La. Admin. Code tit. 48 § I-4451

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-4451 - Pharmaceutical Services

A. All outpatient abortion facility's shall have a controlled dangerous substance (CDS) license issued by the Louisiana Board of Pharmacy and a Drug Enforcement Agency (DEA) registration in accordance with applicable state and federal laws.

B. The outpatient abortion facility shall develop, implement, enforce, monitor, and annually review written policies and procedures that govern the safe storage, prescribing, dispensing, preparing and administering of drugs and biologicals on the licensed premises.

C. Storage Areas. The outpatient abortion facility shall provide a designated secure storage area for storing drugs and biologicals.

1. The designated storage area shall be constructed and maintained to prevent unauthorized access.

2. The designated storage area shall adhere to the manufacturers suggested recommendations for storage of drugs.

3. Locked areas that are used to store medications including controlled substances, shall conform to all applicable federal and state laws, and the outpatient abortion facility's policies and procedures.

D. The outpatient abortion facility shall maintain written records documenting the ordering, receiving, dispensing, and administering of drugs.

E. The outpatient abortion facility shall maintain written records documenting the disposing of unused drugs.

F. The outpatient abortion facility shall maintain written documentation of all drugs prescribed and/or dispensed to each patient, including, but not limited to the:

1. full name of the patient;

2. name of the prescribing and/or dispensing physician;

3. name and strength of the drug;

4. quantity prescribed and/or dispensed; and

5. date of issue.

G. Preparation and Administration of Drugs. The outpatient abortion facility shall develop, implement, enforce, monitor, and review annually written policies and procedures governing the preparation of drugs and biologicals.

1. The outpatient abortion facility shall ensure that all drugs and biologicals are prepared and administered pursuant to an order from an individual, employed or under contractual agreement, who has prescriptive authority in accordance with applicable state laws. Each order shall be in writing, patient specific, dated, timed, and signed by that individual. A copy of such orders shall be maintained in each, individual patient medical record.

H. The outpatient abortion facility shall order and maintain a supply of emergency drugs for stabilizing and/or treating medical and surgical complications on the licensed premises as authorized by the medical director.

La. Admin. Code tit. 48, § I-4451

Promulgated by the Department of Health and Hospitals, Bureau of Health Services Financing, LR 41706 (4/1/2015).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:2175.1 et seq.