07-00: GENERAL REGULATIONS REGARDING DRUGS/PRESCRIPTIONSDefinitions:
"Prescription" means an order for medicine or medicines usually written as a formula by a physician, optometrist, dentist, veterinarian, or other licensed medicinal practitioner. It contains the names and quantities of the desired substance, with instructions to the pharmacist for its preparation and to the patient for the use of the medicine at a particular time and may authorize the pharmacist to substitute a therapeutically equivalent drug that is at a lower cost to the patient and communicate that authorization by any generally accepted means of communication of a prescription from a prescriber to a pharmacist.
"Prescription drug order" means a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.
"Therapeutic class" means a group of similar drug products that have the same or similar mechanisms of action and are used to treat a specific condition;
"Therapeutically equivalent" means drug products from the same therapeutic class that if administered in appropriate amounts will provide the same therapeutic effect, identical in duration and intensity
"Written prescription" means a prescription that is presented to an apothecary, pharmacy or pharmacist in compliance with federal law and regulations, including a written, oral, faxed, or electronic prescription. (5/31/2014, Amended 11/30/2014)
07-00-0001- Facsimile (Fax) Prescription Drug OrderA prescription drug order which is transmitted by an electronic device which sends an exact copy image to the receiver (pharmacy) over telephone lines.
(a) Faxing Schedule II prescriptions(1) Faxing a Schedule II prescription for a home infusion, or intravenous pain therapy patient or both - a prescription, written for a Schedule II narcotic substance to be compounded for direct administration to a home infusion patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion, may be transmitted directly from the prescribing practitioner, by the practitioner or the practitioner's agent, to the pharmacy by facsimile. The facsimile serves as the original written prescription. This exception does not apply to oral dose medications. (Also see Regulation # 07-04-0001)(2) Faxing a Schedule II prescription for a long-term-care patient - a prescription written for a Schedule II substance, for a resident of a long-term-care facility may be transmitted directly from the prescribing individual practitioner, or the practitioner's agent, to the provider pharmacy by facsimile. The facsimile serves as the original written prescription. (See also regulation 07-04-0001)(3) A prescription written for a Schedule II substance, for a home hospice patient may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. It must be noted on the prescription that this is a hospice patient. The facsimile serves as the original written prescription, (see regulation 07-04-0001)(b) Faxing from a long-term-care facility to a pharmacy - a pharmacist may accept a fax prescription from a long-term-care facility provided:(1) For Schedule II drugs, all requirements of a written prescription are met, including the preserver's signature on the faxed order and it is faxed by the nurse/person the physician and the long-term-care facility has designated as his/her "agent" to transmit the order, and must contain the nurse/person's signature.(2) For drugs other than Schedule II, the order is faxed by the nurse/person the physician and the long-term-care facility has designated as his/her "agent" to transmit the order, and must contain the nurse/person's signature.(3) The pharmacist verifies the fax is from the machine in the long-term-care facility.(c) Faxed prescriptions (1) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V which is a prescription drug, or any legend drug, only pursuant to either a written prescription signed by a prescribing individual practitioner or a facsimile of a written signed prescription transmitted directly by the prescribing practitioner, or the practitioner's agent, to the pharmacy or pursuant to an oral prescription made by a prescribing individual practitioner, or the practitioner's agent, and either entered into the pharmacy's electronic prescription system or promptly reduced to writing by the pharmacist.(2) All laws and regulations applicable to oral prescription drug orders shall also apply to all facsimile orders including, but not limited to, generic substitution, maintenance of records, information required, etc.(3) A prescription order transmitted by facsimile device shall contain all prescription information required by federal and state law.