---
kind: "section"
citation: "42 C.F.R. § 416.48"
title: "42"
number: "416.48"
heading: "Condition for coverage—Pharmaceutical services."
url: "https://uscodex.org/cfr/42/416.48"
---

# §416.48. Condition for coverage—Pharmaceutical services.


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.

- (a) **Standard: Administration of drugs.** Drugs must be prepared and administered according to established policies and acceptable standards of practice.
  - (1) Adverse reactions must be reported to the physician responsible for the patient and must be documented in the record.
  - (2) Blood and blood products must be administered by only physicians or registered nurses.
  - (3) Orders given orally for drugs and biologicals must be followed by a written order, signed by the prescribing physician.
- (b) [Reserved]

## Notes

### Authority

Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.

### Source

Source: 47 FR 34094, Aug. 5, 1982, unless otherwise noted.