A curated directory of compounding pharmacies meeting USP <797> sterile compounding standards. These facilities prepare injectables, IV preparations, ophthalmic compounds, and other sterile dosage forms for licensed healthcare providers and facilities.
USP <797> establishes standards for sterile compounding environments, personnel training, beyond-use dating, sterility testing, and quality assurance. Pharmacies must maintain ISO-classified cleanrooms, perform environmental monitoring, and document all compounding activities. The 2023 revision significantly updated requirements for beyond-use dating and sterility testing.
Sterile compounding requires ISO-classified cleanrooms. ISO 5 (Class 100) environments are required for direct compounding activities. ISO 7 (Class 10,000) buffer areas and ISO 8 (Class 100,000) ante-areas provide progressively cleaner environments. Pharmacies must perform regular particle counting and microbial monitoring to maintain classification.
Reputable sterile compounding pharmacies perform sterility testing, endotoxin (pyrogen) testing, potency testing, and particulate matter testing on finished preparations. Certificates of analysis (COA) should be available for each lot. Providers should request COAs and verify that testing is performed by qualified, independent laboratories.
All pharmacies listed below offer sterile compounding services. Click any pharmacy to view the full profile.
Houston, TX
Lakewood, CO
Nicholasville, KY
Hallandale Beach, FL
Gilbert, AZ
Orlando, FL
Ocala, FL
Baltimore, MD
Tampa, FL
Cleburne, TX
Tulsa, OK
Birmingham, AL
La Puente, CA
Atlanta, GA
Cleveland, OH
Hopkinton, MA
Anaheim, CA
Federal Way, WA
Alexandria, VA
Scottsdale, AZ
Houston, TX
San Diego, CA
Swedesboro, NJ
New York, NY
Tampa, FL
San Diego, CA
Randolph, NJ
Wenatchee, WA
Nashville, TN
El Dorado Hills, CA
Woodland Hills, CA
Oklahoma City, OK
Phoenix, AZ
Boca Raton, FL
Frisco, TX
Thonotosassa, FL
Doral, FL
Hallandale, FL
Tomball, TX
Dallas, TX
Oviedo, FL
Pflugerville, TX
Tampa, FL
Livonia, MI
Stafford, TX
Illinois
Palm Harbor, FL
USP <797> establishes standards for sterile compounding to prevent contamination, ensure potency, and protect patient safety. Compliance is required for any pharmacy preparing injectables, ophthalmic preparations, and IV admixtures.
Sterile compounding produces preparations free of microorganisms and particulate matter, such as injectables and IV preparations. Non-sterile compounding produces topical creams, capsules, and oral solutions. Sterile compounding requires specialized cleanroom facilities, equipment, and training.
Request documentation of USP <797> compliance, cleanroom certification records, environmental monitoring results, and certificates of analysis for sterile preparations. PCAB accreditation or state board inspection records provide additional verification. For 503B facilities, FDA inspection records are publicly available.
Beyond-use dates (BUDs) for sterile preparations are determined by the compounding conditions, sterility testing, and storage requirements. The 2023 USP <797> revision updated BUD requirements significantly. Providers should confirm BUDs with their pharmacy partner and ensure proper storage conditions are maintained.