Last updated: June 15, 2026
US Compounding Factory is committed to operating in full compliance with the laws, regulations, and professional standards that govern pharmacy compounding. Compliance is built into every stage of our process, from sourcing and preparation to documentation and delivery, so that every medication we produce is safe, consistent, and patient-ready.
1. Regulatory Framework
We operate under the oversight of the U.S. Food and Drug Administration (FDA), applicable state boards of pharmacy, and the Drug Enforcement Administration (DEA). We maintain the licenses and registrations required to compound and dispense medications in the jurisdictions we serve.
2. Compounding Standards
Our preparations follow United States Pharmacopeia (USP) standards, including:
- USP <795> for non-sterile compounding.
- USP <797> for sterile compounding.
- USP <800> for handling hazardous drugs.
As a 503A compounding pharmacy, we prepare medications pursuant to a valid prescription for an identified patient, in accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act.
3. Quality Assurance
Every active and inactive ingredient is pharmaceutical-grade and accompanied by a certificate of analysis. We verify identity, potency, and purity before use, follow documented procedures for each preparation, and conduct ongoing review and environmental monitoring to ensure consistent quality.
4. Licensing & Accreditation
We maintain current state and federal licensing and pursue recognized accreditations and verifications appropriate to our practice. Our facility and personnel are held to the standards required to safeguard every preparation.
5. Controlled Substances
Where applicable, controlled substances are handled in strict accordance with DEA regulations and state law, including secure storage, recordkeeping, and dispensing only pursuant to valid prescriptions from authorized prescribers.
6. Adverse Event & Recall Reporting
We maintain procedures for documenting and reporting adverse events and for managing product recalls in coordination with the appropriate regulatory authorities and affected providers.
7. Staff Training
Our team receives ongoing training on compounding standards, safety, recordkeeping, and regulatory requirements to ensure compliance is maintained across every role and process.
8. Reporting a Compliance Concern
We encourage providers, patients, and partners to report any compliance concern. Reports are reviewed promptly and handled confidentially. You may reach us using the contact details below.
9. Contact Us
For questions about our compliance program, contact us at info@uscompoundingfactory.com or by mail at 108B New South Road, Hicksville, NY 11801.