Essentials of in-office compounding
In Practice
By Faiza Wasif, MPH, practice management manager and Natasha Pattanshetti, JD, MPH, regulatory policy manager, June 1, 2018
As a dermatologist, you have probably compounded medications at some point during your clinical career. Skin conditions, such as acne, psoriasis, and warts, are often successfully treated using compounded medications. When compounding medications (i.e., preparing not according to a manufacturer’s labeling) for these conditions, dermatologists should be aware of the important federal and state regulations affecting you as prescribers, compounders, and administerers of compounded medications.
The August 2017 article in Dermatology World (staging.aad.org/dw/monthly/2017/august/dos-and-donts-of-in-office-compounding) references the prohibition against compounded drug products that are essentially copies of a commercially available drug product. This prohibition is in the Drug Quality and Security Act (DQSA) of 2013, which Congress passed in response to a fungal meningitis outbreak caused by contaminated compounded sterile injections. In January 2018, the Food and Drug Administration (FDA) issued final guidance (www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf) implementing this legislative prohibition. The FDA explained that compounded medications serve an important need only when FDA-approved drug products are not available since compounded medications have not undergone FDA premarket review for safety, effectiveness, and quality, and pharmacists and physicians are not subject to current Good Manufacturing Practices (cGMPs).
This final guidance describes the FDA’s thinking in implementing this prohibition and how it affects medical and pharmacy practice. When determining whether prescribing or compounding a drug product is allowed, dermatologists should consider the following:
1. Is the drug you are compounding commercially available? If it is not, then it is not subject to this final guidance and can be compounded.
- Compounding is allowed where the reference drug is no longer marketed, discontinued, or on the FDA drug shortage list (www.accessdata.fda.gov/scripts/drugshortages/default.cfm). If it is on the FDA drug shortage list, write on the prescription that it is in shortage and the date the drug shortage list was checked (e.g., lidocaine with epinephrine).
2. Is the drug essentially a copy? If it is not essentially a copy, it can be compounded. If it is essentially a copy, you need to determine whether an exemption applies by assessing the following:
- The compounded drug does not have the same active pharmaceutical ingredient(s) (API) as the commercially available drug product.
- The compounded drug’s API(s) does not have a similar or an easily substitutable dosage strength, which is defined as within 10% of the dosage strength of the commercially available drug product.
- The compounded drug’s API(s) does not have a combination of two or more commercially available drug products that are within 10% of the strengths of the commercially available drug products.
- The compounded drug does not have the same route of administration as the commercially available drug product.
An exception applies to the factors above so that compounding is allowed when the prescriber makes a determination that a change is being made for an identified individual patient that makes a “significant difference” from the commercially available drug product. If applicable, then the prescriber should document on the prescription the significant difference (e.g., “Pt allergic to X inactive ingredient). Unfortunately, cost alone is not sufficient for this exemption to apply.
3. Is this an unanticipated and emergency circumstance? Even if a compounding drug is essentially a copy of a commercially available drug and would otherwise be prohibited to be compounded, it may be compounded when unanticipated and in emergency circumstance as long as this is not done regularly or in an inordinate amount. Congress and the FDA recognize the need for access in this scenario.
Forthcoming regulation of in-office preparations
In addition to the essentially copies prohibition, Congress prohibited compounding under “insanitary conditions” in the DQSA. Physician offices are considered “compounding facilities” subject to FDA’s oversight when medications are prepared in the clinical setting not in accordance with manufacturer’s labeling. In its 2018 Compounding Policy Priorities Plan (www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm592795.htm), FDA shared its plan to publish revised draft guidance for stakeholder comment that will “address concerns raised by some providers who compound small quantities of drugs in their offices for patient use, and as part of their routine clinical practice. This came up in the setting of certain dermatological procedures, for example.” The AADA advocated —and FDA is acknowledging — that the mixing of drugs performed by physicians in low volumes is of negligible risk and should not be subject to the same equipment and process standards as larger compounding operations.
The U.S. Pharmacopeia (USP), an independent, standard-setting organization, is currently revising its Chapter 797 Pharmaceutical Compounding — Sterile Preparations, which will affect in-office preparations, such as buffered lidocaine, diluted kenalog, and reconstituted botulinum toxin (when the manufacturer’s labeling is not followed). Your state pharmacy boards may adopt this chapter, which may affect your preparation of these drugs. The draft revisions will be published for stakeholder comment later this year and are scheduled to be finalized on Dec. 1, 2019. The AADA and other medical specialties and subspecialties are pushing for an exemption from the requirements that will allow in-office preparations to be prepared ahead of time so that clinic flow is not adversely impacted and medical waste is not created.
Additional DermWorld Resources
Sidebar
Compounding conundrum
Learn more about the regulation of and advocacy efforts on in-office preparations as well as office-use compounded medications and the Section 503A Bulk Drug Substances List in the March 2018 issue of Dermatology World at staging.aad.org/dw/monthly/2018/march/the-compounding-conundrum.
Forthcoming regulation
To learn more about the FDA’s 2018 Compounding Policy Priorities Plan, visit www.fda.gov/DrugsGuidanceComplianceRegulatoryInformation.
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