reglab/statecodes huggingface dataset:
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 10 - REGISTRATION OF FREE CLINICS › Section 392-2-10-5 - Alteration of Prescription Filling or Storage Area

Current through 2024-29, July 17, 2024
No free clinic shall alter the physical dimensions of the
					 prescription filling or storage area or add or change the doors, windows or
					 other means of access to the prescription filling or storage area prior to
					 receiving approval from the board. The free clinic shall provide a scaled
					 drawing of the proposed alteration at the time it requests approval.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 10 - REGISTRATION OF FREE CLINICS › Section 392-2-10-6 - Operation of Free clinic

Current through 2024-29, July 17, 2024
A free clinic shall comply with the rules of operation
					 contained in Chapter 15, "Operation of Free clinics" of the board's
					 rules.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 11 - REGISTRATION OF MAIL ORDER PRESCRIPTION PHARMACIES AND LICENSURE OF MAIL ORDER CONTACT LENS SUPPLIERS › Section 392-2-11-1 - Mail Order Prescription Pharmacy

Current through 2024-29, July 17, 2024
1.
Registration
A mail order prescription pharmacy that dispenses
					 prescription drugs or devices by mail or carrier from a facility not located in
					 this State for a patient who resides in this State shall provide the following
					 information on forms supplied by the board, along with such other information
					 as the board may require. Applications will not be considered for approval
					 until they are complete. Incomplete applications will be returned to the
					 applicant.
A. The name, physical
				  address, contact address, telephone number, email address and world wide web
				  address of the mail order prescription pharmacy;
B. All trade or business names used by the
				  mail order prescription pharmacy;
C. Type of ownership or operation (i.e.,
				  partnership, corporation, or sole proprietorship); and
D. The name(s) of the owner and/or operator
				  of the mail order prescription pharmacy, including:
(1) If a partnership, the name, contact
				  address, telephone number and employer identification number of the
				  partnership, and the name and contact address each partner;
(2) If a corporation, the name, physical
				  address, contact address, telephone number and employer identification number
				  of the corporation; the name of the parent company, if any; the name, contact
				  address and title of each corporate officer and director; the name and contact
				  address of each shareholder owning 10% or more of the voting stock of the
				  corporation, including over-the-counter stock, unless the stock is traded on a
				  major stock exchange and not over-the-counter; a certificate of existence from
				  the corporation's state of organization and, for corporations not organized
				  under Maine law, a certificate of authority from the Maine Secretary of State
				  if such certificate is required by
				  13-C M.R.S.A.
				  §1501;
(3) If a sole proprietorship, the name,
				  contact address and social security number of the sole proprietor and the name
				  of the business entity.
E. The DEA number;
F. Verification of licensure for all
				  jurisdictions in which the mail order prescription pharmacy has at any time
				  been licensed;
G. The name, contact
				  address, telephone number and email address of the pharmacist in charge of the
				  mail order prescription pharmacy;
H. A copy of the most recent inspection
				  report from the state in which the drug outlet is located; and
I. The fee required by Chapter 10 of the
				  rules of the Department of Professional and Financial Regulation, Office of
				  Licensing and Registration, entitled "Establishment of License Fees."
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 11 - REGISTRATION OF MAIL ORDER PRESCRIPTION PHARMACIES AND LICENSURE OF MAIL ORDER CONTACT LENS SUPPLIERS › Section 392-2-11-2 - Mail Order Contact Lens Supplier

Current through 2024-29, July 17, 2024
1.
Licensure
A mail order contact lens supplier that fills contact lens
					 prescriptions by mail or carrier for a patient who resides in this State shall
					 provide the following information on forms supplied by the board, along with
					 such other information as the board may require. Applications will not be
					 considered for approval until they are complete. Incomplete applications will
					 be returned to the applicant.
A. The
				  name, physical address, contact address, telephone number, email address and
				  world wide web address of the mail order contact lens supplier;
B. All trade or business names used by the
				  mail order contact lens supplier;
C. Type of ownership or operation (i.e.,
				  partnership, corporation, or sole proprietorship); and
D. The name(s) of the owner and/or operator
				  of the mail order contact lens supplier, including:
(1) If a partnership, the name, contact
				  address, telephone number and employer identification number of the
				  partnership, and the name and contact address of each partner;
(2) If a corporation, the name, contact
				  address, telephone number and employer identification number of the
				  corporation; the name of the parent company, if any; the name, contact address
				  and title of each corporate officer and director; the name and contact address
				  of each shareholder owning 10% or more of the voting stock of the corporation,
				  including over-the-counter stock, unless the stock is traded on a major stock
				  exchange and not over-the-counter; a certificate of existence from the
				  corporation's state of organization and, for corporations not organized under
				  Maine law, a certificate of authority from the Maine Secretary of State if such
				  certificate is required by
				  13-C M.R.S.A.
				  §1501;
(3) If a sole proprietorship, the name,
				  contact address, telephone number and social security number of the sole
				  proprietor and the name of the business entity.
E. The DEA number; if applicable;
F. Verification of licensure for all
				  jurisdictions in which the mail order contact lens supplier has at any time
				  been licensed;
G. The name, contact
				  address, telephone number and email address of the person responsible for
				  licensure of the mail order contact lens supplier; and
H. A copy of the most recent inspection
				  report from the state in which the mail order contact lens supplier is located,
				  if an inspection requirement exists; and
I. The fee required by Chapter 10 of the
				  rules of the Department of Professional and Financial Regulation, Office of
				  Licensing and Registration, entitled "Establishment of License Fees."
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 11 - REGISTRATION OF MAIL ORDER PRESCRIPTION PHARMACIES AND LICENSURE OF MAIL ORDER CONTACT LENS SUPPLIERS › Section 392-2-11-3 - Change of Owner, Location or Pharmacist in Charge; Change in Other Registration or Licensure Information

