A license issued by a state is required in order to engage in the wholesale distribution of prescription drugs in interstate commerce. Under federal law, wholesale distributors must meet requirements for storage and handling, maintenance of records and other personnel requirements. Most states designate the Board of Pharmacy to regulate wholesale distribution; some states have a different regulatory authority.
Many states have strengthened their licensing requirements in recent years, to include additional requirements for surety bonds, background checks, designated representatives and pedigrees, as well as enhancing criminal penalties for knowingly distributing counterfeit products.
The National Association of Boards of Pharmacy in 2004 launched an accreditation program called Verified Accreditation of Wholesale Distributors (VAWD). The VAWD process includes a verification of licensure, an evaluation of policies and procedures and a facility inspection.
HDMA strongly supports tough, rigorous and consistent standards for state licensing of healthcare distributors as required under federal law. Having strong, consistent distributor licensing is a critical component in ensuring that criminals do not infiltrate the supply chain and gain access to prescription medicines. HDMA continues to work with supply chain partners and state and federal officials to develop uniform legislation and regulations pertaining to licensure.
Specifically, HDMA advocates for the following licensure requirements that we believe help deter and prevent the infiltration of counterfeit drugs into clinical practice:
- Stringent application requirements;
- Pre-licensure and regular inspections;
- Surety bonds;
- Criminal background checks;
- Stronger penalties; and,
- Technological solutions to pedigree.