Arkansas Administrative Code
Agency 070 - Board of Pharmacy
Rule 070.00.98-006 - Section II - Board of Pharmacy Regulations
Current through Register Vol. 49, No. 9, September, 2024
SECTION II BOARD OF PHARMACY REGULATIONS
The Arkansas State Board of Pharmacy shall consist of six pharmacist members as provided by Arkansas Code 17-92-201(a)(1) and 17-92-201(d) plus a consumer member and a senior citizen consumer member as provided by Arkansas Code 17-92-201(a)(2). The qualifications, powers, and duties of the Board shall be those enumerated by the provisions of A.C.A. 17-92-201 through 17-92-208. (10/9/80, amended 6/20/91).
The office of the Arkansas State Board of Pharmacy shall be located at 101 East Capitol, Suite 218, Little Rock, Arkansas. All communications thereto may be addressed to Arkansas State Board of Pharmacy, 101 East Capitol, Suite 218, Little Rock, AR 72201. (10/9/89).
Any person or persons seeking information respecting the Arkansas State Board of Pharmacy or desiring to submit complaints or charges thereto or make request thereof shall do so by filing with the Board an instrument in writing, signed by the writer and containing a return address. Communications need not be typed but should be legible. (10/9/80).
Except wherein items of practice and procedure are specifically set out in these Regulations, the practice and procedure before the Arkansas State Board of Pharmacy shall be governed by the provisions of the Pharmacy Practice Act. (10/9/80).
AH certificates of licensure issued by the Arkansas State Board of Pharmacy shall expire on the 31st day of December, following the date of issuance of the same. Every licensed pharmacist engaged in the active practice of pharmacy shall pay to the Board of Pharmacy annually, between January 1st and January 31st a minimum renewal fee as defined in Regulation 01-00-0007. If the renewal fee for any pharmacist certificate be unpaid by the first day of February of any year, the holder that if the renewal be unpaid by April 1st of any year, such certificate shall be null and void, and the thereof must pay a penalty as defined in Regulation 01-00-0007 for each month thereafter, provided, holder thereof must be reinstated as a licensed pharmacist by satisfying the State Board of Pharmacy that he is of the same moral character and temperate habits as was required at the time of the original registration, and satisfy the Board of Pharmacy that he is competent and qualified to compound and fill prescriptions, and must pay a reinstatement fee as defined in Regulation 01-00-0007 for each delinquent year up to a maximum as defined in regulation 58 plus the current year's renewal fee.10/09/80 (Revised 10/14/81, Act of 1985, 6/20/91, and 8/23/96).
The Arkansas State Board of Pharmacy shall meet the second Tuesday in February, the second Tuesday in June, and the second Tuesday in October of each year-unless changed and announced in advance by the Board of Pharmacy. Examination of candidates for licensure to practice pharmacy shall be on dates, time, and place as determined by the Board of Pharmacy. 10/09/80 (Revised 6/20/91)
The fees charged by the Arkansas State Board of Pharmacy for the various examinations, permits, licenses, certificates, and books issued by the board shall be as follows:
All fees for examination for license shall be payable with the application and shall not be subject to refund. All other fees are only refundable if it is determined that there has been an overpayment. 8/23/96 (Revised 6/19/97)
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 State Board of Pharmacy in writing of such change within five days after such change of employment. The said notification must be by letter and must contain the new place of employment of the Licensed Pharmacist, his licensure number, and his renewal number. (10/9/80, amended 10/14/81).
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, upon payment of a fee as defined in Regulation 01-00-0007. (10/9/80 amended 8/23/96)
To be reinstated and immediately practice without supervision, the pharmacist's license shall not have lapsed more than two calendar years.
To be reciprocated and immediately practice without supervision, the pharmacist shall have practiced the profession of pharmacy, as defined by law, and in a licensed facility at least 40 hours per year in the previous two calendar years.
If these criteria are not met, the pharmacist must:
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 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 pays an intern licensure fee as defined in regulation. The application for licensure as an intern will be furnished by the Arkansas State Board of Pharmacy. (Amended 6/23/96).
The Board of Pharmacy is charged with regulating the internship program made to which reference is made in the Arkansas Code § 17-92-301. 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, § 17-92-307, and Regulation 02-01-0002.
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.
All students enrolled in Colleges of Pharmacy outside Arkansas shall license as an intern in Arkansas prior to any participation in the practice of Pharmacy as defined in § 17-92-101, § 17-92-301, and § 17-92-307.
Provided that any licensed intern shall not participate in the practice of Pharmacy as defined in § 17-92-101, § 17-92-301, and § 17-92-307, until said Intern has successfully completed the first professional year on a 2-3 or 2-4 program of study or the second professional year on a 1 -4 program of study in a school or college of pharmacy approved by the Arkansas Board of Pharmacy. The intern license remains valid as long as the intern maintains active student status in a Board-approved College of Pharmacy and for one year (12 calendar months) after graduation from a College of Pharmacy or completion of foreign pharmacist requirements as set forth in Regulation 02-02-0001 A. At this time, the intern license becomes void. The graduate intern may not practice pharmacy until approval by the Board of Pharmacy has been granted and another license as an intern in Arkansas has been granted.
