reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 4.00 - Personal Registration Renewal; Continuing Education Requirements › Section 4.05 - Criteria for Board Approval of Continuing Pharmacy Education Programs

Current through Register 1525, July 5, 2024
The following guidelines are to assist the registered pharmacist in selecting an appropriate continuing education program and the provider in preparing and implementing continuing education programs for Board approval as an authorized provider.
(1) An applicant for status as a Board-approved provider of a continuing education program shall submit a completed application form, available from the Board, for each continuing education program for which the applicant is seeking approval. The form shall include the following:
(a) The objectives of the program, which shall be:
1. clearly stated;
2. the basis for determining content, learning experience, teaching methodologies, and evaluation;
3. specific;
4. obtainable;
5. measurable; and
6. describe the expected outcomes for the learner.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 4.00 - Personal Registration Renewal; Continuing Education Requirements › Section 4.06 - Record-keeping by Registered Pharmacists

Current through Register 1525, July 5, 2024
(1) A pharmacist shall maintain documentation or a statement of credit demonstrating successful completion of the required contact hours of continuing education for a period of at least two years from the date of completion. In order to demonstrate successful completion of required contact hours, a pharmacist must maintain documentation or statements of credit that contains the following information:
(a) the name of the authorized provider;
(b) the participant's name;
(c) the title and number of the continuing education program;
(d) the date of completion of the program; and
(e) the number of contact hours of continuing education earned.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 4.00 - Personal Registration Renewal; Continuing Education Requirements › Section 4.07 - Continuing Education Credit for Pharmacist Instructors

Current through Register 1525, July 5, 2024
A registered pharmacist who is a Board-approved continuing education instructor shall receive continuing education credit for the program taught on a one-time basis annually.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 4.00 - Personal Registration Renewal; Continuing Education Requirements › Section 4.08 - Continuing Education Credit for Postgraduate Pharmacy Curriculum/Program

Current through Register 1525, July 5, 2024
A registered pharmacist who enrolls in a postgraduate pharmacy curriculum, postgraduate pharmacy program or Board-approved postgraduate medical program, shall be awarded contact hours of continuing education for satisfactory completion of each course within said curriculum or program, provided that the sponsor or co-sponsor of the postgraduate curriculum or program is a Board-authorized or ACPE accredited provider of continuing professional education, and provided further that the course provides instruction in one or more of the following areas: pharmacy, pharmaceutical sciences, pharmacy practice, or pharmacy law.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 5.00 - Orally And Electronically Transmitted Prescriptions And Reporting Requirements To The Prescription Monitoring Program (pmp) › Section 5.01 - Foreword

Current through Register 1525, July 5, 2024
Except for the regulations pertaining to electronically transmitted prescriptions, the Department of Public Health and the Board of Registration in Pharmacy, acting jointly under authority of M.G.L. c. 94C, and every other act thereto enabling, and in accordance with the procedures set forth in M.G.L. c. 30A, hereby establish regulations for the implementation of M.G.L. c. 94C.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 5.00 - Orally And Electronically Transmitted Prescriptions And Reporting Requirements To The Prescription Monitoring Program (pmp) › Section 5.02 - Electronically Transmitted Prescriptions

Current through Register 1525, July 5, 2024
(1) Prescriptions or drug orders maybe electronically transmitted from an authorized prescribing practitioner or his or her expressly authorized agent to a pharmacy or pharmacy department of the patient's choice. The prescription or drug order shall be electronically transmitted in a manner that maintains patient confidentiality and in accordance with the requirements of M.G.L. c. 94C, §23(g) and 105 CMR 721.000
et seq.
.
(2) A pharmacist or pharmacy shall not enter into any agreement concerning the provision of a computer, facsimile machine, computer modem or any other electronic device which would adversely affect a patient's freedom to select the pharmacy or pharmacy department of his or her choice.
(3) A pharmacist or pharmacy shall not provide a computer, facsimile machine, computer modem or any other electronic device to a prescriber or health care facility for the purpose of providing an incentive to refer patients to a particular pharmacy or pharmacy department.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 5.00 - Orally And Electronically Transmitted Prescriptions And Reporting Requirements To The Prescription Monitoring Program (pmp) › Section 5.03 - Emergency Situations in Which Controlled Substances in Schedule II May be Dispensed Upon Orally or Electronically Transmitted Prescription

