the requirements for requesting and documenting receipt of those samples, given the PHE social distancing and stay-at-home orders under the pandemic.

The guidance covers several topics including:

  • Physical Collection of Signatures Upon Receipt of Drug Samples
  • Place of Delivery of Prescription Drug Samples
    1. Delivery to Patient’s Home
    2. Delivery to Licensed Practitioner’s Home
    3. Delivery to Pharmacies

For those of you who provide a sampling option, please read this guidance carefully to assure you do not run afoul of the Prescription Drug Marketing Act (PDMA).  Also, please note that delivery of samples directly to pharmacies is still prohibited, even during the PHE.  While other provisions of this guidance will expire when the PHE expires, the provision related to delivery to pharmacies of drug samples will remain in place under PDMA.