Before permitting a student to participate in any way in the practice of Pharmacy, the Preceptor must assure:
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 or alternate for an intern or extern.
The following requirements must be met to be certified by the State Board of Pharmacy for serving as a Preceptor or Alternate:
Violation of any of the rules and requirements set forth in section "02-01" Above may cause the Preceptor or Alternate to lose his certification as such, and may also cause the intern to suffer loss of internship training credit. 10/09/80 (Revised 2/17/8 2/12/86, 2/10/87, 6/20/91, and 8/23/96).
An accredited pharmacy degree program shall be any program which meets at least the Minimum standards established for a recognized Bachelor of Science 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
Before being admitted to the State Board of Pharmacy Examination, each applicant must have the following requisites:
The examination will be held at a site and at a time or during a time Period designated by the Board of Pharmacy, and each applicant will be notified in advance.
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 NABPLEX Score Transfer Form either before the administration date of NABPLEX or within seven days after the examination and fulfill other state requirements for licensure in the state to which the scores are transferred for licensure by examination it that state. Score transfer Forms will be available, upon request, from the Board of Pharmacy office.
If a candidate takes NABPLEX in another participating state, properly transfers the score to Arkansas, and completes other requirements for licensure, Arkansas will license the applicant by the examination process.
The Arkansas Board will provide information related to states participating, NABP fees, and Arkansas fees. 6/20/91
Hereafter, no Temporary License shall be granted 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 Board Office, paid the reciprocity fee, 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, he/she 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 Registration, the Board Member must personally talk to the applicant and ascertain that he/she has passed the Arkansas Jurisprudence Exam.
One is not eligible for an Arkansas license by reciprocity until he 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 in one year from the date of receipt in the Board of Pharmacy Office. 10/09/80 (Revised 4/07/89 and 4/10/92, 2/10/97)
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 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 ACA * 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 ACA * 17-92-313. If immediate action is requested, this hearing shall be within 14 days from the final Board decision. (10/12/88)
Arkansas Tripartite Committee on Continuing Pharmacy Education:
A pharmacy technician may assist the pharmacist in performing the following specific tasks in accordance with specified Policy and Procedures covering the areas described in this section. If the pharmacy technician performs any other task that is defined as the practice of pharmacy, it will be considered a violation.
In a computer system - a pharmacy technician may enter Information into the pharmacy computer. The pharmacy technician shall not make any judgement decisions which could affect patient care. The final verification of prescription information, entered into the computer, shall be made by the supervising pharmacist who is then totally responsible for all aspects of the data and data entry.
The recording of patient or medication information in manual or electronic system for later validation by the pharmacist may be performed by pharmacy technicians.
The ratio shall not exceed two pharmacy technicians to one pharmacist on any one shift. This ratio shall not include pharmacy interns counted as either supportive personnel or pharmacists. Also excluded from the count of supportive personnel are those persons whose functions are not related to the preparation or distribution of medication. Such persons include clerks, secretaries, messengers, and delivery personnel. (8/23/96).
Minimum prescription equipment specifications as authorized by the Arkansas State Board of Pharmacy are:
All drugstores or pharmacies must have on duty an Arkansas Licensed Pharmacist a minimum of 40 hours per week. The said 40 hours per week must be served by a single person and cannot be met by a combination of weekly hours of two or more pharmacists with less than 40 hours each. 10/09/80 (Revised 10/14/81, and 6/20/91)
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. (10/09/80)
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 of 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 community owned an/or sponsored Clinics in which a physician 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 (Revised 2/17/82)
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 81/2 by 11" with letters of at least inch stating "This pharmacy will not provide emergency prescription drugs when the pharmacy is closed." 6/25/83
Any person, corporation or partnership operating a pharmacy in this state desiring to continue such operation must pay a fee for a permit as established by law and/or regulation. If said fee is not paid on or before February 1st of any year, a penalty as defined in Regulation 01-00-0007 shall be levied for each month the pharmacy permit fee is delinquent. If said permit fee is unpaid by April 1st of any 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).
Licensed pharmacy permits will be considered by the Board staff upon written application in such forms as may be adopted by the Board. The permit will be issued in the name of the licensed pharmacist who shall be directly responsible to the Board of Pharmacy for the operation of the prescription department.
Applications for pharmacy permits other than annual renewal of existing permits, will be reviewed by the Board of Pharmacy Staff. Provided that no pharmacy may open for business within 30 days of submission of original application. 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. The pharmacist in charge of the new pharmacy application cannot be the pharmacist in charge of another pharmacy at the time submission of the new pharmacy application. If a post office box is used as the address for the pharmacy, the actual street address must also be included on the application. The Executive Director may require that a representative of the ownership and 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 address given as that of the ownership 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 or drugstore unless the premises are equipped with the necessary appliances for maintenance of proper sanitation and kept in a clean, sanitary and orderly manner.
The permit licenses the pharmacy or drugstore 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 assure compliance with this regulation rests both with the pharmacist and with the pharmacy owner 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, and 6/23/96)
No owner or owners of a drugstore, apothecary, pharmacy, etc., should 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).
This shall include, but not be limited to, the following:
The signature should appear at the end of the printout and it signifies that the pharmacist has reviewed the printout and accepts the responsibility for any prescription with his or her designation or initials on it.
