The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, which aims to create a uniform national licensing standard for wholesale distributors and third-party logistics providers (3PLs). Historically, states have set their own standards for wholesale distributors and 3PLs, causing requirements to vary significantly across states. The proposed rule would require every U.S. wholesale distributor and 3PL to adhere to the same licensure standards. The goal is to improve the security of the drug supply chain and “help protect American consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.” Under the rule, only those licensed according to the national standards would be able to engage in the sale and distribution of prescription drugs. 

Some of the proposed changes include:

• FDA Reporting
  Wholesale distributors and 3PLs must use an electronic system provided by the FDA to report the following information to the FDA for each facility: 
  • The State for which the facility is licensed
  • The facility’s license number
  • The facility’s name and address
  • All trade names under which the facility conducts business.
• Licensure Requirements
  Wholesale distributors and 3PLs must keep their license information current and report any changes that might affect operations such as changes in location or ownership.
• Written Policy and Procedures
  Wholesale distributors and 3PLs must establish, maintain, and follow written policies and procedures for product receipt, security, storage, inventory, shipment, and distribution.
• Recordkeeping and Document Maintenance
  Wholesale distributors and 3PLs will be required to securely store all relevant documents and records for at least three years, while ensuring there are procedures in place to preserve the integrity of the records.
• Standards for Storage
  Wholesale distributors and 3PLs must comply with FDA standards for “good storage practices.” This means that any illegitimate products or other products that are deemed unfit for distribution must be kept separate from saleable products in a clearly defined area until disposal.
• Inspection Procedures
  Wholesale distributors and 3PLs will be required by the FDA to participate in a physical facility inspection prior to issuance of the initial license and then once every 3 years after.
• Personnel Requirements
  Wholesale distributors and 3PLs must set up their facilities so that only personnel with verifiable experience and training have access to areas where products are stored.

These changes will completely reshape licensing requirements and could present significant compliance challenges for wholesale drug distributors and 3PLs. Having the correct counsel that understands the new requirements will be critical in evaluating compliance and proactively preparing for the upcoming changes.

QRCare is a quality and regulatory consultancy service that provides organizations with the support needed to develop and maintain strategic quality and regulatory efforts. Whether they are establishing a system from the ground up, preparing for a supply chain inspection or implementing change control, QRCare offers assistance to customers throughout their quality and regulatory journeys. 

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