Current through Register Vol. 42, No. 11, August 30, 2024
(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:
(a) Licensed
pharmacies;
(b) Mail order
pharmacies or pharmacy benefit programs filling prescriptions for or dispensing
controlled substances to residents of Alabama; and
(c) Licensed physicians, dentists,
podiatrists, and optometrists who dispense controlled substances.
(2) The reporting requirement in
this rule does not apply to a controlled substance dispensed:
(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;
(b) By a practitioner if administered during
the course of a patient's treatment by injection, topical application,
suppository administration, or oral administration; or
(c) By a practitioner as an appropriately
labeled sample medication.
(3) Entities and practitioners shall submit
reports as follows:
(a) Entities shall submit
reports at least once daily by 11:59 p.m.
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. The
daily reporting requirement does not apply on days that the entity or
practitioner's business is closed and no controlled substances are
dispensed.
(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. If electronic transmission is not
feasible, an entity or practitioner may request a waiver.
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. 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. Penalties for noncompliance/non-reporting:
(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.
(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.
(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.
