The age-old process of compounding medications may have been around for decades, but it’s never been more important to understand the rules and regulations governing safety and quality assurance.
This was precisely the focus of the July 2018 Journal of Drugs In Dermatology (JDD) supplement in which the authors construct an ‘algorithm’ for navigating different types of compounding support based on prescriber needs.
Why was this necessary? Since the Drug Quality and Security Act (DQSA) of 2013 was released, guidelines and regulations categorizing the compound industry have become more complex causing many physicians to avoid the practice altogether out of fear of liability.
However, as the JDD authors point out, “compounding serves an important role in the field of medicine” by making custom medical solutions available to patients in need – avoiding the practice is not sustainable. Instead, education is the key.
In light of this important topic, our pharmacy network is helping physicians become informed so they can mitigate risks, protect patients and fully understand how to provide compounded solutions that comply with contemporary standards.
First, how did we get here?
In 2012, contaminated compounded medications produced by the New England Compounding Center infected 800 people with fungal meningitis resulting in 76 fatalities. The DGSQA was an essential response to this catastrophe and it was a wakeup call for the industry and regulators. Tighter controls, safety measures, supervision, regulation, and quality control was critical.
New definitions for 503A and 503B pharmacies
DQSA came in the wake of this tragic event, allowing amendments to the Federal Food, Drug, and Cosmetic Act which would better define types of compounding pharmacies and the oversight they need to protect patients. In summary:
- 503A Compounding Pharmacies: Still operate like a traditional pharmacy and compound patient-specific prescriptions with a more direct relationship to care and physician support. Overseen by state boards and must meet other stringent requirements.
- 503B Compounding Pharmacies: Are categorized as outsourcing facilities due to their scale of operations. They can compound large volumes of compound medications that are not tied to patient prescriptions. Due to their scale, they must meet additional FDA oversight. This is not a perfect process and 483 warning letters are on the rise.
Quality assurance and 483 warning letters
Running a 503B compounding pharmacy and complying with additional CGMP requirements under the FDA is costly. All 503B must register with the FDA and undergo inspections but many do not but continue to keep their doors open. Those that do undergo inspection are often failing inspection or falling under scrutiny with 483 warning letters. 483 warning letters are public information and issued by the FDA with a list of observations and violations. All are publically available.
Quality assurance in compounding: What this looks like in practice:
- What we (VLS Pharmacy) is: A registered 503A Pharmacy
- What that means: We have the capacity to offer tailored, patient-first approaches with personalized attention to the prescriber and patient while providing safety and quality assurance at an exemplary standard. Smaller facilities with expert pharmacists mean tighter controls from start to finish.
- Where we source our active ingredients: All of our active pharmaceutical ingredients (APIs) are sourced from the Pharmacy Compounding Centers of America (PCCA) where we can access over 8,000 pre-tested and verified formulas. PCCAs APIs are sourced from FDA-approved facilities with material safety data sheets (MSDS) and certificates of analysis (COA) that trace the API, and support purity and potency levels.
- What else? As a 503A pharmacy, we are also subject to individual state board regulations and must comply with relevant United States Pharmacopeia (USP) chapters or the National Formulary (NF) monograph. We comply with USP <797> for sterile compounding and USP <71> and <81> for compliance with in-house sterility and antimicrobial assay testing.
- How we go the extra mile: We are members of the PCCA, the International Academy of Compounding Pharmacists (IACP) and UCAP and UCM – an elite network of compounding pharmacies that have passed additional compliance and audit requirements. Making the investment to safeguard our prescribers and guarantee patient safety is our number one priority.