Use our library of resources to learn more about Epicur® and 503B outsourcing facilities for veterinary drug manufacturing. For expert insights on the trends impacting the veterinary community, go to our blog!
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We have received several questions about compounded controlled drugs being sold to hospitals and veterinary offices for office administration. Common questions include:
Have a question that’s not listed? Just send us your question and we will connect with you to get it answered.
What’s the difference? What do you get when you order from a 503B facility? The chart below gives a quick rundown of the key differences between the two. You can also find a more in-depth explanation in our blog!
503A
503B
Type of Facility
Traditional compounding pharmacy
Outsourcing facility that manufactures drugs
Main regulatory oversight
State Board of Pharmacy
FDA
Regulations
USP <795>, <797>, <800>, SBOP
FDA 21 CFR Part 210 and 211 (cGMP)
FDA inspections
For cause (approx. 3k compounding pharmacies)
Random inspections (approx. 69 facilities)
Stability testing of formulation to assign expiration date
Sterility testing as release test for finished product testing (USP General Chapter <71>)
Limited to extended dating and high-risk batches
Finished product testing (potency, endotoxins)
Continuous non-viable particle monitoring during aseptic processing
Retain sampling
High level of documentation to ensure process traceability & tracking
Process & equipment validations
Independent quality department (separate from production)
The map shows which states Epicur Pharma® is currently licensed as an outsourcing facility, as well as the states that are pending activity.
Did you know? When purchasing from an FDA Registered 503B Outsourcing Facility, dispensing and unlimited hospital administration is permitted*.
*Varies based on individual state law. Federal law allows dispensing and administration – FDA Federal SEC. 503B. [21 U.S.C. 353b]
Updated 1/5/2022
The Ohio Board of Pharmacy has updated office stock and dispensing guidance for veterinarians, meaning the 7-day supply limitation does NOT apply to compounded drugs purchased from a 503B outsourcing facility. Read more about the updates!
Epicur Pharma is licensed as a 503B Outsourcing Facility in Ohio. Start your order!
Read the articles and recent news our team has published to learn more about how we’re changing the veterinary industry.
Our white papers discuss current trends in veterinary medicine and offer educational 503B insights. Download our latest resources.
Learn why Stokes Healthcare was inspired to start an 503B outsourcing facility. Watch the Story of Stokes & Epicur.
Connect with our team to learn how Epicur® 503B products can benefit your practice and your patients.
All information provided on this site is for educational purposes only. Every effort has been made to provide accurate and up-to-date information. It is not intended to be used as medical advice for the diagnosis of health problems nor does it include all possible uses, actions, safety measures, side effects, or interactions. Please consult a healthcare provider or veterinarian for the diagnosis and treatment of any health conditions. Epicur Pharma® manufactured veterinary orders are for non food chain animals only. Epicur Pharma® is registered with the FDA as an outsourcing facility.
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