070.00.08 Ark. Code R. 001

Current through Register Vol. 49, No. 10, October, 2024

Rule 070.00.08-001 - Regulation 04 - Pharmacy

REGULATION 4 -PHARMACY

04-00: GENERAL REGULATIONS REGARDING PHARMACIES

04-00-0001 -EQUIPMENT SPECIFICATIONS

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:

(a) Graduates capable of measuring from 0.1ml to at least 120ml

(b) Mortars and pestles--at least one (porcelain or glass)

(c) Hot and cold running water in the prescription department

(d) Spatulas

(e) Ointment slab or ointment papers

(f) Exempt narcotic record book

(g) Class III balance and weights or comparable electronic scale

(h) Equipment for labeling

(i) Refrigeration for the proper storage of biologicals and other medications. Medications shall be stored in a separate compartment or area from food.

Each pharmacy shall maintain a pharmacy library:

(1) available for use by the pharmacist and the patient, including either current drug information manuals, or computers capable of printing current drug information for the pharmacist and patient drug information and monographs for patients.

(2) other pharmacy reference books and periodicals necessary for effective pharmacy practice.

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)

04-00-0002-TIME REQUIRMENTS FOR PHARMACIES AND FOR THE PHARMACIST IN CHARGE

(a) Unless expressly provided otherwise in Board regulations, all pharmacies in Arkansas shall be open a minimum of forty (40) hours per week and have on duty an Arkansas licensed pharmacist in charge. The pharmacist in charge shall be on duty in the pharmacy:

(1) a minimum of fifty (50) percent of the pharmacy hours for pharmacies open 64 hours per week or less, or

(2) at least thirty-two (32) hours per week for pharmacies open more than sixty-four (64) hours per week.

(b) Upon written application and appearance by the owner of a pharmacy before the Board, the Board may approve a minimum number of hours less than forty (40) per week for the pharmacy to be open to the public when the Board determines that the reduced number of hours would not be detrimental to the public health, safety, and welfare. For pharmacies approved to be open less than forty (40) hours per week, the pharmacist in charge shall be on duty in the pharmacy a minimum of fifty (50) percent of the pharmacy hours.

(c) In an emergency situation, the Executive Director of the Board of Pharmacy may determine that the health and welfare of the public might be in peril because of a community's limited access to pharmaceutical services if a pharmacy would be forced to close if it was required to remain open forty (40) hours per week. The Executive Director may approve a retail pharmacy operation for less than forty (40) hours per week for a limited period of time but not beyond the date of the next meeting of the State Board of Pharmacy. Thereafter, the owner of the pharmacy may request an exemption as provided for in section (b) above. The Executive Director must take into consideration the ultimate health and welfare of the patients in the area in making the determination. (10/09/80, Revised 10/14/81, 6/20/91, and emergency 4/2001, 10/2004)

04-00-0003-VENDING MACHINES

The sale of any legend drugs or medicines by means of a coin-operated vending machine is expressly prohibited. (10/09/80)

04-00-0004 -RE-USE OF DRUGS PROHIBITED

The reuse of returned portions of a prescription drug for human consumption is prohibited whether dispensed by order of a prescription or otherwise, except:

(a) to allow patients in nursing facilities to donate unused medications to charitable clinic pharmacies as provided by Ark. Code Ann. § 17-92-1101et seq. and Board Regulations 04-03-0004 and 04-07-0006 or,

(b) to allow return of oral medications packaged in unit dose or blister packs, oral liquids in sealed unit dose packaging, and injectables in sealed unit dose vials or sealed multi-dose vials that have been sent to a long term care facility or correctional facility but have not been opened or partially used by that facility. The aforementioned medications may be returned to the dispensing pharmacy for reuse to another nursing home or correctional facility patient by relabeling the medication if the medication is returned to the pharmacy within 72 hours of delivery to the facility provided that:

(1) The drugs were originally dispensed by that pharmacy to the facility,

(2) Under the pharmacist's professional judgment the drugs are appropriate for return and reuse,

(3) Any pharmacist or pharmacy accepting eligible drugs for return or reuse must adopt written policies and procedures governing such drugs to assure compliance with section (b) of this regulation,

(4) Medications meet all federal and state standards for product integrity to the satisfaction of the dispensing pharmacist,

(5) The pharmacist has the assurance from a healthcare professional responsible for the drugs at the facility that the drugs have been stored in accordance with the manufacturer's recommendations,

(6) Medications requiring refrigeration can not be returned for re-use, and

(7) Controlled substances can not be returned for re-use.

(10/9/80, Revised 6/23/05, and 6/30/2007)

04-00-0005-PICK UP STATIONS

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)

04-00-0006-EMERGENCY PHARMACY SERVICES

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 one (1) inch stating "This pharmacy will not provide emergency prescription drugs when the pharmacy is closed." (6/25/83)

04-00-0007-APPLICATIONS FOR PHARMACY PERMITS

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)

04-00-0008 -REQUIREMENTS FOR A NEW PHARMACY PERMIT

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)

04-00-0009-RESPONSIBILITY OF PHARMACIST, INTERN OR PHARMACY TECHNICIAN

(a) Any pharmacist, intern or pharmacy technician participating in the preparation of orders or dispensing of prescriptions and/or any pharmacist who is responsible for supervising pharmacy personnel participating in the preparation of orders or dispensing of prescriptions is responsible for the validity and legality of the order or prescription.

(b) Any pharmacist who is responsible to supervise pharmacy personnel is also responsible for any shortage of drugs classified as controlled drugs under state or federal law which occurs under their supervision.

(c) In a pharmacy's electronic data processing system that can delineate the individual steps in the prescription filling process, the pharmacist overseeing each step would be specifically responsible for that part of the process.

(d) In a pharmacy's electronic data processing system that is not capable of delineating the individual steps in the prescription filling process, the pharmacist(s) involved in the process will share a corresponding liability for each prescription filled. (Revised 11/6/2008)

04-00-0010-PHARMACIST IN CHARGE

(a) When a pharmacist ceases to be employed as a pharmacist in charge (PIC) at a pharmacy licensed by the Board, the pharmacist must immediately notify the Board in writing. The former PIC must provide an inventory of controlled drugs as defined in Regulation 04-00-0013 to the Board within five days of ceasing employment as the PIC.

