reglab/statecodes huggingface dataset:
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-4 - Maine Rx Plus Prescriptions

Current through 2024-29, July 17, 2024
With each prescription dispensed to a participant in the
					 Maine Rx Plus Program,
					  22 MRSA
					 §2681 et seq., the pharmacy shall
					 disclose to the purchaser in writing the usual and customary price of the
					 prescription to a purchaser not covered by or enrolled in any type of health
					 insurance, prescription drug benefit or 3rd party payor plan, public or
					 private, and the amount of savings provided to the purchaser as a result of the
					 Maine Rx Plus Program. No proprietary information need be disclosed pursuant to
					 this subsection.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-5 - Life of Prescription Drug Orders for Noncontrolled Drugs

Current through 2024-29, July 17, 2024
A pharmacist may fill a prescription drug order for a
					 noncontrolled drug for a period no greater than 15 months from the date
					 written.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-6 - Dispensing Records

Current through 2024-29, July 17, 2024
A pharmacy shall create a dispensing record for each
					 original, refill and transferred prescription drug order that it fills. The
					 dispensing record must include, at a minimum, the following information:
1. The original written or faxed prescription
				  drug order, or record of a telephone or computer prescription drug
				  order;
2. Quantity dispensed, if
				  different than the quantity specified in the prescription drug order;
3. Date of dispensing;
4. Prescription number or its
				  equivalent;
5. Identifiers (e.g.,
				  initials) for the individual pharmacists who-
A. Performed the drug utilization review;
				  and
B. Performed the final check to
				  ensure that the prescription was correct in all respects and ready for
				  dispensing.
The pharmacist is responsible for all work done by others
					 to which the pharmacist has affixed his identifier or permitted another to do
					 so.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-7 - Automated Data Processing System

Current through 2024-29, July 17, 2024
A pharmacy may employ an automated data processing system,
					 subject to the following requirements:
1.
Sight-Readable Documents vs.
				  Printouts
The system shall be capable of producing sight-readable
					 documents of all dispensing records required by Section
					 6 of this chapter. In the case of
					 administrative proceedings before the board, records must be provided in paper
					 printout form;
2.
Completeness and Accuracy
A pharmacist is responsible for the completeness and
					 accuracy of all entries into the system. The system shall be capable of
					 providing a daily printout of the day's prescription drug information. The
					 system or the retail pharmacy shall also be capable of identifying the
					 individual pharmacists who-
A.
				  Performed the drug utilization review; and
B. Performed the final check to ensure that
				  the prescription was correct in all respects and ready for
				  dispensing.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-8 - Transferring Prescriptions for Noncontrolled Drugs

Current through 2024-29, July 17, 2024
Original prescription drug orders for noncontrolled drugs
					 may be transferred between pharmacies for the purpose of refill dispensing
					 provided that the transfer is communicated directly between 2 pharmacists or
					 pharmacy interns, or between a transferring pharmacist or pharmacy intern and a
					 receiving pharmacy technician, and the following additional requirements are
					 met:
1.
Duties of Transferring
				  Pharmacist
The transferring pharmacist shall:
A. Enter the following information in the
				  dispensing record of the original prescription drug order created pursuant to
				  Section
				  6 or
				  7 of this chapter:
(1) A notation that a copy has been issued
				  and that the original prescription is void;
(2) The date of the transfer;
(3) The name of the transferring
				  pharmacist;
(4) The name and
				  address of the pharmacy to which the prescription was transferred;
				  and
(5) The name of the pharmacist
				  who received the prescription information; and
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-9 - Transferring Prescriptions for Controlled Drugs

Current through 2024-29, July 17, 2024
1.
Schedule II Drugs
A prescription drug order for a Schedule II drug may not
					 be transferred.
2.
Schedule III, IV and V Drugs
The transfer of prescriptions for Schedule III, IV and V
					 drugs for the purpose of refill dispensing is governed by
					 21
					 CFR §1306.25, "Transfer Between
					 Pharmacies of Prescription Information for Schedules III, IV, and V Controlled
					 Substances For Refill Purposes" (April 1, 2012) and is incorporated into the
					 board's rules by reference by Section
					 3(4)(b)(13) of this
					 chapter and Chapter 29, Section
					 2 of the board's rules.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-10 - Validity of Prescription Drug Order Upon Unavailability of Practitioner

