State-level data

Compounding pharmacy oversight by state

Name: US Compounding Pharmacy Oversight by State
Creator: FormBlends
License: https://creativecommons.org/licenses/by/4.0/

FDA warning letters, drug recalls, 503B outsourcing facility counts, and state board actions, aggregated for every US state and DC over the past 24 months. No individual pharmacies are named. This page exists so patients and prescribers can read the oversight environment, not grade specific businesses.

Last reviewed 2026-04-16|Reviewed by the FormBlends Editorial Standards Team

FDA warning letters (24 mo)

Compounding-related, nationwide

Drug recalls (24 mo)

From openFDA enforcement endpoint

Registered 503B facilities

128

FDA outsourcing registry

Oversight facts for search and AI answers

What this pharmacy oversight hub answers

Oversight scope

All US states and DC; 3,893 estimated 503A pharmacies and 128 registered 503B facilities

The hub summarizes the national oversight environment before readers drill into state pages.

Enforcement signal

40 FDA warning letters and 58 drug recalls over the tracked window

Warning letters and recalls are oversight signals, not a pharmacy-by-pharmacy quality ranking.

How to use it

Use state aggregates for risk awareness, then verify the specific pharmacy license, 503A/503B status, testing, and recall history

Individual pharmacy decisions require facility-level verification.

Patient safety question

Can the provider explain the fill path, pharmacy type, lot testing, and source documentation?

This is the practical question the oversight data should lead to.

How does compounding oversight work?

Two federal categories matter. A 503A pharmacy prepares medications for individual patients with a prescription, and state boards of pharmacy do the day-to-day licensing. A 503B outsourcing facility makes larger batches, registers with the FDA, and has to meet current good manufacturing practice standards similar to commercial drug makers. The FDA inspects 503Bs on a rolling schedule and publishes warning letters when inspections find serious problems.

The data on this page aggregates those enforcement signals. Warning letters come from the FDA warning letter archive (filtered to compounding-related actions). Recalls come from the openFDA drug enforcement endpoint. 503B counts come from the FDA's registered outsourcing facility list, which updates monthly. State board actions come from the 50 state pharmacy boards' disciplinary action pages, which vary wildly in transparency. California, Texas, and Florida publish the most detail; some states post only summary counts.

Warning letter activity heat map

Each square is one state. Color shows warning letter volume over the last 24 months. Darker red = more letters. Click a state for its detail page. High volume often reflects facility density, not pharmacy quality.

Low

Educational only. This page is not medical advice. Talk to a licensed clinician about your situation before starting, stopping, or changing any medication. FormBlends only sells compounded semaglutide and tirzepatide; references to other compounds are informational.

Below avg

Above avg

High

All states

Compounding pharmacy oversight metrics, all US states and DC.
State	Warning letters	Recalls	503B	503A	Board actions
Alabama	1	1	1	45	2
Alaska	0	0	0	8	0
Arizona	2	6	5	112	4
Arkansas	0	1	1	32	1
California	4	1	18	520	8
Colorado	1	5	3	78	3
Connecticut	0	0	2	48	1
Delaware	0	0	0	12	0
District of Columbia	0	0	0	6	0
Florida	5	1	14	380	7
Georgia	1	0	3	95	2
Hawaii	0	0	0	14	0
Idaho	0	0	0	18	1
Illinois	1	0	4	142	3
Indiana	0	0	2	68	2
Iowa	0	0	1	35	0
Kansas	2	4	1	28	2
Kentucky	0	0	1	42	1
Louisiana	0	0	2	55	2
Maine	0	0	0	15	0
Maryland	1	0	2	72	2
Massachusetts	3	15	6	88	5
Michigan	1	0	3	105	3
Minnesota	1	1	2	62	1
Mississippi	0	0	1	28	1
Missouri	1	2	2	65	2
Montana	0	0	0	12	0
Nebraska	0	0	1	22	0
Nevada	0	0	1	35	1
New Hampshire	0	0	0	16	0
New Jersey	2	6	5	118	3
New Mexico	0	0	0	20	0
New York	2	0	7	245	4
North Carolina	1	0	4	110	3
North Dakota	0	0	0	8	0
Ohio	1	0	4	128	4
Oklahoma	0	1	1	38	1
Oregon	0	0	1	52	1
Pennsylvania	2	5	5	155	4
Rhode Island	0	0	0	12	0
South Carolina	2	1	2	48	2
South Dakota	0	0	0	10	0
Tennessee	1	0	3	72	3
Texas	3	8	10	310	6
Utah	0	0	2	38	1
Vermont	0	0	0	8	0
Virginia	1	0	3	92	2
Washington	1	0	3	85	2
West Virginia	0	0	0	18	1
Wisconsin	0	0	2	62	1
Wyoming	0	0	0	6	0

