070.00.10 Ark. Code R. 001
Current through Register Vol. 49, No. 10, October, 2024
Whenever any licensed pharmacist shall change his 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 of such change within five days after such change of employment. Notification must be made by letter, fax or email and must contain the new place of employment of the licensed pharmacist and his license number. (10/9/80, amended 10/14/81, and 11/13/2006).
Any licensed pharmacist whose certificate has been lost or destroyed may procure a duplicate from the Arkansas State Board of Pharmacy by filing an affidavit that said certificate has been lost or destroyed and by paying a fee as defined in regulation 01-00-0007. (10/9/80 amended 8/23/96).
Any person serving in the armed forces within the State of Arkansas, who is a licensed pharmacist in another state, may obtain a temporary permit to practice pharmacy in the State of Arkansas by furnishing certified proof of his registration from the Board of Pharmacy in his state of original registration, and the payment of a fee as defined in Regulation 01-00-0007. This permit shall entitle the holder thereof to practice in any store where an Arkansas licensed pharmacist is on duty a minimum of forty (40) hours per week. The permit must be renewed at each succeeding meeting of the Board. (10/09/80 amended 8/23/96).
Hereafter no extern, intern, or student of a pharmacy school shall be granted authority from this Board to practice pharmacy in Arkansas and serve any internship period in Arkansas unless he is licensed with the Arkansas State Board of Pharmacy and undergoes a criminal background check pursuant to Regulation 11 and conducted by the Arkansas State Police and the Federal Bureau of Investigation. Applications for an intern's license, and for criminal background checks, will be furnished by the Arkansas State Board of Pharmacy. The applicant will be responsible for the payment of applicable fees for state and federal criminal background check pursuant to written instructions provided by the Board, and for applicable fees for an intern's license to the Board. (Amended 6/23/96, 11/15/2003 and 03/01/2004).
The Board of Pharmacy is charged with regulating the internship program in Arkansas Code § 17-92-307. The Arkansas State Board of Pharmacy recognizes that in order to properly fulfill its obligation to the profession of pharmacy and general welfare and protection of the public health that it must implement and supervise an internship program in the State of Arkansas.
From time to time, as is required to establish a viable internship program, the Board will establish, publish, and disseminate criteria establishing requirements and standards necessary for qualifications for licensure under Arkansas Code § 17-92-305, and § 17-92-307.
Hereafter, every applicant for licensure by examination in Arkansas must have 2,000 hours of acceptable internship training obtained after beginning the professional college curriculum. Up to 1,500 hours of the required 2,000 may be obtained in a training program as part of school curriculum.
(Revised 6/22/84, 4/07/89, 6/20/91, 4/10/92, 10/2004, 11/13/2006, 11/1/2007 and 7/10/2009)
The Arkansas internship-training program requires that a pharmacist, who has been duly certified by the Arkansas State Board of Pharmacy, may serve as preceptor for an intern or extern. A pharmacist must meet the following requirements to be certified as a preceptor by the State Board of Pharmacy:
(Revised 11/13/2006 and 11/1/2007)
Violation of any of the rules and requirements set forth in this section may cause the preceptor to lose his or her certification, and may also cause the intern to lose internship training credit. (10/09/80, Revised 2/17/8 2/12/86, 2/10/87, 6/20/91, 8/23/96 and 11/1/2007).
An accredited pharmacy degree program shall be any program which meets at least the minimum standards established for a recognized Doctor of Pharmacy program by the American Council on Pharmaceutical Education.
At the October Board meeting each year, the Board of Pharmacy shall adopt a specific list (by name) of approved colleges. Until the list is revised, the existing list shall remain valid.
(6/25/83, Revised 11/13/2006)
Before being admitted to the Arkansas State Board of Pharmacy Examination, each applicant must meet the following requirements:
The Arkansas State Board of Pharmacy participates in the National Association of Boards of Pharmacy Score Transfer Program. The Score Transfer Program requires the applicant, or test candidate, to submit a NAPLEX Score Transfer Form before the administration date of NAPLEX and fulfill other state requirements for licensure in the state to which the scores are transferred for licensure by examination in that state.
If a candidate takes NAPLEX in another participating state, properly transfers the score to Arkansas, and completes other requirements for licensure including but not limited to criminal background checks pursuant to Regulation 11, Arkansas will license the applicant by the examination process within twelve (12) months of receipt of the score transfer.