Current through 2024-29, July 17, 2024
Upon a change of ownership, a mail order prescription
					 pharmacy or mail order contact lens supplier shall file a new application with
					 the board by registered mail no less than 7 days prior to the change. Upon a
					 change of location, a mail order prescription pharmacy or mail order contact
					 lens supplier shall file a new application with the board by first class mail
					 no less than 7 days prior to the change. Upon a change of pharmacist in charge
					 (mail order prescription pharmacy) or person responsible for licensure (mail
					 order contact lens supplier), the mail order prescription pharmacy or mail
					 order contact lens supplier shall file a new application with the board by
					 registered mail no later than 7 days after the change. Upon any other change in
					 the information provided by the mail order prescription pharmacy or mail order
					 contact lens supplier in its most recent application, the entity shall notify
					 the board via letter, fax or email within 7 days after the change.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 11 - REGISTRATION OF MAIL ORDER PRESCRIPTION PHARMACIES AND LICENSURE OF MAIL ORDER CONTACT LENS SUPPLIERS › Section 392-2-11-4 - Disciplinary Action

Current through 2024-29, July 17, 2024
The Board may initiate disciplinary action against a mail
					 order prescription pharmacy or mail order contact lens supplier when:
1.
Violation Affecting Individual
				  Maine Citizen
A violation of the Maine Pharmacy Act or board rules
					 affecting a Maine citizen has occurred and the state in which the mail order
					 prescription pharmacy or mail order contact lens supplier is located has taken
					 no action or insufficient action; or
2.
Violation Affecting Maine Citizens
				  Generally
A violation of the Maine Pharmacy Act or board rules
					 affecting Maine citizens generally has occurred.
A mail order prescription pharmacy and mail order contact
					 lens supplier shall provide the board, upon request, with all information
					 needed by the board to carry out its responsibilities under the laws and rules
					 pertaining to mail order prescription pharmacies and mail order contact lens
					 suppliers.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 11 - REGISTRATION OF MAIL ORDER PRESCRIPTION PHARMACIES AND LICENSURE OF MAIL ORDER CONTACT LENS SUPPLIERS › Section 392-2-11-5 - Notice to Consumers

Current through 2024-29, July 17, 2024
A mail order prescription pharmacy and mail order contact
					 lens supplier shall include with each prescription filled prominent notice that
					 complaints against the mail order prescription pharmacy or mail order contact
					 lens supplier may be filed with the Complaint Coordinator, Office of Licensing
					 and Registration, 35 State House Station, Augusta, ME 04333, tel. (207)
					 624-8660, or on the worldwide web at
www.MaineProfessionalReg.org
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 12 - LICENSURE OF MANUFACTURERS AND WHOLESALERS › Section 392-2-12-1 - Scope

Current through 2024-29, July 17, 2024
This chapter applies to manufacturers and
					 wholesalers.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 12 - LICENSURE OF MANUFACTURERS AND WHOLESALERS › Section 392-2-12-2 - Application for Licensure

