Compounding pharmacy statistics 2026: 503A vs 503B, compounded GLP-1s, FDA warning letters and adverse events

US pharmacies specialize in compounding, according to an American Pharmacists Association estimate (2020)¹

This is much lower than the number of pharmacies that do any compounding at all.

US pharmacies reported doing some compounding, in a 2016 Pew Charitable Trusts count cited by the National Academies¹

Based on voluntary listings in a pharmacy database as of 2015, so it may not reflect the true or current number.

facilities were listed on FDA's register of human drug compounding outsourcing facilities (503B) as of September 30, 2026²

Count of facilities listed in FDA's table. Registration is voluntary.

of all US prescriptions are compounded medications, according to rough estimates cited by the compounding industry³

compounded prescriptions dispensed per week by the median 503A compounding pharmacy (2025 survey)³

The median 503A pharmacy also works with 150 prescribers and employs 15 people.

of 503A compounding pharmacies do not accept insurance for compounded preparations (2025 survey)³

Another 25% accept insurance only in limited circumstances.

year the Drug Quality and Security Act created 503B outsourcing facilities, a voluntary category of compounders (enacted November 27, 2013)⁴

503A pharmacies compound based on valid patient-specific prescriptions. 503B facilities must follow CGMP manufacturing rules and may distribute without a named patient, such as to hospitals.

infections and more than 60 deaths in 20 states followed a 2012 contamination event at a Massachusetts compounding pharmacy⁴

The outbreak preceded the 2013 law that created 503B outsourcing facilities.

employees at the median 503B outsourcing facility (2025 survey)³

75% of responding outsourcing facilities distribute sterile preparations to traditional pharmacies for patient-specific dispensing.

of traditional compounding pharmacies compound sterile preparations, while 97% compound non-sterile preparations (2025 survey)³

of traditional pharmacies dispensed compounded GLP-1s sourced from a 503B outsourcing facility in the past two years (2025 survey)³

US patients may be using compounded GLP-1 drugs, according to Novo Nordisk's CEO in January 2026⁵

A company estimate reported by Reuters, not an independent count. No official national count exists.

of compounding pharmacies responding to a 2025 survey compounded semaglutide or tirzepatide preparations in the past two years³

of compounding volume at responding pharmacies was GLP-1s, the third-largest category after hormone replacement therapy (36%) and veterinary (14%) (2025 survey)³

of responding compounding pharmacies contracted to fill compounded prescriptions for a telehealth company in the past two years (2025 survey)³

of US adults who have taken a GLP-1 got it from a medical spa or aesthetic center, and 17% from an online provider or website (2025)⁶

KFF poll fielded October 27 to November 2, 2025. The poll did not ask whether products were compounded.

weight-loss clinics and medical spas in West Virginia and Oklahoma were still offering compounded GLP-1s in a 2025 secret shopper study, after the shortages ended⁷

56.0% offered compounded GLP-1s combined with B vitamins, and 4 of 21 supplying facilities checked were not licensed for sterile compounding.

FDA determined the tirzepatide injection shortage was resolved⁸

503B outsourcing facilities could continue compounding tirzepatide until March 19, 2025.

FDA determined the semaglutide injection shortage was resolved⁸

The 503A grace period was set to April 22, 2025, and the 503B grace period ran until May 22, 2025.

FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk substances⁹

Comments were due by June 29, 2026.

FDA said it intends to restrict GLP-1 active ingredients used in compounded drugs mass-marketed as alternatives to FDA-approved drugs¹⁰

Reported in the Hims & Hers 2025 annual report, which says the company was named in the statement and now uses only 503A pharmacies for compounded GLP-1s.

adverse event reports associated with compounded semaglutide received by FDA as of May 31, 2026¹¹

FDA notes some reports involved hospitalization and may be related to dosing errors with compounded injectable semaglutide. Reports do not prove the drug caused the event.

adverse event reports associated with compounded tirzepatide received by FDA as of May 31, 2026¹¹

compounding-related warning letters issued by FDA in 2025, a major increase from the previous year¹²

FDA also issued 5 untitled letters to compounders and held 6 regulatory meetings with compounders in 2025.

FDA warning letters went to telehealth companies in 2025 for misbranded compounded products promoted with false or misleading claims¹²

For example, implying compounded products were FDA-approved or the same as approved drugs.

companies marketing compounded GLP-1 products received FDA warning letters in September 2025¹⁰

Hims & Hers disclosed that it received two of these letters.

warning letters sent to telehealth companies over compounded GLP-1 marketing on March 3, 2026, FDA's second group since September 2025¹³

letters sent by FDA to compounding stakeholders in 2025 about bulk drug substances not eligible for compounding¹²

GLP-1 exposures (all products, not only compounded) were reported to US poison centers from 2012 to 2023¹⁴

6,920 occurred after July 1, 2021, the study's cutoff for semaglutide's weight-loss approval. Most were unintentional therapeutic errors with mild symptoms.