(4) A pharmacist may dispense new prescription orders transmitted by fax only when signed by the prescribing practitioner and transmitted from the practitioner's office or a long-term-care facility in compliance with all sections of this document. Any faxed new prescription order that is not signed must be treated as a verbal order and verified to the pharmacist's satisfaction that it is legitimate.(5) The original fax shall be assigned the number of the prescription dispensed, and maintained in pharmacy records for at least two years.(6) The receiving fax machine must be in the prescription department of the pharmacy to protect patient/pharmacist authorized prescribing practitioner confidentiality and security.(7) Refill authorizations for prescriptions, other than Schedule II, may be transmitted using a facsimile device. Any faxed authorization to renew or refill a prescription that is not signed must be treated as a verbal order and verified to the pharmacist's satisfaction that it is legitimate.(d) Patient/prescriber consideration (1) No pharmacist shall enter into any agreement with a practitioner or health care facility concerning the provision of facsimile machine services or equipment which adversely affects any person's freedom to choose the pharmacy at which a prescription will be filled.(2) A pharmacy/pharmacist shall not provide a fax machine to a prescriber, a long-term-care facility, or any healthcare facility free of charge or for less than the pharmacy/pharmacist cost.(3) No agreement between a prescriber and a pharmacy shall require that prescription orders be transmitted by facsimile machine from the prescriber to only that pharmacy.(4) A pharmacy/pharmacist shall not enter into any agreement whereby the pharmacy/pharmacist pays to obtain the prescription order by fax or any electronic data transfer. (10/12/93 Amended 2/15/95, 10/14/1997, 7/10/2009, and 5/31/2014)07-00-0002- PRESCRIPTION TRANSFERS(a) The transfer of original prescription information for a legend drug or a controlled substance listed in Schedules III, IV or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the preserver's authorization. Transfers are subject to the following requirements: (1) The transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records the following information: (A) Write the word "Void" on the face of the invalidated prescription.(B) Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information.(C) Record the date of the transfer and the name of the pharmacist transferring the information.(b) The pharmacist receiving the transferred prescription information shall electronically record or reduce to writing the following:(1) Write the word "transfer" on the face of the transferred prescription.(2) Provide all information required to be on a prescription pursuant to 21 CFR 1306.05 and include: (A) date of issuance of original prescription;(B) original number of refills authorized on original prescription;(C) date of original dispensing;(D) number of valid refills remaining and date(s) and locations of previous refill(s);(E) pharmacy's name, address, DEA registration number and prescription number from which the prescription information was transferred;(F) name of pharmacist who transferred the prescription.(c) The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.(d) Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transfer. (Amended 5/31/2014)07-00-0003- SIGNING PRESCRIPTIONSEvery 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 pharmacy is electronically processing prescriptions. If the pharmacy uses an electronic prescription processing system, they must fill prescriptions in accordance with regulation 07-00-0008. (10/09/80, Revised 10/14/81, 6/20/91, and 8/19/99)
07-00-0004- SECRET CODES PROHIBITEDThe 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, and dispensing of secret medicines or drugs being contrary to both the spirit and the letter of the Arkansas Pharmacy Act and the Arkansas Food, Drug, and Cosmetic Act, hereafter no licensed pharmacist or intern shall enter into any agreement or arrangement with a physician, or other practitioner authorized by law to prescribe medicine or drugs, for the compounding and/or dispensing of secret formula or coded prescription. (10/09/80)
07-00-0005- MAINTENANCE AND RETENTION OF DRUG RECORDSAll drug records, including but not limited to purchase invoices, official dispensing records, prescription, and inventory records, must be kept in such a manner that all data is readily retrievable, and shall be retained as a matter of record by the pharmacist for at least two years.
At least every 12 months all prescriptions for legend drugs which are not controlled substances when refilled must be verified by the prescribing practitioner, a new prescription written, and a new prescription number assigned to the prescription. The prescription number of the updated prescription shall be recorded on the new prescription.