Current through 2024-29, July 17, 2024
A pharmacist shall exercise discretion in filling a
					 prescription drug order that was issued by a practitioner who has since become
					 unavailable due to death, disability, retirement, cessation of practice or
					 long-distance relocation. Notwithstanding anything in this chapter to the
					 contrary, a prescription drug order described in this section shall become
					 invalid 6 months after the practitioner first became unavailable.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-11 - Refusal to Fill

Current through 2024-29, July 17, 2024
A pharmacist may refuse to fill a prescription or dispense
					 a drug only as permitted by
					 
					 32 MRSA §13795(2). A
					 pharmacist not qualified to initiate emergency contraception drug therapy in
					 accordance with
					 32 MRSA
					 §§13821 -
					 13825
					 shall not be deemed to have refused to dispense emergency
					 contraceptives.
[NOTE:
					 
					 32 MRSA §13795(2)
					 provides:
2.
Refusal to fill
				  prescription, dispense drug or sell targeted methamphetamine precursor; law
				  enforcement reporting
A pharmacist or person acting at the direction of a
					 pharmacist may exercise discretion and refuse to fill any prescription,
					 dispense any drug or sell any targeted methamphetamine precursor if unsatisfied
					 as to the legitimacy or appropriateness of any prescription presented, the
					 validity of any photographic identification or the identity of any patient
					 presenting a prescription or any person acting on behalf of the patient, or the
					 intention of the customer to use the drug or targeted methamphetamine precursor
					 according to the instructions for use. A pharmacist or person acting at the
					 direction of a pharmacist may make a report to a law enforcement agency when
					 that person has reasonable cause to suspect that a prescription is not
					 legitimate or appropriate, that a person has presented photographic
					 identification that is not valid or that a customer has the intention to use a
					 drug or targeted methamphetamine precursor in a manner inconsistent with the
					 directions for use.]
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS › Section 392-4-19-12 - Security

Current through 2024-29, July 17, 2024
A pharmacy shall ensure the security and confidentiality
					 of prescription drug orders, dispensing records, patient profiles and all other
					 patient records.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 1 - Retail Pharmacies › Section 392-4-20-1-1 - Scope

Current through 2024-29, July 17, 2024
The provisions of this subchapter apply to automated
						pharmacy systems that are wholly located in a retail pharmacy.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 1 - Retail Pharmacies › Section 392-4-20-1-2 - General Use; Control by Pharmacist

Current through 2024-29, July 17, 2024
An automated pharmacy system may be used for a patient
						profile dispensing system only if operation of the system is controlled by a
						pharmacist in all respects. For purposes of this chapter, such control includes
						but is not limited to the ability to fill prescription drug orders; control
						access to the machine; permit, block and monitor all stocking and dispensing
						activity; check inventory levels inside the machine; authenticate users of the
						system; authorize different levels of user access to the system; and deactivate
						or shut down the system.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 1 - Retail Pharmacies › Section 392-4-20-1-3 - Access to Automated Pharmacy System

Current through 2024-29, July 17, 2024
Only a pharmacist, pharmacy intern or a pharmacy
						technician working under the direct supervision of a pharmacist as described in
						Chapter 1, Section 14(1) of the board's rules, or a person legally qualified
						under a health practice act to administer drugs may stock, remove or label
						drugs from an automated pharmacy system. No person with access to an automated
						pharmacy system shall remove more drugs than necessary to fill a
						prescription.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 1 - Retail Pharmacies › Section 392-4-20-1-4 - Verification

