StacksVerified U.S. regulatory reference

42 CFR §416.48

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The ASC must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual designated responsible for pharmaceutical services.
  1. (a)Standard: Administration of drugs. Drugs must be prepared and administered according to established policies and acceptable standards of practice.
    1. (1)Adverse reactions must be reported to the physician responsible for the patient and must be documented in the record.
    2. (2)Blood and blood products must be administered by only physicians or registered nurses.
    3. (3)Orders given orally for drugs and biologicals must be followed by a written order, signed by the prescribing physician.
  2. (b)[Reserved]