South Carolina § 40-43-88 - Sterile preparations.

§ 40-43-88. Sterile preparations.

(A) All sterile pharmaceuticals prepared for dispensing must be labeled in accordance with Section 40-43-86 and include:

(1) name, address, and telephone number of the pharmacy for outpatients and name of the facility for inpatients;

(2) dating of a nonadditive solution if the manufacturer's protective cover, if applicable, is removed before dispensing;

(3) name of prescribing physician;

(4) room number and bed of patient, if applicable; and

(5) special handling, storage requirements, or both.

(B) Bulk or unformulated drug substances and added substances or excipients must be stored in tightly closed containers under temperature, humidity, and lighting conditions that are either indicated in official monographs or approved by suppliers. The date of receipt by the compounding facility must be clearly and indelibly marked on each package of ingredients. After receipt by the compounding facility, packages of ingredients that lack a supplier's expiration date cannot be used after one year unless either appropriate inspection or testing indicates that the ingredient has retained its purity and quality for use in CSPs.

(C) When sterile pharmaceuticals are provided to home care patients, the dispensing pharmacy may supply a nurse with emergency drugs if a physician has authorized the use of these drugs by a protocol or prescription drug order for use in an emergency situation, such as anaphylactic shock.

(D) A licensed health care professional may possess noncontrolled legend drugs or devices such as water for injection, normal saline for an IV, and heparin flushes to facilitate in the administration of prescribed CSPs.

(E) There must be a system that requires an institutional or home infusion pharmacist to be available twenty-four hours a day for a patient, nursing agency, or physician to which the pharmacy is providing services.

HISTORY: 1998 Act No. 366, SECTION 1; 2018 Act No. 143 (H.3926), SECTION 3, eff March 20, 2018; 2024 Act No. 132 (H.3592), SECTION 4, eff May 13, 2024.

Effect of Amendment

2018 Act No. 143, SECTION 3, rewrote the section, revising and broadening associated standards relating to the handling of sterile preparation by pharmacies.

2024 Act No. 132, SECTION 4, deleted (A) to (H) and redesignated former (I) to (M) as (A) to (E).