Current through 2024-29, July 17, 2024
The pharmacist on duty shall verify the prescription
						drug order entered into a computerized pharmacy profile that is interfaced to
						the automated pharmacy system in order to screen for drug allergies and drug
						interactions, prevent therapeutic duplication, and verify appropriate quantity
						and dosage. The pharmacist shall verify the order prior to dispensation of the
						drug to the patient or the patient's authorized representative.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 1 - Retail Pharmacies › Section 392-4-20-1-5 - Responsibilities of Pharmacist on Duty

Current through 2024-29, July 17, 2024
The pharmacist on duty shall:
1. Directly supervise the stocking of
					 previously packaged and labeled drug units into an automated pharmacy system;
					 and
2. Directly supervise the
					 removal of the drug from an automated pharmacy system and the final labeling of
					 the drug after removal from an automated pharmacy system.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 1 - Retail Pharmacies › Section 392-4-20-1-6 - Physical Security; Unauthorized Access

Current through 2024-29, July 17, 2024
A
dispensing machine must be kept locked
						except when unlocking is necessary for loading or servicing. An automated
						pharmacy system must be electronically protected against unauthorized access,
						and must be constructed and installed in such manner as to prevent tampering,
						break-in and theft of inventory.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 1 - Retail Pharmacies › Section 392-4-20-1-7 - Training

Current through 2024-29, July 17, 2024
All persons given access to an automated pharmacy system
						must be adequately trained in the operation of the system. Checklists and
						procedure manuals must be kept up-to-date and must be readily accessible at all
						times.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 1 - Retail Pharmacies › Section 392-4-20-1-8 - Development of Procedures

Current through 2024-29, July 17, 2024
The pharmacist in charge shall develop, implement, and
						maintain procedures for the safe and effective use of medications dispensed via
						an automated pharmacy system. At a minimum, the procedures shall ensure
						that:
1. An automated pharmacy system
					 requires a person to enter a user name and password, or other unique
					 identifier, in order to access the system. User names, passwords and other
					 unique identifiers are assigned or authorized only by the pharmacist in
					 charge;
2. Audit records of access
					 to the system, including records of the delivery, receipt, loading and
					 unloading of drugs, and records of the dispensing of drugs, are electronically
					 tracked and recorded by the system and maintained by the pharmacist in charge,
					 and that such records are available to the board upon request;
3. The automated pharmacy system has a
					 documented and ongoing quality assurance program that monitors total system
					 performance;
4. Timely and
					 documented maintenance is performed on the automated pharmacy system in
					 accordance with the manufacturer's recommendations;
5. The purity, potency, and integrity of the
					 drugs contained in the automated pharmacy system shall be preserved;
6. The automated pharmacy system provides all
					 records required by the Maine Pharmacy Act, the rules of the board, and the
					 federal laws and rules specified in Chapter 29 of the board's rules;
					 and
7. In the event of a
					 consumer-level recall, the pharmacist in charge can access records of all drugs
					 that have been secured in the automated pharmacy system;
8. The pharmacist in charge develops and
					 maintains a comprehensive backup strategy and disaster recovery plan for use in
					 the event of a technical malfunction resulting from loss of power or internet
					 connectivity or a system malfunction; and
9. Requirements for controlled substances
					 security are met.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-1 - Scope

Current through 2024-29, July 17, 2024
The provisions of this subchapter apply to automated
						pharmacy systems that are located in a rural health center or free clinic; or
						in a dispensary, hospital pharmacy, extended care facility, boarding home,
						nursing home, drug abuse treatment center (other than a licensed pharmacy),
						penal institution, family planning center, medical clinic or any other facility
						that is not registered or licensed by the board.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-2 - General Use; Control by Pharmacist

Current through 2024-29, July 17, 2024
An automated pharmacy system may be used for maintaining
						patient care unit medication inventories or for a patient profile dispensing
						system only if the system is under the supervision of a pharmacist in charge
						and is controlled by a pharmacist at all times. For purposes of this chapter,
						such control includes but is not limited to the ability to fill prescription
						drug orders; control access to the machine; permit, block and monitor all
						stocking and dispensing activity; check inventory levels inside the dispensing
						machine; authenticate users of the system; authorize different levels of user
						access to the system; and deactivate or shut down the system or a dispensing
						machine at a point of care location.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-3 - Remote Dispensing