Current through Register 1525, July 5, 2024
(1) "Emergency situations", for the purpose of permitting the dispensing of any controlled substance in Schedule II upon orally or electronically transmitted prescription, means those situations in which the practitioner who intends to prescribe a controlled substance in Schedule II determines:
(a) That the immediate administration of the controlled substance is necessary for the proper treatment of the intended ultimate user;
(b) that no appropriate alternative treatment is available, including administration of a controlled substance which is not in Schedule II; and
(c) that it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the controlled substance prior to the dispensing.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 5.00 - Orally And Electronically Transmitted Prescriptions And Reporting Requirements To The Prescription Monitoring Program (pmp) › Section 5.04 - Reporting Requirements to the Prescription Monitoring Program (PMP)

Current through Register 1525, July 5, 2024
(1)
Pharmacy Reporting Requirements ( 105 CMR 700.012 )
. Every pharmacy registered by the Board and every pharmacy located in a health facility registered with the Commissioner of the Department that dispenses controlled substances in Schedule II pursuant to a prescription shall, in accordance with standards established by the Department, transmit to the Department or its agent, required information for each prescription, in accordance with Prescription Monitoring Program reporting requirements ( 105 CMR 700.012 ). Effective January 1, 2011, every pharmacy registered by the Board that dispenses controlled substances in Schedules II-V shall, in accordance with standards established by the Department, transmit to the Department or its agent, required information for each prescription, in accordance with Prescription Monitoring Program reporting requirements ( 105 CMR 700.012 ). (M.G.L. c. 94C, §§ 24 and 24A)
(2)
Penalties
. Failure to comply with the Prescription Monitoring Program reporting requirements set forth in 105 CMR 700.012 and/or any state law or regulation relating to such reporting requirements may result in formal disciplinary action being initiated against the licensed pharmacist and/or the pharmacy by the Board and/or other state and federal law enforcement agencies.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.01 - Application for Registration to Manage and Operate a Pharmacy or Pharmacy Department; Inspection of a Proposed Pharmacy or Pharmacy Department

Current through Register 1525, July 5, 2024
(1) In order to be registered by the Board to manage and operate a pharmacy or pharmacy department and be issued a permit to do so, the registered pharmacist who shall be responsible for the management and operation of the pharmacy or pharmacy department shall obtain and submit to the Board an application for registration to manage and operate a pharmacy or pharmacy department available from the Board. A completed application shall be:
(a) fully and properly completed and signed, under the penalties of perjury, by the pharmacist who is to manage and operate the pharmacy or pharmacy department;
(b) accompanied by a statement of the scheduled hours during which the pharmacy or pharmacy department is to remain open, including the time of opening and closing during regular business hours for each day of the week;
(c) accompanied by an application, available from the Board, for a Massachusetts controlled substance registration;
(d) accompanied by an application, available from the Board, for a certificate of fitness, if applicable;
(e) accompanied by a check or money order made payable, in the proper amount, to the "Commonwealth of Massachusetts Board of Registration in Pharmacy"; and
(f) accompanied by any additional information as determined by the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.02 - Conditions for Continuing Registration and Operation of a Pharmacy or Pharmacy Department

Current through Register 1525, July 5, 2024
Except as provided by exemptions set forth in 247 CMR 12.00:
Restricted Pharmacy
with respect to restricted pharmacies and 247 CMR 13.00:
Registration Requirements and Minimal Professional Standards for Nuclear Pharmacies
with respect to nuclear pharmacies, the following conditions shall apply to the continuing operation of a pharmacy or pharmacy department:
(1) The premises of the pharmacy or pharmacy department shall at all times be kept in a clean and sanitary manner.
(2) The equipment and publications set forth in 247 CMR 6.01(5)(a)  shall be maintained in the pharmacy or pharmacy department at all times.
(3) The following shall be conspicuously displayed within the pharmacy or pharmacy department:
(a) the pharmacy permit;
(b) the pharmacy's Massachusetts controlled substance registration;
(c) the pharmacy's U.S. Drug Enforcement Administration controlled substance registration; and
(d) whenever applicable, the pharmacy's certificate of fitness.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.03 - Requirements for Reporting to the Board a Change in the Management Operation and/or Ownership of a Pharmacy or Pharmacy Department