Current through 2024-29, July 17, 2024
The manufacturer or wholesaler shall provide the following
					 information on forms supplied by the board, along with such other information
					 as the board may require. Applications will not be considered for approval
					 until they are complete. Incomplete applications will be returned to the
					 applicant.
1. The name, physical
				  address, contact address, telephone number, email address and world wide web
				  address of the wholesaler or manufacturer;
2. All trade or business names used by the
				  wholesaler or manufacturer;
3. The
				  name, address, 24-hour telephone number and email address of a contact person
				  for the facility used by the wholesaler or manufacturer for storing, handling
				  and distributing prescription drugs.
4. Type of ownership or operation (i.e.,
				  partnership, corporation, limited liability company or sole proprietorship);
				  and
5. The name(s) of the owner
				  and/or operator of the wholesaler or manufacturer, including:
A. If a partnership, the name, contact
				  address, telephone number and employer identification number of the
				  partnership, and the name and contact address of each partner;
B. If a corporation, the name, contact
				  address, telephone number and employer identification number of the
				  corporation; the name of the parent company, if any; the name, contact address
				  and title of each corporate officer and director; the name and contact address
				  of each shareholder owning 10% or more of the voting stock of the corporation,
				  including over-the-counter stock, unless the stock is traded on a major stock
				  exchange and not over-the-counter; a certificate of existence from the
				  corporation's state of organization and, for corporations not organized under
				  Maine law, a certificate of authority from the Maine Secretary of State if such
				  certificate is required by
				  13-C M.R.S.A.
				  §1501;
C. If a limited liability company, the name,
				  contact address, employer identification number, telephone number, fax number
				  and email address of the limited liability company; the names and mailing
				  addresses of each member and manager; a certificate of existence from the Maine
				  Secretary of State or, for limited liability companies not organized under
				  Maine law, a certificate of authority or certificate of qualification from the
				  Maine Secretary of State; and the name of the member or manager who will be
				  representing the applicant in matters before the board.
D. If a sole proprietorship, the name,
				  contact address, telephone number and social security number of the sole
				  proprietor and the name of the business entity;
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 12 - LICENSURE OF MANUFACTURERS AND WHOLESALERS › Section 392-2-12-3 - Separate Applications for Separate Facilities

Current through 2024-29, July 17, 2024
The owner must file a separate application for each
					 facility that manufactures or distributes wholesale prescription drugs.
					 Applications need not be filed for business locations at which no manufacturing
					 or distribution occurs.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 12 - LICENSURE OF MANUFACTURERS AND WHOLESALERS › Section 392-2-12-4 - Minimum Qualifications

Current through 2024-29, July 17, 2024
The board will consider the following factors in
					 determining the eligibility for licensure of persons who engage in the
					 manufacture or wholesale distribution of drugs:
1. Subject to
				  5
				  M.R.S.A. §5301 et seq., any findings by
				  the board that the applicant has violated any federal, state or local laws
				  relating to drug manufacturing or distribution;
2. Subject to
				  5
				  M.R.S.A. §5301 et seq., any felony
				  convictions of the applicant under federal, state or local laws;
3. The applicant's past experience in the
				  manufacture or distribution of drugs;
4. The furnishing by the applicant of false
				  or fraudulent material in any application made in connection with drug
				  manufacturing or distribution;
5.
				  Disciplinary action taken by federal, state or local government of any license
				  currently or previously held by the applicant for the manufacture or
				  distribution of drugs;
6.
				  Compliance with previously granted licenses of any kind;
7. Compliance with the requirements to
				  maintain and/or make available to the board or to federal, state or local law
				  enforcement officials those records required to be maintained by manufacturers
				  or wholesale drug distributors; and
8. Accreditation by VAWD.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 12 - LICENSURE OF MANUFACTURERS AND WHOLESALERS › Section 392-2-12-5 - Change of Owner or Location; Change in Other Registration Information

Current through 2024-29, July 17, 2024
Upon a change of ownership, a manufacturer or wholesaler
					 shall file a new application with the board no less than 7 days prior to the
					 change. Upon a change of location, a manufacturer or wholesaler shall file a
					 new application with the board no less than 7 days prior to the change. The
					 licensee shall notify the board of any other change in the information provided
					 on its application within 10 days after the change.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 12 - LICENSURE OF MANUFACTURERS AND WHOLESALERS › Section 392-2-12-6 - Operation of Manufacturer or Wholesaler

Current through 2024-29, July 17, 2024
A manufacturer or wholesaler shall comply with the rules
					 of operation contained in Chapter 16, "Operation of Wholesalers and
					 Manufacturers" of the board's rules.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 12 - LICENSURE OF MANUFACTURERS AND WHOLESALERS › Section 392-2-12-7 - Exception to Prohibition Against Gifts to Practitioners