Current through 2024-29, July 17, 2024
An automated pharmacy system may dispense drugs at one
						or more point of care locations remote from the pharmacist in charge of the
						system or the pharmacist on duty. The pharmacist in charge and pharmacist on
						duty need not be physically present at the point of care location and need not
						be located within the State. However, such pharmacists must be licensed in
						Maine and must be in good standing with the board.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-4 - Access to Automated Pharmacy System

Current through 2024-29, July 17, 2024
1.
Health Care Professionals; Corrections Personnel
Only a pharmacist, allopathic physician, osteopathic
						physician, certified nurse practitioner, registered nurse, licensed practical
						nurse, physician's assistant, dentist, podiatrist, or appropriately-trained
						corrections personnel specifically designated by the warden, superintendent,
						director or chief administrative officer in charge of a penal institution
						may:
A. Accept delivery of
					 prescription medication to be loaded into a dispensing machine at a point of
					 care location;
B. Stock a
					 dispensing machine at a point of care location;
C. Remove drugs from a dispensing machine at
					 a point of care location; and
D.
					 Perform other functions related to an automated pharmacy system.
Except as set forth in subsection 2 below, none of the
						foregoing duties may be performed by a medical technician, medical assistant,
						certified nursing assistant, mental health rehabilitation technician or any
						other person whose profession or occupation is not listed in this
						subsection.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-5 - Verification of Prescription Medication to be Dispensed by an Automated Pharmacy System

Current through 2024-29, July 17, 2024
An automated pharmacy system must use bar code scans or
						other technology to ensure that the prescription medication to be loaded into a
						dispensing machine at a point of care location is the intended drug in the
						intended strength, dosage form and quantity. The pharmacist in charge or
						pharmacist on duty shall verify that the canisters, pockets or containers to be
						inserted into the dispensing machine have been properly filled and
						labeled.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-6 - Transport and Delivery

Current through 2024-29, July 17, 2024
Prescription medication to be dispensed by an automated
						pharmacy system must be transported by courier in locked, tamper-evident
						carriers to the point of care location for loading into a dispensing machine.
						The pharmacy or institution receiving the prescription medication shall
						maintain a delivery log showing the name of the sending pharmacy and pharmacist
						on duty, the name and employer of the courier, the date and time of delivery,
						the drugs delivered, and the name of the person accepting delivery on behalf of
						the pharmacy or institution.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-7 - Insertion of Canisters, Pockets or Containers into Dispensing Machine

Current through 2024-29, July 17, 2024
A dispensing machine at a point of care location must
						use bar code scans or other technology to ensure that the contents of a
						canister, pocket or container are accurately recognized by the machine.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-8 - Dispensing of Drugs

Current through 2024-29, July 17, 2024
A dispensing machine at a point of care location must
						dispense medications exactly in accordance with the prescriptions entered into
						the automated pharmacy system. A dispensing machine at a point of care location
						may only dispense patient-specific drugs to fill an immediate need.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-9 - Verification of Prescription Drug Order; No Final Check Required

Current through 2024-29, July 17, 2024
1.
Verification
The pharmacist on duty shall verify the prescription drug
						order entered into a computerized pharmacy profile that is interfaced to the
						automated pharmacy system in order to screen for drug allergies and drug
						interactions, prevent therapeutic duplication, and confirm appropriate quantity
						and dosage. The pharmacist shall verify the order as soon as practicable after
						administration of the drug to the patient or resident, but in no event more
						than 28 hours afterwards.
2.
No Final Check
No final check on the filled prescription need be
						performed.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-10 - Security; Restricted Access

Current through 2024-29, July 17, 2024
A dispensing machine at a point of care location must be
						kept locked except when unlocking is necessary for loading or servicing. The
						dispensing machine must be electronically protected against unauthorized
						access, and must be constructed and installed in such manner as to prevent
						tampering, break-in and theft of inventory.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-11 - Video Surveillance; 2-Way Communication; Availability of Pharmacist

