[Blog] FDA proposed rule for licensing of wholesalers and third-party logistics
The proposed rule is one of the critical pieces of DSCSA
At the beginning of February, FDA announced the release of the rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers (Docket No. FDA-2020-N-1663) as required by Drug Supply Chain Security Act (DSCSA). The proposed rule is one of the critical pieces of DSCSA, assuring that only those wholesaler drug distributors and third-party logistics providers licensed according to national standards will engage in transactions, sale and distribution of certain prescription drugs with other members of the supply chain.
In which area are national standards aimed to help?
The core task of national standards is to reduce the risks of dangerous, illegally and/ or unregulated distribution of prescription drugs in the United States. The proposed rule for licensing will diminish the distribution of stolen or counterfeited drugs, requiring compulsory licensing of the wholesalers and third-party logistics.
What are the proposed provisions?
The National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers will replace the current 21 Code of Federal Regulations, Part 205, proposing the requirement of the following provisions:
- Licensure application requirements
- Procedures surrounding pre-licensure inspection as well as denial, revocation, and suspension of licenses
- Establish standards for the storage and handling of prescription drugs, including facility requirements and security, inventory management, and equipment maintenance.
- Personnel requirements and qualifications
- Recordkeeping and document maintenance requirements
- Requirements for written policies and procedures
Key provision – FDA is to revise the preemption interpretation of section 585 (b)(1) that would apply to state and local standards, requirements and regulations for licensing.
Which will be the licensing authority if the state does not have a licensing program?
In such cases, when a state does not have a licensed program according to the regulation, the FDA will be the licensing authority.
FDA published information about an upcoming webinar regarding the topic that will provide an overview of the proposed rule and will assist all stakeholders.