FDA 503B outsourcing facilities in New York
New York has 2 FDA-registered 503B outsourcing facilities in the PeptideGrids directory, 1 with FDA drug recalls on record, the earliest registered in 2018. 503B facilities compound sterile medications in bulk under FDA cGMP standards and are a primary supply route for compounded peptides and GLP-1s during drug shortages.
| Facility | City | FDA-registered since | FDA recalls |
|---|---|---|---|
| Pine Pharmaceuticals, LLC | Tonawanda | 2018 | 24 |
| Galaxy Pharmaceuticals, LLC | Albany | 2024 | None on record |
503B compounding in New York
A 503B outsourcing facility registers with the FDA under the Drug Quality and Security Act and is inspected against cGMP manufacturing standards. In addition to that federal registration, a facility shipping into or operating in New York must hold the appropriate state pharmacy license. Verify any facility's current license with the New York State Board of Pharmacy.
Compounded peptides and GLP-1s
503B facilities are a primary supply route for compounded peptides and GLP-1s, including Semaglutide, Tirzepatide, BPC-157, Retatrutide. Browse the full GLP-1 and therapeutic peptide databases, or the national directory.
Frequently asked questions
How many FDA 503B outsourcing facilities are in New York?
2 FDA-registered 503B outsourcing facilities are listed in New York on PeptideGrids, the earliest registered in 2018.
Which New York 503B facilities have FDA recalls on record?
1 of the 2 New York facility has FDA drug recalls on record; the table above shows the count per facility.
How do I verify a pharmacy license in New York?
Use the New York State Board of Pharmacy license lookup to confirm a facility's current license status.
Facilities sourced from the FDA registered outsourcing facilities list. Recall counts from the FDA openFDA drug enforcement database.