Current through Register 1525, July 5, 2024
(1) Whenever there is a change in the pharmacist Manager of Record of a pharmacy or pharmacy department, an application for a change in pharmacist Manager of Record shall be obtained from and promptly submitted to the Board. A completed application shall be fully and properly completed and signed, under the penalties of perjury by a duly authorized representative of the pharmacy or pharmacy department and include;
(a) a sworn statement confirming that a complete inventory of controlled substances in Schedules II, III, IV and V signed by the outgoing pharmacist Manager of Record and the incoming pharmacist Manager of Record has been taken and filed with the pharmacy's controlled substance records In the event the outgoing pharmacist Manager of Record is unavailable due to death, serious illness, or termination for inappropriate handling of controlled substances, a staff pharmacist may be authorized to sign the inventory, provided the Board is notified at the time the application is submitted why the staff pharmacist is signing the inventory;
(b) an application for a certificate of fitness, if applicable;
(c) the pharmacy permit and, if applicable, the pharmacy or pharmacy department's certificate of fitness;
(d) required fee(s); and
(e) any additional information as determined by the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.04 - Requirements for Reporting to the Board a Change in the Configuration, Square Footage, or Location of a Pharmacy or Pharmacy Department

Current through Register 1525, July 5, 2024
(1) Any pharmacy or pharmacy department which is being remodeled in a manner which changes the configuration or square footage of the prescription area shall before commencing any remodeling, submit copies of its structural plans to the Board for approval.
(2) The following requirements shall apply to any pharmacy or pharmacy department moving to a new address. The pharmacy or pharmacy department shall:
(a) submit to the Board a new application and payment of the appropriate fee in accordance with the requirements of 247 CMR 6.01(1)  in advance of any relocation;
(b) return previously issued permits with the application; and
(c) a pharmacy or pharmacy department which has moved to a new address shall not begin to operate in said location until the application has been approved by the Board and until the pharmacy or pharmacy department has received from the Board a permit to manage and operate the pharmacy and a controlled substances registration.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.05 - Continuing Responsibilities of All Registered Pharmacists

Current through Register 1525, July 5, 2024
(1) A registered pharmacist who changes his or her mailing address or name shall notify the Board of such change(s) in writing within ten working days of such change(s). In the case of a change of name, the pharmacist shall submit a sworn statement indicating that the pharmacist has changed his or her name with a photocopy of a valid picture identification card and any other documentation that may be required by the Board.
(2) A registered pharmacist shall not allow or cause to be displayed, in any pharmacy or pharmacy department where said pharmacist is not employed or associated with the pharmacy business, his or her certificate of personal registration to practice pharmacy.
(3) A pharmacist shall carry, or have readily available at all times where the pharmacist is employed, a certificate of personal registration or an official statement from the Board which indicates that the pharmacist is currently registered by the Board to practice pharmacy.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.06 - Renewal of a Pharmacy Permit

Current through Register 1525, July 5, 2024
(1) Each pharmacy or pharmacy department permit issued by the Board shall expire on December 31st of each uneven numbered year following the date of its issuance.
(2) Application for renewal of a pharmacy or pharmacy department permit shall be made by a duly authorized representative of the pharmacy on a renewal application form provided by the Board. Such renewal from shall be fully and properly completed and submitted to the Board in a timely manner.
(3) Each renewal application form submitted to the Board shall be accompanied by a check or money order in the required amount made payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy".
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.07 - Pharmacist Manager of Record

Current through Register 1525, July 5, 2024
(1) The responsibilities of the pharmacist Manager of Record shall include, but may not be limited, to the following:
(a) The maintenance of necessary pharmaceutical equipment and reference texts in accordance with the requirements at 247 CMR 6.01(5)(a);
(b) the proper maintenance of records as required by the Massachusetts Controlled Substances Act (M.G.L. c. 94C), Board regulations at 247 CMR 2.00
et seq
., and all other applicable state and federal laws and regulations;
(c) the maintenance at all times of adequate pharmacy and pharmacy department security consistent Board regulations at 247 CMR 2.00
et seq
., and all other applicable state and federal laws and regulations;
(d) the establishment, monitoring and enforcement of policies and procedures which encourage acceptable standards of practice consistent with Board regulations at 247 CMR 2.00
et seq
., and all other applicable federal and state laws and regulations;
(e) the establishment, monitoring and enforcement of policies and procedures which maintain the standards of professional practice as such standards relate to the dispensing of pharmaceuticals, including the proper supervision of technicians, and the delegation of authority to another pharmacist when not on duty;
(f) the maintenance of adequate staff in the pharmacy or pharmacy department in order to ensure that the practice of pharmacy shall be carried out in accordance with Board regulations at 247 CMR 2.00
et seq
. and all other applicable federal and state laws and regulations;
(g) the maintenance of records relating to the responsibilities of pharmacy technicians as outlined in 247 CMR 8.02(6);
(h) notification to the Board in writing of his or her termination as pharmacist Manager of Record within ten working days;
(i) taking an inventory of controlled substances in Schedules II, III, IV and V, based upon federal biennial inventory requirements, pursuant to the requirements of 247 CMR 6.03(b); and
(j) the establishment of procedures for validating questionable purported controlled substance prescriptions and for reviewing existing prescription information, to deter the willful and unlawful dispensing of controlled substances.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.08 - Certificate of Fitness Issued by the Board Permitting the Manufacture and Sale of Alcoholic Beverages