(b) When a pharmacist in charge ceases to be employed in that position, the pharmacy permit holder must submit the permit issued in the name of the former PIC to the Board within five days.

(c) The pharmacist in charge is responsible for the security and accountability of all drugs, legend and/or controlled, stored in a pharmacy and is responsible for the validity and legality of all prescriptions and/or orders upon which drugs are dispensed in a pharmacy. The security and accountability of drugs classified as controlled drugs under state or federal law is the overall responsibility of the pharmacist in charge. In the event of a shortage of controlled drugs, the pharmacist in charge shall be held primarily responsible for such shortage. The pharmacist in charge is responsible for ensuring that pharmacy staff has been appropriately trained to follow the pharmacy's policies and procedures.

(d) Any pharmacist, when making his or her initial application to be licensed as pharmacist in charge, must satisfactorily complete a test on the requirements and responsibilities of a pharmacist in charge. The test shall be developed and administered by the Board of Pharmacy or its representatives.

(e) The pharmacist in charge named on any licensed pharmacy permit or pharmacist on call as designated by the pharmacist in charge, shall have immediate access to the pharmacy at all times, and if requested by Board of Pharmacy inspectors he/she shall show satisfactory proof of access.

(f) If the pharmacy fails to have on staff a licensed pharmacist acting as the pharmacist in charge due to extended illness, death, resignation, or for any other reason, the pharmacy permit holder shall notify the board within five (5) days and must within thirty (30) days, or such additional time at the discretion of the board, either:

(1) Secure the services of an Arkansas-licensed pharmacist to serve as the pharmacist in charge; or

(2) Cease to operate as a pharmacy in the State of Arkansas. Operation of the pharmacy without a pharmacist in charge beyond the time limits set by the Board is a violation of law and each day so operated will be a separate offense, (emergency--amended 4/2001, 3/14/2007 and 11/6/2008)

04-00-0011-PERMIT REQUIRED

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.

(a) Pharmacies opening for business must first secure a permit and be licensed with the Board of Pharmacy before they may lawfully conduct or operate a pharmacy. A fee defined in regulation 01-00-0007 is charged for issuing such original permit. All pharmacies must register with the Board and secure a biennial permit and pay a renewal fee as defined in regulation 01-00-0007.

(b) Permits must be posted in a conspicuous place. This requirement is not met when a permit is locked in a safe, placed in a desk drawer, or otherwise hidden away.

No pharmacy may open for business, nor may it be inspected for the purpose of obtaining a permit, prior to the approval by the Board. (Revised 11/6/2008)

(c)

04-00-0012-CHANGE OF OWNERSHIP

(a) Upon a change of ownership of a pharmacy as set out herein, a new permit shall be secured by the new owner(s). The new owner(s) can continue operation of the pharmacy for fourteen (14) days after the effective date of the change of ownership; after the said fourteen (14) day period, the permit issued to the prior owner shall be void and same shall be surrendered to the Executive Director of the Board of Pharmacy.

(b) A change of ownership of a pharmacy occurs under, but is not limited to the following circumstances:

(1) A change of ownership of a pharmacy, owned by a SOLE PROPRIETOR, is deemed to have occurred when:

(A) The pharmacy is sold and the sale becomes final or the new owner assumes control of the pharmacy--whichever occurs first.

(B) The proprietor enters into a partnership with another individual or business entity.

(2) A change of ownership of a pharmacy, owned by a PARTNERSHIP, is deemed to have occurred when:

(A) There is an addition or deletion of one or more partners in a partnership to which a pharmacy license has been issued.

(B) The pharmacy is sold and the sale becomes final or the new owner assumes control of the pharmacy--whichever occurs first.

(3) A change of ownership of a pharmacy, owned by a CORPORATION, is deemed to have occurred when:

(A) An individual or business acquires or disposes of twenty percent (20%) or more of the corporation's outstanding shares of voting stock. (This shall not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over the counter market); or

(B) The corporation merges with another business or corporation. (The corporation owning the pharmacy is required to notify the Arkansas State Board of Pharmacy if a change of ownership or merger occurs within the parent corporation of the corporation which owns the pharmacy); or

(C) The corporation's charter expires or is forfeited; or

(D) The pharmacy is sold and the sale becomes final or the new owner assumes control of the pharmacy--whichever occurs first.

(4) A change of ownership of a pharmacy is deemed to have occurred when the pharmacy is leased by another individual or entity who is wholly responsible for the operation of the pharmacy under the terms of the lease agreement.

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)

04-00-0013-INVENTORY REQUIRED

(a) When there is a change of pharmacy permit because of a change of ownership of the pharmacy, an inventory of all drugs now or hereafter classified as Schedule II, III, IV or V drugs under either federal or state statutes shall be made by the pharmacist in charge on the day the new owner takes possession of the pharmacy. A copy of that inventory signed by the pharmacist in charge shall be submitted with the application for change of ownership and the fee for change of ownership as defined in regulation 01-00-0007.

(b) When there is a change of pharmacy permit because of a change of pharmacist in charge only, an inventory of all drugs now or hereafter classified as Schedule II, III, IV or V drugs under either federal or state statutes will be made by the exiting pharmacist in charge and a copy of that inventory signed by said pharmacist shall be furnished to the Arkansas State Board of Pharmacy within seven days after the pharmacist's last day to work at the pharmacy and a copy left with the Controlled Substance Records of the Pharmacy. The new pharmacist in charge shall also immediately inventory all drugs now or hereafter classified as Schedule II, III, IV or V drugs under federal or state statutes and a copy of that inventory signed by the new pharmacist in charge shall be provided to the Arkansas State Board of Pharmacy with the application to change the pharmacy permit's pharmacist in charge.