Provided, however, this regulation recognizes, and in no way affects, the six-month and five-refill limit on controlled drug prescriptions pursuant to A.C.A. 5-64 308(c). (10/09/80, Revised 12/12/86)
07-00-0006- GENERIC SUBSTITUTIONThe Arkansas State Board of Pharmacy recognizes the Federal 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 equivalency within the limitations stipulated in that publication. If the Federal Food and Drug Administration approves a drug product as bioequivalent and publishes that product with an "A" (AA, AB, AN, AO, AP, and AT) rating in the Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book or The Green Book), an Arkansas pharmacist, or any pharmacist dispensing drugs to patients in Arkansas, may substitute that product consistent with law. Conversely, if the drug product is "B" rated, is changed from an "A" rating to a "B" rating, or is not rated, the pharmacist may not substitute without the consent of the prescribing practitioner. When a pharmacist substitutes a bioequivalent drug product for the drug prescribed, the patient shall be notified of the substitution by a pharmacist involved in the dispensing process. (6/21/2001, Amended 5/31/2014)
07-00-0007- A PHARMACIST SHALL NOT DISPENSE A GENERICALLY EQUIVALENT DRUG PRODUCT UNDER ACA § 17-92-503(a) AND (b) OF THE GENERIC SUBSTITUTION ACT IF:(a) In the case of a written prescription, on the prescription the prescriber writes in his or her own handwriting words that specify that no substitution shall be made and then also signs the prescription.(b) The prescriber, in the case of a prescription other than one in writing signed by the prescriber, expressly states at the time the prescription is given, that it is to be dispensed as communicated, and same is either entered into the pharmacy's electronic prescription system orjeduced to writing on the prescription by the pharmacist, or(c) The person for whom the drug product is prescribed indicates the prescription is to be dispensed as written or communicated. (4/07/89, Amended 5/31/2014)07-00-0008- ELECTRONIC PRESCRIPTION PROCESSING AND PATIENT CONFIDENTIALITY(a) Definitions (1) "Confidential information" means information that is personally identifiable and, therefore, can be traced back to the patient or prescribing practitioner that is accessed or maintained by the pharmacist in the patient's records or which is communicated to the patient, as part of patient counseling, which is privileged and may be released only to the patient or prescriber or, as the patient or prescriber directs; to those practitioners, other authorized health care professionals, and other pharmacists where, in the pharmacist's professional judgment, such release is necessary to protect the patient's health and well being; and to such other persons or governmental agencies authorized by law to receive such confidential information, regardless of whether such information is in the form of paper, preserved on microfilm, or is stored on electronic media.(2) "Electronic transmission" means transmission of information in electronic form such as computer-to-computer, electronic device to computer, e-mail, or the transmission of the exact visual image of a document by way of electronic equipment.(3) "Prescription drug order" means a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.(b) Patient confidentiality requirements: (1) Prescription information and other patient health care information shall be maintained in a manner that protects the integrity and confidentiality of such information as provided by rules of the Board.(2) The pharmacy shall provide a mechanism for patients to prevent the disclosure of any information (confidential or otherwise) about them that was obtained or collected by the pharmacist or pharmacy incidental to the delivery of pharmaceutical care other than as authorized by law or rules of the Board.(3) The pharmacist in charge shall: (A) Establish written policies and procedures for maintaining the integrity and confidentiality of prescription information and patient health care information. All employees of the pharmacy, with access to any such information, shall be required to read, sign, and comply with the established policies and procedures.(B) Assure that the requirements of this regulation are established and implemented.(c) Manner of issuance of a prescription drug order(1) A prescription drug order may be transmitted to a pharmacy by electronic transmission. If transmitted by way of electronic transmission, the prescription drug order shall be immediately reduced to a form, by the pharmacist, that may be maintained for the time required by law or rules. Persons other than those bound by a confidentiality agreement, pursuant to a consent agreement, shall not have access to pharmacy records containing personally identifiable confidential information concerning the pharmacy's patients or prescribers.(2) All prescription drug orders, communicated by way of electronic transmission shall: (A) Be sent only to the pharmacy of the patient's choice with no intervening person having access to the prescription drug order.(B) Identify the transmitter's phone number for verbal confirmation, the time and date of transmission, and the pharmacy intended to receive the transmission - as well as any other information required by federal or state law.(C) Be transmitted by the authorized practitioner or the designated agent of the practitioner.(D) Be deemed the original prescription drug order provided it meets the requirement of this regulation and other law or regulation.(3) All electronic equipment, for receipt of prescription drug orders communicated by way of electronic transmission, shall be maintained so as to ensure against unauthorized access. The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of the prescription drug order consistent with existing federal or state laws or regulations.(4) The prescribing practitioner may authorize his or her agent to transmit a prescription drug order, by electronic transmission, to the pharmacy - provided that the identity of the transmitting agent is included in the order.(d) Patient records: (1) Personally identifiable confidential information in the patient medication record, may be released to the patient, the prescriber, other licensed practitioners then caring for the patient, another licensed pharmacist, the Board or it's representatives, or any other person duly authorized by law to receive such information. Personally identifiable confidential information, in the patient medication record, may be released to others only on written release of the patient. Personally identifiable confidential information, in the patient medication record related to identity of the prescriber, may be released only on written release of the prescriber.(e) Discipline: The Board of Pharmacy may refuse to issue or renew, or may suspend, revoke, restrict the licenses or the registration of, or fine any person for divulging or revealing confidential information to a person other than as authorized by rules of the Board.