Current through 2024-29, July 17, 2024
The following definitions apply to terms contained in
					 32 M.R.S.
					 §13759, which constitute exceptions to
					 the general prohibition against manufacturers and wholesalers making gifts to
					 practitioners.
1. For purposes of
				  32 M.R.S.
				  §13759(2)(A)(3),
				  "modest meals and refreshments" means food and beverage of minimal value
				  provided to a practitioner in connection with a meeting or presentation about
				  the benefits, risks, and appropriate uses of prescription drugs or medical
				  devices, disease states, or other scientific information as long as the meeting
				  or presentation occurs in a venue and manner conducive to informational
				  communication. Such food and beverage must be of the type and quantity
				  typically provided for attendees at the venue where the meeting or presentation
				  occurs. For purposes of this section, minimal value means the cost of which is
				  similar to that which a practitioner would pay when dining at his or her own
				  expense as judged by local standards where the event is held.
2. For purposes of
				  32 M.R.S.
				  §13759(2)(C),
				  "reasonable honoraria" means cash, gratuity and/or a gift given to a
				  practitioner in recognition for the Maine licensed practitioner speaking at a
				  professional or educational conference sponsored by a manufacturer or
				  wholesaler. The aggregate value of all cash and gifts received by a
				  practitioner for a particular speaking engagement may not exceed an annual
				  limit of $500 in retail value. Reasonable honoraria does not include or apply
				  to:
A. The fee for service paid to the
				  practitioner for the presentation, travel or lodging reimbursement, or other
				  expenses incurred; or
B. Where
				  the manufacturer or wholesaler sponsoring the event does not participate or
				  have influence over the selection of the practitioner chosen for the speaking
				  engagement or payment for the services rendered by the practitioner.
The term "practitioner" does not include pharmacists.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-1 - Cleanliness and Sanitation

Current through 2024-29, July 17, 2024
The pharmacy department shall at all times be operated in
					 a clean and sanitary manner.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-2 - Hours of Operation; Posting of Hours

Current through 2024-29, July 17, 2024
1.
Minimum Hours of Operation
A retail pharmacy must be open to the public for a minimum
					 of 40 hours per week unless waived by the board for good cause shown, and must
					 be staffed by a pharmacist at all times that the pharmacy is open.
2.
Posting of
				  Schedule
A retail pharmacy shall prominently post in a public area
					 of the store the days and hours that the pharmacy is scheduled to be open to
					 the public.
3.
Adherence to Posted Schedule
A retail pharmacy shall adhere to the schedule posted
					 pursuant to Section
					 2(2) of this
					 chapter.
4.
Deviations From Posted Schedule
A retail pharmacy shall prominently post in a public area
					 of the store any deviation from its posted schedule as soon as the need to
					 deviate from the posted schedule is known by the pharmacy. This posting shall
					 include the period of time the pharmacy will be closed and the name, street
					 address and telephone number of a nearby pharmacy that is available to serve
					 the public during the period of closure.
5.
Reporting of Deviations to
				  Board
Except as set forth in this subsection, a retail pharmacy
					 shall report any deviation from its posted schedule to the board by fax or
					 email no later than the next business day following the deviation. Each day on
					 which a deviation occurs must be separately reported. Reporting may be made by
					 mail if the pharmacy does not have fax or email capability.
No report need be filed for:
A. A deviation of less than four hours
				  duration;
B. A deviation resulting
				  from severe weather conditions, fire, flood, disaster or natural or man-made
				  catastrophe beyond the control of the pharmacy; or
C. Holiday closures.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-3 - Pharmacist in Charge

Current through 2024-29, July 17, 2024
1.
Generally
The business of a retail pharmacy shall be conducted under
					 the direct supervision of a licensed pharmacist who has registered as the
					 pharmacist in charge of that pharmacy with the board. No retail pharmacy may
					 operate without a pharmacist in charge.
2.
Responsibilities
The pharmacist in charge is responsible legally and
					 professionally for all activities related to the practice of pharmacy within
					 the retail pharmacy for which the licensee is registered as pharmacist in
					 charge, and for the pharmacy's compliance with the provisions of the Maine
					 Pharmacy Act, the rules of the board, and the federal laws and rules specified
					 in Chapter 29, Section
					 1 of the board's rules. The
					 responsibilities of the pharmacist in charge include, but are not limited
					 to:
A. The pharmacy's procedures for
				  the procurement, storage, compounding and dispensing of drugs;
B. The recordkeeping systems required in the
				  practice of pharmacy for the purchase, sale, possession, storage and
				  repackaging of drugs;
C. The
				  security of the prescription filling area and its contents;
D. Ensuring that the prescription filling
				  area is operated in conformance with good pharmaceutical practices;
E. Notifying the board of termination of
				  status as pharmacist in charge via letter, fax or email within 7 days of the
				  termination;
F. The supervision of
				  pharmacy technicians and performance of administrative responsibilities
				  relating to pharmacy technicians as required by Chapter 7 of the board's rules;
				  and
G. Ensuring that each
				  pharmacist employed at the pharmacy for which the pharmacist in charge is
				  responsible is licensed with the board.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-4 - Death, Incapacity or Sudden Unavailability of Pharmacist on Duty