The Arkansas State Board of Pharmacy will provide information related to states participating, NAPLEX fees, and Arkansas fees. (6/20/91, Revised 11/15/2003 and 11/30/2010)
No temporary license shall be granted to a reciprocity applicant until the preliminary application has been received and approved by the National Association of Boards of Pharmacy and the applicant has submitted the application to the Arkansas State Board of Pharmacy office, paid the reciprocity fee, undergone a criminal background check pursuant to Regulation 11, supplied a copy of the applicant's birth certificate, submitted proof of required continuing education, and supplied a current photograph of the applicant. The temporary license shall expire at the next meeting of the Board of Pharmacy after the issuance of the temporary license, or when the results of the criminal background check have been received, whichever is later. However, the temporary license will automatically expire 180 days from the date of issue and the holder of the temporary license must cease practicing pharmacy in the State of Arkansas until reciprocity has been granted by the Arkansas State Board of Pharmacy.
Before issuing a temporary license, the Board Member must personally talk to the applicant and ascertain that he/she has passed the Arkansas Jurisprudence Exam.
A pharmacist is not eligible for an Arkansas license by reciprocity until he or she has been licensed six months in his/her state of original licensure by examination. Any practice in Arkansas within this six month period, must be as an intern and under the requirements set out in this criteria (unless consideration is made by the Board of Pharmacy and an exception is approved). The application for reciprocity will become null and void if it has not been completed within one year of the date of receipt in the Board of Pharmacy office. (10/09/80, Revised 4/07/89,4/10/92, 2/10/97, and 11/15/2003)
In defining "unprofessional conduct," the definitions of professional conduct and a pharmacist's duty should be determined. Professional conduct may be defined as complying with all the laws and regulations that apply to a given professional activity.
A pharmacist's duty means the practicing pharmacist has a general duty to qualify himself by attaining and maintaining an acceptable level of professional competence and by using such skill and precaution in the preparation, compounding, dispensing, labeling and distribution of drugs and medical devices whether on prescription or not, so as to prevent injury or death to all who are exposed to his or her professional services; and if the pharmacist is an owner, operator, or director of a pharmacy, he has an additional duty to employ only qualified persons and such other duties as are incidental to the operation of a mercantile business establishment.
Unprofessional or dishonorable conduct by a pharmacist shall mean, among other things, but not limited to:
The Arkansas Administrative Procedures Act § 25-15-211(c) states:
"If the agency finds that public health, safety, or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, summary suspension of a license may be ordered pending proceedings for revocation or other action, which proceedings shall be promptly instituted and determined."
Where the Executive Director of the Board of Pharmacy believes that the above condition exists, he shall call an emergency meeting with proper notifications of involved parties and media. Proper notifications shall be consistent with the Arkansas Administrative Procedures Act. This emergency meeting may be via a conference telephone call to a quorum of Board members.
The Executive Director of the Board of Pharmacy shall introduce evidence why he/she thinks an emergency exists and that a violation of the Pharmacy licensing law or regulation has occurred. The Board shall determine whether the license should be summarily suspended. A hearing shall be scheduled promptly for which notice shall be given pursuant to § 17-92-313. If immediate action is requested, this hearing shall be within 14 days from the final Board decision. (10/12/88)
(Revised 11/30/2010)
(4/07/89, Amended: 04/30/93, 6/98, 8/2001, 7/10/2009 and 11/30/2010)
Prescription equipment appropriate for the pharmacy's specific scope of practice shall be maintained by the pharmacy and may include but is not limited to:
Each pharmacy shall maintain a pharmacy library:
EXCEPTIONS: Pharmacies meeting the requirements of regulation 04-02-0100 or regulation 07-02-0001 shall be exempt from requirements of this regulation when not applicable. (10/09/80, Revised 6/25/83, 4/07/89, 6/07/90, 8/20/97, 11/1/2007 and 11/6/2008)
The sale of any legend drugs or medicines by means of a coin-operated vending machine is expressly prohibited. (10/09/80)
The reuse of returned portions of a prescription drug for human consumption is prohibited whether dispensed by order of a prescription or otherwise, except:
(10/9/80, Revised 6/23/05, and 6/30/2007)
No person, firm, or business establishment shall offer to the public, in any manner, their services as a "pick-up-station" or intermediary for the purpose of having prescriptions filled or delivered, whether for profit or gratuitously. Nor may the owner of any pharmacy or drug store authorize any person, firm, or business establishment to act for them in this manner-provided however, intermediary delivery stations after approval by the Board may be operated in clinics in which a practitioner is in attendance at least one day per week and located in an area where pharmaceutical services are unavailable within ten miles of the clinic provided the filled prescriptions are delivered to a designated representative of the pharmacist filling the prescription. (10/09/80, Amended 2/17/82, and 8/19/99)
Any pharmacy providing prescription drugs to one or more patients in a nursing home or other institution shall provide emergency prescription services for those patients and shall provide information to the nursing home or institution indicating how the pharmacists can be reached after pharmacy hours.
