Arkansas Administrative Code

17 CAR § 160-1901. Procedures for disciplinary action. (a) Before revoking the certificate of licensure of any licensed pharmacist or licensed pharmacy permit, the Arkansas State Board of Pharmacy shall give the licensee proper notice in writing to appear before the board, at suc…

17 CAR § 160-2001. Definitions. As used in this part: (1)(A) “Prescription” means an order for medicine or medicines usually written as a formula by a: (i) Physician; (ii) Optometrist; (iii) Dentist; (iv) Veterinarian; or (v) Other licensed medicinal practitioner. (B) It: (i) Con…

17 CAR § 160-2002. Facsimile (fax) prescription drug order. (a) A prescription drug order that is transmitted by an electronic device which sends an exact copy image to the receiver (pharmacy) over telephone lines. (b) Faxing Schedule II prescriptions. (1)(A) Faxing a Schedule II…

17 CAR § 160-2003. Prescription transfers. (a)(1) The transfer of original prescription information for a legend drug or a controlled substance for the purpose of dispensing is permissible between pharmacies on a one-time basis only. (2) However, pharmacies electronically sharing…

17 CAR § 160-2004. Signing prescriptions. (a) Every licensed pharmacist or intern who shall fill or refill a prescription shall attest that he or she has personally filled said prescription by placing upon said prescription his or her signature with date thereof unless the pharma…

17 CAR § 160-2005. Secret codes prohibited. The treatment of disease, injury, or deformity by secret means or secret drugs being contrary to both the spirit and the letter of the Arkansas Medical Practices Act, Arkansas Code § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-4…

17 CAR § 160-2006. Maintenance and retention of drug records. (a) All drug records, including but not limited to purchase invoices, official dispensing records, and prescription and inventory records: (1) Must be kept in such a manner that all data is readily retrievable; and (2)…

17 CAR § 160-2007. Generic substitution. (a) The Arkansas State Board of Pharmacy recognizes the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book or The Green Book) as the basis for the determination of generic equiva…

17 CAR § 160-2008. Dispensing generically equivalent drug product. A pharmacist shall not dispense a generically equivalent drug product under Arkansas Code § 17-92-503(a) and (b) if: (1) In the case of a written prescription, on the prescription the prescriber: (A) Writes in his…

17 CAR § 160-2009. Electronic prescription processing and patient confidentiality. (a) Definitions. As used in this part: (1) “Confidential information” means information that is personally identifiable and, therefore, can be traced back to the patient or prescribing practitioner…

17 CAR § 160-201. Changes in employment. (a) Whenever any licensed pharmacist shall change his or her place of employment for any reason, it shall be the duty of the former and current employer and said licensed pharmacist to notify the Arkansas State Board of Pharmacy in writing…

17 CAR § 160-2010. Proper practitioner-patient relationship. In accordance with Arkansas Code § 17-92-1004(c) and § 17-92-1003(15), an in-person physical exam of the patient performed by a practitioner, physician, doctor or other prescribing health professional (“a practitioner”)…

17 CAR § 160-2011. Therapeutic substitution. (a) A pharmacist whose practice is located within this state may substitute medications for therapeutically equivalent medications. (b) However, a pharmacist shall not substitute a medication for a therapeutically equivalent medication…

17 CAR § 160-202. Replacement of pharmacist’s certificate. Any licensed pharmacist whose certificate has been lost or destroyed may procure a duplicate from the Arkansas State Board of Pharmacy by: (1) Filing an affidavit that said certificate has been lost or destroyed; and (2) …

17 CAR § 160-203. Practice after inactivity when reciprocating or reinstating a license. (a) To be reinstated and immediately practice without supervision, the pharmacist’s license shall not have lapsed by more than two (2) calendar years. (b) To be reciprocated and immediately p…

17 CAR § 160-2101. Controlled substances approved by the Food and Drug Administration. (a) Any wholesale drug company or drug manufacturer doing business in Arkansas pursuant to Acts 1969, No. 173, as amended by Acts 1979, No. 75, and Acts 1981, No. 257 shall not distribute any c…

17 CAR § 160-2102. Drug products must have a new drug application or an abbreviated new drug application. (a)(1) In order to provide for the protection of the public health and safety, drug products that are offered for sale by or stored at the premises of any manufacturer, distr…

17 CAR § 160-2201. Standards for compounding and dispensing sterile products. (a) The purpose of this rule is to provide standards in the conduct, practices, and operations of a pharmacy preparing and dispensing products requiring sterility, such as: (1) Injectables; (2) Ophthalm…

17 CAR § 160-2202. Good compounding practices. (a)(1) This rule describes the requirements of minimum current good compounding practice for the preparation of drug products by pharmacies or other facilities with permits issued by the Arkansas State Board of Pharmacy. (2)(A) Compo…

17 CAR § 160-2301. Drug samples. (a) Definitions. As used in this part: (1) “Coupon” means a form that may be redeemed as part of, or all of, the cost of a prescription for a legend drug after it has been dispensed; (2)(A) “Drug sample” means a unit of a legend drug that: (i) Is …

17 CAR § 160-2401. Schedule II prescription drugs. (a)(1) Emergency prescriptions. In the case of an emergency situation, as defined by this rule, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual …

17 CAR § 160-2402. Partial filling of a Schedule II prescription. (a)(1) The partial filling of a prescription for a controlled substance listed in Schedule II is permissible. (2)(A) If the pharmacist is unable to supply the full quantity called for in a written or emergency oral…

17 CAR § 160-2403. Computer records for partial filling. (a) Information pertaining to current Schedule II prescriptions for patients in an LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if the system has th…