In lieu of signing a daily hard copy printout, the pharmacist in charge of the pharmacy may maintain a bound log book in which an individual pharmacist involved in such dispensing may sign a statement each day, attesting to the fact that the prescription information entered into the computer that day has been reviewed by him and is correct as shown. The log should identify the time of day at which the pharmacist started filling prescriptions and the time of day at which the pharmacist stopped filling prescriptions. Said log book shall be maintained, by the pharmacist in charge or his successor, in the pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized prescription. The pharmacy must still provide a daily hard copy printout of each day's prescription order activity as described in 33. E. 3. (A) above.
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 the following equipment:
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 # 09-00-001 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. 10/09/90 (Revised 04/10/92, and 6/23/96, and 8/23/96).
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.
The 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.
5;. "Unit Dose Distribution System" is a pharmacy-coordinated method of dispensing and controlling medications in hospitals in which medication are dispensed in single unit packages for a specific patient on orders of a physician where not more than 24-hour supply of said medications is dispensed, delivered, or available to the patient.
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 theP & 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.
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 Pharmacists1 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)
Hospitals using mechanical storage and delivery machines for Legend Drugs must secure a Hospital Pharmaceutical Services Permit, and such machines shall be stocked only by a Licensed Pharmacist under such permit. Drugs may be obtained from such 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 said machine. Use of these machines shall not be to circumvent adequate pharmaceutical services. (Amended 8/23/96).
In accordance with the Drug Enforcement Administration's final ruling June 30,1977, which allows a pharmacy to use a data processing system as an additional manner of storing and retrieving prescription refill information for Schedule III and IV controlled substances, the following proposed regulation is submitted to regulate the use of Electric Data Processing (EDP) systems for holders of Hospital Pharmaceutical Services Permits in the State of Arkansas.
INTERPRETATION: The Patient Medication Profile is the basic document used by the Hospital Pharmacist to monitor a patient's medication regimen, drug compliance, drug interactions, allergies and drug usage.
Patient name, patient identification number, practitioner's name, drug name, drug strength and dosage form, number of doses issued, initials, name or identification number of pharmacist approving original order into the system, and date original order was entered into the system.
INTERPRETATION: The Patient Daily Medication Printout is a supporting document to the Patient Medication Profile. It is printed on a daily basis and may be used to fill patient medication orders for transport to the patient care area and may serve as a daily log of all medication issued on any given day.
INTERPRETATION: Since the Patient Medication Printout is a supporting document to the Patient Medication Profile, some information such as practitioner's name, initials, name or identification number of pharmacist entering the original order into the system and the date of the original order may or may not be duplicated because the information is readily retrievable from the base document.
In lieu of signing this daily hard copy printout, the pharmacist in charge of the hospital pharmacy may maintain a bound log book in which an individual pharmacist involved in such dispensing may sign a statement each day, attesting to the fact that the prescription information entered into the computer that day has been reviewed by him and is correct as shown.
The log should identify the time of day at which the pharmacist started filling pharmacist stopped filling prescriptions. Said log book shall be maintained, by the pharmacist in charge or his successor, in the hospital pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized prescription.
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.
. 04-07-0003 -POLICIES AND PROCEDURES FOR CLINICS
All policies and procedures related to the Charitable Clinic Permit must first be approved by the Board staff before a permit will be issued to insure compliance with all existing laws and regulations.
The staff of the Board of Pharmacy is authorized to approve and issue charitable clinic permits for:
Packaged and labeled prescription drugs shall be initialed by the pharmacist to assure accuracy and appropriateness. The prescribing practitioner or a licensed nurse may issue these pre-dispensed prescription drugs, by placing the patients name, date of issue and prescription number on the label at the time of issue to patients on order of the prescriber.
The prescription number as placed on the label of the dispensed prescription drug is to be placed with the prescribing practitioner's order in the patients medical record. The pharmacist shall monitor patients medical records to assure that medication profiles and prescription orders are maintained and utilized.
Since the pharmacist is not present when the patient receives the medication, the pharmacist shall develop protocol to assure that the patient is monitored and counseled by the prescribing practitioner or nurse consistent with the requirements of Board of Pharmacy Regulation 09-00-0001.
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)
A Nursing Home Pharmacist in Charge hereinafter referred to as a Consultant pharmacist in charge is a Pharmacist who assumes the ultimate responsibility to assure adherence to all law and regulation concerning pharmacy services in the Nursing home permitted in his or her name.
The Consultant Pharmacist in Charge is required to perform a majority of the consultative services provided in the home and must assure that other consultant pharmacists assisting him or her in the home are aware of and abide by pharmacy law and regulations and policy arid procedures of the home.
A Nursing Home Consultant Pharmacist is herein-after referred to as Consultant Pharmacist is a Pharmacist who practices as a consultant in one or more homes to assist the Consultant Pharmacist in Charge.
Any pharmacist desiring to serve as a Consultant Pharmacist in Charge for a nursing home shall so notify the Board of Pharmacy and secure a Nursing Home Consultant's Permit which shall designate the home for which he or she is responsible.
