503A and 503B compounding.
Two federal pathways for compounded medicines. 503A serves individual patients on a prescription. 503B produces office-use stock in FDA-registered outsourcing facilities.
Patient-specific compounding.
Preparations compounded for one identified patient on a valid prescription, at the strength and in the dosage form the prescriber specifies.
- Prepared by
- State-licensed compounding pharmacies in the Omni Health Supply network.
- Requires
- A valid prescription for an identified individual patient.
- Standards
- USP <795> for nonsterile preparations and USP <797> for sterile preparations, under state board of pharmacy oversight and inspection.
- Release
- Pharmacist verification of every preparation before it ships.
- Dating
- Beyond-use dates assigned under USP <795> and <797>.
- Ships to
- The patient or the prescribing practice, as the destination state allows.
- Ordering
- Electronic prescription through the provider portal, with patient, directions and refills captured once.
Office-use stock from outsourcing facilities.
Batch-produced preparations from FDA-registered outsourcing facilities, for administration in your practice without a patient-specific prescription.
- Prepared by
- FDA-registered 503B outsourcing facilities.
- Requires
- An order from a licensed practice. Patient-specific prescriptions are also accepted.
- Standards
- Current good manufacturing practice under 21 CFR parts 210 and 211, with FDA registration and inspection.
- Release
- Batch testing for potency, sterility and bacterial endotoxins, with a certificate of analysis for every lot.
- Dating
- Expiration dates supported by stability data.
- Ships to
- The practice.
- Ordering
- Office stock by vial, carton or case, as one-time or recurring orders.
What each label carries.
Required label contents differ by pathway.
| Field | 503APatient-specific | 503BOffice use |
|---|---|---|
| Facility | Dispensing pharmacy name and contact | Outsourcing facility name and contact |
| Identifier | Prescription number | Lot or batch number |
| Patient | Patient name | Office use only, when not dispensed to a patient |
| Prescriber | Prescriber name | Ordering practice |
| Instructions | Directions for use, quantity and refills | Dosage form, strength, quantity and route |
| Dating | Beyond-use date | Expiration date |
| Statement | State-required statements | This is a compounded drug |
| Storage | Storage and handling | Storage and handling |
Dosage forms.
Six formats across hormone therapy, metabolic and weight management, sexual health, dermatology and hair, and longevity and wellness.
Sterile injectables
Single-dose and multi-dose vials prepared under aseptic conditions. 503B batches are tested for sterility and endotoxins before release.
Capsules
Custom strengths and excipients for patient-specific oral dosing.
Troches
Rapid-dissolve lozenges for buccal administration.
Topicals
Creams, gels and solutions in metered or standard packaging.
Nasal sprays
Metered-dose sprays in calibrated pumps.
Sublinguals
Tablets and drops for sublingual administration.
State licensure.
A 503A pharmacy must be licensed in the state where the patient receives the preparation. Each order routes to a partner pharmacy licensed for the destination address.
- 503A routing checks the partner pharmacy's license against the ship-to state on every order.
- 503B office stock ships to practices subject to the requirements of the practice's state.
- Your provider account shows which preparations can ship to each practice and patient address.
Order 503A and 503B from one account.
Physicians, nurse practitioners, physician assistants and practices open one account for both pathways.
