Compounded Topical Pain Creams Review of Select Ingredients for Safety, Effectiveness, and Use (2020) / Chapter Skim
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4 Gaps in Regulation, Oversight, and Surveillance
4 Gaps in Regulation, Oversight, and Surveillance
Pages 63-86
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From page 63... ...
. While FDA's role in overseeing compounding has expanded in recent decades, state entities such as state boards of pharmacy are currently the primary regulators of drug compounding practices (The Pew Charitable Trusts and NABP, 2018)
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From page 64... ...
Throughout this chapter, the committee will provide a brief overview of current regulations for compounded medication compared to FDA-approved medications, as well as highlighting opportunities to address current gaps in the system. FDA Drug Approval Process for Human Prescription and Human Over-the-Counter Drug Products FDA's drug development and approval processes are intended to ensure patients receive safe and effective medications.
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From page 65... ...
Broad use of the drug in patients with other concomitant diseases or patients who are using other medications may lead to adverse events that were not observed in clinical studies. Manufacturers of approved drugs are required to submit regular safety updates to FDA, including results of further studies and individual reports of adverse events from clinicians and the public.
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From page 67... ...
The figure does not offer a complete summary of the complex regulatory framework for all drug products or compounded preparations. Compounding preparations can be made from either bulk drug substances or FDA-approved products that are subsequently modified.
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From page 68... ...
However, Congress has clarified the role FDA plays in regulating compounding in recent decades, under provisions of the FDCA.4 Federal law in the United States establishes two categories of compounding, referred to as "503A pharmacy compounding" and "503B outsourcing facilities." These two categories were created by the Food and Drug Administration Modernization Act of 1997 and the Drug Quality and Security Act of 2013, which added Sections 503A and 503B of the FDCA, respectively. (See Figure 4-1 for a visual description comparing select steps within the statutory and regulatory processes for FDA-approved drugs and compounded preparations.)
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From page 69... ...
Outsourc ing facilities are not exempt from current good manufacturing practice requirements. Unlike 503A compounding pharmacies, 503B outsourcing facilities must report adverse events to FDA and are subject to routine FDA inspections on a risk-based schedule.
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From page 70... ...
On the other hand, there are also greater risks associated with the formulation of large batches of drugs -- such as contamination and s ubpotent/superpotent preparations -- that would affect a much larger group of patients. SOURCES: The Pew Charitable Trusts, 2016a; The Pew Charitable Trusts and NABP, 2018; Federal Food, Drug, and Cosmetic Act.
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From page 71... ...
. Figure 4-2 depicts the geographic distribution of 503B outsourcing facilities across the nation.8 Sections 503A and 503B also place limits on the bulk drug substances (i.e., active pharmaceutical ingredients)
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From page 72... ...
Anyone with sufficient information can nominate bulk drug substances to the lists and anyone may challenge the nomination of a bulk drug substance to either list during a notice-and-comment period. However, until the lists are finalized, FDA's interim policy authorizes facilities to compound any bulk drug substance that has been nominated to the lists with sufficient information for FDA to evaluate the substance in the future, except when FDA has identified significant safety risks related to the use of the substance in compounding (FDA, 2017b,c)
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From page 73... ...
USP standards for compounding were first included in the federal law in Section 503A of the FDCA. State-Level Regulation and Oversight As described in this chapter, while FDA provides some regulations for compounding preparations, state boards of pharmacy retain primary responsibility for the regulation and oversight of 503A compounding pharmacies.
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From page 74... ...
NOTES: At the time of this report, revised versions of select USP chap ters have been published. A discussion of proposed revisions to the published chapters can be found at https://www.usp.org/compounding/ compounding-appeals (accessed April 16, 2020)
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From page 75... ...
These gaps include • Variable inspections of compounding pharmacies and outsourcing facilities, • State-level variability in the oversight of compounding, • Insufficient labeling requirements, and • Insufficient data collection and surveillance of dispensed com pounded preparations (The Pew Charitable Trusts, 2016b)
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From page 76... ...
Furthermore, compounding performed in licensed physicians' offices is not regulated in the same way as 503A compounding pharmacies -- in most states, there is no oversight of this practice by state boards of medicine or pharmacy (NABP, 2017; The Pew Charitable Trusts, 2016a)
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From page 77... ...
. SOURCE: The Pew Charitable Trusts and NABP, 2018.
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From page 78... ...
Insufficient Data Collection and Surveillance The committee encountered difficulty in securing publicly available, accurate data on the use, safety, and effectiveness of compounded preparations in general, and of compounded topical pain creams in particular. It is likely that multiple barriers to data collection contribute to this dearth of evidence (Glassgold, 2013; McPherson et al., 2019)
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From page 79... ...
Owing to the substantial growth in demand for compounded preparations, regulatory gaps remain a high-priority concern. Conclusion 4-2 Surveillance, data collection, and adverse event reporting for compounded topical pain creams are not mandatory in most cases and lack standardization.
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From page 80... ...
Based on current federal law, there is no specific requirements for 503A compounding pharmacies or 503B outsourcing facilities to include safety information or drug warnings on their labels or package inserts. Manufactureres, individuals who compound, and clinicians can report adverse events to FDA via FDA's Adverse Events Reporting System, which can be publicly searched and is subject to analysis.
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From page 81... ...
(see Chapter 7 and Appendix F for a discussion of adverse events associated with the use of compounded topical pain creams)
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From page 82... ...
Compounding Priorities • develop a more flexible, risk-based approach to current good To manufacturing practice requirements for outsourcing facilities, includ ing the establishment of a Center of Excellence on Compounding for Outsourcing Facilities and finalized guidance to help individuals who compound identify insanitary conditions; • restrict compounding of drugs that are essentially copies of FDA To approved drugs; • advance policies related to compounding from bulk drug sub To stances by 503A compounding facilities and 503B outsourcing facili ties, and to develop lists of bulk drug substances; • solidify FDA's partnership with state regulatory authorities in To compounding oversight and regulating interstate distribution of compounded products, with FDA to focus on outsourcing facilities and on the 503A facilities that present the greatest risks; • finalize biological products guidance and clarify other policies on To activities that individuals who compound undertake; and • monitor compliance and take enforcement action when needed. To SOURCES: Gottlieb, 2018; Gottlieb and Abram, 2019.
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From page 83... ...
2017b. Interim policy on compounding using bulk drug substances under section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for industry.
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From page 84... ...
and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs. https://www.fda.gov/news-events/press-announcements/statement fda-commissioner-scott-gottlieb-md-and-deputy-commissioner-anna-abram-new-2019- efforts (accessed April 8, 2020)
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From page 85... ...
U.S. compounding pharmacies market.
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