(e) Security: To maintain the confidentiality of patient and prescriber records, the computer system shall have adequate security and system safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records. Once the drug has been dispensed, any alterations in prescription drug order data shall be documented - including the identification of the pharmacist responsible for the alteration.
(f) Providing electronic equipment by pharmacists or pharmacies to practitioners or health care facilities prohibited A pharmacist or pharmacy shall not provide a computer modem or other similar electronic device to a prescriber or health care facility for the purpose of providing an incentive to the practitioner or health care facility to refer patients to a particular pharmacy or department. This shall not prohibit a hospital from providing in-house equipment for the use of practitioners and the hospital pharmacy to communicate within the facility. (Amended 10/2000, 3/2001)
07-00-0009- PROPER PRACTITIONER-PATIENT RELATIONSHIPIn accordance with Ark. Code Ann. § 17-92-1004(c) and Ark. Code Ann. § 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") prior to the issuance of any prescription is required in order to establish a valid prior patient-practitioner relationship for purposes of Ark. Code Ann. § 17-92-1004(c) and a "Proper Physician-Patient Relationship" for purposes of Ark. Code Ann. § 17-92-1003(15), unless:
(a) the prescribing practitioner is consulting at the specific request of another practitioner who: (1) maintains an ongoing relationship with the patient;(2) has performed an in-person physical exam of the patient; and(3) has agreed to supervise the patient's ongoing care and use of prescribed medications; or(b) the prescribing practitioner interacts with the patient through an on-call or cross-coverage situation.(Emergency 10/31/2007, 2/25/2008) 07-00-0010- THERAPEUTIC SUBSTITUTIONA pharmacist may substitute a therapeutically equivalent drug that is at a lower cost to the patient only after the prescriber grants such authorization for each prescription. A prescriber may authorize a pharmacist to dispense a therapeutically equivalent drug product as part of a written prescription as defined to include a written, oral, faxed, or electronic prescription by indicating Therapeutic Substitution Allowed or May Therapeutically Substitute or abbreviating "TSA" or "MTS" as part of the prescription verbally, in writing or by utilizing a separate signature line to show such authorization.
(a) Therapeutic equivalence may be established with clinical publications comparing dosages of drugs in a therapeutic class.(b)(1) Before dispensing, the pharmacist shall discuss verbally any suggested substitution with the patient and inform the patient that the patient has a right to refuse the substitution. This discussion shall include without limitation:(A) Notification to the patient that the therapeutically equivalent drug does not contain the identical active ingredient present in the prescribed drug; and(B) All differences in dosage and frequency between the prescribed drug and the therapeutically equivalent drug.(c) The pharmacist shall send notice of the substitution to the prescriber in writing or by electronic communication within twenty-four (24) hours after the drug is dispensed to the patient.(d) This section does not apply to specific acts of drug therapy management or disease state management delegated to a pharmacist based upon a written protocol or patient care plan approved by a physician under § 17-92-101(16)(A)(ix); (Adopted 11/30/2014)07-04: CONTROLLED SUBSTANCES07-04-0001- SCHEDULE II PRESCRIPTION DRUGS(a) Emergency Prescriptions - In the case of an emergency situation, as defined by this regulation, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner - provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (never more than 72 hours). Dispensing, beyond the emergency period, must be pursuant to a written prescription signed by the prescribing individual practitioner. For the purposes of authorizing an oral prescription for a controlled substance listed in Schedule II of the Arkansas Controlled Substance List, the term "emergency situation" means those situations in which the prescribing practitioner determines that: (1) Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user;(2) No appropriate alternative treatment is available (which includes the administration of a drug which is not a Schedule II), and(3) It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the pharmacist dispensing the drug prior to the dispensing. The prescription shall be immediately reduced to writing by the pharmacist. Within seven (7) days after authorizing an emergency oral prescription, the prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The statement "Authorization for Emergency Dispensing," and the date of the oral order, must be on the face of the prescription. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription, which had earlier been reduced to writing. The pharmacist shall notify the nearest office of the DEA if the prescribing practitioner fails to deliver a written prescription-failure of the pharmacist to do so shall void the authority conferred by this regulation to dispense without a written prescription of a prescribing practitioner.