(c) It is acceptable and preferable if the inventory is made jointly by the exiting and the new pharmacist in charge, signed by both pharmacists, and supplied to the Arkansas State Board of Pharmacy with the application for change of pharmacist in charge.

(d) If a joint inventory is not provided, both copies of said inventory (exiting pharmacist in charge and new pharmacist in charge) must be received by the Board before a new permit will be issued. (10/09/83, Revised 6/25/80, 6/20/96 and 11/6/2008)

04-00-0014-OWNER'S RESPONSIBILITY - PHARMACIST IS LICENSED

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)

04-01: PHARMACY PERMIT FEES

04-01-0001-PERMIT FEES

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)

04-02: REGULATIONS REGARDING RETAIL PHARMACIES

04-02-0001-APPLICATIONS FOR PHARMACY PERMITS

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)

04-02-0002-REQUIREMENTS FOR A NEW RETAIL PHARMACY PERMIT

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.

04-02-0003-LEASED OPERATIONS-PHARMACY IS A DEPARTMENT OF ANOTHER BUSINESS

(a) In any building, firm, or place of business where the pharmacy is a leased operation, and/or in situations where the pharmacist in charge does not own a substantial part of the business and is not manager of the total operation, and/or where the pharmacy is a department in a larger business that is not a drugstore or pharmacy, the prescription department shall be completely separated from the remainder of the building by some type of partition and said department shall be arranged and constructed so that the public will not have access to any legend drugs or medicine.

(b) The prescription area or department of any pharmacy, firm or place of business must be constructed so that it may be locked to prevent unauthorized persons from entering it in the absence of a licensed pharmacist (or other authorized prescription personnel.)

(c) A copy of the signed lease must be submitted with the application of the original permit, and at such other times as the original lease is changed or renewed.

04-02-0004-NECESSARY EQUIPMENT REQUIRED

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.

04-02-0010 -REGULATING THE USE OF ELECTRONIC DATA PROCESSING IN LIEU OF PRESENT RECORD KEEPING SYSTEMS IN PHARMACIES HOLDING PHARMACY PERMITS

(a) These regulations shall be construed, if possible, so as not to be in violation of, or in conflict with, any federal regulation or requirement and if any part hereof is held invalid because of such conflict such invalidity shall not affect other provisions or applications of these regulations which can be given effect without the invalid provisions and to this end, the provisions of these regulations are declared severable. In any event DEA permission to use electronic data processing record keeping systems must be obtained.

(b) The Arkansas State Board of Pharmacy must approve the system prior to implementation.

(c) Input of drug information into the system may be performed only by a pharmacist, or by a pharmacy technician under the supervision of a pharmacist. The final verification of prescription information into the computer, shall be made by the supervising pharmacist who is then totally responsible for all aspects of the data and data entry. Any judgmental decision concerning patient utilization of drugs must be performed by a pharmacist.

(d) The original prescription order must be numbered, dated, initialed or signed by the dispensing pharmacist at the time of the first filling of the prescription order, and filed according to regulation.

(e) An electronic data processing system must be readily accessible electronically online or by hard copy, and shall be capable of printing a hard copy record. Said hard copy record, or electronic data base record, shall be available upon request by a Board of Pharmacy representative or other state or federal agencies with authority to obtain such records within 48 hours of the request. The system must be capable of furnishing the following information:

(1) Must provide online retrieval (electronic record or hard copy) of original prescription order information. This shall include, but not be limited to, the following:

(A) Original prescription order number, date filled; full name and address of patient; name, address and DEA number (if applicable) of practitioner.

(B) Trade name (or generic name and manufacturer's name), strength, dosage form and quantity of drug dispensed.

(C) Number of authorized refills or, if not refillable, it must be so indicated.

(2) Must provide online retrieval (electronic record or hard copy) of refill history of each prescription order to include, in addition to information specified in this section, but not limited to the following:

(A) Initials or code designation of dispensing pharmacist for each refill.

(B) Date refilled.

(C) Number of authorized refills remaining.

(3) Daily Prescription Record

(A) Must provide a daily prescription record, or hard copy printout of each day's prescription order activity, to include but not limited to the following:

(i) Date of record.

(ii) Prescription order number, patient's name, name of drug, quantity dispensed and dosage form of drug, practitioner's name and DEA number (if applicable), and dispensing pharmacist's designation or initials on each prescription.

(iii) If the pharmacy is using a hard copy printout, it may be replaced by monthly log containing same information. This information must be maintained at pharmacy for a period of two years.

(iv) Any electronic data processing system must ensure strict confidentiality of patient records.

(v) All required information must be entered on the records of all prescription orders filled at the pharmacy including non-refillable prescriptions and must be maintained for a period of no less than two (2) years.

(vi) Must be capable of producing a patient profile (electronic record or hard copy) indicating all drugs being taken and dates of refills for the patient.

(vii) A pharmacy shall make arrangements with supplier of data processing services or materials to assure continuing adequate and complete prescription orders and dispensing records. If for any reason the relationship with said supplier terminates, the pharmacy shall assure the continuity of records.

(viii) The pharmacist in charge of the pharmacy shall maintain a bound log book in which each individual pharmacist or individual intern involved in dispensing of prescriptions shall sign a statement each day, attesting to the fact that the prescription information entered into the computer that day has been reviewed by him or her and is correct as shown. The log shall identify the time of day at which the pharmacist or intern started filling prescriptions and the time of day at which the pharmacist or intern stopped filling prescriptions. Said log book shall be maintained, by the pharmacist in charge or his successor, in the pharmacy for a period of two years after the date of dispensing the appropriately authorized prescription.

(4) Must be capable of providing a refill-by-refill audit trail for any specific strength and dosage form of any drug in the system to contain but not limited to the following:

(A) Practitioner's name.

(B) Name and address of patient.

(C) Name of drug (must include manufacturer's name if generic name used).

(D) Quantity dispensed on original and each refill.

(E) Prescription order number.

(F) Initials or code designation of dispensing pharmacist on original and each refill.

(G) Date of original and each refill.