Current through Register 1525, July 5, 2024
(1) Pursuant to authority granted to it under M.G.L. c. 138, § 29, the Board may issue to a registered pharmacist who is the Manager of Record of a pharmacy or pharmacy department a certificate of fitness permitting the pharmacy to use alcohol for the manufacture of U.S. Pharmacopoeia or National Formulary preparations and all medicinal preparations unfit for beverage purposes, and to sell alcohol as authorized under M.G.L. c. 138.
(2) A pharmacist Manager of Record, acting on behalf of a pharmacy or pharmacy department, may apply to the Board for the issuance of a certificate of fitness. A completed application shall:
(a) be fully and properly completed and signed, under penalties of perjury, by the pharmacist Manager of Record who shall manage and operate the pharmacy or pharmacy department; and
(b) be accompanied by a check or money order, in the proper amount, made payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy."
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.09 - Closing of a Pharmacy or Pharmacy Department

Current through Register 1525, July 5, 2024
(1) Any person who intends to close a pharmacy or pharmacy department registered by the Board shall officially notify the Board in writing, by certified mail, at least 14 days, before the intended closing, unless otherwise authorized by the Board, and shall provide the Board with the following information:
(a) The name, address and telephone number of the pharmacy or pharmacy department;
(b) the pharmacy permit number;
(c) the pharmacy controlled substance registration number issued by the Board;
(d) the pharmacy certificate of fitness number issued by the Board, if applicable;
(e) the name of the pharmacist Manager of Record of the pharmacy or pharmacy department;
(f) the date on which the intended closure shall take place;
(g) the intended procedures for closing the pharmacy or pharmacy department;
(h) verification that adequate advance notice of the closure has been given to customers of the pharmacy or pharmacy department; and
(i) the intended procedures for disposal of controlled substances, or the intended procedures for transfer of controlled substance in accordance with 247 CMR 6.10.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.10 - Distribution of Controlled Substances Upon Discontinuance or Transfer of Business of a Pharmacy or Pharmacy Department

Current through Register 1525, July 5, 2024
(1) Any person who intends to transfer controlled substances in Schedules II through VI from one pharmacy or pharmacy department to another pharmacy or pharmacy department within the Commonwealth shall officially notify the Board in writing, by certified mail at least 14 days before the intended transfer, unless otherwise authorized by the Board, and shall provide the Board with the following information:
(a) The name, address and telephone number of the transferor pharmacy or pharmacy department;
(b) the name, address and telephone number of the transferee pharmacy or pharmacy department.
(c) the pharmacy permit number of the transferor pharmacy or pharmacy department;
(d) the pharmacy permit number of the transferee pharmacy or pharmacy department;
(e) the pharmacy controlled substance registration number of the transferor pharmacy or pharmacy department;
(f) the pharmacy controlled substance registration number of the transferee pharmacy or pharmacy department;
(g) the name and pharmacist registration number of the Manager of Record of the transferor pharmacy or pharmacy department;
(h) the name and pharmacist registration number of the Manager of Record of the transferee pharmacy or pharmacy department;
(i) the date on which the transfer of the controlled substances will take place; and
(j) the intended security procedures for transfer of the controlled substances.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.11 - Inspections of Pharmacies and Pharmacy Departments

Current through Register 1525, July 5, 2024
The Board or its designees may visit a pharmacy or pharmacy department at any time without prior notice and inspect it, its staff, activities, and records to determine compliance with state law and 247 CMR 2.00
et seq.
The Board may also inspect pharmacies and pharmacy department premises pursuant to 247 CMR 11.12.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.12 - Deficiency Statements

Current through Register 1525, July 5, 2024
After every Board inspection in which any violation of 247 CMR 2.00
et seq
. is observed, the Board or its designees shall prepare a deficiency statement citing every violation observed, a copy of which shall be sent to the pharmacy or pharmacy department.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.13 - Plans of Correction

