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FDA register as of 2026-09-02

503B outsourcing facilities in New Jersey

The FDA lists 8 registered 503B outsourcing facilities in New Jersey as of 2026-09-02: 4 inspected, 4 with a Form 483, 0 with a warning letter or equivalent action. These are the facilities the FDA inspects directly. New Jersey's many 503A compounding pharmacies are licensed by the state board instead and are not on this list.

FacilityLast FDA inspectionForm 483RecallAction
Denver Solutions, LLC, dba Leiters Health
Buena, NJ
Not yet inspectedNo inspection yet
Empower Clinic Services New Jersey
East Windsor, NJ
Not yet InspectedNo inspection yet
Hyalo Technologies Limited Liability Company
Somerset, NJ
Not yet inspectedNo inspection yet
Imprimis NJOF, LLC
Ledgewood, NJ
8/18/2026YesNoOpen
Molecular PharmaGroup
New Providence, NJ
8/11/2025Yes (483)NoUntitled Letter Issued 2/5/2026
Quva Pharma, Inc.
Bloomsbury, NJ
4/4/2025Yes (483)NoOpen
Sankav Pharmaceuticals, LLC
Hackettstown, NJ
Not yet inspectedNo inspection yet
Stokes Healthcare Inc., dba Epicur Pharma
Mt. Laurel, NJ
5/23/2025Yes (483)NoOpen

Compounding pharmacies in New Jersey that are not on this list

A 503A pharmacy in New Jersey holds a state permit and answers to the state board of pharmacy; it never appears on the FDA's 503B list, and its absence here says nothing about it. The board's license lookup is the record for those pharmacies: find it in the NABP directory of boards. What separates the two kinds: 503A vs 503B, in the statute's words.

Other states with registered facilities

Source: FDA — Registered Outsourcing Facilities, page dated 2026-09-02 by the FDA, re-downloaded at every build; state grouping is from the FDA's own facility column. “Open” means the inspection classification is not yet final. Full list: all states. Looking for one pharmacy by name? Look it up.

Before you sign

Is the pharmacy on your label in this table?

If it is, click through to its record. If it isn't, it is most likely a state-licensed 503A pharmacy; the board holds its license.

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Three checks before you sign

  1. Find the pharmacy on the label. Compounded drugs name the pharmacy that made them, not the telehealth brand that sold them. That name is what you look up.

  2. Read the public record. Whether it is an FDA-registered 503B facility or a state-licensed 503A pharmacy, when it was last inspected, and what the FDA wrote down.

  3. Compare the approved path. What the FDA-approved version costs today next to the compounded one, and which licensed providers prescribe it — so the choice is yours, made on the record.

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