(5) If the pharmacy closes, it shall be the responsibility of the pharmacist in charge to assure that all prescription records are readily retrievable and can be easily accessed. The pharmacist in charge, at the date of closing, shall store said records and within fourteen (14) days of closing shall notify the Board of Pharmacy where said records are located. That pharmacist in charge shall insure that a hard copy printout or a retrievable electronic record of any prescription records shall be produced and made available to a Board of Pharmacy representative on their request and to any other person authorized by law to examine or receive copies of prescription records. The records must be kept in a readily retrievable format for a period of two years from the official closing date of the pharmacy.

(6) In event of computer breakdown (down time), the pharmacy must have an approved auxiliary record keeping system. This system must contain all necessary information to insure prompt data entry into system as soon as computer is available.

(7) If maintaining the Daily Patient Medication Record electronically, the data must be backed up at least daily (preferably continuously.)

(f) In a pharmacy system that can delineate the individual steps in the prescription filling process, the pharmacist overseeing each step would be specifically responsible for that part of the process.

(g) In a system that is not capable of delineating the individual steps in the prescription filling process, the pharmacist(s) involved in the process will share a corresponding liability for each prescription filled. (10/09/80, Revised 6/19/97, 10/00 and 3/14/2007).

04-02-0011-CENTRAL FILL PHARMACY

A retail pharmacy with a licensed pharmacy permit may also act as a central fill pharmacy if the following requirements are met.

(a) Definitions

(1) "Central fill pharmacy" means a pharmacy which is licensed by the Arkansas State Board of Pharmacy ("the Board") to prepare legend and controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a licensed retail pharmacy and to deliver the labeled and filled prescriptions in accordance to federal and state law; provided, however, the central fill pharmacy may deliver prescriptions for controlled substances only in accordance with DEA regulations. Such central fill pharmacy shall be deemed "authorized" to fill prescriptions on behalf of a retail pharmacy only if the retail pharmacy and central fill pharmacy have a contractual relationship providing for such activities or share a common owner. Both the retail pharmacy and the central fill pharmacy involved in these activities share a corresponding responsibility regarding central fill prescriptions.

(b) Record keeping

(1) Every retail pharmacy that utilizes the services of a central fill pharmacy must keep a record of all central fill pharmacies, including name, address and DEA number that are authorized to fill prescriptions on its behalf. The retail pharmacy must also verify the registration for each central fill pharmacy authorized to fill prescriptions on its behalf at the beginning of each registration period for the central fill pharmacy. These records must be made available upon request for inspection.

(2) Every central fill pharmacy must keep a record of all retail pharmacies, including name, address and DEA number, for which it is authorized to fill prescriptions. The central fill pharmacy must also verify the registration for all retail pharmacies for which it is authorized to fill prescriptions at the beginning of each registration period for each retail pharmacy. These records must be made available upon request for inspection.

(c) Provision of prescription information of Schedule II controlled substances.

(1) Prescriptions for controlled substances listed in Schedule II may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the prescription information must:

(A) Write the word "CENTRAL FILL" on the face of the original prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted and, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal;

(B) Ensure that all information required to be on a prescription pursuant to federal and state law is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information);

(C) Maintain the original prescription for a period of two years from the date the prescription was filled;

(D) Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier), the identity of carrier and the name of the retail pharmacy employee accepting delivery.

(2) The central fill pharmacy receiving the transmitted prescription must:

(A) Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and DEA registration number of the retail pharmacy transmitting the prescription;

(B) Keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist filling the prescription, and the date of filling of the prescription;

(C) Track the prescription drug order during each step in the filling process and identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any portion of the process including transmission, filling, dispensing, or delivery.

(D) Keep a record of the date the filled prescription was delivered to the retail pharmacy, the method of delivery (i.e. private, common or contract carrier) and the identity of the carrier.

(3) Central fill pharmacies shall not be authorized to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner,

(d) Provision of prescription information for initial and refill prescriptions of legend or schedule III, IV or V controlled substances.

(1) Prescriptions for legend or controlled substances listed in Schedule III, IV or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the prescription information must:

(A) Write the word "CENTRAL FILL" on the face of the original prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted and the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal;

(C) Indicate in the information transmitted the number of refills already dispensed and the number of refills remaining;

(D) Maintain the original prescription for a period of two years from the date the prescription was last refilled;

(E) Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier), the identity of the carrier and the name of the retail pharmacy employee accepting delivery.

(2) The central fill pharmacy receiving the transmitted prescription must:

(B) Keep a record of the date of receipt of the transmitted prescription, the name of the licensed pharmacist filling the prescription, and dates of filling or refilling of the prescription;

(D) Keep a record of the date the filled prescription was delivered to the retail pharmacy, the method of delivery (i.e. private, common or contract carrier) and the identity of the carrier. Prescriptions for controlled substances that are prepared by the central fill pharmacy may only be delivered to the ultimate user in accordance with DEA regulations.

(e) Carriers to transport filled prescriptions

(1) Central fill pharmacies must comply with all federal and state requirements when using private, common or contract carriers to transport filled prescriptions to the ultimate user or to a retail pharmacy for delivery to the ultimate user. When central fill pharmacies contract with private, common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106.

(2) Retail pharmacies must comply with all federal and state laws when using private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy. When retail pharmacies contract with private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106.

(f) Labeling

The central fill pharmacy shall:

(1) Affix to the package a label showing the retail pharmacy name and address and a unique identifier, which shall be the central fill pharmacy's DEA registration number or a Board assigned identifier, indicating that the prescription was filled at the central fill pharmacy

(2) Indicate in some manner which pharmacy filled the prescription (e.g., "Filled by ABC Pharmacy for XYZ Pharmacy").

(3) Comply with all other labeling requirements of federal and state statutes.

(g) Policies and Procedures

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:

(1) Outline the responsibilities of each of the filling, originating, and dispensing pharmacies

(2) Include a list of the name, address, telephone numbers, and all license / registration numbers of the pharmacies involved in centralized prescription filling

(3) Include policies and procedures for:

(A) Notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription filling and the name of that pharmacy

(B) Protecting the confidentiality and integrity of patient information

(C) Dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received

(D) Complying with federal and state laws and regulations

(E) Operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems

(F) Annually reviewing the written policies and procedures and documenting such review.