Current through 2024-29, July 17, 2024
1.
Video Surveillance
A dispensing machine at a point of care location must be
						under video surveillance by the pharmacist in charge or pharmacist on duty 24
						hours per day, 7 days per week. Video surveillance consists of separate video
						cameras trained on the front face of the machine and all other sides of the
						machine that open for loading. The cameras must be set up so as to facilitate
						visual identification of persons who service, stock, log on to or remove
						product from the machine. The video cameras must continually transmit color
						images at a frame rate no less than 15 frames per second.
The board may grant a waiver from this requirement in
						whole or in part upon a showing that other security measures in place at the
						point of care location provide equivalent protection to the requirements of
						this subsection.
2.
2-Way Communication
There must also be a 2-way, real-time voice and video
						communication link in operation at all times (24/7) between the pharmacist in
						charge or pharmacist on duty and any person who services, stocks, logs on to or
						removes product from the machine.
3.
Availability of Pharmacist
A pharmacist must be available by telephone at all times
						(24/7) to consult with a pharmacy technician or person legally qualified under
						a health care act to administer drugs regarding any drug dispensed by an
						automated pharmacy system if a pharmacist is not available at the point of care
						location where the drug is dispensed.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-12 - Training

Current through 2024-29, July 17, 2024
All persons given access to a dispensing machine at a
						point of care location must be adequately trained in the operation of the
						automated pharmacy system. Checklists and procedure manuals must be kept
						up-to-date and must be readily accessible at all times.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-13 - Development of Procedures

Current through 2024-29, July 17, 2024
The pharmacist in charge shall develop, implement,
						maintain and follow procedures for the safe and effective use of drugs
						dispensed from an automated pharmacy system. At a minimum, the procedures shall
						ensure that:
1. An automated pharmacy
					 system requires a person to enter a user name and password, or other unique
					 identifier, in order to access the system. User names, passwords and other
					 unique identifiers are assigned or authorized only by the pharmacist in
					 charge;
2. Audit records of access
					 to the system, including records of the delivery, receipt, loading, unloading,
					 and returning of canisters, and records of the dispensing of drugs, are
					 electronically tracked and recorded by the system and are maintained by the
					 pharmacist in charge, and that such records are available to the board upon
					 request;
3. Before an automated
					 pharmacy system is deployed at a new point of care location, the pharmacist in
					 charge has tested and validated the system to ensure that the system is
					 releasing drugs properly;
4. The
					 pharmacist in charge monitors an automated pharmacy system for proper use and
					 tests the accuracy of the system at least every 6 months, and whenever any
					 change or upgrade is made to the system;
5. Timely and documented maintenance is
					 performed on the dispensing machine and all other components of an automated
					 pharmacy system in accordance with the manufacturer's
					 recommendations;
6. The purity,
					 potency, and integrity of the drugs contained in the automated pharmacy system
					 is preserved;
7. The automated
					 pharmacy system provides all records required by the Maine Pharmacy Act, the
					 rules of the board, and the federal laws and rules specified in Chapter 29 of
					 the board's rules;
8. In the event
					 of a consumer-level recall, the pharmacist in charge can access records of all
					 drugs that have been secured in the automated pharmacy system;
9. The pharmacist in charge develops and
					 maintains a comprehensive backup strategy and disaster recovery plan for use in
					 the event of a technical malfunction resulting from loss of power or internet
					 connectivity or a system malfunction; and
10. Requirements for controlled substances
					 security are met.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20 - AUTOMATED PHARMACY SYSTEMS › Subchapter 2 - Institutional Pharmacies › Section 392-4-20-2-14 - Waiver: Hospital Pharmacies

Current through 2024-29, July 17, 2024
For good cause shown, the board may waive or modify any
						of the requirements of this Subchapter upon application by a hospital pharmacy.
						As part of its application, the hospital pharmacy shall demonstrate that
						alternate means of achieving the goal of the requirement at issue can be
						implemented.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-1 - Scope

