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FDA Registered 503B Outsourcing Facility

503B Manufacturing Resources

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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DEA Manufacturer FAQs

We have received several questions about compounded controlled drugs being sold to hospitals and veterinary offices for office administration. Common questions include:

  • Does Epicur have a DEA manufacturer license?
  • Why is this required?
  • What products are available through Epicur’s DEA manufacturer license?


Check out the answers to these questions and others from our team of experts!

Have a question that’s not listed? Just send us your question and we will connect with you to get it answered.

503A vs. 503B

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)

Active States

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 5/13/2021

Videos

Play Video
An Introduction to Epicur® Pharma
Play Video
Why 503Bs are Important
Play Video
Fighting COVID-19 Drug Shortages


Learn why Stokes Healthcare was inspired to start an 503B outsourcing facility
. Watch the Story of Stokes & Epicur.

Have more 503B questions?

Connect with our team to learn how Epicur® 503B products can benefit your practice and your patients.