Before a pharmacist is licensed as a Consultant Pharmacist or Consultant Pharmacist in Charge, he or she must certify to the Board of Pharmacy that he or she has satisfactorily completed a test on requirements developed by the Board to explain the pharmaceutical duties and responsibilities in a nursing home and that the Pharmacist has read and understands these regulations and will abide by them.
A Consultant Pharmacist in Charge shall not be issued in any instance where a full-time Consultant Pharmacist in Charge is already responsible for 1,500 or more residents, unless that pharmacist has submitted a written explanation of need and that request has been approved by the Director of the Board of Pharmacy.
In no instance shall a Consultant Pharmacist in Charge Permit be issued if the pharmacist is already responsible for more than 2,000 residents.
For renewal of a Nursing Home Consultant's Permit, it is required that, in addition to the C.E. required for all pharmacists, Consultant pharmacists must annually obtain three (3) hours of C.E. specifically relating to his/her role as a consultant in a nursing home.
The Consultant Pharmacist or Consultant Pharmacist in Charge in a nursing home is involved in drug storage, distribution and utilization in that home.
These responsibilities might be divided into five general areas.
The Pharmaceutical services are under the supervision of a qualified Consultant Pharmacist or Consultant Pharmacist in Charge who is responsible for developing, coordinating, and supervising all pharmaceutical services. The Consultant Pharmacist in charge in the contract with the home must assure that pharmacist consultation is available on a 24-hour-per-day basis. A Pharmacist (if not a full-time employee) devotes a sufficient number of hours based upon the needs of the facility, during regularly scheduled visits to carry out these responsibilities. The Consultant Pharmacist in Charge submits a written report at least quarterly to the Quality Assurance and Patient Assessment Committee on the status of the facility's pharmaceutical services and staff performance.
The Consultant Pharmacist or Consultant Pharmacist in Charge shall assist the home in developing procedures to assure provisions of emergency drugs and shall report to the Board of Pharmacy any pharmacy refusing to provide emergency drugs for the pharmacy's regular patients in the home.
The Consultant Pharmacist in Charge shall be responsible for full compliance with Federal and State laws governing legend drugs (including controlled substances).
The Consultant Pharmacist or Consultant Pharmacist in Charge should inform himself of all laws and regulations pertaining to nursing homes and should communicate with the state agencies involved with enforcement and regulation of nursing homes.
To properly perform his duties, the Consultant Pharmacist or Consultant Pharmacist in Charge shall spend sufficient time to evaluate discontinued medication, destroy unused medication, check entries in Bound Controlled Drugs Book, file the completed disposition sheets with the patient's permanent record, and make general observations at the nursing stations.
This record shall indicate the day the Consultant Pharmacist in Charge or any assisting Consultant Pharmacist visited the home, a brief statement of purpose, finding, and actions.
The Consultant Pharmacist supervises and develops procedures for control and accountability of all drugs and biologicals throughout the facility. Only approved drugs and biologicals are used in the facility and are dispensed in compliance with Federal and State laws. Records of receipt and disposition of all controlled drugs are maintained in sufficient detail to enable an accurate reconciliation. The pharmacist determines that drug records are in order and that an account of all controlled drugs is maintained and reconciled.
The controlled drugs shall be sent to the Health Department by the Administrator and the Health Department receipt of drugs destroyed shall be reconciled with the nurse/pharmacist inventory by the Consultant Pharmacist in Charge.
The primary responsibility of the Consultant Pharmacist or Consultant Pharmacist in Charge to the patient concerns applying his or her expertise on drugs to the patient's specific situation. To assist the Consultant Pharmacist or Consultant Pharmacist in Charge, the Department of Health and Human Services has developed INDICATORS FOR SURVEYOR ASSESSMENT OF THE PERFORMANCE OF DRUG REGIMEN REVIEWS. These shall be considered to the minimum standards for an adequate drug regimen review.
Adherence to the INDICATORS shall not be the sole criteria for considering a review to be adequate; however, failure to consider and utilize the INDICATORS shall be justification for the finding of inadequate review.
In conjunction with, or in addition to, the INDICATORS the Consultant Pharmacist or Consultant Pharmacist in Charge should routinely and systematically review each patient's chart considering:
A Consultant Pharmacist or Consultant Pharmacist in Charge shall quarterly in ICF/MR facilities and monthly in nursing facilities\ review each patient's medication record, consult with the director of nursing or the patient's physician, and check orders against medication card, Kardex, and actual medication.
All legend drugs (including controlled substances) on the premises of a nursing home except for the emergency tray as defined by the State Board of Pharmacy, shall be stored under lock and always be in a properly labeled container as dispensed upon a prescription by the pharmacy of the patient's choice.
It is the responsibility of the Consultant Pharmacist or Consultant Pharmacist in Charge to ascertain that medications are properly labeled, properly stored, refrigerated when needed, expiration dates routinely checked, and that appropriate accessory and cautionary instructions are on all medications when required.
REQUIREMENTS:
Heparin Flush - Pediatric (one strength)
Heparin Flush - Adult (one strength)
Sterile Water For Injection -- small volume
Sodium Chloride For Injection -- small volume
Adrenalin (Epinephrine) Injection - ampoules only
Benadryl (Diphenhydramine) Injection - ampoules only
* Note: For Heparin, Adrenalin and Benadryl, all patients should have a precalculated dose.