Current through 2024-29, July 17, 2024
The provisions of this chapter apply to self-service
					 customer kiosks for pickup of refill prescriptions that are located in retail
					 pharmacies. A kiosk may be stocked only with refill prescriptions for
					 noncontrolled substances. New prescriptions, or prescriptions for controlled
					 substances, may not be delivered via kiosk. A self-service customer kiosk may
					 operate only when the licensed pharmacy is open.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-2 - General Use

Current through 2024-29, July 17, 2024
Subject to the limitations contained in Section 1 of this
					 chapter, a prescription filled at a retail pharmacy in accordance with Chapter
					 19 of the board's rules, or a prescription filled at a central fill drug outlet
					 in accordance with Chapter 21 of the board's rules, may be delivered to the
					 patient or representative of the customer via a self-service kiosk located at
					 the retail pharmacy where the prescription is dispensed, or the retail drug
					 outlet that receives the filled prescription from a central fill drug outlet.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-3 - Placement Within Retail Pharmacy

Current through 2024-29, July 17, 2024
A self-service customer kiosk must be located within,
					 adjacent to or clearly within sight of the pharmacy. A self-service customer
					 kiosk is deemed to be part of the licensed pharmacy.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-4 - Loading of Finished Refill Prescriptions

Current through 2024-29, July 17, 2024
Only a pharmacist or pharmacy technician may load finished
					 refill prescriptions available for delivery into a self-service customer kiosk
					 for pickup by the patient or a representative of the patient.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-5 - Identification of Patient or Patient's Representative

Current through 2024-29, July 17, 2024
A self-service customer kiosk must provide a method of
					 identifying a patient or representative of the patient such that a finished
					 prescription is delivered from a kiosk only to its intended
					 recipient.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-6 - Opportunity for Counseling

Current through 2024-29, July 17, 2024
A self-service customer kiosk must prominently notify
					 customers that patient counseling is available at the pharmacy counter in
					 connection with drugs delivered via the kiosk. Counseling may also be provided
					 by a pharmacist reachable at a toll-free telephone number who has access to the
					 patient profile. Instructions on how to contact a pharmacist via toll-free
					 telephone must be displayed by the kiosk and must also be printed on the
					 customer receipt.
[NOTE: See Chapter 25 of the board's rules, entitled
					 "Patient Counseling."]
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-7 - Physical Security; Restricted Access

Current through 2024-29, July 17, 2024
A self-service customer kiosk must be-
A. Electronically protected against
				  unauthorized access;
B. Be bolted
				  to the floor or installed in a wall;
C. Be constructed in such manner as to
				  prevent tampering, break-in and theft of inventory; and
D. Able to sound an alarm if break-in is
				  attempted.
[NOTE: Chapter 13, Section 6(6) of the board's rules
					 requires that self-service customer kiosks be monitored by security
					 cameras.]
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-8 - Removal of Unclaimed Prescriptions; Accountability

Current through 2024-29, July 17, 2024
Only a pharmacist or pharmacy technician may remove
					 unclaimed prescriptions from a self-service customer kiosk or open the kiosk
					 for any purpose. The pharmacist in charge shall administer a system of
					 accountability for self-service customer kiosks at a retail drug outlet,
					 including but not limited to records of prescriptions delivered and a time log
					 that identifies and describes the activity of each patient, representative of a
					 patient, pharmacist and pharmacy technician who stocks, receives drugs from,
					 removes drugs from or accesses the kiosk for any reason.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-9 - Testing

Current through 2024-29, July 17, 2024
Before a self-service customer kiosk is deployed, the
					 pharmacist in charge shall test the kiosk to ensure that it releases drugs
					 properly. The pharmacist in charge must monitor performance of the kiosk on an
					 ongoing basis and test the kiosk for accuracy whenever any change or upgrade is
					 made to the automated pharmacy system.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-10 - Purity and Potency

Current through 2024-29, July 17, 2024
The purity, potency, and integrity of the drugs contained
					 in a self-service customer kiosk must be preserved.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 20-A - SELF-SERVICE CUSTOMER KIOSKS › Section 392-4-20-A-11 - Maintenance