Current through Register 1525, July 5, 2024
A pharmacy or pharmacy department shall submit to the Board a written plan of correction of violations cited in a deficiency statement prepared pursuant to 247 CMR 6.12 within 15 business days after the deficiency statement is sent. Every plan of correction shall set forth, with respect to each deficiency, the specific corrective step(s) to be taken, a timetable for such steps, and the date by which compliance with the relevant 247 CMR section will be achieved. The timetable and the compliance dates shall be consistent with achievement of compliance in the most expeditious manner possible. A plan of correction which does not meet the requirements of the relevant 247 CMR section shall be considered unacceptable by the Board and returned to the pharmacy or pharmacy department.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.14 - Duty to Report Certain Improper Drug Dispensing to the Board

Current through Register 1525, July 5, 2024
Effective January 1, 2010, a pharmacy licensed by the Board is required to report to the Board any improper dispensing of a prescription drug that results in serious injury or death, as defined by the Board, as soon as is reasonably and practicably possible but not later than 15 business days after discovery or being informed of such improper dispensing. The duty to report to the Board any improper dispensing of a prescription drug that results in serious injury or death, pursuant to M.G.L. c. 112, § 39D and 247 CMR 6.14(2), shall be in addition to the Continuous Quality Improvement (CQI) Program requirements of 247 CMR 15.00. Only those events of improper dispensing of a prescription drug that result in serious injury or death are required to be reported to the Board, in accordance with M.G.L. c. 112, § 39D and 247 CMR 6.14(2).
(1)
Definitions
. For purposes of reporting to the Board, as required by M.G.L. c. 112, § 39D:
(a)
Improper Dispensing of a Prescription Drug
shall mean the incorrect dispensing of a prescribed medication that is received by a patient, as more particularly described in 247 CMR 15.01:
Quality-related Event
or
QRE.
(b)
Pharmacy
, as referenced in 247 CMR 6.14, shall mean a pharmacy, or a group of pharmacies under common ownership and control of one entity, licensed by the Board pursuant to M.G.L. c. 112.
(c)
Serious Injury
shall mean an injury that is life threatening, results in serious disability or death, or requires a patient to undergo significant additional treatment measures.
(d)
Serious Disability
shall include, but is not limited to, injuries requiring major intervention and loss, or substantial limitation, of bodily function lasting greater than seven days (
e.g
. bodily function related to breathing, dressing/undressing; drinking; eating; eliminating waste products; getting into and out of bed, chair,
etc
.; hearing; seeing; sitting; sleeping or walking).
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 6.00 - Registration, Management And Operation Of A Pharmacy Or Pharmacy Department › Section 6.15 - Duty to Report Certain Factors of Pharmacy Operations

Current through Register 1525, July 5, 2024
(1)
Definitions.
(a) Abnormal Results means results of viable and nonviable testing, such as for environmental contaminants and potency, that are not within acceptable
United States Pharmacopeia General Chapter 797
standards or criteria.
(b) Accreditation means a process by which a professional association or non-governmental agency grants recognition to a pharmacy for demonstrated ability to meet certain pre-defined criteria.
(c) Disciplinary actions means actions including, but not limited to revocation, suspension, probation, censure, reprimand, or restriction of the license to operate a pharmacy or practice pharmacy, denial of application for renewal, denial or restriction of privileges or termination from Medicare or Medicaid programs including any adverse actions or fines imposed by a state or federal agency.
(d) Federal agency means any U.S. Government agency that has regulatory purview over the clinical practice of pharmacy or of pharmacy operations, including, but not limited to, all agencies in the U.S. Department of Health and Human Services, the U.S. Occupational Safety and Health Administration, and the U.S. Department of Justice.
(e) State agency means any U.S. State or Territory that licenses or otherwise regulates pharmacies or pharmacist practice.
(f) Sterile compounding means the preparation, mixing, assembling, packaging, and labeling of a drug or device that is required to be prepared in accordance with
United States Pharmacopeia General Chapter 797
and dispensed pursuant to a valid prescription as defined by 247 CMR 2.00.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 7.00 - Wholesale Druggists › Section 7.01 - Scope and Purpose

Current through Register 1525, July 5, 2024
The purpose of 247 CMR 7.00 is to implement the Federal Prescription Drug Marketing Act of 1987 ("PDMA"), U.S.  Public Law 100-293, codified at 21 US.C. §§ 321
et seq.
The PDMA requires that all entities engaged in the interstate and/or intrastate wholesale distribution of prescription drugs be licensed in each state where they are engaged in such activity.
247 CMR 7.00 applies to every wholesale distributor located in the Commonwealth of Massachusetts who engages in the sale, distribution, or delivery at wholesale of prescription drugs.
The purpose of 247 CMR 7.00 is to provide minimum standards, terms and conditions for the licensing by the Board of Registration in Pharmacy of persons located in Massachusetts who engage in the sale, distribution, or delivery at wholesale of prescription drugs.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 7.00 - Wholesale Druggists › Section 7.02 - Licensing Requirements

