A pharmacy may prepare a compounded drug product to be sold over the counter without a prescription order. The product shall not contain an ingredient which exceeds recommended strengths and doses for over the counter drugs. The finished product shall not be one for which a prescription is required. It shall be properly labeled with the product's name, directions for use, list of active ingredients, and any necessary warnings. A compounded product shall be sold directly to the patient after professional interaction or consultation between the pharmacist and the patient. The product may be prepared in advance in reasonable amounts in anticipation of estimated needs. The product shall be stored within the prescription department. The product may not be sold in bulk to other pharmacies or vendors for resale.
Structure Code of Alabama
Title 34 - Professions and Businesses.
Chapter 23 - Pharmacists and Pharmacies.
Article 7 - Compounding of Drugs.
Section 34-23-150 - Definitions.
Section 34-23-151 - Continuing Education; Technician Assistance; Duties of Pharmacist.
Section 34-23-152 - Designation and Maintenance of Compounding Area.
Section 34-23-153 - Use, Maintenance, and Inspection of Compounding Equipment.
Section 34-23-154 - Drug Components to Meet Certain Requirements.
Section 34-23-155 - Drug Product Containers and Closures.
Section 34-23-156 - Compounding Procedures.
Section 34-23-158 - Retention of Records.
Section 34-23-159 - Preparation of Compounded Drug Products for Over the Counter Sale.
Section 34-23-160 - Preparation of Compounded Drug Products for Prescriber's Office Use; Labeling.