(11/15/2003, Revised 3/14/2006)

04-02-0012- RETAIL PHARMACY OFF SITE ORDER ENTRY

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").

(a) Definitions

(1) "Off-site order entry pharmacy" means a retail pharmacy which is licensed by the Board to process legend and controlled substance prescriptions that remotely accesses another pharmacy's electronic data base from outside the pharmacy in order to process prescription drug orders, provided the pharmacy establishes controls to protect the privacy and security of confidential records.

(2) "Off-site order entry" does not include the dispensing of a prescription drug order but includes any of the following:

(A) receiving, interpreting, or clarifying prescription drug orders;

(B) data entering and transferring of prescription drug order information;

(C) performing drug regimen review;

(D) reconciling third party insurance claims;

(E) obtaining refill and substitution authorizations;

(F) interpreting clinical data for prior authorization for dispensing;

(G) performing therapeutic interventions; and

(H) providing drug information concerning a patient's prescription.

(3) "Drug regimen review" means an evaluation of prescription drug orders and patient profile records for:

(A) known allergies;

(B) rational therapy-contraindications;

(C) reasonable dose and route of administration;

(D) reasonable directions for use;

(E) duplication of therapy;

(F) drug-drug interactions;

(G) drug-food interactions;

(H) adverse drug reactions; and

(I) proper utilization, including over-utilization or under-utilization.

(a) The Arkansas State Board of Pharmacy may approve a request for off-site order entry where the retail pharmacy can demonstrate that the procedure will result in an improvement in patient care by increasing the amount time for pharmacist involvement in the process of medication review for safety and efficacy prior to the administration of the medication to the patient. Off-site order entry shall be prohibited out of state for prescriptions dispensed in the state of Arkansas.

(b)

(1) The pharmacist-in-charge or the permit holder of the retail pharmacy shall submit a written request for off-site order entry a minimum of 30 days prior to the Board meeting at which the pharmacist seeks Board approval.

(2) The request shall be accompanied by a policy and procedure manual for off-site order entry which shall be maintained at all pharmacies involved in off-site order entry 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:

(A) outline the responsibilities of each of the pharmacies;

(B) include a list of the name, address, and telephone numbers of the pharmacies involved in off-site prescription order entry; and

(C) include policies and procedures for:

(i) patient confidentiality and full compliance with HIPAA requirements;

(ii) maintenance of appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any processing and the store it was processed in;

(D) specify that only a pharmacist or pharmacy technician holding a current Arkansas license or registration in good standing shall enter orders at a remote or off-site entry location that is a duly licensed pharmacy.

(E) comply with federal and state laws and regulations; and

(F) include procedures for annually reviewing the written policies and procedures for needed modification with documentation of such review.

(d) General requirements.

(1) A Pharmacy may utilize the services of an off-site order entry pharmacy provided the pharmacies:

(A) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a non-dispensing function; and have;

(B) the same owner; or

(C) entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations.

(2) An off-site order entry pharmacy shall comply with the provisions contained in regulations 04-02-0010 REGULATING THE USE OF ELECTRONIC DATA PROCESSING IN LIEU OF PRESENT RECORD KEEPING SYSTEMS IN PHARMACIES HOLDING PHARMACY PERMITS and 07-00-0008 ELECTRONIC PRESCRIPTION PROCESSING AND PATIENT CONFIDENTIALITY to the extent applicable for the specific processing activity and this section including:

(A) duties which must be performed by a pharmacist; and

(B) supervision requirements for pharmacy technicians.

(3) Off-site order entry may only be performed by a retail pharmacy as appropriately licensed by the Arkansas State Board of Pharmacy

(e) Notifications to patients.

(1) A pharmacy that outsources off-site prescription order entry to another pharmacy shall prior to outsourcing their prescription:

(A) notify patients that prescription processing may be outsourced to another pharmacy; and

(B) give the name of that pharmacy; or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may process the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy.

(f) Records. All pharmacies shall maintain appropriate records which identify, by prescription drug order, the name(s), initials, or identification code(s) of each pharmacist or pharmacy technician who performs a processing function for a prescription drug order. Any record generated in this process whether in a hard copy or electronic format shall be maintained for a minimum period of two years from the last date of entry. Such records may be maintained:

(1) separately by each pharmacy and pharmacist; or

(2) in a common electronic file as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy and pharmacist.

(g) In the operation of the off-site order entry, patient confidentiality and full compliance with HIPAA requirements shall be observed at all times. (6/30/2007)

04-02-0100-NUCLEAR PHARMACY

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,

(a) Definitions:

(1) Authentication of Product History-Identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical or other drug.

(2) "Nuclear pharmacy" means a pharmacy which provides radiopharmaceutical services, and shall be licensed by the Arkansas State Board of Pharmacy.

(3) "Practice of nuclear pharmacy" means a patient-oriented service that embodies the scientific knowledge and professional judgment required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs.

(4) "Qualified nuclear pharmacist" means a pharmacist who holds a current license issued by the Arkansas State Board of Pharmacy, and who is certified as a nuclear pharmacist by a certification board recognized by the Arkansas State Board of Pharmacy, or satisfies each of the following requirements:

(A) Meets minimal standards of training for status as an authorized user of radioactive material, as specified by the Arkansas Department of Health, Division of Radiation Control and Emergency Management of the Nuclear Regulatory Commission.

(B) Has successfully completed a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from a College of Pharmacy approved by the Arkansas State Board of Pharmacy, or other training program recognized by the Arkansas State Board of Pharmacy, with the minimum 200 hours apportioned as follows:

(i) Radiation physics and instrumentation

(ii) Radiation protection

(iii) Mathematics pertaining to the use and measurement of radioactivity

(iv) Radiation biology

(v) Radiopharmaceutical chemistry

(C) Has attained a minimum of 500 hours of clinical/practical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist in, but not limited to, the following areas:

(i) Procuring radioactive materials

(ii) Compounding radiopharmaceuticals

(iii) Performing routine quality control procedures

(iv) Dispensing radiopharmaceuticals

(v) Distributing radiopharmaceuticals

(vi) Implementing basic radiation protection procedures

(vii) Consulting and educating the nuclear medicine community, pharmacists, other health professionals, and the general public.