17 CAR § 160-2404. Time limit on a new Schedule II prescription. (a) Prescriptions written for Schedule II controlled substances may be dispensed up to six (6) months from the date written if the pharmacist is certain of the validity of the prescription. (b) An exception to this …

17 CAR § 160-2405. Theft or loss of controlled drugs. (a) In the event a holder of a pharmacy permit issued by the Arkansas State Board of Pharmacy under Arkansas Code § 17-92-405 and 17 CAR § 160-1501 has suffered a theft or loss of controlled substances, said permit holder shal…

17 CAR § 160-2406. Schedule V — Exempt products and pharmacist-authorized drugs. (a) A pharmacist-authorized drug is a nonprescription drug that is subject to the same restrictions as are imposed for ephedrine, pseudoephedrine, or phenylpropanolamine under: (1) Arkansas Code §§ 5…

17 CAR § 160-2407. Schedule V — Exempt narcotics. A controlled substance listed in Schedule V that is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., may be dispensed by a pharmacist without a prescription to a purcha…

17 CAR § 160-2408. Schedule V — Ephedrine, pseudoephedrine, or phenylpropanolamine. (a) As provided in Arkansas Code § 5-64-1101 et seq., unless dispensed under a valid prescription, all sales or transfers of ephedrine, pseudoephedrine, or phenylpropanolamine are subject to the f…

17 CAR § 160-2501. Prescription Delivery Standards. (a) Pharmacies providing home delivery services in Arkansas shall: (1) Contact the patient or caregiver for approval prior to any billing or delivery of medications; (2) Notify the patient of the delivery plan and expected arriv…

17 CAR § 160-2601. Definitions. As used in this part, unless the context otherwise requires: (1) “Blood” means whole blood collected from a single donor and processed either for transfusion or further manufacturing; (2) “Blood component” means that part of blood separated by phys…

17 CAR § 160-2602. Sales permit required. It shall be unlawful for any person to sell or offer for sale by advertisement, circular, letter, sign, or oral solicitation or any other means any prescription drug unless the person holds and possesses a permit authorizing such sale as …

17 CAR § 160-2603. Wholesale distributors, third-party logistics providers, manufacturers, and outsourcing facilities — Permit required. (a)(1) Every wholesale distributor, third-party logistics provider, manufacturer, and outsourcing facility that shall engage in the distributio…

17 CAR § 160-2604. Shipment to certain licensed professionals. (a) All wholesale distributors must, before shipping to a recipient in this state any prescription drug as defined in this part, ascertain that the person to whom shipment is made is either a licensed physician licens…

17 CAR § 160-2605. Minimum required information for licensure. (a) The Arkansas State Board of Pharmacy requires the following from each wholesale drug distributor as part of the initial licensing procedure and as part of any renewal of such license: (1) The name, full business a…

17 CAR § 160-2606. Minimum qualifications. (a) The Arkansas State Board of Pharmacy will consider the following factors in determining eligibility for licensure of persons who engage in the wholesale distribution of prescription drugs: (1) Any convictions of the applicant under a…

17 CAR § 160-2607. Personnel. The licensed wholesale distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the wholesale distribution of drugs.

17 CAR § 160-2608. Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records. (a) The following are required for the storage and handling of prescription drugs and for the establishm…

17 CAR § 160-2609. Written policies and procedures. (a) Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures that shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including pol…

17 CAR § 160-2610. Responsible persons. Wholesale drug distributors shall establish and maintain lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of the…

17 CAR § 160-2611. Compliance with federal, state, and local laws. (a) Wholesale drug distributors shall operate in compliance with applicable federal, state, and local laws and rules. (b) Wholesale drug distributors that deal in controlled substances shall: (1) Register with the…

17 CAR § 160-2612. Salvaging and reprocessing. Wholesale drug distributors shall be subject to the provisions of any applicable federal, state, or local laws or rules that relate to prescription drug product salvaging or reprocessing, including 21 C.F.R. pt. 207, 21 C.F.R. pt. 21…

17 CAR § 160-2613. Applicability. Nothing in this part shall apply to the sale of chemicals or poisons for use for nonmedical purposes or for uses as insecticides or biologics or medicine used for the cure, mitigation, or prevention of disease of animals or fowl or for agricultur…

17 CAR § 160-2614. Inspection of premises and records. (a) The Arkansas State Board of Pharmacy may conduct inspections upon all premises, including delivery vehicles, purporting or appearing to be used by a person licensed under this part. (b) The board, in its discretion, may a…

17 CAR § 160-2701. Definitions. As used in this part: (1) “Home medical equipment, legend device, and medical gas supplier” means a person, business, corporation, agency, company, etc., licensed to supply home medical equipment, medical gases, and/or legend devices to patients on…

17 CAR § 160-2702. Licensure required. (a)(1) No person or entity subject to licensure shall sell or rent or offer to sell or rent directly to patients in this state any home medical equipment, legend devices, and/or medical gases unless the person or entity is licensed as requir…

17 CAR § 160-2703. Standards of practice. (a)(1) Written policies and procedures must be: (A) Available for review; and (B) Designed to meet all the following standards. (2) Documentation of all staff training must be kept in each employee’s personnel file. (3) All local, state, …

17 CAR § 160-2801. Definitions. As used in this part unless the context otherwise requires: (1) “Board” means the Arkansas State Board of Pharmacy; (2) “Person” includes: (A) An individual; (B) A general or limited partnership; (C) A corporation; (D) A business firm; (E) A limite…