Current through 2024-29, July 17, 2024
The retail drug outlet and pharmacist in charge are
					 responsible for timely and documented maintenance of self-service customer
					 kiosks in accordance with the manufacturer's recommendations.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 21 - CENTRAL PRESCRIPTION PROCESSING › Section 392-4-21-1 - Generally

Current through 2024-29, July 17, 2024
1.
Noncontrolled Drugs
A central fill drug outlet and/or central processing
					 center may fulfill a request for the processing, filling or refilling of a
					 noncontrolled prescription drug order from a retail drug outlet, rural health
					 center or free clinic; or from a dispensary, hospital pharmacy, extended care
					 facility, boarding home, nursing home, drug abuse treatment center, penal
					 institution, family planning center, medical clinic or any other facility that
					 is not registered or licensed by the board, and may deliver the processed,
					 filled or refilled prescription drug order to the retail drug outlet or other
					 health care facility identified in this subsection in accordance with the terms
					 of this chapter.
2.
Controlled Drugs
A central fill drug outlet and/or central processing
					 center may fulfill a request for the processing, filling or refilling of a
					 controlled prescription drug order from a retail drug outlet and may deliver
					 the processed, filled or refilled prescription drug order to the retail drug
					 outlet in accordance with the terms of this chapter.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 21 - CENTRAL PRESCRIPTION PROCESSING › Section 392-4-21-2 - Location and Licensure

Current through 2024-29, July 17, 2024
The central fill drug outlet or central processing center
					 must be located in the United States or its territories or the District of
					 Columbia. If located in Maine, the facility must be registered as a retail drug
					 outlet. If located outside of Maine, the facility must be registered in the
					 manner of a mail order prescription pharmacy as set forth in Chapter 11 of the
					 board's rules.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 21 - CENTRAL PRESCRIPTION PROCESSING › Section 392-4-21-3 - Contract or Common Ownership

Current through 2024-29, July 17, 2024
A central fill drug outlet or central processing center
					 that processes, fills or refills a prescription drug order must have a contract
					 with or have the same owner as the retail drug outlet or other health care
					 facility identified in Section
					 1(1) of this chapter
					 from which it received the prescription drug order. The contract must include
					 provisions that protect the confidentiality of patient information.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 21 - CENTRAL PRESCRIPTION PROCESSING › Section 392-4-21-4 - Labeling

Current through 2024-29, July 17, 2024
In addition to the information required by
					  32 M.R.S.A.
					 §13794, the prescription container must
					 clearly show:
1. The name and address
				  of the originating drug outlet;
2.
				  The name and address or the unique identifier of the central fill drug outlet
				  (bar code or symbol acceptable);
3.
				  Identifying information of the originating drug outlet, such as the tracking
				  number (bar code or symbol acceptable); and
4. Patient information.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 21 - CENTRAL PRESCRIPTION PROCESSING › Section 392-4-21-5 - Policies and Procedures

Current through 2024-29, July 17, 2024
1.
Audit
				  Trail
A drug outlet that utilizes central fill or central
					 processing services shall have policies and procedures in place that include an
					 audit trail that documents the prescription filling process and identifies the
					 individuals accountable for each step of the process.
2.
Performance of Final Check
The central fill drug outlet and the retail drug outlet or
					 other health care facility identified in Section
					 1(1) of this chapter
					 shall both perform a final check to ensure that the filled prescription
					 corresponds to the prescription drug order, and that the prescription is
					 correct in all respects and ready for dispensing. If there is no pharmacist on
					 site at the point of care location and the drug is dispensed by an automated
					 pharmacy system in accordance with Chapter 20 of the board's rules, the final
					 check may be performed by a pharmacy technician under the direct supervision of
					 a pharmacist, or by a person legally qualified under a health practice act to
					 administer drugs.
3.
DUR and Patient Counseling
The central fill drug outlet and the retail drug outlet or
					 other health care facility identified in Section
					 1(1) of this chapter
					 are both responsible for patient counseling and for compliance with the drug
					 utilization review requirements contained in the Medicaid laws, rules and other
					 materials specified in Chapter 29, Section
					 1(9) of the board's
					 rules.
4.
Notice to
				  Patients
A retail drug outlet that utilizes central fill services
					 must inform its patients, by posting or otherwise, that prescription drug
					 orders accepted at the retail drug outlet may be filled by a central fill drug
					 outlet.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 21 - CENTRAL PRESCRIPTION PROCESSING › Section 392-4-21-6 - Freedom of Choice