* If a container is opened and partially used it is intended that any unused portion be immediately discarded.
This list can be expanded only by the Board of Pharmacy; and if expanded, notice will be provided in the Board's Newsletter.
(Revised 10/12/93 Revised 10/14/97)
The following is a list of categories of drugs which are acceptable in emergency kits in long-term care facilities in accordance with Regulation 05-00-0004(A)(4) of the Arkansas State Board of Pharmacy. In every instance where injectables are indicated, only single-dose injectables are acceptable.
ANALGESICS, CONTROLLED DRUGS
Schedule II-Injectable-
Limit: one (1)
Maximum quantity: two (2)
Schedule II, IV, or V-
Limit: three (3)
Maximum quantity: If oral: six (6) If Injectable: two (2)
ANTIBIOTICS
Oral Doses-
Limit: five (5)
Maximum quantity: five (5)
Parenteral Doses-
Limit: three
Maximum quantity: one (1)
ANTICOAGULANT
Limit: one (1)
Maximum quantity: three (3)
ANTIDIARRHEALS
Limit: one(1)
Maximum quantity: ten (10)
ANTIHISTAMINE INJECTABLES
Limit: two (2)
Maximum quantity: four (4)
ANTINAUSEANTS
Limit: three (3)
Maximum quantity: four (4)
ANTIPSYCHOTIC INJECTABLES
Limit: two (2)
Maximum quantity: four (4)
ANXIOLYTICS
Limit: one(1)
Maximum quantity: four (4)
CARDIAC LIFE SUPPORT MEDICATIONS
Injectables:
The content and quantity of injectable cardiac life support medications is to be recommended by the Pharmacy Services Committee at the Long-term Care facility and approved by the Executive Director of the Arkansas State Board of Pharmacy.
Hypertensive Crisis Oral Medications:
Limit: three (3)
Maximum quantity: eight (8)*
*When nitroglycerine sublinqual is used: quantity-1 bottle of 25 HYPOGLYCEMICS
Limit: three (3)
Maximum quantity: two (2)
INJECTABLE SEIZURE CONTROL MEDICATIONS
Limit: two (2)
Maximum quantity: four (4)
LARGE VOLUME PARENTERALS
Limit: three (3)
Maximum quantity: two (2)
POISON CONTROL
Limit: two
Maximum quantity: two (2)
Before revoking the certificate of licensure of any licensed pharmacist or licensed pharmacy permit, the Board of Pharmacy shall give such person proper notice in writing to appear before such Board, at such time and place as the Board may direct, to show cause if any he has, why his certificate or permit should not be revoked. Said notice shall be signed by the Executive Director of the State Board of Pharmacy and shall set forth in clear concise language the nature of the charge against such person. Mailing a copy of such notice by registered mail, addressed to such person at his address appearing upon the records of the State Board of Pharmacy concerning the issuance of his certificate or permit or the last renewal thereof, shall be sufficient service to such notice. At such hearing, the Board shall have power to subpoena witnesses and the President or Chairman of said Board shall have the power to administer oaths and such Board shall hear evidence. If the Board finds, after such hearing, that the certificate of Iicensure or permit of such person should be revoked, the same shall be done forthwith.
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 has personally filled said prescription by placing upon said prescription his signature with date thereof. 10/09/80 (Revised 10/14/81, and 6/20/91)
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 effects, 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)
If a product is listed on the Arkansas Non-Equivalent Drug Product List and the FDA approves a competitive product as bioequivalent and publishes the products with an "A" rating in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book) Arkansas pharmacists may substitute that product consistent with law until this list is revised. Conversely, if the change is from an "A" rating to a "B" rating, the pharmacist may not substitute without the consent of the prescribing physician if the pharmacist is aware of the "B" rating.
A prescription written for any brand name drug listed can only be changed with consent of the prescribing physician. If written generically, once the pharmacist has selected a manufacturers product the physician shall be notified if another company's product is used.
Leucovorin Calcium Tablets
Levothyroxine Tablets
Phenytoin Sodium Tablets and Capsules
Quinidine Gluconate Oral
Theophyiline Capsules, Controlled Release and Tablets
Warfarin Sodium Tablets
CONFIDENTIALITY
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 ANDA, or exemption therefrom 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 compounding and/or dispensing sterile parenteral products other than manufactured units prepared ready for use.
Pharmacies and pharmacists dispensing sterile parenteral products in quantities of 48 hours or less and expiration times of 72 hours or less shall adhere to all of this regulation except section VIII which applies to pharmacies or pharmacists dispensing sterile parenteral products in quantities of more than 48 hours and/or expiration times of more than 72 hours.
Pharmacies and pharmacists dispensing sterile parenteral 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 participates in or supervises the preparation and sterilization of parenteral medications shall be able to provide proof of proper knowledge and training in this specific area of practice by completing an open book test administered by the Board of Pharmacy prior to practice.
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 hospitals where medications may be provided as demanded by policies and procedures.
Any pharmacist in charge who performs or supervises the preparation or sterilization of parenteral medications shall:
Any pharmacy dispensing sterile parenteral solutions shall meet or exceed the following requirements:
In addition to regular labeling requirements, the label shall include:
The pharmacist in charge of the pharmacy dispensing sterile parental solutions shall provide the following or assure that they are provided prior to providing medications.