(D) Has submitted an affidavit of experience and training to the Board of Pharmacy.

(5) "Quality assurance procedures" means all activities necessary to assure the quality of the process used to provide radiopharmaceutical services, including authentication of product history and maintenance of all records as required by pertinent regulatory agencies.

(6) "Quality control testing" means the performance of chemical, biological and physical tests on compounded radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals.

(7) "Radiopharmaceutical" means any drug which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but which does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term also includes any biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

(8) "Radiopharmaceutical Services" means the procurement, storage, handling, compounding, preparation, labeling, quality control testing, dispensing, distribution, transfer, record keeping, and disposal of radiochemicals, radiopharmaceuticals, and ancillary drugs, and also includes quality assurance procedures, radiological health activities, and consulting activities associated with the use of radiopharmaceuticals, health physics, and any other activities required for provision of pharmaceutical care.

(b) General requirements for pharmacies providing radiopharmaceutical services

(1) A permit to operate a nuclear pharmacy, providing radiopharmaceutical services, shall only be issued to a facility employing a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs shall be under the direct supervision of a qualified nuclear pharmacist, who shall be in personal attendance when the nuclear pharmacy is open for business. The pharmacist-in-charge shall be responsible for all operations of the nuclear pharmacy.

(2) The permit to operate a nuclear pharmacy is effective only so long as the nuclear pharmacy also holds a current Arkansas Department of Health or Nuclear Regulatory Commission license.

(3) Nuclear pharmacies shall have adequate space and equipment commensurate with the scope of services required and provided. All pharmacies handling radiopharmaceuticals shall include, but not be limited to, the following areas: radiopharmaceutical preparation/dispensing area; radioactive material shipping/receiving area; radioactive material storage area; and radioactive waste decay area. The application for a permit to operate a nuclear pharmacy shall include detailed floor plans and no material change may be made without the permission of the Board.

(4) The nuclear pharmacy professional service area shall be secured from unauthorized personnel and must be totally enclosed and lockable.

(5) Nuclear pharmacies shall maintain records of acquisition, inventory and disposition of all radioactive materials in accordance with Board and Arkansas Department of Health or Nuclear Regulatory Commission statutes and regulations.

(6) Nuclear pharmacies shall compound and dispense radiopharmaceuticals in accordance with accepted standards of radiopharmaceutical quality assurance. The Board of Pharmacy recognizes that the preparation of radiopharmaceuticals involves the compounding skills of the nuclear pharmacist to assure that the final drug product meets accepted professional standards.

(7) A radiopharmaceutical shall be dispensed only to a licensed practitioner authorized by the Arkansas Department of Health or Nuclear Regulatory Commission to possess, use, and administer such drug. A radiopharmaceutical shall be dispensed only upon receipt of a prescription or medication order from such licensed practitioner. Otherwise, a radiopharmaceutical may be transferred to a person who is authorized to possess and use such drug for non-clinical applications.

(8) A nuclear pharmacy, upon receipt of an oral prescription order for a radiopharmaceutical, shall immediately have the prescription order reduced to writing, or recorded in a data processing system, which writing or record shall contain at least the following:

(A) the name of the institution and prescriber, or prescriber's agent;

(B) the date of dispensing and the calibration time of the radiopharmaceutical;

(C) the name of the procedure;

(D) the name of the radiopharmaceutical;

(E) the dose or quantity of the radiopharmaceutical;

(F) the serial number assigned to the order for the radiopharmaceutical;

(G) any specific instructions;

(H) the initials of the person who dispensed the order.

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.

(9) The immediate outer container shield of a radiopharmaceutical to be dispensed shall be labeled with:

(A) the name and address of the pharmacy;

(B) the name of the prescriber;

(C) the date of dispensing;

(D) the serial number assigned to the order for the radiopharmaceutical;

(E) the standard radiation symbol;

(F) the words "Caution Radioactive Material";

(G) the name of the procedure;

(H) the radionuclide and chemical form;

(I) the amount of radioactivity and the calibration date and time;

(J) if a liquid, the volume;

(K) if a solid, the number of items or weight;

(L) if a gas, the number of ampoules or vials;

(M) molybdenum 99 content to USP limits; and

(N) the name of the patient or the words "Per Physician's Order" in the absence of a patient name. The requirements of this subsection shall be met when the name of the patient is readily retrievable from the physician upon demand.

When the prescription is for a therapeutic or blood-product radiopharmaceutical, the patient name shall appear on the label prior to dispensing.

(10) The immediate inner container label of a radiopharmaceutical to be dispensed shall be labeled with:

(A) the standard radiation symbol;

(B) the words "Caution Radioactive Material";

(C) the identity of the radionuclide;

(D) the chemical form;

(E) the name of the procedure; and

(F) serial number of the radiopharmaceutical.

(11) When a radiopharmaceutical is dispensed under the authority of an Investigational New Drug Application (IND), the nuclear pharmacy records shall include an investigator's protocol for the preparation of the radiopharmaceutical, a copy of the Institutional Review Board approval form (or letter), and a letter from the manufacturer (sponsor) indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

(12) Each nuclear pharmacy shall have a current copy of state and applicable federal regulations governing the safe storage, handling, use, dispensing, transport, and disposal of radiopharmaceuticals.

