by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

USP 797 Revisions

USP offers a number of tools for USP 797 revisions, including:

• USP 797 FAQs

• USP 797 Commentary

• USP 797 Open Forum Presentation presented and recorded on November 8, 2022

• USP 797 Open Forum Slides presented on November 8, 2022

CSP Categories

Category 1 CSPs are compounded under the least controlled environmental conditions and assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less when refrigerated (see USP 797 revisions for additional requirements). Category 2 CSPs require more environmental controls and testing and may be assigned a BUD of greater than 12 hours at controlled room temperature or more than 24 hours if refrigerated. Category 2 CSP formulations may not exceed BUD limits established in Table 13 of 797 revisions.

Revisions to USP 797 contain Category 3 CSPs, which offer longer possible BUDs compared to Category 1 and Category 2 CSPs. Category 3 BUDs are found in Table 14 of the revised Chapter 797 (see below).

Category 3 CSPs have a number of additional requirements. For example, Category 3 CSPs must be supported by a stability-indicating assay validated using USP 1225, Validation of Compendial Procedures. The sterile preparation must follow the same ingredients and procedures as the stability assay, as well as packaged using the exact container-closure system and made of the same materials used in the study.

Category 3 CSPs, such as injectables or ophthalmic solutions, must pass the appropriate particulate matter test once for each formulation. Injections must pass particulate testing according to USP 788, Particulate Matter in Injections, while ophthalmic solutions must pass particulate testing according to USP 789, Particulate Matter in Ophthalmic Solutions. Additionally, the container-closure systems used for injections and ophthalmic solutions must pass testing according to USP 1207, Package Integrity Evaluation — Sterile Products, for each formulation. Both Category 2 and Category 3 multidose CSPs must pass antimicrobial effectiveness testing in accordance with USP 51.

ENDOTOXIN TESTING

Category 1 sterile preparations do not require endotoxin testing. Category 2 sterile injectable preparations compounded from one or more nonsterile components and assigned a BUD that requires sterility testing must be tested for endotoxin content in accordance with USP 85, Bacterial Endotoxins. If a Category 2 sterile preparation is compounded from one or more nonsterile components but is assigned a BUD that does not require sterility testing, endotoxin testing is not required; however, endotoxin testing is suggested. Category 3 sterile injectable preparations compounded from one or more nonsterile component(s) must be tested for endotoxin content.

GARBING PRACTICES

Beyond the data and test(s) supporting the formulation, additional requirements exist in the revisions to 797 for everyone entering a buffer room where Category 3 CSPs are prepared. Anyone entering a buffer room where Category 3 CSPs are prepared must follow stricter garbing practices:

• Compounders are not allowed any exposed skin in the buffer room (e.g., face and neck must be covered).

• All low-lint outer garb must be sterile, including the use of sterile sleeves over gauntlet sleeves when restricted access barrier system (RABS is used.

• Once a compounder leaves a classified area, disposable garbing items must be discarded and laundered garb must not be reused without being laundered and re-sterilized with a validated cycle.

• The facility’s SOPs must describe disinfection procedures for reusing goggles, respirators and other reusable equipment.

PCCA offers resources to help pharmacies navigate the changing compounding standards and regulatory environment, including our blog on FDA Insanitary Conditionsand limited USP training courses at eLearning Compounding Training.

PCCA offers additional resources to our members, including all courses offered in our eLearning Compounding Training, multiple online webinars and training sessions and, for members with Clinical Services, Speakers Bureau to guide, assist and educate compounding pharmacy staff. Members with Clinical Services may also contact our Clinical Services team for help with formulas and other compounding concerns.

Part 2 of USP 797: Revisions & Impacts, can be found here.

The complete version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.