All pharmacies (other than hospital and institutional) who do not provide emergency drug services for non-institutionalized patients shall post a sign at least 8/4 by 11" with letters of at least one (1) inch stating "This pharmacy will not provide emergency prescription drugs when the pharmacy is closed." (6/25/83)
Pharmacies shall apply for licensure and renewal on forms provided by the Board. The permit will be issued to qualified applicants in the name of the licensed pharmacist who shall be directly responsible to the Board of Pharmacy for the operation of the pharmacy. (Revised 11/15/2003 and 11/6/2008)
Applications for pharmacy permits, other than biennial renewal of existing permits, will be reviewed by the Board of Pharmacy Staff. Applications for a pharmacy permit for a new pharmacy must have the name and license number of the pharmacist in charge at the time of submission and cannot be altered except by submission of an application for change of pharmacist in charge and the fee as defined in regulation 01-00-0007. If a post office box is used as the address for the pharmacy, the actual location including street address must also be included on the application as all pharmacy permits are for a specific physical location. The Executive Director may require that a representative of the owner(s) and the pharmacist in charge appear before the Board of Pharmacy to finalize the application. (Revised 11/6/2008)
The permit licenses the pharmacy to which it is issued and is not transferable. It is issued on the application of the owner and the licensed pharmacist in charge, on the sworn statement that it will be conducted in accordance with the provisions of law.
The responsibility to ensure compliance with this regulation rests both with the pharmacist and with the pharmacy permit holder if they are not the same. (10/09/80, Revised 2/17/82, 6/13/85,2/10/87, 4/07/89, 6/20/91, 6/23/96, and 11/6/2008)
No owner or owners of a drugstore, apothecary, pharmacy, etc., shall allow any of its employees to profess to the public in any manner that they are a licensed pharmacist when they are not licensed. (10/9/80, amended 6/20/91 and 11/6/2008)
(Adopted 11/30/2010)
Any person, corporation or partnership operating a pharmacy in this state desiring to continue such operation must pay a renewal fee for the permit as established by law and/or regulation. If the fee is not paid on or before February 1st of any even-numbered year, a penalty as defined in regulation 01-00-0007 shall be levied for each month the pharmacy permit fee is delinquent. If the permit fee is unpaid by April 1st of any even-numbered year, the licensed pharmacy shall be expunged from the records of the State Board of Pharmacy, and the owner and/or pharmacist in charge thereof shall, within thirty days, remove all drug signs and legally dispose of all prescription legend drugs. (10/9/80, amended 6/13/85, amended 6/20/91 & 8/23/96)
Retail pharmacies shall apply for licensure and renewal on forms provided by the Board. The permit will be issued to qualified applicants in the name of the licensed pharmacist who shall be directly responsible to the Board of Pharmacy for the operation of the prescription department. (Revised 11/15/2003)
No retail pharmacy may open for business within thirty (30) days of submission of the original application. Applications for a pharmacy permit for a new retail pharmacy must have the name and license number of the pharmacist in charge at the time of submission and cannot be altered except by submission of an application for change of pharmacist in charge and the fee as defined in regulation 01-00-0007. The pharmacist in charge of the new pharmacy application cannot be the pharmacist in charge of another pharmacy at the time of submission of the new pharmacy application. The Executive Director may require that a representative of the owner(s) and the pharmacist in charge appear before the Board of Pharmacy to finalize the application. After review by the Board of Pharmacy staff, an "Inspection Request Form" will be sent to the mailing address of the pharmacy making application. The inspection request form must be received in the Board of Pharmacy office at least one week before the facility will be ready for inspection.
Upon approval of the inspection of the physical facility by the Board of Pharmacy inspector, the Executive Director will complete the final approval of the application and the permit number will be issued.
No pharmacy permit shall be issued or continued for the conduct of a pharmacy unless the premises are equipped with the necessary appliances for maintenance of proper sanitation and kept in a clean, sanitary and orderly manner.
(Adopted 11/30/2010)
A retail pharmacy with a licensed pharmacy permit may also act as a central fill pharmacy if the following requirements are met.