Current through 2024-29, July 17, 2024
A retail pharmacy shall immediately cease filling and
					 dispensing prescription drug orders upon the death, incapacity or sudden
					 unavailability of a sole pharmacist on duty until a replacement pharmacist
					 arrives at the pharmacy.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-5 - Prescriptions to be Filled Only in Prescription Filling Area

Current through 2024-29, July 17, 2024
Prescriptions may only be filled and dispensed in the
					 prescription filling area of the retail pharmacy. A retail pharmacy may request
					 a waiver of this limitation from the board by demonstrating, to the
					 satisfaction of the board, that a lack of convenient public access to a retail
					 pharmacy exists and that the public health and safety requires that drugs be
					 dispensed at a location remote from the retail pharmacy.
Nothing in this section shall prevent a retail pharmacy
					 from delivering a prescription to the home or business of a patient under
					 arrangements supervised by a pharmacist.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-6 - Security of Prescription Filling Area

Current through 2024-29, July 17, 2024
1.
Absence of Pharmacist From Prescription Filling Area
A retail pharmacy and pharmacist on duty shall ensure that
					 no person remains in the prescription filling area during the absence of a
					 pharmacist from the prescription filling area other than a pharmacy technician,
					 pharmacy intern or an authorized person.
2.
Dispensing of Prescriptions in the
				  Absence of a Pharmacist
A retail pharmacy may not dispense prescription drugs
					 pursuant to an original prescription drug order in the absence of a pharmacist
					 from the prescription filling area. A retail pharmacy may not dispense
					 prescription drugs pursuant to a renewal prescription drug order in the absence
					 of a pharmacist from the store premises.
3.
Acceptance of Walk-In Prescription
				  Drug Orders in the Absence of a Pharmacist
A pharmacy technician may accept prescription drug orders
					 from walk-in patients in the absence of a pharmacist from the prescription
					 filling area only when the pharmacist-
A. Is taking a customary and reasonable work
				  break;
B. Is in the vicinity of the
				  store in which the retail pharmacy is located or is in a closed-shop pharmacy
				  at the same location as the retail pharmacy;
C. Is not engaged in any activity that would
				  interfere with his/her immediate availability; and
D. Is reachable by the pharmacy technician
				  during the absence.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-7 - Compounding

Current through 2024-29, July 17, 2024
1.
Scope
This section applies to non-sterile compounding pharmacies,
					 for which no separate license or endorsement is required other than the general
					 retail pharmacy license or closed-shop pharmacy license. A sterile compounding
					 pharmacy must be separately licensed pursuant to Chapter 37 of the board's
					 rules.
2.
Operational Requirements
A. USP Chapter
				  795 - A non-sterile compounding pharmacy shall comply in all respects with
				  United States Pharmacopeia USP 36-NF 31, General Chapter <795>,
				  Pharmaceutical Compounding - Nonsterile Preparations, 2013-14 edition, Vol. 1,
				  p. 355. ("Chapter 795"). The board incorporates Chapter 795 into this chapter
				  by reference. Chapter 795 may be obtained from:
National Technical Information Service
5285 Port Royal Road
Springfield, VA 22161
(703) 605-6400
-or-
U.S. Pharmacopeial Convention
www.usp.org
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-8 - Signs

Current through 2024-29, July 17, 2024
All retail pharmacies shall identify their location by an
					 interior or exterior sign that identifies the establishment as a pharmacy
					 through the word or words "pharmacy," "druggist," "drugs," "drug store," "Rx,"
					 "apothecary," or the like. The pharmacy may display the sign upon issuance of
					 the pharmacy's license by the board. The sign must be immediately removed or
					 covered upon the nonrenewal, surrender or revocation of the establishment's
					 license, or upon the permanent closing of the pharmacy.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 13 - OPERATION OF RETAIL PHARMACIES › Section 392-3-13-9 - Permanent Closing of a Retail Pharmacy

Current through 2024-29, July 17, 2024
1.
Notification
A. A retail pharmacy
				  shall notify the board of the pharmacy's permanent closing at least 14 days
				  prior to closing. The notice shall include the name and address of the pharmacy
				  to be closed; the date of closure; the name and address of the pharmacy
				  acquiring the prescription inventory; and the name and address of the pharmacy
				  acquiring the prescription files and patient profiles.
B. A retail pharmacy shall notify the DEA of
				  the pharmacy's permanent closing at least 14 days prior to closing. The notice
				  shall include the name, address, and DEA registration number of the pharmacy to
				  be closed; the name, address, and DEA registration number of the pharmacy
				  acquiring the controlled substances; and the date on which the transfer will
				  occur.
C. A retail pharmacy shall
				  notify the general public of the pharmacy's permanent closing at least 14 days
				  prior to closing. The notice shall include the date of closure and the new
				  location of the pharmacy's patient prescription files. Notice shall be given by
				  prominent posting in a public area of the store and by display advertisement in
				  a newspaper of general circulation in the area served by the
				  pharmacy.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 14 - PHARMACY SERVICES AT RURAL HEALTH CENTERS › Section 392-3-14-1 - Consulting Pharmacist; Monthly Inspection