(c) Minimum equipment

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:

(1) Radionuclide Dose Calibrator;

(2) Refrigerator;

(3) Single or multiple channel scintillation counter with well-type Nal(TI) or Ge(Li) detector;

(4) Radiochemical fume hood and filter system with suitable air sampling equipment;

(5) At least two GM survey meters (including one high-range meter);

(6) Microscope and hemacytometer;

(7) Supplies to perform quality assurance testing;

(8) Syringe and vial radiation shields;

(9) Lead-shielded drawing station;

(10) Decontamination supplies;

(11) Supplies to perform quality assurance testing;

(12) Lead transport shields for syringes and vials; and

(13) D.O.T. approved USA Type A, 7A approved transport containers and other labels and supplies for shipping radioactive materials. (10/14/98 and 11/1/2007)

04-03REGULATIONS REGARDING RETAIL SPECIALTY PHARMACIES

04-03-0001 -SPECIALTY PHARMACY PERMITS

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.

04-03-0002METHADONE CLINIC SPECIALTY PHARMACY PERMIT

(a) Definitions:

(1) "Methadone clinic pharmacy" means the place in which a licensed professional prepares methadone or buprenorphine to be administered and/or dispensed to a patient of the clinic.

(2) "Dispensing" means the preparation of one or more doses of methadone or buprenorphine in properly labeled, patient specific containers and delivery of said drugs to the patient to consume away from the clinic; only a licensed pharmacist or physician holding a dispensing permit issued by the Arkansas State Medical Board shall dispense methadone.

(3) "Administering" means giving a single dose of methadone or buprenorphine to a patient to consume on-site; a physician shall administer or supervise the administration of methadone and the clinic pharmacist shall retain appropriate methadone administration records.

(b) Permit

(1) Applications for methadone clinic permits shall be submitted pursuant to regulation 04-02-0001.

(2) Any pharmacist shall notify the Board of Pharmacy in writing and ascertain that a methadone clinic pharmacy permit has been issued to the clinic before beginning practice in that clinic.

(c) Pharmacy operations

(1) The pharmacist in charge shall provide written policies, procedures, and protocols for the operation of the pharmacy and shall obtain the approval of same by the Executive Director of the Pharmacy Board prior to operation of said pharmacy.

(2) A methadone clinic pharmacy shall stock and dispense methadone or buprenorphine only.

(d) Physical Facilities

(1) The pharmacy shall be a controlled area for the storage, safeguarding, preparation, and dispensing of methadone, a Schedule II narcotic, and buprenorphine, a Schedule III controlled substance, and shall have adequate facilities for pharmaceutical services including the procurement, storage, distribution, security and control of said drug consistent with all federal and state laws and regulations.

(2) The pharmacy shall have all equipment necessary to carry out the functions of the methadone clinic pharmacy and is otherwise exempt from regulation 04-02-0004; the equipment must be identified in the policies and procedures of each methadone clinic specialty pharmacy.

(e) Licensed pharmacist personnel requirements

(1) A methadone pharmacy shall be open to serve its patients, with a pharmacist or pharmacists on duty, a minimum often (10) hours per week or, if necessary, a greater period of time in order to perform pharmacy duties necessary to ensure patient safety.

(2) The pharmacy's operating hours must be approved by the Executive Director of the Arkansas State Board of Pharmacy. (Revised 11/15/2003)

04-03-0003- STUDENT HEALTH CLINIC PHARMACY PERMIT

(a) Definitions:

(1) "Student Health Clinic Pharmacy" means a pharmacy located on a university or college campus for the purpose of filling prescriptions for students or employees or their spouses or dependents.

(2) "Board" means the Arkansas State Board of Pharmacy.

(b) Permit

(1) Applications for student health clinic pharmacy permits shall be submitted pursuant to regulation 04-02-0001.

(2) Any pharmacist shall notify the Board of Pharmacy in writing and ascertain that a student health clinic pharmacy permit has been issued to the clinic before beginning practice in that clinic.

(c) Pharmacy operations

(1) The pharmacist in charge shall provide written policies, procedures, and protocols for the operation of the pharmacy and shall obtain the approval of same by the Board prior to operation of said pharmacy.

(2) A student health clinic pharmacy may stock and dispense legend and controlled substances

(d) Physical Facilities

(1) The pharmacy shall be a controlled area for the storage, safeguarding, preparation, and dispensing of legend and controlled substances, and shall have adequate facilities for pharmaceutical services including the procurement, storage, distribution, security and control of said drugs consistent with all federal and state laws and regulations.

(2) The pharmacy shall have all equipment specified in regulation 04-00-0001.

(e) Licensed pharmacist personnel requirements

(1) The pharmacy's minimum operating hours must be approved by the Board prior to operation of said pharmacy.

(2) A pharmacist or pharmacists must be on duty during all hours of operation.

(3) The pharmacist in charge must work fifty-percent (50%) of the hours of operation. (07/15/2004)

04-03-0004-PERMIT FOR PILOT PROGRAM FOR DONATED PRESCRIPTION MEDICATIONS PURSUANT TO ARK. CODE ANN. § 17-92-1101 ET SEQ.

(a) The definitions in Ark. Code Ann. § 17-92-1102 are applicable in the regulation unless the context otherwise requires.

(b) Permit

(1)

(A) Application for a pilot program permit for the reuse of donated prescription medications authorized by Ark. Code Ann. § 17-92-1101et seq. shall be on a form provided by the Board, signed by the pharmacist in charge, and shall be submitted pursuant to Board regulation, but the fee for the application will be waived. The application and documentation identified in the following subparagraph shall be delivered to the Board's office 30 days prior to the meeting at which the applicant desires to appear for consideration of its application.

(B) The application shall be accompanied by appropriate documentation including:

(i) that necessary to qualify the applicant as a charitable clinic as defined in Ark. Code Ann. § 17-92-1102(1),

(ii) written policies and procedures for the operation of the charitable clinic pharmacy,

(iii) protocols to include the procedure for screening and determining that the patient qualifies on the basis of income below two hundred percent (200%) of the federal poverty level,

(iv) a depiction of the physical facilities for the pharmacy and a description of provisions for security for and access to the pharmacy,

(v) a statement of any fees charged to patients,

(vi) a list stating the pharmacy's hours of operation, equipment and library materials, and

(vii) the proposed contract with nursing home(s) for donation of unused prescription mediations, and

(C) The pharmacist in charge and an appropriate officer or director of the organization shall appear before the Board for its consideration of the application.