Any pharmacy providing cytotoxic and/or radioactive drugs shall establish procedures assuring the return and proper destruction of any unused radioactive or cytotoxic drugs.
In every instance, the pharmacist in charge should monitor the delivery, storage, and administration records of medications dispensed from his/her pharmacy.
The following Good Compounding Practices (GCPs) are meant to apply only to thecompounding of drugs by Arkansas licensed pharmacies.
The recommendations contained herein are considered to be the minimum current good compounding practices for the preparation of drug products by licensed pharmacies for dispensing and/or administration to humans or animals.
Pharmacists, engaged in the compounding of drugs, shall operate in conformance with applicable pharmacy law and regulations.
The following definitions apply to these Good Compounding Practices.
Based on the existence of a pharmacist/patient/ prescriber relationship and the presentation of a valid prescription, or in anticipation of Prescription Drug Orders based on routine regularly observed prescribing patterns, pharmacists may compound, for an individual patient, drug products that are commercially available in the marketplace.
Pharmacists shall first attempt to receive, store, or use drug substances for compounding that have been made in an FDA inspected facility. If unobtainable from an FDA-inspected facility or if the FDA and/or the company cannot document FDA inspection, pharmacists shall receive, store, or use drug components in compounding prescriptions that meet official compendia requirements. If neither of these requirements can be met, pharmacists shall use their professional judgment in the procurement of acceptable alternatives.
Pharmacists may compound drugs in limited quantities prior to receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/prescriber relationship, and provided that they maintain the prescriptions on file for all such products compounded at the pharmacy (as required by State law). The compounding of inordinate amounts of drugs in anticipation of receiving prescriptions without any historical basis is considered manufacturing.
Pharmacists shall not offer compounded drug products to other State-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a prescriber to administer to an individual patient. Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business (e.g., promote, advertise, or use salespersons) to compound specific drug products.
The distribution of inordinate amounts of compounded products without a prescriber/patient/pharmacist relationship is considered manufacturing.
As in the dispensing of all prescriptions, the pharmacist has the responsibility and authority to inspect and approve or reject all components, drug product containers, closures, in-process materials, and labeling; and the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for the proper maintenance, cleanliness, and use of all equipment used in prescription compounding practice.
All pharmacists who engage in drug compounding, shall be competent and proficient in compounding and shall maintain that proficiency through current awareness and training. Competency and proficiency in the art of compounding for all pharmacists shall be evaluated, documented, and maintained in the files of the pharmacy. Every pharmacist who engages in drug compounding must be aware of and familiar with all details of these Good Compounding Practices.
Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of the drug compounding operation.
Pharmacies engaging in compounding shall have a specifically designated and adequate area (space) for the orderly compounding of prescriptions, including the placement of equipment and materials. The drug compounding area for sterile products shall be separate and distinct from the area used for the compounding of non-sterile drug products. The area(s) used for the compounding of drugs shall be maintained in a good state of repair.
Bulk drugs and other chemicals or materials used in the compounding of drugs must be stored adequately labeled containers in a clean, dry area or, if required, under proper refrigeration.
Adequate lighting and ventilation shall be provided in all drug compounding areas. Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug product. The area(s) used for the compounding of drugs shall be maintained in a clean and sanitary condition.
f sterile (aseptic) products are being compounded, the following conditions shall be met: See Board Regulation #07-02-0001 If radiopharmaceuticals are being compounded, the following conditions shall be met: See Board Regulation # 04-02-0100
If drug products with special precautions for contamination, such as penicillin, are involved in a compounding operation, appropriate measures, including either the dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its use for the preparation of other drugs, must be utilized in order to prevent cross-contamination.
Equipment used in the compounding of drug products shall be of appropriate design, appropriate capacity, and suitable located to facilitate operations for its intended use and for its cleaning and maintenance. Equipment used in the compounding of drug products shall be of suitable composition so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond that desired.
Equipment and utensils used for compounding shall be cleaned and sanitized immediately prior to use to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond that desired. In the case of equipment, utensils, and containers/closures used in the compounding of sterile drug products, cleaning, sterilization, and maintenance procedures as set forth in Board Regulation # 07-02-0001 must be followed.
Equipment and utensils used for compounding drugs must be stored in a manner to protect from contamination. Immediately prior to the initiation of compounding operations, they must be inspected by the pharmacist and determined to be suitable for use.
Automatic, mechanical, electronic, other types of equipment, and limited commercial scale manufacturing or testing equipment, may be used in the compounding of drug products. If such equipment is used, it shall be routinely inspected, calibrated (if necessary), or checked to ensure proper performance.
It is recognized that non-pharmacists may perform any of the set-up and maintenance procedures not defined as the practice of pharmacy.
Components, drug product containers, closures, and bagged or boxed components of drug product containers and closures used in the compounding of drugs shall be handled and stored in a manner to prevent contamination and to permit unhindered cleaning of the work area, (e.g., floors) and inspection.
Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug beyond the desired result. Components, drug product containers, and closures for use in the compounding of drug products shall be rotated so that the oldest stock is used first. Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug product. Drug product containers and closures shall be clean and, where indicated by the intended use of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Drug product containers and closures intended for the compounding of sterile products must be handled, sterilized, stored, and in general maintained in keeping with Board Regulation # 07-02-0001. Methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures used in the preparation of sterile pharmaceuticals.