Current through Register 1525, July 5, 2024
(1) Every wholesale distributor located in the Commonwealth of Massachusetts who engages in wholesale distribution of prescription drugs shall be licensed by the Board in accordance with the laws and regulations of the Commonwealth before engaging in such wholesale distribution.
(2) Applications for a license to conduct a wholesale drug business in the Commonwealth shall be made upon application forms furnished by the Board. Each application shall be completely filled out and signed by each applicant under oath before a notary public. The Board shall not consider any applications within 15 days after the date of its filing with the Board. The Board shall not consider any application which has been improperly completed or which is not accompanied by the appropriate fee(s).
(3) The Board may require a hearing upon the merits of any application for a license to conduct a wholesale drug business. Where such a hearing is required, the Board shall give the applicant seven days notice by certified mail, of the date, time, and place of the hearing.
(4) Any person who is engaged in the wholesale drug business at more than one location shall obtain a license for each location.
(5)
Minimum Required Information for Licensure
. The Board requires the following information from each wholesale drug distributor as part of the initial licensing procedure and as part of any renewal of such license:
(a) The name, full business address, and telephone number of the applicant or licensee;
(b) all trade or business names used by the applicant or licensee;
(c) addresses, telephone numbers, and the names of contact persons for each facility used by the applicant or licensee for the storage, handling, and distribution of prescription drugs;
(d) the type of ownership or operation
(i.e.,
partnership, corporation, or sole proprietor-ship); and
1. if a person, the name of the person;
2. if a partnership, the name of each partner, and the name of the partnership;
3. if a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation, and the name of the parent company if any;
4. if a sole proprietorship, the full name of the sole proprietor and the name of the business entity;
5. an indication as to whether the applicant or licensee will distribute controlled substances, legend drugs, and/or over-the-counter drugs, as well as a statement concerning the types of drugs to be distributed.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 7.00 - Wholesale Druggists › Section 7.03 - Penalties

Current through Register 1525, July 5, 2024
(1) The agents of the Board may inspect and investigate all wholesale drug distributors of drugs and medicines and shall report all violations of Board regulations and statutes to the Board. Board agents shall provide to the licensee a copy of the inspection report within 15 days of such inspection. At the direction of the Board, Board agents may apply for criminal complaints to be issued against persons guilty of any such violations.
(2) Every person who is licensed to conduct a wholesale drug business shall not sell or deliver drugs to any unauthorized person, whether upon prescription, at retail, or otherwise.
(3) Except under the direct supervision of a registered pharmacist, and in compliance with federal Current Good Manufacturing Practices (CGMP's), a person who is licensed to conduct a wholesale drug business shall not package or repackage any drug for resale, nor shall said person label or relabel any drug container.
(4) The Board may, after hearing or by agreement, suspend or revoke any licenses granted under 247 CMR 7.00 for any violation of federal, state or local drug laws or regulations or for any violation of Board laws or regulations governing the wholesale drug business.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 7.00 - Wholesale Druggists › Section 7.04 - Minimum Requirements for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance of Prescription Drug Distribution Records

Current through Register 1525, July 5, 2024
The following shall constitute minimum requirements for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their officers, agents, representatives, and employees:
(1)
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 prescription drugs that are outdated, damaged, 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 Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 8.00 - Pharmacy Interns And Technicians › Section 8.01 - Pharmacy Interns

Current through Register 1525, July 5, 2024
(1) To be eligible for licensure as a pharmacist, a candidate shall have completed a Board-approved pharmacy internship, which shall include:
(a) at least 1500 hours of Board-approved pharmacy internship experience, of which:
1.at least 1000 hours has been acquired in a pharmacy or pharmacy-related setting approved by the Board; and
2.at least 500 hours has been acquired in any one, or any combination of Board-approved internships(s) in the following areas:
a.clinical pharmacy;
b.demonstration project;
c.manufacturing;
d.analytical or industrial pharmacy; or
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 8.00 - Pharmacy Interns And Technicians › Section 8.02 - Pharmacy Technicians

Current through Register 1525, July 5, 2024
(1) No individual may serve as a pharmacy technician without holding a valid pharmacy technician license from the Board.
(2) An application for a pharmacy technician license shall be made on forms prescribed by, and available from, the Board. The application shall include:
(a) the applicant's name;
(b) the applicant's address;
(c) the applicant's date of birth; and
(d) a recent passport-size photo revealing the applicant's likeness.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 8.00 - Pharmacy Interns And Technicians › Section 8.03 - Pharmacy Technician Trainees

