AL Code § 20-2-213 (2021)
2021 Code of Alabama|Title 20 - Food, Drugs and Cosmetics.|Chapter 2 - Controlled Substances.|Article 10 - Controlled Substances Prescription Database.|Section 20-2-213 - Reporting Requirements.

Section 20-2-213Reporting requirements. (a) Each of the entities designated in subsection (b) shall report to the department, or to an entity designated by the department, controlled substances prescription information as designated by regulation pertaining to all Class II, Class III, Class IV, and Class V controlled substances in such manner as may be prescribed by the department by regulation.  (b) The following entities or practitioners are subject to the reporting requirements of subsection (a):  (1) Licensed pharmacies, not including pharmacies of general and specialized hospitals, nursing homes, and any other health care facilities which provide inpatient care, so long as the controlled substance is administered and used by a patient on the premises of the facility.  (2) Mail order pharmacies or pharmacy benefit programs filling prescriptions for or dispensing controlled substances to residents of this state.  (3) Licensed physicians, dentists, podiatrists, or optometrists who dispense Class II, Class III, Class IV, and Class V controlled substances directly to patients, but excluding sample medications. For the purposes of this article, sample medications are defined as those drugs labeled as a sample, not for resale under the laws and regulations of the Federal Food and Drug Administration. Controlled substances administered to patients by injection, topical application, suppository administration, or oral administration during the course of treatment are excluded from the reporting requirement. (c) The manner of reporting controlled substance prescription information shall be in such manner and format as designated in the regulations of the department.  (d) The following data elements shall be used in transmitting controlled substance prescription information:  (1) Name or other identifying designation of the prescribing practitioner.  (2) Date prescription was filled or medications dispensed.  (3) Name of person and full address for whom the prescription was written or to whom the medications were dispensed.  (4) National Drug Code (NDC) of controlled substance dispensed.  (5) Quantity of controlled substance dispensed.  (6) Name or other identifying designation of dispensing pharmacy or practitioner.  (7) Other data elements consistent with standards established by the American Society for Automation in Pharmacy as may be designated by regulations adopted by the department.  (8) Method of payment and third-party payor identification of the controlled substance dispensed. (e) In addition to any other applicable law or regulation, the failure of a licensed pharmacy or pharmacist or a licensed practitioner to comply with the requirements of this section shall constitute grounds for disciplinary action against the license of the pharmacy, pharmacist, or licensed practitioner by the appropriate licensing board or commission, and the imposition of such penalties as the licensing board or commission may prescribe. The department shall report to the appropriate licensing board, agency, or commission the failure of a licensed pharmacist or a licensed practitioner to comply with the reporting requirements of this section. Any report made by the department to a licensing board, agency, or commission shall be deemed a formal complaint and shall be investigated and appropriate action taken thereon. (Act 2004-443, p. 781, §4; Act 2013-256, p. 666, §1; Act 2016-315, §1.)