There shall be written procedures for the compounding of drug products to assure that the finished products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include a listing of the components (ingredients), their amounts (in weight or volume), the order of component mixing, and a description of the compounding process. All equipment and utensils and the container/closure system, relevant to the sterility and stability of the intended use of the drug, shall be listed. These written procedures shall be followed in the execution of the drug compounding procedure.
Components for drug product compounding shall be accurately weighed, measured, or subdivided as appropriate. These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight or measure is correct as stated in the written compounding procedures. If a component is transferred from the original container to another (e.g., a powder is taken from the original container, weighed, placed in a container, and stored in another container) the new container shall be identified with the:
To assure the reasonable uniformity and integrity of compounded drug products, written procedures shall be established and followed that describe the tests or examinations to be conducted on the product compounded (e.g., degree of weight variation among capsules). Such control procedures shall be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final drug product. Such control procedures shall include, but are not limited to, the following (where appropriate):
Appropriate written procedures designed to prevent microbiological contamination of compounded drug products purporting to be sterile shall be established and followed. Such procedures shall include validation of any sterilization process.
In the case where a quantity of a compounded drug product in excess of that to be initially dispensed in accordance with Subpart A is prepared, the excess product shall be labeled or documentation referenced with the complete list of ingredients (components), the preparation date, and the assigned beyond-use date based upon the pharmacist's professional judgment, appropriate testing, or published data. It shall also be stored and accounted for under conditions dictated by its composition and stability characteristics (e.g., in a clean, dry place on a shelf or in the refrigerator) to ensure its strength, quality, and purity.
At the completion of the drug preparation operation, the product shall be examined by the pharmacist for correct labeling.
Any procedures or other records required to be maintained in compliance with these Good Compounding Practices shall be retained for the same period of time as each State requires for the retention of prescription files.
All records required to be retained under these Good Compounding Practices, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of any such inspection.
Records required under these Good Compounding Practices may be retained either as the original records or as true copies, such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. (10/12/93)
Provided, however, a legend 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.
Unprofessional conduct pursuant to Regulation # 02-04-0001 shall include the following:
The possession of a "Drug Sample" by a pharmacy, pharmacist or licensed intern shall be considered unprofessional conduct unless prior approval has been obtained from the Board of Pharmacy or unless the sample was provided for personal use by the pharmacist, intern, or his family,
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 D.E.A. 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 60 days and dispensing cannot occur after 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 Five 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 Five exempt product, for more than ten 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 30 days, when sales in two consecutive months total more than four 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 A.C.A. 17-92-405 and Regulation # 04-05-0001 of the Regulations of the Arkansas State Board of Pharmacy has suffered:
Said inventory shall be furnished by said holder within seven days of the occurrence of said loss or the discovery of loss. 10/09/83
As used in this Regulation, unless the context otherwise requires.
It shall be unlawful for any person to sell or offer for sale by advertisement, circular, letter, sign, or oral solicitation or any other means any prescription drug unless the person holds and possesses a permit authorizing such sale as provided by this regulation.
CORPORATION, is deemed to have occurred when:
The Arkansas Board of Pharmacy reserves the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest.
The licensed wholesale distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the wholesale distribution of drugs.
The following are required for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their officers, agents, representatives, and employees.
Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors shall include in their written policies and procedures the following:
Wholesale drug distributors shall establish and maintain lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.
. 08-00-0011 -COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAWS.
Wholesale drug distributors shall operate in compliance with applicable Federal, State, And local laws and regulations.
Wholesale drug distributions that deal in controlled substances shall register with the appropriate State Controlled substance authority and with the Drug Enforcement Administration (DEA), and shall comply with all applicable State, local, and DEA regulations.
Wholesale drug distributors shall be subject to the provisions of any applicable Federal, State, or local laws or regulations that relate to prescription drug product salvaging or reprocessing, including Chapter 21, parts 207,210d, 211 of the Code of Federal Regulations.
Nothing in this regulation shall apply to the sale of chemicals or poisons for use for non medical purposes or for uses as insecticides or biologies or medicine used for the cure, mitigation, or prevention of disease of animals or fowl or for agricultural uses which comply with the requirements of the Federal Food, Drug, and Cosmetic Act and all amendments thereto UNLESS THOSE PRODUCTS ARE PRESCRIPTION DRUGS UNDER THIS REGULATION.
The Board may conduct inspections upon all premises, including delivery vehicles, Purporting or appearing to be used by a person licensed under this regulation. The Board, in its discretion, may accept a satisfactory inspection by the United States Food and Drug Administration (USFDA) or a state agency of another state which the Board determines to be comparable to that made by USFDA or the Arkansas Board of Pharmacy. 6/22/84 (Revised 6/20/91, 6/23/96, and 8/23/96).