Current through Register 1525, July 5, 2024
(1) No individual may serve as a pharmacy technician trainee without holding a valid Pharmacy Technician Trainee License from the Board.
(2) A pharmacy technician trainee shall:
(a) be at least 16 years of age or older;
(b) be a high school graduate or the equivalent or currently enrolled in a program which awards such degree or certificate;
(c) be of good moral character; and
(d) not have been convicted of a drug related felony or admitted to sufficient facts to warrant such findings.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 8.00 - Pharmacy Interns And Technicians › Section 8.04 - Certified Pharmacy Technicians

Current through Register 1525, July 5, 2024
(1) No individual may work as a certified pharmacy technician without holding a valid pharmacy technician license from the Board.
(2) Certified pharmacy technician means a pharmacy technician that is certified by a Board-approved certifying body.
(3) In the event that a certified pharmacy technician's certification lapses, that technician shall:
(a) be limited to performing the duties and responsibilities of a pharmacy technician, as set forth in 247 CMR 8.02;
(b) use the title "pharmacy technician"; and
(c) be counted as a "pharmacy technician" in calculating supervisory ratios, as set forth in 247 CMR 8.06(3).
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 8.00 - Pharmacy Interns And Technicians › Section 8.05 - Requirements for the Handling of Schedule II Controlled Substances by Pharmacy Interns, Certified Pharmacy Technicians, Pharmacy Technicians, and Pharmacy Technician Trainees

Current through Register 1525, July 5, 2024
(1) Accountability for and security of Schedule II controlled substances shall be the direct responsibility of the pharmacist.
(2) Under the supervision of a pharmacist:
(a) a pharmacy technician may assist in the transporting of Schedule II controlled substances; and
(b) a certified pharmacy technician may assist in the transporting and handling of Schedule n controlled substances; provided, the pharmacist has approved the certified pharmacy technician or pharmacy technician to assist the pharmacist in the handling or transporting of Schedule II controlled substances, in accordance with 247 CMR 8.05(2) and as evidenced by written policies and procedures to be followed in the pharmacy. Such policies and procedures shall be made available to the Board on request.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 8.00 - Pharmacy Interns And Technicians › Section 8.06 - Duties of a Pharmacist Utilizing Pharmacy Interns, Certified Pharmacy Technicians, Pharmacy Technicians, and Pharmacy Technician Trainees

Current through Register 1525, July 5, 2024
(1) A pharmacist Manager of Record or the Director of Pharmacy in an institutional pharmacy which utilizes certified pharmacy technicians, pharmacy technicians, or pharmacy technician trainees shall make the following available to the Board upon request:
(a) a list of currently employed certified pharmacy technicians, pharmacy technicians, and pharmacy technician trainees;
(b) a written description of the duties delegated to certified pharmacy technicians, pharmacy technicians, and pharmacy technician trainees; and
(c) a written description of the scopes of responsibility for certified pharmacy technicians, pharmacy technicians, and pharmacy technician trainees.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 8.00 - Pharmacy Interns And Technicians › Section 8.07 - Renewal Procedures

Current through Register 1525, July 5, 2024
(1) A pharmacy technician license shall expire every two years on the birthdate of the licensee.
(2) A pharmacy technician license must be timely renewed to continue practice as a pharmacy technician. Any practice as a pharmacy technician after the expiration date of a pharmacy technician license shall constitute unlicensed practice as a pharmacy technician subjecting the individual to any and all penalties established for unlicensed practice.
(3) A pharmacy technician whose license has lapsed may renew such license upon filing of a renewal application and payment of an annual license, applicable back fees, and a late fee, as established by the Commissioner of Administration and Finance, pursuant to M.G.L. c. 7, § 3B.
(4) A pharmacy technician whose license has lapsed for more than two years may be required to meet other conditions as determined by the Board as a prerequisite to license renewal.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 9.00 - Code Of Professional Conduct; Professional Standards For Registered Pharmacists, Pharmacies And Pharmacy Departments › Section 9.02 - Transfer of Prescriptions

Current through Register 1525, July 5, 2024
(1) A prescription may be transferred between pharmacies or pharmacy departments, at the patient's request, for the purpose of dispensing authorized refills on the prescription provided that:
(a) refills remain on the prescription; and
(b) the prescription authorizing the refill has not expired.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 9.00 - Code Of Professional Conduct; Professional Standards For Registered Pharmacists, Pharmacies And Pharmacy Departments › Section 9.03 - Advertising

