LAWS, RULES, AND REGULATIONS August 2020 Asa Hutchinson, Governor John Clay Kirtley, Pharm.D. Executive Director Arkansas Department of Health Arkansas State Board of Pharmacy 322 South Main Street, Suite 600 Little Rock, AR 72201 Phone: 501.682.0190 Fax: 501.682.0195 [email protected] www.pharmacyboard.arkansas.gov 10/8/2020 Arkansas State Board of Pharmacy Members Lenora Newsome, P.D. President, Smackover Rebecca Mitchell, Pharm.D. Vice President/Secretary, Greenbrier Deborah Mack, P.D. Member, Bentonville Lynn Crouse, Pharm.D. Member, Lake Village Brian Jolly, Pharm.D. Member, Beebe Carol Rader, RN Public Member, Fort Smith Amy Fore, MHSA, FACMPE, FACHE Public Member, Fort Smith 10/8/2020 Board of Pharmacy Law Book - Acts Table of Contents Pharmacy Practice Act A 17-92-101 Definitions……………………………………………………… 1-4 17-92-102 Exemptions…………………………………………………….. 4-5 17-92-103 Pharmacy laws unaffected……………………………………... 5 17-92-104 Privilege tax unaffected……………………………………….. 5 17-92-105 Prohibited acts – Penalties……………………………………... 6 17-92-106 Injunctions……………………………………………………… 6 17-92-107 Prosecutions – Disposition of fines……………………………. 6 17-92-108 Fees…………………………………………………………….. 6-10 17-92-109 Prescriptions for optometrists………………………………….. 10 17-92-110 Prescriptive authority of advance practice nurses……………… 10 17-92-111 Construction of Acts 1997, No. 1204………………………….. 10 17-92-112 Prescriptions for physician assistants…………………………. 10 17-92-201 Members – Qualifications……………………………………… 11 17-92-202 Members – Oath……………………………………………… 11 17-92-203 Members – Compensation…………………………………….. 11 17-92-204 Organization and proceedings…………………………………. 12 17-92-205 Rules and regulations – Enforcement………………………….. 12-13 17-92-206 Issuance of bulletins – Annual Reports………………………... 14 17-92-207 Maintenance of office………………………………………….. 14 17-92-208 Employees……………………………………………………… 14 17-92-209 Medications Administration Advisory Committee…………….. 15 17-92-301 License Required………………………………………………. 15 17-92-302 Unlicensed practice – Penalty…………………………………. 15-16 17-92-303 Unlawful use of professional title – Penalty…………………… 16 17-92-304 Board administration – Support services………………………. 16 17-92-305 Application – Qualification of applicants……………………… 16-17 17-92-306 Examinations…………………………………………………… 17 17-92-307 Internship required……………………………………………... 17 17-92-308 Reciprocity……………………………………………………... 17-18 17-92-309 Registration and certificate…………………………………….. 18 17-92-310 Failure to renew………………………………………………... 18-19 17-92-311 Revocation, suspension, or non-renewal – Grounds…………… 19-20 17-92-312 Revocation and fine – Adulteration of drugs…………………... 20 17-92-313 Revocation – Procedure………………………………………... 20 17-92-314 Revocation – Appeals………………………………………….. 20 17-92-315 Alternative penalties…………………………………………… 20-21 17-92-316 Credential required for professional pharmacy service………... 21-22 17-92-317 Criminal Background Checks………………………………….. 22-24 17-92-401 Applicability to out-of-state operations………………………... 24-25 17-92-402 Licensed pharmacist required………………………………….. 25 17-92-403 Licensed pharmacist required – Exceptions…………………… 25-27 17-92-404 Pharmacy permit required……………………………………… 27 i 17-92-405 Pharmacy permit – Application………………………………... 27-28 17-92-407 Revocation – Grounds………………………………………….. 28 17-92-408 Revocation – Procedure………………………………………... 28 17-92-409 Pharmacy library required……………………………………… 28-29 17-92-410 Records of poison sales………………………………………… 29 17-92-411 Prescription contents and labels………………………………... 29 17-92-412 Nursing home consultant permit……………………………….. 29-30 17-92-501 Penalty………………………………………………………….. 30 17-92-502 Rules and regulations…………………………………………... 30 17-92-503 Generic substitutions…………………………………………… 30-31 17-92-505 Labeling………………………………………………………… 31 17-92-506 Price Lists………………………………………………………. 31 17-92-601 Short title……………………………………………………….. 32 17-92-602 Definitions……………………………………………………… 32 17-92-603 Advisory Committee for Hospital Pharmacies………………… 32 17-92-604 Regulatory authority…………………………………………… 32-33 17-92-605 Hospital pharmacy license – Services permitted………………. 33 17-92-606 Hospital pharmaceutical permit………………………………... 34 17-92-607 Unlawful for hospital to hold licensed pharmacy permit – 34 Exemptions…………………………………………………….. 17-92-701 Definitions……………………………………………………… 34 17-92-702 Administration………………………………………………….. 34-35 17-92-703 Functions……………………………………………………….. 35 17-92-704 Board review…………………………………………………… 35 17-92-705 Notification of procedures, rights, and responsibilities – Failure 35 to comply……………………………………………………….. 17-92-706 Funding………………………………………………………… 35-36 17-92-707 Liability………………………………………………………… 36 17-92-801 Powers and duties of Arkansas State Board of Pharmacy……... 36 17-92-901 Definitions……………………………………………………… 36-37 17-92-902 License required………………………………………………... 