Health Chapter 420-7-2 ALABAMA STATE BOARD OF HEALTH ALABAMA DEPARTMENT OF PUBLIC HEALTH ADMINISTRATIVE CODE CHAPTER 420-7-2 CONTROLLED SUBSTANCES TABLE OF CONTENTS 420-7-2-.01 Authority 420-7-2-.02 Definitions 420-7-2-.11 Prescription Drug Monitoring Program – Collection Of Fees To Support Database 420-7-2-.12 Prescription Drug Monitoring Program Reporting To Database By Dispensers 420-7-2-.13 Access To Database Appendix Controlled Substances List 420-7-2-.01 Authority. (1) The Alabama Controlled Substances List, shown as Appendix to this Chapter, comprises a complete listing of said substances, pursuant to Code of Ala. 1975, Sections 20-2-1, et seq. (2) The Controlled Substances List shall be published annually, reflecting the date of adoption and the effective date. (3) As substances are designated, rescheduled or deleted as controlled substances, the appendix and other publications shall be amended accordingly by adding to said listing a slip-sheet of the action taken and the effective date. Each annual publication, as provided in (2) above, will contain any amendment occurring during that year. Author: Alabama Department of Public Health Statutory Authority: Code of Ala. 1975, §§20-2-1, et seq. History: Filed September 1, 1982. 420-7-2-.02 Definitions. Supp. 12/31/16 7-2-1 Chapter 420-7-2 Health (1) Controlled Substance. A drug, substance or immediate precursor in Schedules I through V of Rule 420-7-2-.03 of this Chapter. (2) Drug. (a) Substances recognized as drugs in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States or official national formulary or any supplement to any of them; (b) Substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals; (c) Substances (other than food) intended to affect the structure or any function of the body of man or animals; and (d) Substances intended for use as a component of any article specified in paragraphs (a), (b) or (c) of this subdivision. Such term does not include devices or their components, parts or accessories. (3) Immediate Precursor. A substance which the State Board of Pharmacy has found to be and by rule designates as being the principal compound commonly used or produced primarily for use and which is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail or limit manufacture. (4) Marihuana. All parts of the plant Cannabis sativa L., whether growing or not, the seeds thereof, the resin extracted from any part of the plant and every compound, manufacture, salt, derivative, mixture or preparation of the plant, its seeds or resin. Such term does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture or preparation of the mature stalks (except the resin extracted therefrom), fiber, oil or cake or the sterilized seed of the plant which is incapable of germination. (5) Narcotic Drug. Any of the following, whether produced directly or indirectly by extraction from substances of Supp. 12/31/16 7-2-2 Health Chapter 420-7-2 vegetable origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis: (a) Opium and opiate and any salt, compound, derivative or preparation of opium or opiate. (b) Any salt, compound, isomer, derivative or preparation thereof which is chemically equivalent or identical with any of the substances referred to in paragraph (a), but not including the isoquinoline alkaloids of opium. (c) Opium poppy and poppy straw. (d) Coca leaves and any salt, compound, derivative or preparation of coca leaves and any salt, compound, isomer, derivative or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine. (6) Opiate. Any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction sustaining liability. Such term does not include, unless specifically designated as controlled under this section, the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). Such term does include its racemic and levorotatory forms. (7) Opium Poppy. The plant of the species Papaver somniferum L., except its seeds. (8) Poppy Straw. All parts, except the seeds, of the opium poppy, after mowing. Author: Alabama Department of Public Health Statutory Authority: Code of Ala. 1975, §§20-2-1, et seq. History: Filed September 1, 1982. 420-7-2-.11 Prescription Drug Monitoring Program - Collection Of Fees To Support The Database. (1) Act No. 2004-443 requires that the following licensing boards shall assess a surcharge in the amount of $10.00 per year on the controlled substance registration Supp. 12/31/16 7-2-3 Chapter 420-7-2 Health certificate issued or renewed each year to a licensee of the respective boards in the State of Alabama. This requirement is to be implemented effective October 12, 2004. A list of the affected licensing boards follows: (a) Alabama State Board of Medical Examiners (b) Alabama Board of Optometry (c) Alabama Board of Dental Examiners (d) Alabama State Board of Veterinary Medical Examiners (e) Alabama State Board of Podiatry (2) By the 10th of each quarter, each affected licensing board shall remit payment of $10.00 for each controlled substance registration certificate issued or renewed. The remittance shall be made payable to the Alabama Department of Public Health, Office of Professional and Support Services. (3) By October 30 of succeeding years, each affected licensing board shall certify the number of controlled substance registration certificates issued or renewed during the prior fiscal year. The certification shall be made to the Alabama Department of Public Health, Office of Professional and Support Services. (4) Funds remitted to the Alabama Department of Public Health pursuant to this section shall be deposited into the Alabama State Controlled Substance Database Trust Fund. The funds shall be used exclusively for the development, implementation, operation, and maintenance of the controlled substances prescription database. Author: Charles C. Thomas, R.Ph., State Pharmacy Director Statutory Authority: Code of Ala. 1975, §§22-21-20, et. seq. History: New Rule: Filed February 18, 2005; effective March 25, 2005. 420-7-2-.12 Prescription Drug Monitoring Program Reporting To Database By Dispensers. Supp. 12/31/16 7-2-4 Health Chapter 420-7-2 (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. Supp. 12/31/16 7-2-5 Chapter 420-7-2 Health (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. 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. Supp. 12/31/16 7-2-6 Health Chapter 420-7-2 420-7-2-.13 Access To Database.