cGMP (current Good Manufacturing Practice)
cGMP is the FDA’s set of manufacturing-quality regulations for drug producers — covering facilities, equipment, personnel, process controls, testing, and records — that 503B outsourcing facilities must follow and that traditional 503A compounding pharmacies are not held to.
- FDA manufacturing-quality regulation
- Mandatory for 503B outsourcing facilities
- Batch records, release testing, stability programs
- Not required of 503A pharmacies
What cGMP requires in practice
Documented, validated processes; controlled environments with monitoring; qualified equipment; trained personnel; batch records for every lot; release testing before distribution; stability programs supporting expiration dates; and recall procedures. The “c” means current — the standard evolves and manufacturers are expected to keep up.
cGMP versus USP compounding standards
503A pharmacies compound under USP chapters (<795>, <797>, <800>), which are pharmacy-practice standards focused on the individual preparation. cGMP is a manufacturing standard focused on the process and the batch. Both produce safe medication when followed; cGMP produces more documentation, longer dating, and more predictable lots — at the cost of lead times and minimums.
- 503B: cGMP, FDA-inspected, batch records, release testing
- 503A: USP standards, state-board oversight, per-prescription compounding
Why it matters when choosing a pharmacy bench
A 503B source gives a program manufacturer-grade documentation for its quality story. Whether a given product can come from a 503B depends on the FDA’s 503B bulks list and copy rules at the time, so most programs pair 503A pharmacies for patient-specific dispensing with 503B supply where the rules allow.
Compliance handled, so you can build
Lithos runs the clinicians, pharmacies, and 50-state rules behind your care program — one API.
Frequently asked questions
Are compounded drugs made under cGMP?
Only those from 503B outsourcing facilities. 503A pharmacies compound under USP pharmacy standards, which are different and less manufacturing-oriented.
Does cGMP mean FDA-approved?
No. cGMP governs how a product is made; approval governs whether a specific drug may be marketed. 503B products are cGMP-compounded but not FDA-approved.
Should a telehealth program prefer 503B for everything?
Not necessarily. 503B has narrower rules on what it may compound and comes with lead times and minimums. Most programs use both categories for different jobs.