Current through 2024-29, July 17, 2024
Each rural health center must have a consulting pharmacist
					 who inspects the rural health center on a monthly basis pursuant to a written
					 contract between the pharmacist and the rural health center. The consulting
					 pharmacist shall send a report of each inspection to the medical director and
					 the administrator of the rural health center within 10 days after the
					 inspection.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 14 - PHARMACY SERVICES AT RURAL HEALTH CENTERS › Section 392-3-14-2 - Limitation on Prescription Authority

Current through 2024-29, July 17, 2024
No rural health center may dispense Schedule II controlled
					 substances.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 14 - PHARMACY SERVICES AT RURAL HEALTH CENTERS › Section 392-3-14-3 - Recordkeeping

Current through 2024-29, July 17, 2024
1.
Prescription Drug Orders Filled
				  From Inventory
A practitioner shall write all prescription drug orders in
					 duplicate. The original shall be given to the drug outlet provider daily. The
					 copy shall be kept at the rural health center.
2.
Daily Reports
A rural health center shall provide the provider drug
					 outlet with a daily report of each medication dispensed from inventory, the
					 patient name, and all other information needed for the patient profile.
3.
Patient Profiles and
				  Medication Records
Patient profiles shall be maintained at the provider drug
					 outlet. Medication records shall be kept at the rural health center.
4.
Labels and
				  Containers
A. Each rural health center
				  shall use its own label for prescription drugs. The consulting pharmacist shall
				  ensure that the labels used by the rural health center contain complete and
				  accurate directions for use. The rural health center shall provide the patient
				  with verbal directions as to proper medication usage.
B. The consulting pharmacist shall ensure
				  that each prescription container provided by the provider drug outlet lists the
				  lot number, manufacturer and expiration date of the medication.
C. The consulting pharmacist shall ensure
				  that the provider drug outlet supplies the rural health center with the latest
				  package inserts of all medications in the formulary.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 14 - PHARMACY SERVICES AT RURAL HEALTH CENTERS › Section 392-3-14-4 - Storage and Security

Current through 2024-29, July 17, 2024
A rural health center shall ensure the security of drugs
					 at all times. A rural health center shall keep drugs in a locked storage area
					 during non-business hours. A rural health center that provides pharmacy
					 services must be protected by an alarm system.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 14 - PHARMACY SERVICES AT RURAL HEALTH CENTERS › Section 392-3-14-5 - Freedom of Choice

Current through 2024-29, July 17, 2024
A rural health center shall advise its patients of their
					 right to choose a source of pharmaceutical services.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 15 - OPERATION OF FREE CLINICS › Section 392-3-15-1 - Pharmacist in Charge

Current through 2024-29, July 17, 2024
1.
Generally
The activities of a free clinic shall be conducted under
					 the direct supervision of a licensed pharmacist who has registered as the
					 pharmacist in charge of that drug outlet with the board. No free clinic may
					 operate without a pharmacist in charge.
2.
Responsibilities
The pharmacist in charge is responsible legally and
					 professionally for all activities related to the practice of pharmacy within
					 the free clinic for which the licensee is registered as pharmacist in charge,
					 and for the drug outlet's compliance with the provisions of the Maine Pharmacy
					 Act, the rules of the board, and the federal laws and rules specified in
					 Chapter 29, Section
					 1 of the board's rules. The
					 responsibilities of the pharmacist in charge include, but are not limited
					 to:
A. The drug outlet's procedures
				  for the procurement, storage, compounding and dispensing of drugs;
B. The recordkeeping systems required in the
				  practice of pharmacy for the purchase, sale, possession, storage and
				  repackaging of drugs;
C. The
				  security of the prescription filling area and its contents;
D. Ensuring that the prescription filling
				  area is operated in conformance with good pharmaceutical practices;
				  and
E. Notifying the board of
				  termination of status as pharmacist in charge via letter, fax or email within 7
				  days of the termination.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 15 - OPERATION OF FREE CLINICS › Section 392-3-15-2 - Death, Incapacity or Sudden Unavailability of Pharmacist on Duty

Current through 2024-29, July 17, 2024
A free health clinic shall immediately cease filling and
					 dispensing prescription drug orders upon the death, incapacity or sudden
					 unavailability of a sole pharmacist on duty until a replacement pharmacist
					 arrives at the drug outlet.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 15 - OPERATION OF FREE CLINICS › Section 392-3-15-3 - Security of Prescription Filling Area

