§ 34-23-160 — Preparation of Compounded Drug Products for Prescriber’s Office Use; Labeling

Alabama § 34-23-160

• Jurisdiction: Alabama
• Title 34: Professions and Businesses
• Ch. 23: Pharmacists and Pharmacies
• Art. 7: Compounding of Drugs

Text

(a) A pharmacy may prepare a compounded drug product for a prescriber’s office use. An order by a prescriber indicating the formula and quantity ordered shall be filed in the pharmacy. The product shall be administered in the prescriber’s office and shall not be dispensed to the patient. A record of the compounded drug product may be kept as a prescription record in the computer of the pharmacy. A label may be generated and a number assigned by the computer of the pharmacy for the compounded product. A record of the product’s written procedure shall be on file in the pharmacy as provided in Section 34-23-158. A record of the product’s sale to the prescriber shall remain on file at the pharmacy for not less than one year. The record shall contain the following information:
(1) The name and address of the prescriber.
(2) The date of sale.
(3) A description and amount of the product sold.
(b) The label on the compounded product shall include the following information:
(1) The designated name and the strength of the finished product.
(2) The quantity dispensed.
(3) The date on which the product was compounded.
(4) The beyond use date.
(5) A lot or batch number.
(6) Any other information the pharmacist deems necessary.
(7) The name and address of the pharmacy.
(c) The label shall include the phrase For Office Use.

Legislative History

(Act 2003-389, p. 1094, §11; Act 2017-422, §1.)