What Is Patient-Specific Compounding? The Gray Areas May Surprise Pharmacists
A Florida-based compounding pharmacy regularly compounds to “patient profiles,” working from original patient-specific prescriptions to then create compounded doses for patients who fit those profiles—patients who, for instance, might be allergic to certain dyes, or patients who have difficulty swallowing medications in pill form and need a liquid formulation instead. Compounding to profiles of common patient prescriptions saves the pharmacy time, the operator reasons, and also helps his clients help their patients more quickly without having to always wait for a new, specific patient prescription to formulate a common dose.
The only problem? This isn’t patient-specific compounding, even though it is compounding done with specific patients in mind. This compounding pharmacy is no longer considered a “traditional” compounder by the Food and Drug Administration, and may be subject to increased scrutiny and penalties for being out of compliance.1
For a compounding pharmacy to be considered a “traditional” compounder and to be governed under section 503A of the Compounding Quality Act, rather than the more regulation-heavy section 503B, its pharmacists must only compound “patient-specific” prescriptions. It seems like a straightforward proposition—one patient, one prescription—but in situations like the practices of the Florida pharmacy, the FDA’s legal definition of “patient-specific” reveals more nuance. Pharmacists, pharmacy operators and outsourcing facility operators should fully understand how the FDA views patient-specific compounding so they can make sure to stay in compliance.2
What Is the FDA’s Definition of Patient-Specific Compounding?
The Florida compounding pharmacy that is aggregating patient prescriptions and preparing sterile doses in volumes larger than one, might not technically be in violation of the Compounding Quality Act, according to experts who have reviewed the gaps in the legislation. They are likely, however, in violation of the spirit of the FDA’s regulatory framework.
Most observers believe that the FDA means for traditional patient-specific compounding to encompass only the creation of one compounded drug per one patient prescription, a small scale that more accurately mirrors compounding in its form since the beginning of pharmacy practice and ancient Egyptian times. The issues start to arise when pharmacies attempt to any kind of scaling of their practices in order to create efficiency for their business model.3
The lack of specific definitions of scale in the FDA’s laws governing compounding make it difficult to know at what scale a compounder is no longer considered “traditional.” The United States Pharmacopeia guidelines surrounding sterile compounding also do not specify at what scale they should be applied and what scale is too large for the guidelines to adequately ensure safety.
The regulations also do not specifically address in-office compounding, usually done in physicians’ offices to allow physicians access to short-term sterile doses for commonly aggregated patient prescriptions. While this practice has not usually been included in any traditional definition of “patient-specific” compounding, the fact that it isn’t specifically mentioned may lead traditional compounders who do provide these doses to physicians’ offices to believe they are still in compliance despite this practice.4
Where Does This Leave Compounding Pharmacies and Physician In-Office Compounders?
Even with a close reading, very little about either the FDA’s Drug Quality and Security Act or Compounding Quality Act changed the day-to-day operations and regulatory framework for traditional, one-prescription-to-one-patient compounders. The acts also significantly clarified the compliance burden for large-scale manufacturers who do not compound to patient prescriptions at all.
For the pharmacies in between, however, there is not as much clarity as perhaps there should be. Pharmacies that compound for specific prescriptions but not necessarily for the treatment of one patient, use aggregate prescriptions or who might prepare compounds for short-term in-office storage so physicians can have compounds on-hand for patients who fit those profiles do not have any more clarity. The classification of “outsourcing facility,” intended for some of the pharmacies who fall in between a traditional compounder and a manufacturer, remains voluntary for now, and much enforcement still occurs at the state level.
State regulations can also complicate the definition of whether pharmacies are in compliance with “patient-specific” only when compounding for one patient. Not all states even require patient-specific compounding, in opposition to the spirit of the Compounding Quality Act. Other states, including Florida, require special extended scope permits for specific kinds of patient-specific compounding, particularly parenteral or enteral treatments, further clouding the picture for pharmacies.5
Generally speaking, the safest route is the narrowest interpretation of the “patient-specific” description. Pharmacies who may be providing physicians’ offices with doses or compounding to aggregate prescriptions should look into registering as outsourcing facilities if it applies to their situation. They can also begin taking a long look at quality control practices and current good manufacturing practices (CGMP) in anticipation of potential tightening up of federal regulations regarding the type of compounding they practice.
The Government Accountability Office will be required to issue a report within the next year, marking three years since the passage of the Compounding Quality Act and assessing its effectiveness in ensuring drug safety. The report might shed more light on the gray areas surrounding patient-specific compounding, in-office compounding and whether state or federal authority and enforcement will ultimately take precedence on these matters.6
In the meantime, however, responsible pharmacy operators should stay up to date on the regulatory environment and learn whether any of their pharmacy’s practices might put them outside the definition of a “traditional” compounding pharmacy as covered under section 503A of the Compounding Quality Act. If so, it might be a good idea to align quality assurance and quality control, and pay close attention to any FDA updates.
Pharmaceutica North America is a premier provider of high-quality bulk active pharmaceutical ingredients, unit-dose APIs and custom compounding kits. Contact us to learn more about how our products can help you provide the best possible patient care.
- “Ensuring the Safety of Compounded Drugs,” May 21, 2014, http://www.pewtrusts.org/en/research-and-analysis/analysis/2014/05/21/ensuring-the-safety-of-compounded-drugs ↩
- “Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act,” August 2015, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434171.pdf ↩
- “Quality Standards for Large Scale Sterile Compounding Facilities, May 21, 2014, http://www.clinicaliq.com/images/stories/clinicaliq_compounding%20quality%20standards.pdf ↩
- “Regulating Compounding Pharmacies,” May 1, 2014, http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=114 ↩
- “Managing drug therapies in patients receiving enteral and parenteral nutrition,” June 1, 2000, http://www.pharmaceutical-journal.com/learning/learning-article/managing-drug-therapy-in-patients-receiving-enteral-and-parenteral-nutrition/11097109.article; “Special Pharmacy Permit Application and Information,” April 2014, http://floridaspharmacy.gov/Applications/ap_sppermit.pdf ↩
- “The Drug Quality and Security Act–Mind the Gaps,” Jan. 9, 2014, http://www.nejm.org/doi/full/10.1056/NEJMp1314691; “Regulating Compounding Pharmacies,” May 1, 2014, http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=114 ↩