Current through 2024-29, July 17, 2024
1.
Absence of Pharmacist From Prescription Filling Area
A free clinic and pharmacist on duty shall ensure that no
					 person remains in the prescription filling area during the absence of a
					 pharmacist from the prescription filling area other than an authorized pharmacy
					 technician or an authorized person.
2.
Dispensing of Prescriptions in the
				  Absence of a Pharmacist
No free clinic may dispense prescription drugs pursuant to
					 an original prescription drug order in the absence of a pharmacist from the
					 prescription filling area. No free clinic may dispense prescription drugs
					 pursuant to a refill prescription drug order in the absence of a pharmacist
					 from the clinic premises.
3.
Acceptance of Walk-In Prescription
				  Drug Orders in the Absence of a Pharmacist
An authorized pharmacy technician may accept prescription
					 drug orders from walk-in patients in the absence of a pharmacist from the
					 prescription filling area only when the pharmacist-
A. Is taking a customary and reasonable work
				  break;
B. Is in the vicinity of the
				  free clinic;
C. Is not engaged in
				  any activity that would interfere with his/her immediate availability;
				  and
D. Is reachable by the
				  authorized pharmacy technician during the absence.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 15 - OPERATION OF FREE CLINICS › Section 392-3-15-4 - Limitation on Prescription Authority

Current through 2024-29, July 17, 2024
No free clinic may dispense Schedule II controlled
					 substances.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 15 - OPERATION OF FREE CLINICS › Section 392-3-15-5 - Storage and Security

Current through 2024-29, July 17, 2024
A free clinic shall ensure the security of drugs at all
					 times. A free clinic shall keep drugs in a locked storage area during
					 non-business hours. A free clinic must be protected by an alarm system.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 16 - OPERATION OF WHOLESALERS AND MANUFACTURERS › Section 392-3-16-1 - Purpose

Current through 2024-29, July 17, 2024
The purpose of this chapter is to implement the Federal
					 Prescription Drug Marketing Act of 1987 by providing minimum standards, terms
					 and conditions for the operation of wholesale drug distributors, including
					 manufacturers.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 16 - OPERATION OF WHOLESALERS AND MANUFACTURERS › Section 392-3-16-2 - Minimum Requirements for the Storage and Handling of Prescription Drugs and the Establishment and Maintenance of Prescription Drug Records

Current through 2024-29, July 17, 2024
1.
Personnel
A wholesale drug distributor shall employ adequate levels
					 of personnel with the education and experience necessary to safely and lawfully
					 engage in the wholesale distribution of drugs.
2.
Facilities
All facilities at which prescription drugs are stored,
					 warehoused, handled, held, offered, marketed or displayed shall:
A. Be of suitable size and construction to
				  facilitate cleaning, maintenance and proper operations;
B. Have storage areas designed to provide
				  adequate lighting, ventilation, temperature, sanitation, humidity, space,
				  equipment and security conditions;
C. Have a quarantine area for storage of
				  drugs that are outdated, damaged, defective, deteriorated, misbranded or
				  adulterated, or that are in immediate or sealed secondary containers that have
				  been opened;
D. Be maintained in a
				  clean and orderly condition; and
E.
				  Be free from infestation by insects, rodents, birds or vermin of any
				  kind.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 17 - OPERATION OF NUCLEAR DRUG OUTLETS › Section 392-3-17-1 - Compliance with Maine Radiation Control Program

Current through 2024-29, July 17, 2024
The board hereby incorporates by reference into this
					 chapter the following rules of the Department of Human Services, Bureau of
					 Health, Division of Health Engineering:
1. Chapter 220, Part C, "Licensing of
				  Radioactive Material (October 1, 2003);" and
2. Chapter 220, Part G, "Medical Use of
				  Radioactive Material (June 1, 2003)."
Copies of these rules may be obtained from-
Maine Radiation Control Program
Department of Human Services
11 State House Station
Augusta, ME 04333
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 17 - OPERATION OF NUCLEAR DRUG OUTLETS › Section 392-3-17-2 - Obligations

