US Pharmacopeia (USP) 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 1st, 2021. Pharmacopeial Forum, PF 48(3) proposed the revisions with a deadline for submitting comments by July 31st, 2022.
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. Chapter <1079.3> Temperature and Humidity Monitoring over Time is still available for comments and describes the available technologies and performance characteristics and provides recommendations for qualifying performance. 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:
- <1079> Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
- <1079.1> Storage and Transportation of Investigational Drug Products
- <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
- <1079.3> Monitoring Devices – Time, Temperature, and Humidity
- <1079.4> Qualification of Storage Areas
- <1079.5> Qualification of Shipping Systems
- <1079.6> Transport Route Profiling Qualification
- <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.
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