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503A and 503B Compounding Pharmacies

We are a 503A compounding pharmacy. But what are 503A and 503B compounding pharmacies, and why should you care about understanding the difference?

VLS Pharmacy is a 503A Compounding Pharmacy. What does this mean for you? Skip to this section.

Whether you have been actively working with a compounding pharmacy, or you’re just beginning to search for a facility to work with, understanding what type of pharmacy you are collaborating with is important. This can help you answer important questions including: How is patient safety impacted? How can I be assured that I am working with an established, certified and quality-assured facility that has the proper and effective oversight? Read on to learn more:

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, 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:

  1. Fulfill individual patient-specific prescriptions approved by a prescribing practitioner.
  2. Are staffed by a licensed pharmacist with additional training in compounding in a licensed facility.
  3. All acts of compounding must be overseen by a licensed pharmacist and in a licensed pharmacy (or Federal facility).
  4. Comply with state boards of pharmacy regulations.
  5. 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>.
  6. Each and every bulk substance (i.e. active pharmaceutical ingredient) used for the compounding process must be:
    1. Made at an FDA-registered facility
    2. Accompanied by a valid Certificate of Analysis (COA)
  7. 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

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.

VLS Pharmacy is a 503A Compounding Pharmacy. What does this mean for you?

At our 503A compounding pharmacy, you will enjoy the following benefits:

  • Patient-first individualized approach; we treat compounded medication as a work of art. We work closely with prescribers and design a customized medication, commercially not available, with patients’ allergies, comorbidities and concurrent medications in mind. We will reach out personally to every patient and educate on the usage and side effects of every compound.
  • Never compromise on quality; we uphold the most stringent quality control measures internally in terms of garbing and gowning and apply the same International Organization for Standardization (ISO) standards for equipment. In addition, we conduct external quality assurance testing on all of our finished products.
  • Ultra-competitive pricing; we don’t produce large quantities of compounds in advance. Instead, we only compound when patients need them. Because we have been serving our communities over 30 years, we can pass along the savings from our established relationship with our wholesalers directly to our patients.
CategoryVLS 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.

Third-party testing

USP

<797> sterile rooms, one segregated for hazardous drugs

<71> and <81> compliance for in-house sterility and anti-microbial assay testing

MonitoringEnvironmental monitoring is performed in our sterile facilities 24/7/365

The Highest Standards in The Compounding Pharmacy Industry

ACHC and PCAB

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.

PCCA Member

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.

IACP

IACP Member

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.

UCAP

UCAP/UCM

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.

To learn more, please read about our sterile compounding facilities or contact our office to speak to our team.

Resources:

FDA Compliance Guidelines
FDA: 503A
FDA Outsourcing Facilities

Intravenous Drugs

  • Nutritional therapy
  • Pain relief
  • Chelation
  • Anti-nausea
  • TriMix/BiMix

Intramuscular Drugs (I.M)

  • Vitamins
  • Hormone therapies

Subcutaneous Drugs
(S.C. or S.Q.)

Preservative-free Formulations (PF) and Multi-dose Vials (MDV).

Ophthalmic Drops

  • Antibiotic
  • Steroid
  • Anti-viral
  • Coming soon: Platelet Rich Plasma eye serum

See our full list sterile medical compounds here.

Back To Prescribers

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For compounded medications, please call: 1-844-857-5588. For all other matters, please call: 1-844-446-3088.