07-04-0002- PARTIAL FILLING OF A SCHEDULE II PRESCRIPTIONThe partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription).
The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.
A prescription, for a Schedule II controlled substance written for a patient in a long-term-care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness, may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist may contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record, on the prescription, whether the patient is "terminally ill" or an "LTCF patient".
For each partial filling, the dispensing pharmacist shall record, on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable), the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist.
Prior to any subsequent partial filling, the pharmacist is to determine that the additional partial filling is necessary. The total quantity of Schedule II controlled substances dispensed, in all partial filling, must not exceed the total quantity prescribed. A Schedule II prescription for a patient in a LTCF or a patient with a medical diagnosis documenting a terminal illness, if partially filled, shall be totally dispensed within sixty (60) days and dispensing cannot occur after sixty (60) days or after the medication has been discontinued by the prescriber.
07-04-0003- COMPUTER RECORDS FOR PARTIAL FILLINGInformation, pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness, may be maintained in a computerized system - if the system has the capability to permit:
(a) Output (display or print) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of medication authorized (to include dosage, form, strength and quantity) and listing of the partial fillings that have been dispensed under each prescription.(b) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted.(c) Retrieval of partially filled Schedule II prescription information is the same as required for Schedule III and IV prescription refill information. The authority to dispense Schedule II prescriptions for partial quantities does not apply to other classes of patients - such as a patient with severe intractable pain who is not diagnosed as terminal.
07-04-0004- TIME LIMIT ON A NEW SCHEDULE II PRESCRIPTIONPrescriptions 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. An exception to this would be prescriptions written for a patient classified as terminally ill or a long-term-care facility patient and these prescriptions are valid for 60 days from date of issue and may be partially filled. (2/15/95, Amended 10/14/97)
07-04-0005- THEFT OR LOSS OF CONTROLLED DRUGSIn the event a holder of a pharmacy permit issued by the Arkansas State Board of Pharmacy under AC A § 17-92-405 and Board Regulation 04-05-0001 has suffered a theft or loss of controlled substances. Said permit holder shall:
i. Notify Arkansas Department of Health Division of Pharmacy Services and Drug Control, the nearest Drug Enforcement Administration Diversion Field Office, and the Arkansas State Board of Pharmacy immediately upon discovery by phone or fax, andii. Deliver a completed DEA Form-106 to each of the agencies listed in (a) within 7 days of the occurrence of said loss or the discovery of said loss. (10/09/83 Revised 6/26/03 and 7/27/2011)07-04-0006- SCHEDULE V-EXEMPT PRODUCTS & 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 Ark. Code Ann. § 5-64-1103(c) and (d)(4) and § 5-64-1104.(b) A pharmacist may dispense a Schedule V exempt product or a Pharmacist Authorized Drug only after making a professional determination that there is a legitimate medical and pharmaceutical need for the product. A pharmacist must base the decision to dispense on factors relevant to the patient's medical need and the appropriateness of the requested product, including, without limitation: 1. the patient's medication filling history as maintained in the pharmacy's system;2. the pharmacist's personal knowledge of the patient; and/or3. the pharmacist's screening of the patient's existing medical conditions and physical symptoms as appropriate for the treatment being considered. The screening may include a review of the patient's medical history, disease history, prescription history, physical symptoms, and relevant vital signs, such as blood pressure. All screening performed by the pharmacist must be documented and maintained in the patient's pharmacy record.(c) A pharmacist should not dispense a Schedule V exempt product or Pharmacist Authorized Drug if the pharmacist is aware of information indicating that the patient is inappropriately self-medicating. If the patient does not provide a satisfactory explanation regarding inappropriate self-medicating, the pharmacist must decline to dispense the product and refer the patient to a physician. 