USP and FDA Propose Updates to Good Storage and Distribution Practices

August 30, 2022

Updates have been announced by FDA and for USP <1079>. In this blog we cover these changes.

USP

USP <1079> has a series of chapters on Good Storage and Distribution Practices. Chapter <1079> applies to organizations and individuals involved in the storage and transportation of drug products. It describes a risk-based approach to the storage and transportation of finished drug products and risk mitigation strategies.

The chapter formerly entitled "Good Storage and Distribution Practices for Drug Products" is undergoing comprehensive revisions. The current version of the chapter is official as of February 1, 2021. Pharmacopeial Forum, PF 48(3) proposed the revisions with a deadline for submitting comments by July 31, 2022.

Chapter <1079.3> is still available for comments. <1079.3> Temperature and Humidity Monitoring over Time "describes the available technologies and performance characteristics and provides recommendations for qualifying performance. [...] This chapter is being developed to build out the <1079> series of chapters on Good Storage and Distribution Practices."

Divided into the following sections, Chapter <1079.3> contains:

  • Introduction
  • Temperature-measurement devices
  • Electronic time-temperature history recorders
  • Chemical temperature indicators
  • Relative humidity measurement technologies
  • Calibration of temperature- and humidity-monitoring devices
  • The use of historical temperature data
  • Standards for temperature and humidity data reporting
  • References

Chapter <1079.3> provides background information about the science and technology of temperature and humidity monitoring over time. It describes the available technologies and performance characteristics and provides recommendations for qualifying performance. Currently, this topic resides in <1118> Monitoring Devices - Time, Temperature, and Humidity. USP is developing <1079.3> and omitting <1118> to continue their efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices. Outlined is the current plan for the series:

  1. <1079> Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
  2. <1079.1> Storage and Transportation of Investigational Drug Products
  3. <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
  4. <1079.3> Monitoring Devices - Time, Temperature, and Humidity
  5. <1079.4> Qualification of Storage Areas
  6. <1079.5> Qualification of Shipping Systems
  7. <1079.6> Transport Route Profiling Qualification
  8. <1079.7> Information Systems for Distribution Validation/Verification Studies

Draft Chapter <1079.2> proposed changes are to address the utility and application of mean kinetic temperature (MKT) for the evaluation of temperature excursion in controlled room temperature (CRT) and controlled cold temperature (CCT) products. <1079.2> intent is to support the inclusion of the controlled cold temperature definition to Packaging and Storage Requirements <659> and USP's position on the proper use of MKT.

USP is also revising <659> Packaging and Storage Requirements. That draft can be found at <659> Draft.

The revision of Good Storage and Distribution Practices for Drug Products <1079> intent is to identify common risks in the storage and transportation of drug products by recommending mitigation strategies and proper application of MKT.

Additionally, to support the inclusion of the controlled cold temperature definition as well as USP's position on the proper use of MKT, two Stimuli articles give more background and rationale:

  • The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions for Controlled Cold Temperature Drugs
  • Proper and Improper Application and The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions

The USP drafts are available at USP's Website.

FDA

Also, in February 2022, the FDA announced the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs). The proposed rule will set national licensing standards for both federal and state licensure for WDDs and 3PLs. When finalized, the proposed rule should provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain.

Enacted November 2013, the proposal goes back to the Drug Quality and Security Act (DQSA). The DQSA includes, besides others, provisions designed to strengthen the integrity of the pharmaceutical distribution supply chain, including the requirement of the FDA to establish by regulation national standards for the licensure of prescription drug wholesale distributors.

Currently, the requirements for wholesale drug distributors vary significantly across state lines. This creates a patchwork system of regulations. For example, the state requirements and standards for licensure can vary on different topics, such as:

  • 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 certain, specific organizations in order to receive licensure in certain States

This proposed rule would provide clarity and consistency across states for Wholesale Distributors and Third-Party Logistics Providers seeking licensure.

When effective, every U.S. Wholesale Distributors and Third-Party Logistics Providers will be held to these standards. Only those licensed according to the proposed national standards would be able to engage in transactions related to the sale and distribution of certain prescription drugs with other members of the supply chain. Where a state does not have a licensing program in accordance with the regulation, FDA would be the licensing authority. I.e., the National Standards will help diminish opportunities for dangerous and criminal conduct affecting the supply of prescription drugs in the United States, as, theft and diversion of prescription drugs are public health issues that can lead to patient harm. Since, unlicensed wholesale distributors are often involved in incidents of distributed stolen or counterfeit drugs.

As such, FDA is proposing to replace the current 21 Code of Federal Regulations, Part 205 which provides guidelines for state licensing of wholesale prescription drug distributors with a revised, new Part 205. When finalized, the revision will implement the licensure requirements of the DSCSA and provide oversight of licensure of Third-Party Logistics Providers and Wholesale Distributors.

The revisions include:

  • Licensure application requirements.
  • Procedures surrounding pre-licensure inspection as well as denial, revocation, and suspension of licenses.
  • Establishment of 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.

Further information on the background and content of the planned changes can be found in

National Standards for the Licensure of Wholesale Drug Distributors Third–Party Logistics Providers

Drug Supply Chain Security Act (DSCSA)

Drug Supply Chain Security Act Resources for State Officials

Drug Supply Chain Security Act Law and Policies




Life Science Consulting

August 30, 2022

FDA Proposes New Rule for Distribution Compliance

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...

Read More
Quality & Compliance GMP

August 30, 2022

FDA Outlines Policies for Compounding Drug Products That Are Essentially Copies of Approved Drugs Under Section 503B of the FD&C Act

In our preceding FDA News article, we focused on the content of the first draft guidance, which addresses restrictions concerning the compounding of drug products that are essentially copies of...

Read More
Agency Alerts General Regulatory

August 30, 2022

FDA to Establish Pilot Program Under Drug Supply Chain Security Act

FDA will hold a public workshop in early April to discuss a proposed pilot program to enhance the safety and security of the pharmaceutical distribution supply chain. During this workshop, the Agency...

Read More