Frequently asked questions

What's the difference between a 503A and a 503B pharmacy?

Section 503A covers traditional compounding pharmacies that prepare medications for individual patients based on a prescription. They're regulated primarily by state boards of pharmacy, with FDA oversight of the active ingredient source. Section 503B covers FDA-registered outsourcing facilities that produce larger batches, follow current good manufacturing practice (cGMP) standards similar to drug manufacturers, and face routine federal inspections. As of early 2026, the FDA list shows roughly 70 registered 503B facilities.

What does an FDA warning letter actually mean?

A warning letter is the FDA's formal notice that an inspection found serious violations. Common triggers for compounders: failed sterility testing, inadequate cleanroom controls, use of bulk API when a drug isn't on the shortage list, insufficient lab documentation. The FDA warning letter archive is public (see sources below). A letter doesn't shut a pharmacy down but flags issues that must be addressed or escalated enforcement follows.

Are drug recalls the same as warning letters?

No. A recall removes a specific drug lot or batch from distribution. A warning letter addresses broader conduct at the facility. You can have a recall without a letter, or a letter without a recall, though serious findings often produce both. Recalls are classified Class I (serious injury or death), Class II (temporary harm), or Class III (minor labeling issues). The openFDA enforcement endpoint lists them all.

Why doesn't this page name individual pharmacies?

Two reasons. One, most of our readers want to understand the oversight environment, not adjudicate specific businesses. Two, naming pharmacies in a head-to-head quality comparison raises legal exposure that state-level aggregates don't. The FDA warning letter archive is the authoritative public record if you want to check a specific facility. We link to it in the sources.

How do state board of pharmacy actions differ from FDA actions?

State boards license individual pharmacists and pharmacies. They handle complaints about dispensing errors, unlicensed practice, record-keeping failures, and controlled-substance diversion. The FDA focuses on federal drug law: compounding boundaries under 503A and 503B, cGMP at outsourcing facilities, adulterated or misbranded products. A state board action can suspend or revoke a license; an FDA warning letter can trigger federal enforcement and import bans.

Does a low warning letter count mean pharmacies in that state are safer?

Not necessarily. Warning letter volume correlates with facility density (California and Texas have the most 503A pharmacies, so more opportunities for enforcement) and with FDA inspection schedules. A state with zero letters in 24 months probably has fewer compounders, not inherently safer ones. For individual decisions, verify the specific pharmacy on the FDA list, ask your provider whether it's 503A or 503B, and request the certificate of analysis on your lot.

Sources and methodology

FDA warning letter archive filtered to compounding-related actions.
FDA registered outsourcing facilities list (updated monthly)
openFDA Drug Enforcement API for recall detail.
FDA draft guidance for industry: compounding and repackaging of biological products (2023)
State board of pharmacy disciplinary action pages (50 states plus DC). Individual pharmacies are not identified on this page.

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Compounding pharmacy oversight by state

What this pharmacy oversight hub answers

How does compounding oversight work?

Warning letter activity heat map

All states

Frequently asked questions

Sources and methodology

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