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compounding

Does Your Pharmacy Offer Compounding? What You Need to Know

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Pharmaceutical compounding is an important part of the care that pharmacy staff provide for patients daily. The United States Pharmacopeia (USP) sets national standards for nonsterile and sterile pharmacy compounding in USP <795> and USP <797> respectively. These standards outline the information needed to compound a safe pharmaceutical product, from training requirements to personal garbing, to beyond-use dates, and more. On November 1, 2022, USP issued major updates to USP <795> and USP <797>. Pharmacies around the country had until November 1, 2023, to put these changes into practice. As a pharmacist, it is important to understand and implement the most updated USP guidelines to ensure the accuracy and safety of all the products the pharmacy generates. Reviewing these major changes will also be critical for pharmacists studying for licensure!

Why where USP <795> and <797> changed?

USP <795> and <797> were updated for the following reasons:

  • To reflect improvement in pharmacy practice and science
  • To provide clarification on information that was commonly misunderstood
  • To integrate ideas from stakeholders

Updates to USP <795> for nonsterile pharmacy compounding

Multiple updates were made to USP <795> including training and personal garbing requirements, specifications for compounding areas, instructions for using master formulation and compounding records, and changes to beyond-use dates (BUDs). The following tables highlight some of the updates to the USP <795> requirements.

BUDs were the biggest change when USP <795> was updated in 2022. Nonsterile compounds are now defined by their water activity instead of being categorized as nonaqueous or water-containing. Water activity (Aw) is used to determine how likely contamination by microbes and/or degradation by hydrolysis is to occur for nonsterile compounded products. Aqueous products have an Aw ≥ 0.6 and nonaqueous products have an Aw < 0.6.

Updates to USP <797> for sterile pharmacy compounding

Many updates were made to USP <797>. The most notable update was a change in the definition of microbial contamination categories for sterile compounded products. This definition change was reflected in many of the other updates including personal garbing, aseptic technique evaluations, and beyond-use dates. Requirements for master formulation records and compounding recorders were also specified. The following tables compare the old USP <797> requirements to the new USP <797> requirements but do not represent all the changes made.

  • Category 1 compounds must be prepared in at least an ISO Class 5 area that is placed in a segregated compounding area. These compounds require the least amount of environmental control.
  • Category 2 compounds must be prepared in a cleanroom and require more control of the environment than category 1 compounds.
  • Category 3 compounds must be prepared in a cleanroom. They undergo additional sterility testing and have added requirements for the area in which they are compounded so that they can have longer BUDs. Those requirements include additional training, sterile garb, cleaning, and monitoring of the environment.
*CRT = controlled room temperature

Putting these changes into practice!

USP <795> and <797> have recently been updated to improve standards of practice in compounding. These changes encompass a wide variety of updates from personal garbing to beyond-use dates. It is important to implement and follow these new guidelines in every pharmacy that provides compounding services for the health and safety of all patients.

Margaret M., APPE Student

References

  1. USP Compounding Standards and Beyond-Use Dates. United States Pharmacopeia. Available at: https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-bud-factsheet.pdf. Accessed August 20, 2024.
  2. USP <795> Key Changes. American Society of Health-System Pharmacists. Available at: https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/compounding/docs/USP-795-Key-Changes.pdf. Accessed August 20, 2024.
  3. USP <797> Key Changes. American Society of Health-System Pharmacists. Available at: https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/compounding/docs/USP-797-Key-Changes.pdf. Accessed August 20, 2024.
  4. <795> FAQs. United States Pharmacopeia. Available at: https://go.usp.org/USP_GC_795_FAQs?_gl=1*3djyew*_gcl_au*MTEyNjE5NjUxMi4xNzI0MTYwODgz*_ga*MTEzMjYzODUzOC4xNzI0MTYwODgz*_ga_DTGQ04CR27*MTcyNDE2MDg4My4xLjEuMTcyNDE2NjU3Mi4wLjAuMA. Accessed August 20, 2024.
  5. <797> FAQs. United States Pharmacopeia. Available at: https://go.usp.org/USP_GC_797_FAQs?_gl=1*xwon9t*_gcl_au*MTEyNjE5NjUxMi4xNzI0MTYwODgz*_ga*MTEzMjYzODUzOC4xNzI0MTYwODgz*_ga_DTGQ04CR27*MTcyNDE3MjQ4NS4yLjAuMTcyNDE3MjQ5MC4wLjAuMA. Accessed August 20, 2024.
  6. Revisions to USP Compounding Standards <795> and <797>. National Community Pharmacist Association. Available at: https://ncpa.org/sites/default/files/2022-11/2022-ncpa-usp-presentation.pdf. Accessed August 20, 2024.

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The Compounding Conundrum of Personalized Medicine

It is no wonder personalized medicine has been taking a rise, after all the one size fits all approach seen in manufactured medicine cannot work for everyone. For patients with unique healthcare needs, compounding can be incredibly useful but the catch is these medications do not actually go through a traditional approval process. Why is that important? It means these medications and products have not been reviewed, studied, and evaluated by a third party regulatory entity such as the Food and Drug Administration (FDA).

Compounding is defined as the process of “combining, mixing, or altering ingredients to create medications tailored to the needs of an individual patient”.1 For example, a patient with allergies to certain ingredients in a medication such as a preservative or dye can receive a modified compounded form instead.1 Another example is a patient who may require an alternate dosage form such as a liquid as opposed to a tablet which is especially prominent in pediatric or geriatric populations.1

Access to compounding services are invaluable for some patients, however, vigilance is critically important in this particular field of practice. In the absence of FDA review and approval, guaranteeing the safety, efficacy and quality of these medications can be tricky… so tricky you might even call it a compounding conundrum. The interactable module below outlines common pharmaceutical ingredients used in compounding.3

In 2012, a Massachusetts pharmacy caused more than 750 infections and more than 60 fatalities across 20 states due to fungal contamination.2 This event would lead to passing of the Drug Quality and Security Act (DQSA) which was officially enacted the following year.2 A prior blog post of ours outlined the need for REMS programs and Why We Can’t Be Hasty When It Comes to Drug Safety, the same is particularly true here as patients can be placed in serious harms way when appropriate measures or precautions are not taken in compounding. The following links below assembled by the United States Pharmacopeial (USP) Convention are highly useful in better understanding appropriate standards for compounding and have been linked below for your convenience: 

The FDA also provides a plethora of compounding guidance and resources found here as it is trying to gain a more involved approach given the recent deaths and news from a lack of quality assurance or sterility in compounded products causing patient harm. For example, there is a federal law that specifies a 5% limit on distribution for out of state drugs compounded by pharmacies and physicians under Section 503A of the FDCA. The FDA plans not to enforce this rule until after states sign and finalize the memorandum of understanding (MOU) as ultimately it is under the state jurisdiction and regulation to oversee compounding pharmacies. 

References

  1. U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Accessed May 6, 2021. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  2. U.S. Food and Drug Administration. Compounding Laws and Policies. Accessed May 6, 2021. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  3. Ansel, HC, Loyd VA. Pharmaceutical Dosage Forms And Drug Delivery Systems. 10th ed. Lippincott-Williams & Wilkins; 2014.

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