Hyman Phelps and McNamara Hyman Phelps and McNamara
PDMA and State Licensing
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The Prescription Drug Marketing Act

The Prescription Drug Marketing Act (PDMA) as implemented under the federal FD&C Act imposes certain regulatory requirements on distribution of prescription drugs including the distribution of samples and formulation of drug pedigrees. Some of the functions required under the PDMA are specifically implemented at the state level. HPM advises clients on compliance with these requirements at the federal and state level which includes licensing, recordkeeping, reporting, security, and labeling.

State Licensing

The majority of states have implemented in-state and non-resident licensing requirements for companies that manufacture, distribute and sell prescription and non-prescription drugs and medical devices. Many states now impose specific drug pedigree requirements as well. HPM has assisted clients in determining which licenses are required and in obtaining the appropriate authority to distribute drugs in each state.

Primary Contacts:

Anne Marie Murphy

Larry Houck

John Gilbert, Jr.