What Do Compounding Pharmacies Need to Know About the New USP ?
At a recent regional chapter meeting for a major compounding pharmacy association, a speaker showed an animation of colorful balls bouncing into a bucket. “Count how many red ones go into the bucket,” she instructed the audience.
The balls slowly bounced from the sides and dropped into the bucket, first one at a time, then two, then three, until suddenly it was impossible to follow the red bouncing balls in the sea of other colors, balls moving so quickly that the audience’s eyes darted everywhere on the screen.
The demonstration was meant to illustrate how easy it can be to lose track of crucial regulatory information as a compounding pharmacy operator. The different balls could easily represent various proposed Food and Drug Administration final rules, compliance deadlines, legislative updates, state-level guidances, chapters and updates from United States Pharmacopoeial Convention, or any number of pieces of regulatory information a pharmacy operator needs to track.
Which ones are “red” and important? What’s legally binding? What needs to be implemented by when?
With so much to follow already, the recent formal approval of USP General Chapter <800> on hazardous drugs throws yet another bouncing ball into the mix and has crystallized the concerns of some in the pharmaceutical industry that too much is in flux at a crucial time for compounding pharmacies.1
What does USP <800> Cover and How Does it Affect Compounding Pharmacies?
Taken alone, USP <800> is not a dramatic departure from any existing guidance in other chapters that cover compounding. The chapter builds on existing industry consensus practices to present a more comprehensive guide on the handling of hazardous drugs in healthcare settings.
USP <800> builds on information from general chapters <795> and <797> on non-sterile and sterile compounding and is designed to protect healthcare workers who may handle hazardous materials. At a glance, the chapter:
- Works from the premise that no “acceptable” level of exposure to hazardous drugs exists
- Prioritizes the use of adequate personal protection equipment and engineering controls
- Uses the National Institute for Occupational Safety and Health (NIOSH) definition of a hazardous drug, based on carcinogenicity, teratogenicity, developmental toxicity, genotoxicity, organ toxicity at low doses in humans or animals, or reproductive toxicity in humans.
- Covers receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, altering, counting, crushing or pouring of hazardous drugs.
- Will be officially implemented on July 1, 2018.2
Where USP <800> complicates things for compounding pharmacies is by adding yet another layer of regulatory framework during an already-complex time for compounding pharmacists.
Simultaneous updates to USP general chapter <797> on sterile compounding actively rejected language in the FDA’s Drug Quality and Security Act related to whether “mixing, reconstituting, or similar acts…performed in accordance with direction…provided by the product’s manufacturer” constituted compounding. The FDA’s Food, Drug and Cosmetic Act stated that those activities do not add up to compounding, whereas the USP stated that they do.
As American Pharmacists Association Director of Regulatory Affairs Jillanne Schulte told Pharmacy Today magazine, “We are concerned that once everything settles, we’ll have to look at <800> and make another set of revisions to harmonize everything.”3
How to Incorporate USP <800> Into Your Regulatory Compliance Plan
Compounding pharmacies and all healthcare providers who handle hazardous materials will need to be in compliance with the new chapter by July 2018. The additional time prior to implementation will help providers overcome potentially significant challenges on the road to implementation, including:
- Facility design: Storage areas and containers for certain types of hazardous will be required to conform to air change and air pressure specifications. Some pharmacies will have trouble adapting existing facilities and may need new configurations.
- Environment: HVAC systems and refrigeration systems will need to be in compliance, which could mean extensive checks and even reworking of these systems.
- Cleaning: The new chapter includes specific information on de-activation and guidelines on disinfection.
Industry experts also expect further standardization aimed at a national regulatory system for drug safety and consistency. Compounding pharmacy operators should be aware of this legislative trend and stay up to date on the latest. This includes the FDA’s Drug Supply Chain and Security Act (DSCSA), designed to create a national standard for identifying, managing and tracing drugs. The Act is planned to be in place and enforceable by 2023.4
For compounding pharmacy operators concerned with losing track of all these bouncing balls, a broad framework for staying informed could be an information system built like a funnel:
- At the top, federal level regulatory framework: This would certainly include the Drug Quality and Security Act, the Compound Quality Act and all proposed and final rules related to both, as well as upcoming legislation like the DSCSA.
- Next, state-level legislation: In the historical absence of a federal-level regulatory system, many compounding-related laws and guidelines are at the state level. While the FDA’s Memorandum of Understanding (MOU) with many states gives precedence to the developing federal laws, not all existing state laws have been defined at the federal level. You must know your local laws. Working with a regional or state chapter of a national compounding association can help.
- Next, what’s legally binding: Not all guidelines or rules are legally binding, or won’t be legally binding until a future date. It’s a good idea to build major dates into your 5- and 10-year plan, and revisit those plans annually to update milestone dates.
- At the bottom, what’s good practice even if it’s not legally binding: Some suggestions or industry best practices are simply good business and good practice even if they are not required by law. Which ones make sense for your pharmacy will vary depending on your size, role and client mix, but it can often lead to better quality and service if you treat the best guidelines as if they were the letter of the law.
USP General Chapter <800> represents a step in the regulatory framework many industry observers predicted, and the aim of protecting healthcare workers during handling of hazardous drugs is, of course, a laudable goal. We should all aim for the highest possible safety standards for our pharmacists and other staff.5
As another bouncing ball to follow in the regulatory picture, however, USP <800> represents an additional burden and further distortion of that regulatory picture for some in the compounding pharmacy industry.
The future likely holds only more action in all areas of compounding regulation, so it will be crucial for the compounding pharmacy operator to become highly informed about potential new requirements down the road.
Pharmaceutica North America is a premier provider of high-quality active pharmaceutical ingredients to compound pharmacies and compound manufacturers. Contact us to learn more about how our APIs and custom compounding kits can help your pharmacy provide the best possible compound medications.
- “Safe handling of hazardous drugs: USP publishes new chapter <800>,” March 22, 2016, https://www.pharmacist.com/safe-handling-hazardous-drugs-usp-publishes-new-chapter#main-content ↩
- “General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings,” accessed April 4, 2016, http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings ↩
- “Safe drug handling,” ibid. ↩
- “Regulation Update: Two Pharmacy Rules to Prevent Drug Contamination in 2016,” March 21, 2016, http://www.infectioncontroltoday.com/articles/2016/03/regulation-update-two-pharmacy-rules-to-prevent-drug-contamination-in-2016.aspx ↩
- “USP <800> What you need to know…” accessed April 4, 2016, http://c.ymcdn.com/sites/www.pssny.org/resource/resmgr/USP_800_presentaton_to_PSSNY.pdf ↩