The Impact of New Drug Compounding Standards on Your Practice

Dawn Holcombe, MBA, FACMPE, ACHE
Editor-in-Chief
President, DGH Consulting, South Windsor, CT

On August 31, 2021, proposed revisions to the United States Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding – Sterile Compounding (USP <797>) were published. For several years, different versions of USP <797> have fostered concern and confusion about whether these pharmacy standards apply to (and will impact) the drug preparation and handling that is an integral part of oncology medical practices, as well as other specialties.

Medical Practices versus Compounding Pharmacies

Oncology medical practices deliver chemotherapy treatments to patients through in-office infusions and injections under the direct supervision of physicians as part of the scope of practice of their medical license. Clinical staff members in these practices are trained to prepare, mix, reconstitute, and administer antineoplastic and supportive care drugs that have been approved by the US Food and Drug Administration (FDA) for cancer treatments in the office setting. This is a cornerstone of the care we provide, and patients rely on timely access to these treatments in their community.

Compounding pharmacies—which are regulated under federal and state policies, standards, and laws—combine, admix, dilute, pool, reconstitute, repackage, or otherwise alter a drug or bulk drug substance to create a sterile medication. They do this in a dedicated space, without the added responsibilities of patient treatment administration, monitoring, education, and constant medical assessment and intervention as needed—unlike the medical practices that both prepare and administer treatments.

Do Medical Practices Compound, and Does That Matter?

Under the current USP <797>, it is assumed that medical practices compound sterile products, and therefore fall under USP <797> standards for those who choose to make that application. The current official version of USP <797> was last updated in 2008, and explicitly included language that made the minimum practice and quality standards for compounding of sterile products applicable to all persons and places where such drugs are compounded, including products that are “prepared strictly according to the instructions appearing in manufacturers’ approved labeling (product package inserts).”1

However, the FDA’s definition of compounding is different from the current version of USP <797> for the precise type of drug preparation activities that medical practices perform when they follow FDA-approved package inserts. Under Section 503A of the Federal Food, Drug & Cosmetic Act, 503 A(f) “compounding” is defined as follows2:

As used in this section, the term ‘compounding’ does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.

But now, with the August 31, 2021, publication of the proposed USP <797>, compounding is defined by USP in lockstep with the FDA definition of compounding, which appears to support that what medical practices do is not compounding. Part of the reason for this language is likely because the FDA approval of the drug covers the parameters under which the drug should be prepared, and if the variables of preparation are met by strict compliance with the instructions in the package insert, then the prepared drug meets the FDA criteria for approval for use. Medical practices that do not deviate from approved package insert instructions can then be assumed to have prepared the drug in a safe manner, and thus not acted as a compounder of sterile products (which will have a higher degree of variation and necessary controls).

The proposed USP <797> language under section 1.4 Preparation Per Approved Labeling is as follows3:

Compounding does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.

Preparing a conventionally manufactured sterile product in accordance with the directions in the manufacturer’s approved labeling is out of scope of this chapter only if:

  1. The product is prepared as a single dose for an individual patient; and
  2. The approved labeling includes information for the diluent, the resultant strength, the container closure system, and storage time.

Effect of the New USP <797> Compounding Definition on Medical Practices

The new definition of compounding has tremendous potential, depending on how we prepare our position and reference both the FDA and proposed USP <797> definitions in our own states. USP guidelines and standards are not enforceable in and of themselves but may become enforceable only when another entity chooses to reference them in an enforceable manner. Many states, with involvement from their boards of pharmacy, have referenced USP <797> directly or by using language and phrasing

For years, the National Association of Boards of Pharmacy (NABP) has been exploring whether state boards of pharmacy should take a larger role in inspecting and overseeing medical practices for the handling of drugs. In 2017, the NABP published a lead article in its newsletter, Innovations, which included the following statement4:

In a second compounding-related report issued in 2016, “Best Practices for State Oversight of Drug Compounding,” the Pew Charitable Trusts reaffirmed its conclusion that “quality standards must be the same wherever compounding occurs.” The report noted the importance of having a mechanism to identify and oversee physician office compounding, whether that should occur through the board of medicine or the board of pharmacy. The report’s authors recommended collaboration between NABP and the Federation of State Medical Boards to “identify appropriate oversight systems, whether through state medical boards, state boards of pharmacy, or other appropriate entities.”

