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June 2, 2022 Life Science Consulting

FDA Proposes New Rule for Distribution Compliance

William Present GxP Auditor

FDA has announced the availability of a proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs).

The proposed rule sets standards for federal and state licensure for WDDs and 3PLs.

The draft’s intent is to provide greater assurance that supply chain participants are qualified to distribute prescription drugs to strengthen the supply chain.

Currently the requirements for wholesale drug distributors vary between states. Those requirements and standards for licensure vary on different topics, such as. All this leads to different regulations.

  • The length of time for which records must be maintained
  • Qualifications of facility managers and designated representatives
  • Facility requirements
  • Licensure duration
  • Renewal procedures
  • Exemptions from the definition of wholesale distribution
  • Inspection and approval requirements by specific organizations to receive licensure in certain states

The current version of 21CFR205 is not very extensive and is divided as:

  • 205.1 – Scope
  • 205.2 – Purpose
  • 205.3 – Definitions
  • 205.4 – Wholesale drug distributor licensing requirement
  • 205.5 – Minimum required information for licensure.
  • 205.6 – Minimum qualifications
  • 205.7 – Personnel
  • 205.8 – Violations and penalties
  • 205.50 – Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.

The proposal is much more comprehensive and contains a series of very detailed requirements as:

  • 205.1 – Scope
  • 205.2 – Purpose
  • 205.3 – Definitions

Subpart A—Third-Party Logistics Providers Licensure Standards

  • 205.4 – Requirement that third-party logistics providers be licensed
  • 205.5 – General application requirements for licensure
  • 205.6 – Federal licensure process
  • 205.7 – Changes to information, location, or ownership of a licensed 3PL
  • 205.8 – Expiry and renewal
  • 205.9 – Licensure denial, suspension, reinstatement, revocation, and voluntary termination: notice and opportunity to request a hearing
  • 205.10 – Good storage practices for 3PL facilities
  • 205.11 – Personnel requirements necessary for good storage practices
  • 205.12 – Required written policies and procedures
  • 205.13 – Recordkeeping and document maintenance
  • 205.14 – 3PLs must provide upon request a list of trading partners
  • 205.15 – Requirements for initial and annual reporting to the Food and Drug Administration
  • 205.16 – Inspections

Subpart B—Approved Organizations for 3PLS

  • 205.17 – Use of approved third-party organizations
  • 205.18 – General qualifications of approved organizations
  • 205.19 – Process and procedures for approval by the Food and Drug Administration

Subpart C—Wholesale Distributors Licensure Standards

  • 205.20 – Requirement that prescription drug wholesale distributors be licensed
  • 205.21 – Surety bond requirement
  • 205.22 – General application requirements for licensure
  • 205.23 – Federal licensure process
  • 205.24 – Changes to information, operation, location, or ownership of a wholesale distributor
  • 205.25 – Prohibited persons and qualifications for key personnel
  • 205.26 – National standards for the storage and handling of prescription drugs for wholesale distribution
  • 205.27 – Standards for the establishment and maintenance of records of the distribution of prescription drugs
  • 205.28 – Inspections
  • 205.29 – Requirements for initial and annual reporting to the Food and Drug Administration
  • 205.30 – Licensure denial, suspension, reinstatement, revocation, and voluntary termination—notice and opportunity to request a hearing

Subpart D—Approved Organizations for Wholesale Distributors

  • 205.31 – Use of approved third-party organizations

205.32 – General qualifications of approved organizations

205.33 – Process and procedures for approval by the Food and Drug Administration

Thus, the new Part 205 would implement licensure requirements for Drug Supply Chain Security to further improve security of track trace by providing oversight of licensure of 3PLs and WDDs. Where, 3PL facilities would be required to obtain a 3PL license for each facility. And each WDD would be licensed by the State or the FDA.

Follow the below link for more details https://www.federalregister.gov/documents/2022/02/04/2022-01929/national-standards-for-the-licensure-of-wholesale-drug-distributors-and-third-party-logistics#sectno-reference-205.1



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