070.00.09 Ark. Code R. 003
A prescription drug order which is transmitted by an electronic device which sends an exact copy image to the receiver (pharmacy) over telephone lines.
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 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)
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, 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)
All 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)
The Arkansas State Board of Pharmacy recognizes the Federal Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange 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), 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)
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.
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.
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)
In 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:
In order to protect the public health and safety, drug products offered for sale by, or stored at the premises of, a manufacturer, wholesaler, distributor, or pharmacy location in Arkansas, which do not have the required NDA or AND A, or exemption there from referenced in the above paragraph, are hereby declared to be contraband and subject to surrender to and destruction by the Arkansas State Health Department.
This suspension or revocation would occur only after proper hearings are held by the Board of Pharmacy. (10/14/81, Revised 6/20/91)
The purpose of this regulation is to provide standards in the conduct, practices, and operations of a pharmacy preparing and dispensing products requiring sterility, such as injectables, ophthalmics, and inhalants.
Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of a commercially available FDA-approved drug product is generally prohibited. However, in special circumstances a pharmacist may compound an appropriate quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available based on documentation provided by the prescribing physician of a patient specific medical need (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The recommended methodology for documenting unavailability is to print the screen of wholesalers showing back-ordered, discontinued, or out-of-stock items. This or similar documentation must be available when requested by the Board.
Except for those products where stability prohibits advanced compounding, all products dispensed by the pharmacy shall be in a form ready for administration, except in health care facilities where medications may be provided as demanded by policies and procedures.
Pharmacies and pharmacists dispensing sterile products shall comply with all applicable federal, state, and local law and regulation concerning pharmacy and also these additional rules:
Any pharmacist in charge who performs or supervises the preparation or sterilization of sterile medications shall:
Pharmacy technicians participating in the preparation of sterile products shall have completed a Board approved pharmacist supervised training and testing program in sterile product preparation as described in Board regulation 03-00-0006(b). Documentation of training and testing shall be available.
Any pharmacy dispensing sterile parenteral solutions shall meet or exceed the following requirements:
All pharmacies preparing and dispensing sterile products must provide:
In addition to regular labeling requirements, the label shall include:
The pharmacist in charge of the pharmacy dispensing sterile parenteral solutions shall provide the following or assure that they are provided prior to providing medications.
Any pharmacy providing cytotoxic drugs shall establish procedures assuring the return and proper destruction of any unused radioactive or cytotoxic drugs or other hazardous material (destruction containers for needles).
In every instance, the pharmacist in charge shall monitor the delivery, storage, and administration records of medications dispensed from his/her pharmacy.
It is recommended that all pharmacies have an anteroom designed to be separate from the buffer room. The anteroom should be available for the decontamination of supplies and equipment, and donning of protective apparel. A sink should be available in the anteroom area so that personnel can scrub prior to entering the buffer room.
Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of a commercially available FDA-approved drug product is generally prohibited. However, in special circumstances a pharmacist may compound an appropriate quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available based on documentation provided by the prescribing physician of a patient specific medical need (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The recommended methodology for documenting unavailability is to print the screen of wholesalers showing back-ordered, discontinued, or out-of-stock items. This or similar documentation must be available when requested by the Board.
The following words or terms, when used in this regulation, shall have the following meaning, unless the context clearly indicates otherwise:
Provided, however, a legend drug includes prescription drugs subject to the requirement of Section 503(b)(1) of the federal Food, Drug, and Cosmetic Act which shall be exempt from Section 502(f)(1) if certain specified conditions are met.
Upon written request stating the purpose or use of drug sample and quantity to be possessed, the Board shall approve possession of sample drugs when reasonably necessary to serve a public purpose when consistent with federal and state law. The Board may impose any conditions upon possession as determined appropriate.
The pharmacist in charge of the pharmacy where the drug samples will be located shall maintain same separated from other stock and in original sample packages.
No compensation shall be charged for sample drugs. (10/12/86)
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.
The 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.
Information, 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:
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.
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. 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)
A pharmacist may sell a Schedule V exempt product only after a personal consultation with the patient wanting to purchase the product. A determination must be made confirming that the person has a medical need for the product.
If the pharmacist has reason to believe that the patient has self-medicated with a Schedule V exempt product, for more than ten (10) days, the sale should not be repeated without a valid explanation. If the pharmacist does not accept the explanation, the patient should be referred to a physician.
The pharmacist or pharmacy should seriously question situations where records suggest that the patient is self-medicating by buying these products more than twice in thirty (30) days, when sales in two (2) consecutive months total more than four (4) or when it appears the patient makes purchases every month.
If a sale is made, the pharmacist must:
(6/07/90)
In 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:
(10/09/83 & 6/26/03)
070.00.09 Ark. Code R. 003