What Can Practices Do Now?

The language of the new proposed USP <797> related to compounding may offer opportunities to practices in states where adherence to USP <797> is the strongest. Under the right circumstances, if we can prove that the FDA-approved labels for the drugs we use fit the parameters of the proposed USP <797> label, we have a chance to start a discussion in those states. There are many more variables involved in addressing the challenges and deep-seated perceptions regarding gaps in quality and safety practices in medical offices, but this is a good step forward.

Medical practices can prepare by taking the following steps:

  • Submit comments during the current comment period on proposed USP <797> to express support for Section 1.4 and emphasize that medical practices prepare drugs strictly according to FDA-approved drug package inserts, and thus should appropriately be exempted from the USP <797 and in turn, USP <800> standards for sterile compounding. The proposed chapter and comments submission template may be found at https://www.uspnf.com/notices/general-chapter-797-proposed-revision.
  • Identify the landscape in your own state related to drug compounding, the scope of local pharmacy board reach, and any obvious overtures toward medical office drug oversight.
  • Identify whether and how the term “drug compounding” is defined in state legislation or regulatory policy. I can help with preferred language if you wish to pursue improvements.
  • Learn how you can conduct your own self-assessment to identify potential weaknesses that might present an opportunity for strengthening your internal practices and procedures before challenges come from the outside. I can help with some resources if needed.
  • Determine whether this topic has risen in your state (perhaps in an exploratory discussion during recent board of pharmacy meetings).
  • Communicate with others regarding what you are seeing and what next steps might make sense in your market. Feel free to reach out to me at This email address is being protected from spambots. You need JavaScript enabled to view it. because this is new ground and will require a very delicate balance.
  • You will find that there is an opportunity for collaboration and alignment with the pharmacy community. Patient safety is the primary goal, but there may be various ways to achieve that goal given the different modalities in the medical world versus the pharmacy world.

Conclusions

The tension between the pharmacy regulatory community and the medical community may be misdirected but is sincere out of a desire for patient and product safety by the pharmacy regulators. There are tight parameters for drug handling and safety that are an integral part of the pharmacy community lexicon. It can be frustrating for them to watch different drug handling and safety processes in medical practices because physicians are granted drug administration and treatment under their medical scope of practice.

Collaboration and discussion to explore where oversight of medical drug preparation lies will be the path to an ongoing parallel road for the pharmacy and medical worlds. Burning bridges will not be productive in the long run. We have seen productive relationships develop in some states where the parties at the table started out in opposite corners. It can be done, and the rewording of this proposed USP <797> language around the definition of compounding may be the lynchpin to tempering some of those high tensions.

References

  1. The US Pharmacopeial Convention. USP <797> pharmaceutical compounding—sterile preparations. May 1, 2020. www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-797-rb-notice-20200424.pdf. Accessed September 23, 2021.
  2. US Food and Drug Administration. Section 503A of the Federal Food, Drug, and Cosmetic Act. www.fda.gov/drugs/human-drug-compounding/section-503a-federal-food-drug-and-cosmetic-act. Accessed September 23, 2021.
  3. The US Pharmacopeial Convention. Proposed revisions to USP <797> pharmaceutical compounding–sterile preparations. August 31, 2021. https://go.usp.org/l/323321/20210831/5kmjww/323321/16304645801icecobH/797_PHARMACEUTICAL_COMPOUNDING_STERILE_PREPARATIONS_POST_Revised.pdf. Accessed September 23, 2021.
  4. National Association of Boards of Pharmacy. National reports raise questions about oversight of drug compounding in physician’s offices. Innovations. 2017;46:6-8.

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