Current through Register 1525, July 5, 2024
(1) A pharmacist shall not utilize false, deceptive or misleading advertising.
(2) Whenever a pharmacist advertises the consumer price for a particular prescription drug, said advertisement shall not contain any representation, either expressed or implied, concerning that drug's safety, effectiveness, or indications for use.
(3) Any pharmacist who advertises a prescription drug in a manner which provides price information to consumers shall include the following information regarding each advertised prescription drug:
(a) The proprietary name, if any;
(b) the established or generic name, if any;
(c) the quantity of active ingredient per dosage unit of the prescription drug product whenever the prescription contains a single active ingredient;
(d) the strength of the prescription whenever said product contains more than one active ingredient by a relevant strength that can be associated with the product without indicating each active ingredient; the established name and quantity of each active ingredient shall not be required whenever said product contains more than one active ingredient;
(e) the dosage form; and
(f) the price charged for filling a prescription.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 9.00 - Code Of Professional Conduct; Professional Standards For Registered Pharmacists, Pharmacies And Pharmacy Departments › Section 9.04 - Requirements for Dispensing and Refilling Prescriptions

Current through Register 1525, July 5, 2024
(1) Whenever a prescription drug has been distributed solely under a generic name, the dispensing pharmacist shall record on the prescription the name of the manufacturer or, if the manufacturer's name is not available, the name of the distributor, packer, or repacker.
(2) The information on the label which the pharmacist, pharmacy intern, pharmacy technician or pharmacy technician trainee affixes to a prescription drug container shall be clearly printed or typed.
(3) Only a pharmacist, pharmacy intern, and certified pharmacy technician who has the approval of the pharmacist on duty may receive new prescriptions over the telephone from a prescriber or authorized agent.
(4) A pharmacist who refills a prescription for a controlled substance in Schedules in through VI shall record on the prescription:
(a) the date of dispensing;
(b) the amount of the drug dispensed; and
(c) his or her initials.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 9.00 - Code Of Professional Conduct; Professional Standards For Registered Pharmacists, Pharmacies And Pharmacy Departments › Section 9.05 - Maintenance of Prescription Files

Current through Register 1525, July 5, 2024
A pharmacist shall maintain prescription files as follows:
(1) Prescriptions for controlled substances in Schedule II shall be segregated from all other records and shall be maintained in a separate file identified as such.
(2) Prescriptions for controlled substances in Schedules III, IV, and V shall be maintained in a separate file identified as such.
(3) Prescriptions for controlled substances in Schedule VI, prescriptions for non-controlled substances, and prescriptions for syringes and instruments adaptable to hypodermic administration, shall be segregated from all other records and shall be maintained together in a separate file identified as such.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 9.00 - Code Of Professional Conduct; Professional Standards For Registered Pharmacists, Pharmacies And Pharmacy Departments › Section 9.06 - Procedures for Verifying a Practitioner's Prescriptive Authority

Current through Register 1525, July 5, 2024
A prescription written by a practitioner may be filled only if the pharmacist called upon to fill such prescription, in the exercise of that pharmacist's professional judgment, determines that:
(1) The prescription is issued pursuant to a valid patient/practitioner relationship and for a legitimate medical purpose by an authorized practitioner acting in the course of his or her professional practice;
(2) the prescription is authentic; and
(3) the dispensing is in accordance with M.G.L. c. 94C, § 19(a).
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 9.00 - Code Of Professional Conduct; Professional Standards For Registered Pharmacists, Pharmacies And Pharmacy Departments › Section 9.07 - Maintaining Patient Records, Conducting a Prospective Drug Utilization Review and Patient Counseling

Current through Register 1525, July 5, 2024
The purpose of 247 CMR 9.07 is to enhance the public health and welfare by requiring that pharmacists offer consultation to patients regarding their prescriptions in order to promote optimum therapeutic outcomes, avoid patient injury and reduce medication errors.
(1)
Patient Records
.
(a) A pharmacist or pharmacist's designee shall maintain a confidential record for all patients for whom prescriptions are dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the pharmacist to identify previously dispensed drugs at the time the prescription is presented for dispensing. The pharmacist or pharmacist's designee shall make a reasonable effort to obtain, record and maintain the following information:
1.name, address, telephone number, date of birth or age, and gender of the patient for whom the prescription is intended;
2.individual history, including known drug allergies and drug reactions;
3.a comprehensive list of medications and relevant devices dispensed by the pharmacy; and
4.the pharmacist's comments relevant to the patient's drug therapy.