Regulation Update: Two Pharmacy Rules to Prevent Drug Contamination in 2016

By Kenneth Maxik

Since the passage of the Affordable Care Act, the healthcare industry has introduced a number of regulatory changes to improve patient care. In the past year, following a string of deadly compounding errors, such as a New England meningitis outbreak that resulted in 64 patient deaths, many such changes have focused on standardized guidelines for handling, preparing, and storing drugs in a hospital environment. Two rules in particular, USP <797> and USP <800>, published by the U.S. Pharmacopeial Convention (USP), focus on preventing contamination and will require the attention of patient safety experts in 2016.

General Chapter <797> Pharmaceutical Compounding – Sterile Preparations

In 2004, USP published General Chapter <797>, introducing a national standard – enforceable by state boards of pharmacy and other regulatory entities – for patients and staff who engage in compounding. This chapter was revised in 2008, and again proposed changes were released in 2015, to further reduce the risk of contamination. The most recent changes were open for public comment from November 2015 to January 2016, and are now under USP review. If finalized as-is, they will include:

• A broader definition of compounding that’s more inclusive than the current FDA definition –
specifically, the chapter rejects language in the Federal Food, Drug and Cosmetic Act, which states “compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the direction contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with labeling” [21 USC 321 (k) and (m)];
• A new term, “in-use time,” to describe the time before which a manufactured product or a compounded dilution bag must be used after it has been punctured;
• A requirement for master formulation and compounding records for all batch and non-sterile compounding activities, replacing the previous requirement for written compounding procedures and preparation records;
• Additional environmental control requirements, including viable air and surface sampling monthly (previously, USP mandated periodic sampling based upon a risk assessment, but not with a specific regularity) to detect microbial contamination; and
• An increase in staff competency with visual observation of handwashing and garbing techniques, and media fill and fingertip testing conducted quarterly instead of annually (based upon type of compounding being conducted).

While these guidelines may certainly reduce the risk of contamination and compounding errors, hospitals must plan for increased time and cost associated with staff competency and environmental testing.

General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings

In February 2016, USP published USP <800> to define processes for handling hazardous drugs in healthcare settings and to help promote patient safety, worker safety, and environmental protection.
 
The scope of USP <800> extends to all personnel who compound hazardous drug preparations, including pharmacists, nurses, veterinarians, and others, as well as all places where receiving, storing, compounding, dispensing, administering, and/or disposal may occur.

While USP <800> reflects industry consensus practices, many hospitals will face challenges on the path to compliance. Recognizing these difficulties, USP has delayed official implementation to July 2018 to allow entities additional time to meet new requirements related to:
• Facility design, including separate storage areas for certain hazardous drugs that must meet specific pressure and air change requirements;
• Compounding practices, including specifications for the Containment Segregated Compounding Area, or C-SCA (a separate, negative pressure room with at least 12 air changes per hour for use with compounding hazardous drugs); and
• Cleaning, including specific de-activation and disinfection guidelines.

As a result of the new chapter, most facilities will need to change the manner in which they’re preparing and storing hazardous medications both for sterile and non-sterile compounding, and review their HVAC system, refrigeration, and facility design for compliance.

While USP’s most recent changes represent a sizable step toward national drug safety and consistency, experts expect more regulation to promote standardization in the future. For example, In October 2015, CMS posted the Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications to address “accepted pharmacy principles,” such as those set forth by USP – meaning more stringent review by CMS and regulatory bodies related to compliance with USP <797>. Additionally, the FDA is rolling out the Drug Supply Chain Security Act (DSCSA), fully enforceable by 2023, to set forth a national standard for governing the identification, management and traceability of drugs.

Kenneth Maxik is director of patient safety and compliance for CompleteRx and has more than 20 years of pharmacy operations and management experience. Leveraging a deep understanding of the changing healthcare landscape, he works closely with hospitals and health systems across the country to help their organizations stay ahead of current and imminent regulatory standards.