The central fill pharmacy shall:
A policy and procedure manual as it relates to centralized filling shall be maintained at the filling, originating, and dispensing pharmacies and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall:
(11/15/2003, Revised 3/14/2006)
The purpose of this section is to provide standards for remote or off-site order entry in retail pharmacies within Arkansas licensed by the Arkansas State Board of Pharmacy ("the Board").
The practice of nuclear pharmacy is hereby recognized as a specialty of pharmacy practice regulated by the Arkansas State Board of Pharmacy. As such, the following rules are included to address those areas specific, or unique to, this specialty practice. These regulations are intended to supplement the regulations of other state and federal agencies,
Orders for routine diagnostic radiopharmaceuticals, which have been previously established by the nuclear pharmacist with the physician, may be taken by a pharmacy technician and entered into the computer. The nuclear pharmacist shall verify the label with the written order. However, whenever an order is for a therapeutic or blood-product radiopharmaceutical, the prescription order must be received by a nuclear pharmacist and the patient's name must be obtained and recorded prior to dispensing.
When the prescription is for a therapeutic or blood-product radiopharmaceutical, the patient name shall appear on the label prior to dispensing.
The professional area of the pharmacy shall have equipment appropriate for the pharmacy's specific scope of practice which may include but is not limited to the following:
The Board may issue a specialty pharmacy permit for a facility to provide unique aspects of pharmaceutical care to an identified patient population as provided in regulation 04-03-0001 et seq. Said specialty pharmacies and the pharmacists practicing therein shall comply with applicable federal and state laws and regulations, including Arkansas Pharmacy Law, A.C.A. § 17-92-101et seq., and Board Regulations, including without limitation regulations regarding retail pharmacies 04-02-0001et seq., which are not expressly superseded by the regulation applicable to the specific type of specialty pharmacy.
The pharmacy shall be locked when a pharmacist is not present in the pharmacy and shall have adequate facilities for performing pharmaceutical services including the procurement, storage, distribution, security and control of said drugs consistent with all federal and state laws and regulations.
The pharmacist in charge shall obtain approval by the Board's Executive Director prior to any change in any item identified in subparagraph (b) (1) (B) (i) - (vii) of this regulation.
The Board of Pharmacy may issue a restricted charitable clinic pharmacy technician permit for the sole purpose of performing pharmacy technician duties as a volunteer in a prescription drug redispensing program permitted in accordance with Board Regulation 04-03-0004(b). (6/23/05, Revised 6/30/07)
Out of State pharmacies shall comply with the following qualifications to be, and remain, licensed in Arkansas by the Board.
Provided, however, the Board may grant an exemption from licensing under A.C.A. § 17-92-401 upon application by any non-resident pharmacy which confines its dispensing activity to isolated transactions. In determining whether to grant an exemption, the Board shall consider:
Nothing herein shall be construed to mandate that an out of state pharmacy comply with Board regulation 09-00-0001 if such compliance would cause the out of state pharmacy to violate law or regulation of the state wherein the facility of the dispensing out of state pharmacy is located.
The responsibility to ensure compliance with this regulation rests both with the Arkansas pharmacist in charge and with the pharmacy owner if they are not the same.
(10/09/90, Revised 04/10/92, 6/23/96, 8/23/96,10/12/99, 11/15/2003, 7/16/2006 and 11/6/2008).
All hospitals shall have adequate provisions for pharmaceutical services regarding the procurement, storage, distribution, and control of all medications. All federal and state regulations shall be complied with.
"Hospital pharmacy" shall also mean the place or places in which drugs, chemicals, medicines, prescriptions or poisons are compounded for the dispensing to hospital employees, members of the immediate families of hospital employees, patients being discharged, and other persons in emergency situations.
"Hospital pharmacy" shall also mean the provision of pharmaceutical services as defined in the Pharmacy Practice Act by a pharmacist to a patient of the hospital.
"Unit dose distribution system" also means a system that meets the requirement of a "Unit Dose Distribution System," provided that up to a 72-hour supply may be sent to the floor once a week if the system has been reviewed and approved administratively by the Board of Pharmacy.
An act, restricted to nursing personnel as defined in Nurses Practice Act 43 of 1971, in which a single dose of a prescribed drug or biological is given a patient. This activity includes the removal of the dose from a previously dispensed, properly labeled container, verifying it with the prescriber's orders, giving the individual dose to the proper patient and recording the time and dose given.
There is a committee of the medical staff to confer with the pharmacist in the formulation of policies, explained as follows:
The hospital has a pharmacy directed by a licensed pharmacist. The pharmacy is administered in accordance with accepted professional principles.
