FDA Proposes Rule to Strengthen Pharmaceutical Supply Chain

FDA recently proposed a rule to provide greater assurance that supply chain participants are sufficiently qualified to distribute prescription drugs, strengthening the pharmaceutical supply chain.

The rule, National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers, required by the Drug Supply Chain Security Act (DSCSA), will clarify and provide consistency for wholesale distributors and third-party logistics providers seeking licensure.

When final, every US wholesale distributor and third-party logistics facility will follow rule standards. And only those licensed according to the proposed national standards can engage in transactions related to the sale and distribution of certain prescription drugs with other supply chain members.  

Current requirements for wholesale drug distributors vary across state lines, creating confusion. And theft and diversion of prescription drugs are public health issues that can endanger patients.

The DSCSA and Congress believe a uniform national standard would address these issues. According to FDA, national standards will help diminish opportunities for criminal conduct affecting the supply of prescription drugs throughout the country.

FDA is also proposing to replace the current 21 Code of Federal Regulations, Part 205, which provides guidelines for state licensing of wholesale prescription drug distributors. When finalized, the new regulation will implement the licensure requirements of the DSCSA and provide oversight of licensure of third-party logistics providers and wholesale distributors.

Provisions of the current regulation include licensure application requirements, personnel requirements and qualifications, recordkeeping and document maintenance requirements, and written policies and procedures.

Additionally, the FDA will revise the procedures surrounding pre-licensure inspection and denial, revocation, suspension of licenses, and the storage and handling of prescription drugs.

A key provision in the proposed rule includes FDA’s revised preemption interpretation of section 585(b)(1) that would apply to state and local licensure standards, requirements, and regulations.

Once the rule is finalized, state and local governments may not establish or continue licensure requirements for third-party logistics providers or wholesale drug distributors unless the conditions are the same as federal requirements.

Chester “Chip” Davis Jr, president and CEO of the Healthcare Distribution Alliance (HDA), released a statement emphasizing that the company is “pleased” that FDA has recognized the need for a uniform licensing framework across all 50 states.

“Healthcare distributors anticipate that once the rules are finalized, they will enhance the security and efficiency of the supply chain and expedite the delivery of vital medicines, vaccines and healthcare products to practitioners, dispensers and, ultimately, the patients who need them,” Davis said.

“HDA looks forward to taking a closer look at the proposed standards to fully understand the requirements and their impact on the supply chain and will provide public comments accordingly,” he concluded.