37-38 17-92-903 Exemption from license and permit requirements……………... 38-39 17-92-904 Supply order required………………………………………….. 39 17-92-905 Labeling………………………………………………………… 39 17-92-906 Regulations……………………………………………………... 39-40 17-92-907 Manufacture, shipment, or sale of medical gases……………… 40 17-92-908 Revocation or suspension of license…………………………… 40-41 17-92-909 Advisory committee to the board………………………………. 41 17-92-1001 Title…………………………………………………………….. 41 17-92-1002 Purpose…………………………………………………………. 41 17-92-1003 Definitions……………………………………………………… 41-43 17-92-1004 Requirements for Internet sales………………………………… 43 17-92-1005 Requirements for Internet sites………………………………… 43-44 17-92-1006 Disclaimers or limitations of liabilities………………………… 44 17-92-1007 Enforcement……………………………………………………. 44 ii Miscellaneous Statutes Related to B Pharmacy 17-1-103 Registration, certification, and licensing for criminal 1 offenders………………………………………………………... 17-80-102 Subpoena power of boards – Enforcement…………………….. 1-2 17-80-103 Immunity of board members…………………………………… 2 17-80-104 Continuing education requirements……………………………. 2-3 iii Uniform Controlled Substances Act C 5-64-101 Definitions……………………………………………………… 1-6 5-64-201 Director’s duties………………………………………………... 6-7 5-64-202 Nomenclature…………………………………………………... 7 5-64-203 Criteria for Schedule I………………………………………….. 7 5-64-205 Criteria for Schedule II…………………………………………. 7 5-64-207 Criteria for Schedule III………………………………………... 7 5-64-209 Criteria for Schedule IV………………………………………... 8 5-64-211 Criteria for Schedule V………………………………………… 8 5-64-213 Schedule VI established………………………………………... 8 5-64-214 Criteria for Schedule VI………………………………………... 8 5-64-215 Substances in Schedule VI……………………………………... 8-9 5-64-216 Schedule revisions……………………………………………… 9 5-64-307 Order forms…………………………………………………….. 9 5-64-308 Written prescriptions…………………………………………… 9 5-64-1005 Exemptions……………………………………………………... 9-10 5-64-1006 Suspicious order reports………………………………………... 10-11 5-64-1101 Possession – Penalty…………………………………………… 11 5-64-1102 Possession with intent to manufacture – Unlawful 11-12 distribution……………………………………………………… 5-64-1003 Retail sales limit………………………………………………... 12-14 iv Insurance Policies – Prescription D Drug Benefits 23-79-149 Prescription drug benefits……………………………………… 1 23-79-601 Definitions……………………………………………………… 2 23-79-602 Diabetes self-management training – Licensed providers – 2-3 Prescription by physician………………………………………. 23-79-603 Requirements…………………………………………………… 3 23-79-604 Exclusions……………………………………………………… 3 23-79-605 Regulations……………………………………………………... 3 23-79-606 Applicability – Delivery within state…………………………... 3-4 23-79-607 Applicability – Exceptions……………………………………... 4 v Food, Drug, and Cosmetic Act E 20-56-201 Title…………………………………………………………….. 1 20-56-202 Definitions……………………………………………………… 1-3 20-56-203 Applicability……………………………………………………. 3 20-56-204 Notice of minor violations……………………………………… 3 20-56-205 Penalties – Exceptions………………………………………….. 3-4 20-56-206 Duty of prosecuting attorney…………………………………… 4 20-56-207 Injunction authorized…………………………………………… 4-5 20-56-208 Adulterated food……………………………………………….. 5-6 20-56-209 Misbranded food………………………………………………... 6-7 20-56-210 Adulterated drug or device……………………………………... 7-8 20-56-211 Misbranded drug or device……………………………………... 8-10 20-56-212 Adulterated cosmetic…………………………………………… 10-11 20-56-213 Misbranded cosmetic…………………………………………… 11 20-56-214 False or misleading advertisement……………………………... 11-12 20-56-215 Prohibited acts………………………………………………….. 12 20-56-216 Adulterated, misbranded, or abandoned food, drug, device, or 13-14 cosmetic – Procedures………………………………………….. 20-56-217 Contamination with microorganisms…………………………... 14 20-56-218 Poisonous or deleterious substance – Regulation for use………. 14-15 20-56-219 State Board of Health – Authority to regulate………………….. 15 20-56-220 State Board of Health – Inspection……………………………... 15-16 20-56-221 State Board of Health – Publication and dissemination of 16 information……………………………………………………... 20-56-222 State Board of Health – Enforcement of subchapter…………… 16 20-56-223 State Board of Health – Enforcement of federal law…………... 16 vi Controlled Substances and Legend F Drugs 20-64-501 Applicability……………………………………………………. 1 20-64-502 Construction……………………………………………………. 1 20-64-503 Definitions……………………………………………………… 1-3 20-64-504 Sales – Permit required…………………………………………. 3 20-64-505 Wholesale distributor – Permit required……………………….. 3 20-64-506 Wholesale distributors – Shipment to certain licensed 3 professionals……………………………………………………. 20-64-507 Regulations……………………………………………………... 4 20-64-508 Revocation or suspension of licenses…………………………... 4 20-64-509 Penalties………………………………………………………… 4-5 20-64-510 Hearing procedures……………………………………………... 5 20-64-511