(D) The contract with the nursing home for supplying donated prescription drugs must be renewed biennially.

(E) Either volunteer or paid health care professionals shall deliver pharmaceutical services for the pharmacy.

(2) Prior to opening the charitable clinic pharmacy, the pharmacist in charge shall notify the Board in writing identifying each pharmacist who will work at the pharmacy and, within ten days thereafter, provide similar notice of any changes in pharmacists working in the pharmacy.

(c) Pharmacy operations

(1) A pharmacy holding a permit under this regulation shall stock and dispense purchased legend drugs, donated prescription drugs, samples, and medications received from manufacturer-sponsored prescription drug assistance programs or any other sources; provided, however that the pharmacy shall not stock or dispense any controlled substance.

(2) Pharmacists shall dispense all medications to patients on individual prescriptions, shall properly label all drugs dispensed, and shall comply with requirements for storing, safeguarding, preparing and keeping records for prescription drugs as described in Board Regulation 04-07-0006.

(3) The pharmacist in charge shall cause the approved written policies, procedures, contracts with nursing homes, and protocols for the operation of the pharmacy to be maintained and available in the pharmacy for use by pharmacy staff and review by State Board of Pharmacy inspectors.

(d) Physical Facilities

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.

(e) Changes in pharmacy operations

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.

(f) Limited Use Technician Permit

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)

04-04: OUT OF STATE PHARMACIES

04-04-0001-OUT OF STATE PHARMACY REGULATION

Out of State pharmacies shall comply with the following qualifications to be, and remain, licensed in Arkansas by the Board.

(a)

(1) The pharmacy holds a current license in good standing in the state(s) in which it is located.

(2) Each pharmacist dispensing drugs into Arkansas shall be licensed as a pharmacist in Arkansas or in the state where he practices if that state has standards of licensure at least equivalent to those of Arkansas.

(b) A pharmacist currently licensed in Arkansas, shall be named in the application and shall serve as the pharmacy's pharmacist in charge for the Arkansas permit and as the contact person for communications by the Board. Said Arkansas Pharmacist shall be an employee of the out of state pharmacy who shall be present at the pharmacy's physical location at least fifty (50) percent of the number of hours per week the pharmacy is open up to a maximum of twenty (20) hours per week. The pharmacist in charge for the Arkansas Permit need not be the same person as the pharmacist in charge of the pharmacy pursuant to the law in the state in which the pharmacy is located.

(1) That pharmacist will be responsible for receiving and maintaining publications distributed by the Board.

(2) If at anytime the pharmacist so designated as the pharmacist in charge for the Arkansas permit shall leave that capacity or not be able to serve in that capacity, the pharmacy shall notify the Board within ten (10) calendar days and designate another Arkansas licensed pharmacist to perform this function by written notice to the Board within thirty (30) calendar days.

(c) The out of state pharmacy shall apply for licensure and renewal on forms provided by the Board. The Board may require such information as reasonably necessary to carry out the provisions of A.C.A. § 17-92-401, including, without limitation, the name, address and position of each officer and director of a corporation or of the owners if the pharmacy is not a corporation.

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:

(1) The number of prescriptions dispensed or reasonably expected to be dispensed into Arkansas.

(2) The number of patients served or reasonably expected to be served in Arkansas.

(3) Whether the pharmacy has promoted its services in Arkansas.

(4) Whether the pharmacy has a contract(s) with any employer(s) or organization(s) to provide pharmacy services to employees or other beneficiaries in Arkansas.

(5) Medical necessity.

(6) The effect on the health and welfare of persons in Arkansas.

(7) Any other relevant matters.

(d) The pharmacy shall pay a biennial license fee as defined in regulation 01-00-0007. When there is a change of Arkansas licensed pharmacist in charge, the fee for said change shall be paid as defined in regulation 01-00-0007. Final notification, to the Arkansas State Board of Pharmacy, of the new Arkansas licensed pharmacist in charge shall be on a form furnished by the Arkansas State Board of Pharmacy and accompanied by the fee for said change.

(e) The pharmacy shall maintain records of drugs dispensed to Arkansas addresses in such a manner so as to be readily retrievable upon request. These records shall be made available for inspection by the Board or by Arkansas law enforcement authorities.

(f) The pharmacy shall timely respond to any request for information from the Board or law enforcement authorities.

(g) The pharmacy shall maintain an incoming toll free telephone number for use by Arkansas customers to be answered by a pharmacist with access to patient records. This service shall be available a minimum of 40 hours a week, six days per week during normal business hours. This telephone number plus others available for use shall be printed on each container of drugs dispensed into Arkansas. The toll free number shall have sufficient extensions to provide reasonable access to incoming callers.

(h) Generic drugs shall be dispensed into Arkansas pursuant to the Arkansas Generic Substitution Act; provided, however, nothing herein shall be construed to mandate that an out of state pharmacy comply with the Arkansas Generic Substitution Act if such compliance would cause the out of state pharmacy to violate the Generic Substitution Act of the state wherein the facility of the dispensing out of state pharmacy is located.

(i) The facilities and records of the pharmacy shall be subject to inspection by the Board: provided, however, the Board may accept in lieu thereof satisfactory inspection reports by the licensing entity using similar standards of the state where the pharmacy is located.

(j) Each out of state pharmacy doing business in Arkansas by dispensing and delivering or causing to be delivered prescription drugs to Arkansas consumers shall designate a resident agent in Arkansas for service of process.

(k) Each out of state pharmacy doing business in Arkansas shall comply with Board of Pharmacy regulation 09-00-0001 (Patient Information, Drug Use Evaluation, and Patient Counseling).

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.

(l) Upon a change of ownership of a pharmacy as set out herein, a new permit shall be secured by the new owner(s). The new owner(s) can continue operation of the pharmacy for fourteen (14) days after the effective date of the change of ownership; after the said fourteen (14) day period, the permit issued to the prior owner shall be void and same shall be surrendered to the Executive Director of the Board of Pharmacy.

(m) A change of ownership of a pharmacy occurs under, but is not limited to the following circumstances: