Section 34-23-160 - Preparation of compounded drug products for prescriber's office use; labeling(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.(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.(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.Ala. Code § 34-23-160 (1975)
Amended by Act 2017-422,§ 1, eff. 8/1/2017.Act 2003-389, p. 1094, §11.