1. (1) Entities and practitioners that dispense controlled substances, Class II-V, shall report controlled substances prescription information to the Prescription Drug Monitoring Program database. These entities and practitioners include but are not limited to:

   1. (a) Licensed pharmacies;
   2. (b) Mail order pharmacies or pharmacy benefit programs filling prescriptions for or dispensing controlled substances to residents of Alabama; and
   3. (c) Licensed physicians, dentists, podiatrists, and optometrists who dispense controlled substances.

2. (2) The reporting requirement in this rule does not apply to a controlled substance dispensed:

   1. (a) By a pharmacy of a hospital, nursing home, or other inpatient health care facility if administered and used by a patient on the facility’s premises;
   2. (b) By a practitioner if administered during the course of a patient’s treatment by injection, topical application, suppository administration, or oral administration; or
   3. (c) By a practitioner as an appropriately labeled sample medication.

3. (3) Entities and practitioners shall submit reports as follows:

   1. (a) Entities shall submit reports at least once daily by 11:59 p.m.

      1. 1. If an entity or practitioner does not dispense a controlled substance on a specific day, the entity or practitioner shall report that zero controlled substances were dispensed.
      2. 2. The daily reporting requirement does not apply on days that the entity or practitioner’s business is closed and no controlled substances are dispensed.

   2. (b) Reports must be in electronic format according to American Society for Automation in Pharmacy Standards using the U.S. Postal Service’s Postal Addressing Standards.

      1. 1. If electronic transmission is not feasible, an entity or practitioner may request a waiver.
      2. 2. An entity or practitioner who receives a waiver may submit prescription information in an alternate format approved by the Prescription Drug Monitoring Program.

      3. 3. Entities and practitioners shall submit waiver requests and reports formatted pursuant to a valid waiver to:

         Alabama Department of Public Health
         Prescription Drug Monitoring Program
         The RSA Tower, Suite 1010
         P.O. Box 303017
         Montgomery, AL 36130-3017
         Fax: (334) 206-5663

      4. 4. Penalties for noncompliance/non-reporting:
   3. (a) On a monthly basis or as designated by the Prescription Drug Monitoring Program, licensing boards shall supply an electronic listing to the Prescription Drug Monitoring Program of entities and practitioners required to report controlled substances.
   4. (b) The Prescription Drug Monitoring Program will monitor the list of entities and practitioners provided by the licensing boards for compliance in reporting to the database.
   5. (c) The Department will notify the appropriate licensing board of an entity or practitioner’s failure to report. Upon notification of a non-reporting entity or practitioner, the relevant licensing board shall investigate and report to the Department the outcome.

Author: Nancy Bishop, R. Ph., State Pharmacy Director

Statutory Authority: Code of Ala. 1975, §22-21-20, et. seq.

History: New Rule: Filed October 20, 2005; effective November 24, 2005. Amended: Filed February 17, 2006; effective March 24, 2006. Amended: Filed October 20, 2014; effective November 24, 2014. Amended: Filed August 19, 2016; effective October 3, 2016.