What is a 503B or 503A compounding pharmacy, and why should you care about understanding the difference?
Whether you have been actively working with a compounding pharmacy, or you’re just beginning to search for a facility to work with, understanding this distinction is important. The landscape is changing, and it’s key to be aware that over the past several months several 503B compounding pharmacies have dropped their outsourcing registration, close to 30 have been referred to their state board by FDA and many have still not had any FDA inspection.
What does this mean for your patient safety? How can you be assured that you are working with an established, certified and quality-assured facility that has the proper and effective oversight? Read on to learn more:
First, what are 503A and 503B?
503A and 503B are sections of FDA’s Food, Drug and Cosmetic Act (FDCA) that outline stringent regulations for compounded drug products.
Upholding 503A or 503B registrations are an investment in time, money, technology, staff training and regulatory certification. As facilities grow (particularly in the case of 503B outsourcing suppliers), it can become more difficult to maintain standards of service and pass inspection.
What is a 503A Compounding Pharmacy?
503A compounding pharmacies are what you know as ‘traditional’ patient-focused compounding facilities in that they:
- Fulfill individual patient-specific prescriptions approved by a prescribing practitioner.
- Are staffed by a licensed pharmacist with additional training in compounding in a licensed facility.
- All acts of compounding must be performed by a licensed pharmacist and in a licensed pharmacy (or Federal facility).
- Comply with state boards of pharmacy regulations.
- Produce compounds in compliance with United States Pharmacopeia (USP) chapters or the National Formulary (NF) monograph. These compliance standards ensure patient safety and maintain drug quality and purity. For human sterile medications, these chapters are called USP <797> and <795>.
- Each and every bulk substance (i.e. active pharmaceutical ingredient) used for the compounding process must be:
- Made at an FDA-registered facility
- Accompanied by a valid Certificate of Analysis (COA)
- Do not compound drugs that have been withdrawn or removed from the market or have been otherwise proven to be unsafe or ineffective by FDA.
503B facilities are designated as “outsourcing facilities” meaning they produce large batches of compounded drugs with or without prescriptions to be sold to healthcare facilities as office use only.
- All 503B pharmacies must adhere to the same rules and regulations as a 503A pharmacy but they must also comply with additional CGMP requirements, which many are unable to do.
- Unlike 503A pharmacies, 503B facilities are unable to collaborate directly with physicians on customized formulas and products.
- Although all 503B pharmacies are required under law to register with the FDA, many have not registered.
Form 483 Warning Letters
- To ensure public health compliance, FDA conducts inspections of facilities that manufacture, process or pack FDA-regulated products (including compounding pharmacies). At the conclusion of an inspection, a facility may be issued a Form 483 or a Warning Letter with a list of observations or violations and a timeline for correction.
- Many 503B pharmacies are falling under scrutiny as they are failing inspection and having to close their doors due to the high cost of adhering to FDA’s stringent USP certification. Many have received 483s. All 483s and warning letters are public information and are posted here on FDA’s website: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/default.htm
VLS Pharmacy is a 503A Compounding Pharmacy. What does this mean for you?
- A benefit of a 503A compounding pharmacy is a patient-first approach with a focus on individualized, prescription-based compounding.
- We uphold similar standards as major pharmaceutical producers, but without the scale that dilutes service and personalized attention that we provide to you and your patients.
- Our pricing is reflective of small-scale, carefully supervised compounded medications in contrast to standardized, bulk production.
- There is ample opportunity and desire to establish a relationship between the prescribers, pharmacy, and patient which is proven to yield the most successful outcomes.
|Category||VLS Pharmacy Compliance|
|Quality & Safety|
All active ingredients sourced from FDA approved facilities with MSDS and COA to support purity and potency
Access to 8,000 pre-tested PCCA proprietary formulas that are pre-tested and verified.
<797> sterile rooms, one segregated for hazardous drugs
<71> and <81> compliance for in-house sterility and anti-microbial assay testing
|Monitoring||Environmental monitoring is performed in our sterile facilities 24/7/365|
The Highest Standards in The Compounding Pharmacy Industry
PCAB // ACHC Accredited
VLS Pharmacy has earned the Pharmacy Compounding Accreditation Board (PCAB) accreditation as part of the Accreditation Commission for Healthcare (ACHC) service. This is the result of following the highest compliance standards in the industry set out by the United States Pharmacopeia (USP) Convention.
As a proud member of the Professional Compounding Centers of America (PCCA), we exclusively source our Active Pharmaceutical Ingredients (APIs) from PCCA. This guarantees an industry-led standard of quality and provides total transparency with every ingredient we use for compounds.
As a member of the International Academy of Compounding Pharmacists (IACP), we are a part of a community of leading compounding pharmacies in the nation that are committed to innovation, integrity, safety, and credibility.
In 2016, we were granted United Credentialing and Accreditation Program (UCAP) status by Focus Scripts. This process initiated us into an elite, small network of compounding pharmacies that have passed strict compliance and audit requirements. Patients will benefit most from claims through Optim, Catamaran (and more to come) are more likely to be approved.