Current through 2024-29, July 17, 2024
A nuclear drug outlet shall register with the board as a
					 retail drug outlet pursuant to Chapter 8 of the board's rules and is subject to
					 all provisions of the board's rules that apply to retail drug outlets. A
					 nuclear drug outlet shall comply with the rules identified in Section
					 1 of this chapter with respect to all
					 aspects of radiopharmaceutical practice, including but not limited to the
					 compounding, storage, dispensing, labeling and delivery of radioactive drugs;
					 licensure by the Division of Health Engineering; and the employment and
					 designation of authorized nuclear pharmacists. An authorized nuclear pharmacist
					 shall comply with the rules identified in Section
					 1 of this chapter with respect to all
					 aspects of radiopharmaceutical practice, including but not limited to the
					 compounding, storage, dispensing, labeling and delivery of radioactive drugs;
					 and the credentialing of such individual as an authorized nuclear
					 pharmacist.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 3 - OPERATION OF DRUG OUTLETS › Chapter 18 - STERILE PHARMACEUTICALS

Current through 2024-29, July 17, 2024
Summary:
This chapter sets forth rules governing
				  the preparation, labeling and distribution of sterile pharmaceuticals.
[repealed]
STATUTORY AUTHORITY:
					  32 M.R.S.A.
					 §§13720 ,
					 13721(1)
					 ,
					 13722
					 ,
					 13723
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 392-4-19-1 - General Requirements for Prescription Drug Orders

Current through 2024-29, July 17, 2024
1.
Required Information
Prescription drug orders shall contain, at a minimum, the
					 following information:
A. Date of
				  issuance by practitioner;
B. Name
				  and address of the patient [or patient location if an institution];
C. Name and address of the practitioner [if
				  not a staff physician at an institution];
D. DEA number of practitioner [in the case of
				  controlled substances];
E. Name,
				  strength, dosage form and quantity [or stop date, and route of administration]
				  of drug prescribed;
F. Refills
				  authorized; and
G. Directions for
				  use by patient.
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 392-4-19-2 - Requirements for Prescription Drug Orders for Controlled Substances

Current through 2024-29, July 17, 2024
1.
Schedule II Drugs
No pharmacist may fill a written prescription drug order
					 from a Maine health care provider for a Schedule II drug that does not comply
					 with Chapter 1 of the rules of the Department of Public Safety, Maine Drug
					 Enforcement Agency, entitled "Requirements for Written Prescriptions of
					 Schedule II Drugs," adopted May 30, 2002 and effective January 1, 2003. The
					 board hereby incorporates Chapter 1 into this chapter by reference. A copy of
					 the rule may be obtained from-
Department of Public Safety
Maine Drug Enforcement Agency
166 State House Station
Augusta, ME 04333-0166
[NOTE: PL 2003, c. 326, amending
					  32 MRSA
					 §13786-A(2)-(4), sets
					 forth special requirements for filling a prescription drug order for a Schedule
					 II drug written by an out-of-state practitioner.]
2.
All Controlled Substances
A. A controlled substance may not be
				  pre-printed on a prescription blank.
B. No pharmacist may fill a prescription drug
				  order for a controlled substance that is presented to the pharmacist more than
				  90 days after the date of the prescription.
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 392-4-19-3 - Additional Requirements for Specific Forms of Prescription Drug Orders

Current through 2024-29, July 17, 2024
1.
Telephone Prescription Drug
				  Orders
A pharmacist or pharmacy intern may accept an original or
					 renewal prescription drug order telephoned to a pharmacy by a practitioner or
					 authorized agent of the practitioner. A pharmacy technician may accept an
					 original or renewal prescription drug order telephoned to a pharmacy by a
					 practitioner or authorized agent of the practitioner to the extent authorized
					 by the pharmacist on duty.
2.
Facsimile Prescription Drug
				  Orders
A. A pharmacist, pharmacy
				  intern or pharmacy technician may accept a prescription drug order transmitted
				  by facsimile machine or facsimile computer software directly to a pharmacy.
				  Facsimile transmission of prescription drug orders for Schedule II controlled
				  drugs is subject to the requirements of
				  21 CFR
				  §1306.11(a), (e), (f) and
				  (g).
[NOTE: Title
					 21 CFR
					 §1306.11(a), (e), (f) and
					 (g) require that the original manually-signed
					 prescription for a Schedule II controlled drug must be presented to the
					 pharmacist before the actual dispensing of the medication, except in the case
					 of certain compounded substances, prescriptions written for a resident of a
					 long term care facility, or prescriptions written for a patient enrolled in a
					 hospice care program. For these prescriptions, the facsimile serves as the
					 original written prescription.]
B. The prescription must contain the name of
				  the practitioner and the authorized agent of the practitioner, if applicable,
				  the date and time of the transmission, and the name of the pharmacy intended to
				  receive the transmission.
C. If the
				  person transmitting a prescription drug order by facsimile is the patient or
				  authorized agent of the patient, the original prescription must be presented by
				  the patient or authorized agent at the time the prescription is
				  dispensed.
D. A pharmacy shall use
				  a non-fading or bond paper to ensure the preservation of facsimile prescription
				  drug orders for a period of 2 years.