Current through 2024-29, July 17, 2024
Systems providing for the electronic transfer of
					 information shall not infringe on a patient's freedom of choice as to the
					 provider of prescription services.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 22 - SALE OF SCHEDULE V CONTROLLED SUBSTANCES › Section 392-4-22-1 - Applicability

Current through 2024-29, July 17, 2024
This chapter applies to Schedule V controlled substances,
					 and to exempt narcotic preparations as defined in
					  32 MRSA
					 §13722(1)(E).
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 22 - SALE OF SCHEDULE V CONTROLLED SUBSTANCES › Section 392-4-22-2 - Retail Sale by Pharmacist

Current through 2024-29, July 17, 2024
A pharmacist may sell an over-the-counter Schedule V
					 product at retail to a person 18 years of age or older without a prescription
					 drug order provided that the pharmacist obtains from the purchaser at time of
					 sale photographic proof of identification as described in
					 
					 32 MRSA §13795(1) for
					 entry into the exempt narcotic log or record of disposition.
A pharmacist shall exercise professional discretion
					 pursuant to
					 
					 32 MRSA §13795(2) to
					 ensure that the Schedule V product is being sold for medical purposes
					 only
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 22 - SALE OF SCHEDULE V CONTROLLED SUBSTANCES › Section 392-4-22-3 - Limitation on Purchases

Current through 2024-29, July 17, 2024
A drug outlet may not sell either of the following to the
					 same patient in a 48 hour period without a prescription drug order:
1. No more than 240 ml of any other Schedule
				  V product containing opium; or
2.
				  No more than 120 ml of any other Schedule V product.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 23 - ACCOUNTING FOR PRESCRIPTION DRUGS › Section 392-4-23-1 - Perpetual Inventory

Current through 2024-29, July 17, 2024
A retail pharmacy that dispenses Schedule II controlled
					 substances shall maintain perpetual inventory records. These records shall
					 indicate all receipts and dispersals of Schedule II controlled substances and
					 shall state at any point in time the current inventory quantities of each such
					 drug on hand. The perpetual inventory shall be maintained contemporaneously and
					 shall be made available for inspection by the board at the pharmacy for a
					 period of 5 years.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 4 - DISPENSING PRESCRIPTION DRUGS › Chapter 23 - ACCOUNTING FOR PRESCRIPTION DRUGS › Section 392-4-23-2 - Disposal of Drugs

Current through 2024-29, July 17, 2024
1.
Controlled Drugs
In disposing of controlled drugs, a pharmacy shall comply
					 with 21
					 CFR §1307.21, entitled "Procedure for
					 Disposing of Controlled Substances" and other applicable guidance from DEA. The
					 board incorporates
					 21 CFR
					 §1307.21 (April 1, 2012) into this
					 chapter by reference. Title
					 21 CFR
					 §1307.21 may be obtained from the U.S.
					 Government Printing Office, FDsys / Federal Digital System, at the following
					 URL-
http://www.gpo.gov/dfsys/
[NOTE: On December 21, 2012 DEA proposed new rules for the
					 disposal of controlled substances. 77 Fed.Reg. 75784. The proposed rules would
					 repeal 21 CFR
					 §1307.21.]
2.
Non-controlled Drugs
In disposing of non-controlled drugs, a pharmacy shall
					 comply with the Hazardous Waste Management Rules (Chapters 850, 851, 853-857)
					 of the Department of Environmental Protection, to the extent applicable, and
					 other guidance from that department and the U.S. Environmental Protection
					 Agency.