Hyman Phelps and McNamara
Drug Supply Chain and Distribution
The legal landscape for the distribution of pharmaceutical products is rapidly evolving. HPM has extensive experience with the multitude of federal and state laws, regulations, and policies affecting clients across the supply chain.

Drug Supply Chain Security Act (DSCSA)
This recently enacted law, also known as Title II of the Drug Quality and Security Act, significantly changes the requirements for the distribution of prescription drugs in the United States. The DSCSA affects entities from throughout the supply chain, including manufacturers, distributors, wholesalers, third-party logistics providers (3PLs), repackagers, and pharmacies. The DSCSA creates a national prescription drug track and trace system that will eventually lead to the implementation of a fully electronic and interoperable system by late 2023. In addition to new track and trace requirements, the DSCSA also creates new licensing and operating standards for wholesalers and 3PLs. HPM has been at the forefront of this laws implementation and advises clients across the supply chain on compliance with its requirements.

Prescription Drug Marketing Act of 1987 (PDMA)
Although the PDMAs impact will be reduced by the enactment of the DSCSA, the PDMA continues to be an important law affecting the distribution of prescription drugs. This law imposes certain regulatory requirements on the distribution of prescription drugs, including the distribution of samples and requirements for storage nad handling of prescription drugs. HPM has advised clients since its enactment on the PDMAs requirements, including licensing, recordkeeping, reporting, security, and labeling.

State Licensing
Every state and territory has enacted a licensing scheme for the distribution of prescription products and will likely continue under the DSCSA. Most states have both resident and non-resident licensing requirements for drug wholesalers, but many also impose licensing requirements for drug manufacturers and 3PLs. In addition, several states have also implemented licensing programs for the distribution of prescription and non-prescription devices as well as non-prescription drugs. Certain states also require distributors to obtain a VAWD accreditation with the National Association of Boards of Pharmacy. HPM has substantial experience advising clients on state licensing requirements and has developed contacts with many state agencies.

Primary Contacts:

Larry Houck

John Gilbert, Jr.

Karla Palmer

Mark Schwartz

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