There is a pharmacy directed by a licensed pharmacist, defined as follows:
Facilities are provided for the storage, safeguarding, preparation, and dispensing of drugs, defined as follows:
Personnel competent in their respective duties are provided in keeping with size and activity of the department, explained as follows:
Through the administrator of the hospital, the P & T Committee shall establish policies and procedures that include, but are not limited to the following:
Records are kept of the transactions of the pharmacy and correlated with other hospital records where indicated. All medication shall be properly labeled. Such record and labeling requirements are as follows:
Policies are established to control the administration of toxic or dangerous drugs with specific reference to the duration of the order and the dosage, explained as follows:
Therapeutic ingredients of medications dispensed are included (or approved for inclusion) in the United States Pharmacopoeia, N.F. and U.S. Homeopathic Pharmacopoeia, or Accepted Dental Remedies (except for any drugs unfavorably evaluated therein) and drugs approved by provisions of the Arkansas Act 436 of 1975, or are approved for use by the P & T Committee of the hospital staff, explained as follows:
Any take-home prescription dispensed to patients at time of discharge from the hospital shall be for drugs and quantities consistent with the immediate medical needs of the patient.
The minimum requirements for licensed pharmacists in hospitals are:
At no time will the hospital pharmacy be open and in operation unless a licensed pharmacist is physically present except:
The American Society of Health-System Pharmacists' most recent statement on hospital drug control systems and Guidelines for Institutional Use of Controlled Substances shall be required reading by hospital pharmacists. (Revised 6/25/83,4/7/89, 6/15/95, 8/2001, 11/1/2007, 11/6/2008 and 11/30/2010)
Hospitals using mechanical storage and delivery machines for legend drugs must secure a hospital pharmaceutical services permit, and these machines shall be stocked only by a licensed pharmacist under this permit. Drugs may be obtained from these machines only by a physician, or registered or licensed professional nurse or student nurse, or an intern or resident physician, or a licensed pharmacist acting under the prescribed rules of safety procedures as promulgated by the individual hospital or institution using the machine. Use of these machines shall not be to circumvent adequate pharmaceutical services. (Amended 8/23/96)
The Patient Daily Medication Record is a document, whether electronic or hardcopy, which supports the Patient Medication Profile. The Patient Daily Medication Record provides a daily refill-by-refill audit trail on all drugs dispensed and supplements the base document, the Patient Medication profile. This record is produced on a daily basis. It may be used to fill patient medication orders, for transport to the patient care area. This record must show all medications dispensed on any given day.
The purpose of this section is to provide standards for remote or off-site order entry in hospital pharmacies within the state of Arkansas.
The above competencies shall be in written policy and procedure and shall include training, testing and ongoing assessment of skills.
Schedule II injectable
Limit: one (1)
Maximum quantity: two (2)
Limit: one (1)
Maximum quantity: ten (10)
Limit: two (2)
Maximum quantity: six (6)
Limit: one (1)
Maximum quantity: four (4)
Limit: one (1)
Maximum quantity: four (4) (Amended 10/2001)
The Arkansas State Board of Pharmacy may provide for the issuance of a charitable clinic pharmacy permit to clinics and facilities furnishing medical care and dental care to poor and underprivileged persons, in which drugs are dispensed without charge to such persons on orders or prescriptions of practitioners authorized by law to prescribe or administer said drugs and to which the requirements of a licensed pharmacist on duty for a minimum of forty (40) hours shall not apply.
All medication for patients shall be on individual prescription basis, and the pharmacist shall dispense drugs, properly labeled, and adhere to the requirements for proper storage, safeguarding, preparation and record keeping for prescription drugs.
All policies and procedures related to the charitable clinic pharmacy permit must first be approved by the Board staff before a permit will be issued to ensure compliance with all existing laws and regulations.
The staff of the Board of Pharmacy is authorized to approve and issue charitable clinic permits for:
Other facilities meeting the requirements of this regulation and where a pharmacist is present when medications are provided to the patient shall not be restricted to a medication formulary. (Revised 04/30/93)
The charitable clinic pharmacy shall dispense donated prescriptions medications only to indigent patients as defined in Ark. Code Ann. § 17-92-1102(4)
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:
(Adopted 2/2001, Revised emergency 6/2003 & 10/26/2003, Revised 11/30/2010)
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:
In the event a holder of a pharmacy permit issued by the Arkansas State Board of Pharmacy under ACA § 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)
070.00.10 Ark. Code R. 001