The licensure requirements of this act will apply to all companies, agencies, and other business entities that are in the business of supplying medical equipment to patients in their home and which bill the patient or the patient's insurance, Medicare, Medicaid, or other third-party payor for the rent or sale of that equipment. The application for a license shall be on a form, furnished by the Board, and shall be accompanied by payment of fee as defined in Regulation 01-00-0007. The Board shall require a separate license for each facility directly or indirectly owned or operated, within this state, by the same person or business entity within this state, or for a parent entity with divisions, subdivisions, subsidiaries, and/or affiliate companies when operations are conducted at more than one location and there exists joint ownership and control among all the entities.
The provider must assure that only trained order intake personnel receive referrals.
The intent of this regulation is to improve pharmaceutical care by defining basic standards of care. Pharmacy care/ pharmaceutical care is defined as the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes are:
Pharmaceutical care (clinical pharmacy) involves four major functions on behalf of the patient;
In order to effectively counsel patients, the pharmacist must, through communication with the patient or caregiver, make a reasonable effort to obtain, record, and maintain the following information for each patient. It is recognized that most of this can be obtained using "qualified pharmacy employees" and designed forms, etc.
Drug-Drug Contraindications as defined by the Board. (Is this medication contraindicated with another medication the patient is taking?) It is recognized that the ultimate decision to use the medication or not use the medication rests with the physician who has more complete patient information. It is the pharmacist's responsibility to monitor the patient's medication therapy in the areas addressed in this regulation and inform the physician of the suspected problem.
If a problem is suspected and the physician is informed, the pharmacist shall document the process.
* A pharmacist shall counsel the patient or caregiver "face to face" if the patient or caregiver is in the pharmacy. If not, a pharmacist shall make a reasonable effort to counsel the patient or caregiver;
* Alternative forms of patient information may be used to supplement, but not replace face to face patient counseling;
* Patient counseling, as described herein, shall also be required for outpatients of hospitals and institutions when medications are dispensed on discharge from the hospital or institution.
* Patient counseling as described in this Regulation shall not be required for inpatients of a hospital or institution where a nurse or other licensed health care professional is authorized to administer the medication. However, the pharmacist shall provide drug therapy counseling when professionally deemed to be appropriate and when medications are provided by the pharmacy, when a pharmacist is on duty and a patient is discharged from the hospital or institution.
* The pharmacist shall maintain and make available to all patients appropriate patient-oriented reference materials USP-DI or Facts and Comparisons Patient Drug Facts or an equivalent or better as determined by the Board.
* It is recognized that the ultimate decision to not provide patient counseling rests with the physician. If the physician in specific instances (blanket requests not accepted) requests that information NOT be provided to the patient and gives reason, the pharmacist should honor that request in almost all instances.
PATIENT COUNSELING shall mean the effective communication by the pharmacist of information, as defined in this act to the patient or caregiver, in order to improve therapeutic outcome by encouraging proper use of prescription medications and drug delivery devices.
Recognizing that a pharmacist cannot be expected to recognize all possible drug interactions and also recognizing that the pharmacist and the patient does not have time to explain the numerous side effects of drugs, the pharmacy shall maintain a computer program which will identify Significant Drug Interactions (These are drugs with side effects which may be managed most effectively if the patient is aware of the specific side effect and what to do if it occurs.) The pharmacist in charge will be responsible for assuring that the computer system adequately flags and warns the pharmacist of any occurrence of significant drug interactions or significant side effects. (If a pharmacy was in business before September 1,1997, and a that time, did not have a computer system, said pharmacy may substitute Patient Drug Facts or other drug interaction manuals to reference drug interactions and side effects for effective patient counseling. This method should only be used until such time as the pharmacy acquires and adequate computer program as described in this section.)
The pharmacist will be responsible for counseling the patient on these interactions with verbal and, where appropriate, written information. (2/12/91, 2/10/98)
In order to be certified to provide Diabetes Self-Management Training, a pharmacist shall complete an educational program which is approved by the Arkansas State Board of Pharmacy and in compliance with the National Standards for Diabetes Self-Management Education as developed by the American Diabetes Association.
The standards for the educational program are as follows:
WRITTEN PROTOCOL OF A PHYSICIAN.
The purpose of this regulation is to provide standards for the maintenance of records of a pharmacist engaged in the provision of drug therapy management as authorized in § 17-92-101(14) and § 17-92-205(a).
Expenses considered for reimbursement by the Board shall be in the areas of travel as determined by the Board, phone or other necessary communication expenses, secretarial help, postage, food when traveling out of town of residence and acting on behalf of the Pharmacy Support Group other than meetings not to exceed $13 per day, unless specifically approved by the Board, limited meeting room costs and other expenses deemed appropriate by the "committee". Meal expense may be paid without overnight stay.
It is recognized that the Board will also consider special and specific requests for expenses to cover costs related to education or ability enhancement of committee or intervenor members to improve the Group or better serve the Group. 6/20/91
Every location holding a retail/wholesale prophylactic license issued by the Board including pharmacies shall cause periodic inspection and tests of prophylactics and contraceptives in order to determine their condition and shall report damaged or inferior merchandise to the Inspector of the Board of Pharmacy.
The Inspector of the Arkansas State Board of Pharmacy shall have free access to inspect and test all prophylactics and contraceptives. And any such merchandise considered to be out-dated, not properly labeled, or inferior in any way may be disposed of and cannot be sold, in order to protect the health and welfare of the general public. 10/09/80 (Revised 6/20/91)
