Does my ASC need a CLIA, a Pharmacy License, and a DEA Registration?

1. Do we need CLIA?

• Yes, if: Your ASC performs any laboratory testing on-site (beyond simple waived tests like fingerstick glucose, urine dipstick, or pregnancy tests).

• Waived tests: If you only plan to perform simple, low-complexity tests (urine dip, glucose checks, etc.), you’ll need a CLIA Certificate of Waiver.

• Moderate/High complexity tests: Anything more advanced (e.g., pathology, molecular tests) would require a higher-level CLIA certificate and compliance with more stringent standards.

• How to get it: You apply through CMS Form CMS-116 (Application for Certification). In California, applications go through the Laboratory Field Services (LFS) branch of the Department of Public Health, which manages CLIA licensing at the state level.

2. Do I need a DEA registration for this ASC?

• Yes, if controlled substances are stored, ordered, or administered on site.

• Most ASCs keep controlled substances (e.g., midazolam, fentanyl, morphine, ketamine, propofol mixed with controlled adjuncts), so a DEA registration for the ASC address is required.

• The DEA registration is site-specific, meaning you’ll need one tied to the physical address of the ASC.

• Application: DEA Form 224 (New Application for Registration).

3. Will we need a CA Board of Pharmacy license?

• Yes, if you plan to:

  • Purchase, store, and dispense legend drugs (non-controlled but prescription-only medications), OR

  • Operate an in-house pharmacy.

• Most ASCs don’t need a full pharmacy license, but instead require:

  • A Clinic License (from the CA Board of Pharmacy) for the ASC to purchase and stock prescription drugs, OR

  • A Wholesaler/Distributor license for suppliers.

• If you are only administering medications on site (not dispensing them for patients to take home), then typically the Clinic License is what applies, not a full retail pharmacy license.