Summary of Differences Between 503A and 503B
| 503A | 503B | |
|---|---|---|
| Purpose | Dispense compounded medications for individual patients | Distribute compounded medications for office-use use only in a clinician’s office or healthcare facility |
| Regulation | Primarily state regulated | Primarily FDA regulated |
| Who pays | Prescriber or patient* *based on state regulations | Prescriber or clinic |
| Benefit | Medication compounded to meet each patient’s needs, including personalized doses or combinations decided by the prescriber | Medications and hormone therapies compounded for office use |
| Delivery | Shipped directly to the patient | Shipped to the clinic or healthcare facility |
503A and 503B compounding
503A pharmacies and 503B outsourcing facilities are types of compounding facilities that are regulated by state and federal regulatory agencies. Compounding has become popular as more clinicians recognize the benefits of prescription medications and hormones that are personalized for their patients. However, there are some important differences between 503A pharmacies and 503B outsourcing facilities.
What is a 503A compounding pharmacy?
503A pharmacies are state-regulated compounding pharmacies that make individualized formulations following a prescription written for a specific patient by a specific prescriber. This designation refers to section 503A of the Food, Drug, and Cosmetic Act, which specifies requirements for the compounding of drug preparations for individual patients.
503A pharmacies are the “traditional” type of compounding pharmacy, producing individualized prescriptions. Medications, including hormones, prepared by a 503A compounding pharmacy are intended for patient-specific use.
Benefits of a 503A pharmacy
Prescribing with a 503A pharmacy like Belmar Pharmacy gives the prescriber the flexibility to meet each patient’s individual medical needs. Belmar’s customizable approach to compounded medications allows us to meet very specific requirements for individual patients. For example, we can:
- Personalize doses for a specific patient
- Compound active ingredients not available commercially
- Create formulations to accommodate allergies
- Concentrate creams to maximize ease of administration
- Combine multiple ingredients into one dosage form for better patient adherence
What is a 503B outsourcing facility?
503B outsourcing facilities are large-scale, FDA-regulated facilities that produce compounded medications, including hormones. This designation refers to section 503B of the Food, Drug, and Cosmetic Act, which describes the requirements that must be met for drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility. The 503B designation was created with the passage of the Drug Quality and Security Act (DQSA) in 2013.
A 503B outsourcing facility manufactures large batches of medications to be sold to doctors’ offices, clinics, hospitals, and other healthcare facilities. 503B facilities do not sell products directly to patients or sell medications that would be administered outside of a medical facility. Medications produced by 503B facilities are for in-office administration only.
Belmar Select Outsourcing are our FDA-regulated 503B outsourcing facilities. They produce sterile hormone pellets and injectable testosterone cypionate blends in large quantities and distribute them directly to prescribers. Learn more about Belmar Select Outsourcing.
Benefits of a 503B outsourcing facility
Ordering from a 503B outsourcing facility enables clinicians to maintain a supply of medications, including hormones that are not commercially available. This allows clinicians the flexibility to provide care that meets their patients’ needs.
An FDA-registered outsourcing facility must meet certain requirements for manufacturing quality as defined by Current Good Manufacturing Practices (cGMP). These are the same requirements that large pharmaceutical manufacturers must meet. Belmar Select Outsourcing uses only active pharmaceutical ingredients from FDA-registered facilities and has robust quality assurance processes. This helps ensure consistent quality which is especially important for sterile medications and hormones, such as injectables.
Regulation and distribution
As noted, 503A pharmacies are primarily state-regulated and require provider-issued prescriptions for individual patients. 503B pharmacies—which are, in fact, outsourcing facilities—are primarily regulated by the FDA. They can produce medications in large quantities without a prescription.
Belmar’s 503A pharmacies are able to dispense compounded medications to patients in all 50 U.S. states and are primarily regulated by each state’s board of pharmacy. Our FDA-registered 503B outsourcing facilities can ship to healthcare facilities in 48 states and Washington, DC. Maintaining multiple pharmacies and outsourcing facilities nationwide provides the scale and flexibility to meet the needs of any size practice, everywhere in the U.S.
Dosage forms Belmar offers
With 503A pharmacies and 503B outsourcing facilities across the country, Belmar Pharma Solutions can supply medications for a wide range of health needs in a variety of dosage forms, including:
503A:
- Creams (topical and vaginal)
- Capsules (oral)
- Tablets (oral, sublingual, and vaginal)
- Pellets
- Solutions and suspensions (oral and topical)
- Troches (buccal)
- Suppositories (rectal and vaginal)
- Gels (topical)
- Injectables (intramuscular, subcutaneous, intracavernosal)
503B:
- Testosterone, estradiol, and anastrozole implantable pellets
- Testosterone cypionate blends in injectable form
Choosing a 503A pharmacy or 503B facility
Both 503A pharmacies and 503B outsourcing facilities play an important role in meeting the needs of clinicians and patients when it comes to delivering personalized medicine. So which is the correct choice for your healthcare practice? The answer depends on what you are trying to accomplish. When you need an individualized prescription compounded for a specific patient, a 503A pharmacy is the right choice.
When you need non-patient-specific compounded medications, including hormones for office use without a patient prescription, a 503B outsourcing facility is the right solution. This enables clinicians to maintain a supply of customized formulations in quantity, allowing administration to patients during an office visit.
It’s important to choose a compounding pharmacy or outsourcing facility that has a solid track record of compounding quality medications. Belmar Pharma Solutions has been practicing the art and science of compounding since 1985, with a reputation for consistent quality and a commitment to patient safety.
About Belmar 503A and 503B pharmacies
Belmar Pharma Solutions has both 503A pharmacies for compounding individual patient medications and 503B outsourcing facilities for manufacturing compounded medications, including hormones in large quantities. We offer:
- Multiple 503A pharmacies across the country, enabling us to compound a wide range of medications and bioidentical hormones to support personalized medicine. Explore medications.
- Two FDA-registered 503B outsourcing facilities that produce sterile hormone pellets and injectable testosterone cypionate blends for in-office administration. Learn more about Belmar Select Outsourcing.
- Robust quality processes to ensure consistent quality, whether ordering a single prescription for a patient or in large quantities for use in your practice.
- A Customer Experience Team dedicated to providing responsive service and support for your 503A prescriptions and 503B office-use orders.