1. For ephedrine, pseudoephedrine, or phenylpropanolamine products, a pharmacist should question a patient regarding inappropriate self-medicating when records indicate that the patient may be exceeding the maximum recommended daily dose.2. For Schedule V exempt narcotics, a pharmacist should question a patient regarding inappropriate self-medicating when records indicate that the patient has been dispensed a Schedule V exempt product: A. more than ten (10) days;B. more than twice in a thirty (30) day period;C. more than four (4) times in two (2) consecutive months; or(d) The Arkansas State Board of Pharmacy may revoke or suspend a certificate of licensure, license, registration or permit or may refuse to issue a certificate of licensure, license, registration or permit to any person or entity that dispenses or sells a Schedule V exempt product or Pharmacist Authorized Drug in violation of a state or federal pharmacy law or regulation.(e) A pharmacist is immune from civil liability for refusing to dispense, sell, transfer or otherwise furnish a Schedule V exempt product or Pharmacist Authorized Drug based on a professional determination or a determination of age or identity.(f) Nothing in this regulation shall be interpreted to require that a Schedule V exempt product or Pharmacist Authorized Drug must be sold upon request. There shall be no penalty or other disciplinary action taken against a pharmacist who chooses not to sell these products to a patient or individual. (Adopted 7/27/2011) 07-04-0007- SCHEDULE V-EXEMPT NARCOTICSA controlled substance listed in Schedule V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:
(a) Such dispensing is made only by a pharmacist and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist);(b) Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4 ounces) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period;(c) The purchaser is at least eighteen (18) years of age;(d) The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish suitable identification (including proof of age where appropriate);(e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the recordkeeping requirement of§ 21CFR 1304.04); and(f) A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State or local law. (6/07/90 Revised 7/27/2011)07-04-0008- CHEDULE V-EPHEDRINE. PSEUDOEPHEDRINE OR PHENYLPROPRANOLAMINE(a) As provided in Ark. Code Ann. § 5-64-1101, et seq., unless dispensed under a valid prescription, all sales or transfers of ephedrine, pseudoephedrine or phenylpropanolamine are subject to the following quantity limits and restrictions: (1) In a single transaction, no more than three (3) packages of one (1) or more products that contain ephedrine, pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or salts of isomers;(2) In a single transaction, no more than a single package of any product that contains ephedrine, pseudoephedrine, or phenylpropanolamine, that contains more than ninety-six (96) pills, tablets, gelcaps, capsules, or other individual units or more than three grams (3g) of ephedrine, pseudoephedrine, or phenylpropanolamine, or their salts, isomers, or salts of isomers, or a combination of any of these substances, whichever is smaller;(3) In a single transaction, any product containing ephedrine, pseudoephedrine, or phenylpropanolamine, unless: (A) The product is sold in a package size of not more than three grams (3g) of ephedrine, pseudoephedrine, or phenylpropanolamine base and is packaged in a blister pack, each blister containing not more than two (2) dosage units;(B) When the use of a blister pack is technically infeasible, that is packaged in a unit dose packet or pouch; or(C) In the case of a liquid, the drug is sold in a package size of not more than three grams (3 g) of ephedrine, pseudoephedrine, or phenylpropanolamine base; or(4) No product containing ephedrine, pseudoephedrine, or phenylpropanolamine may be sold or transferred to any person under eighteen (18) years of age, unless the person is purchasing an exempt product under Ark. Code Ann. § 5-64-1103(b).(5) No more than 5 grams of any product containing ephedrine or 9 grams of any product containing pseudoephedrine or phenylpropanolamine to a single patient in any 30 day period.(b) A pharmacist may not dispense and a pharmacy technician or intern may not sell or transfer ephedrine, pseudoephedrine, or phenylpropanolamine unless the patient has provided either: (1) a driver's license or non-driver's identification card issued by the Arkansas Department of Finance and Administration that contains a photograph of the person, the person's date of birth, and a functioning magnetic stripe or bar code; or(2) An identification card issued by the United States Department of Defense to active duty military personnel and their dependents that contains a photograph of the person and the person's date of birth.(c) In addition to documenting the professional determination required by Regulation 07-04-0006(a), a sale of ephedrine, pseudoephedrine, or phenylpropanolamine must also be approved by scanning the license or identification card into the real-time electronic logbook using the magnetic stripe or bar code except and unless using a military ID as described in regulation 07-04-0008(b)(2) in which case the identification may be manually entered into the real-time electronic logbook.(d) A pharmacist, pharmacy or pharmacy employee must also comply with Federal law prohibiting the sale of more than 3.6 grams of ephedrine, pseudoephedrine, or phenylpropanolamine to a patient in any 24 hour period. (Adopted 7/27/2011, Amended 5/31/2014)