reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 10.00 - Disciplinary Proceedings › Section 10.01 - Purpose

Current through Register 1525, July 5, 2024
The purpose of 247 CMR 10.00 is to outline the procedures used by the Board in order to handle complaints received against Board registrants or licensees. The Board may take disciplinary action against a registered pharmacist, pharmacy technician, pharmacy, pharmacy department, wholesale license, and/or controlled substance registration issued by the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 10.00 - Disciplinary Proceedings › Section 10.02 - Definitions

Current through Register 1525, July 5, 2024
Adjudicatory Hearing
means a formal administrative hearing held by the Board conducted to determine the truth and validity of complaints filed against a registrant or licensee. Such hearing is held pursuant to M.G.L. c. 30A and 801 CMR 1.01:
Formal Rules
.
Complaint
means a communication filed with the Board or the Division of Health Professions Licensure which the Board determines, after investigation, merits further consideration or action.
Conviction
shall include any guilty verdict or finding of guilt and any admission to or finding of sufficient facts to warrant a finding of guilt, regardless of adjudication, a continuance without a finding, and any plea of guilty or
nolo contendere
, of or to a crime in any jurisdiction, which has been accepted by the court, whether or not a sentence has been imposed. A conviction of any person licensed or registered by the Board shall be conclusive evidence of the commission of that crime in any disciplinary proceeding against such person based upon the conviction.
Investigative Conference
means an informal discussion relating to a complaint held with the Board.
Order to Show Cause
means a document served by the Board upon a registrant ordering the registrant or licensee to appear before the Board for a formal adjudicatory hearing.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 10.00 - Disciplinary Proceedings › Section 10.04 - Investigative Conference

Current through Register 1525, July 5, 2024
To facilitate disposition of any complaint, the Board may schedule an investigative conference at any time prior to the commencement of a formal adjudicatory proceeding. The Board shall give timely notice of the conference, and this notice shall include a general statement of the nature of the issues to be discussed.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 10.00 - Disciplinary Proceedings › Section 10.05 - Disposition by the Board

Current through Register 1525, July 5, 2024
After receipt of a complaint and all related investigative materials, the Board may schedule an investigative conference or may schedule a formal adjudicatory hearing pursuant to M.G.L. c. 30A and 801 CMR 1.01:
Formal Rules
if it determines that one is required.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 10.00 - Disciplinary Proceedings › Section 10.06 - Disciplinary Action

Current through Register 1525, July 5, 2024
Actions which may be taken by the Board are:
(1)
Dismissal
of the complaint.
(2)
Advisory Letter
. An official written document retained in the Board's files delineating the Board's concerns with the registrant's or licensee's professional practice. An advisory letter does not constitute formal disciplinary action.
(3)
Reprimand or Censure of the Registrant or Licensee
. A reprimand constitutes formal disciplinary action. A censure is a severe reprimand.
(4)
Probation
. Probation constitutes disciplinary action against the registrant or licensee and consists of a period of time during which the registrant or licensee may practice under conditions imposed by the Board pursuant to a formal adjudicatory hearing or consent agreement.
(5)
Suspension/Revocation of Personal Registration, Pharmacy Permit, License or Controlled Substances Registration
. Suspension or revocation of a personal registration, pharmacy permit, license or controlled substance registration may be imposed pursuant to a decision and order of the Board following a formal adjudicatory hearing or following the execution of a consent agreement.
(6)
Consent Agreement
. A resolution of a complaint agreed upon by the Board and the registrant or licensee which may contain conditions placed by the Board on the registrant's or licensee's professional conduct and practice and which may include the voluntary suspension or surrender of a personal registration, pharmacy permit, license or controlled substance registration. The voluntary surrender of a personal registration, pharmacy permit, license, or controlled substance registration, may be permanent or for a fixed period of time. The voluntary surrender agreement shall:
(a) be in writing and be signed by the registrant or the licensee and the Board;
(b) recite the facts upon which the agreement is based and shall include, but not be limited to provisions addressing reinstatement and any conditions the Board may elect to impose;
(c) state that the registrant or licensee realizes that the voluntary surrender of his or her personal registration, pharmacy permit, license or controlled substance registration, is an act which deprives him or her of all privileges of registration and is not subject to judicial review; and
(d) be placed in the registrant's or licensee's Board file as part of the registrant's or licensee's permanent Board records.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 10.00 - Disciplinary Proceedings › Section 10.07 - Suspension Prior to Hearing

Current through Register 1525, July 5, 2024
If, based upon affidavits or other documentary evidence, the Board determines that a licensee is an immediate or serious threat to the public health, safety, or welfare, the Board may suspend or refuse to renew a license pending a final hearing on the merits of the allegations regarding the licensee. A hearing limited to the determination of the necessity of the summary action shall be afforded the licensee within seven days of the Board's action.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 10.00 - Disciplinary Proceedings › Section 10.08 - Summary Cease and Desist and Quarantine Notice

Current through Register 1525, July 5, 2024
(1) If, based upon affidavits or other evidence, the Board or Board President determines that a registrant or licensee or the products prepared by a registrant or licensee are an immediate or serious threat to the public health, safety, or welfare, the Board or Board President may:
(a) issue a Cease and Desist Notice and/or Quarantine Notice, requiring non-disciplinary cessation or restriction of any and all pharmacy operations, and prohibiting the use of medications prepared by or in possession of a pharmacy; or
(b) issue a Cease and Desist Notice placing non-disciplinary restrictions on a Board registrant or licensee, to the extent necessary, to avert a continued threat, pending final investigation results.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.01 - Requirement of a Controlled Substance Registration

Current through Register 1525, July 5, 2024
(1) In accordance with the Massachusetts Controlled Substances Act, M.G.L. c. 94C, the Board may issue a controlled substance registration to a pharmacy, outsourcing facility, or wholesale drug business that intends to engage in any activity for which a controlled substance registration is required by law.
(2) No pharmacy, outsourcing facility, or wholesale drug business shall engage in any activity for which registration is required until a controlled substance registration has been issued by the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.02 - Standard for Issuance of a Controlled Substance Registration

Current through Register 1525, July 5, 2024
The Board shall issue a controlled substance registration to an applicant unless it determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the Board shall consider, but shall not be limited to considering, the following factors:
(1) The maintenance of effective controls against diversion of controlled substances;
(2) compliance with applicable federal, state and local laws and regulations;
(3) any conviction of the applicant under any federal and/or state law relating to any controlled substance;
(4) past experience in the manufacture or distribution of controlled substances;
(5) furnishing by the applicant of false or fraudulent material in any application filed under the provisions of M.G.L. c. 94C or other applicable state or federal law or regulation;
(6) suspension or revocation of the applicant's federal registration to manufacture, distribute or dispense controlled substances as authorized by federal law; and
(7) any other factors relevant to, and consistent with, the public health and safety.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.03 - Requirement of a Pharmacy License, Outsourcing Facility Registration, or Wholesale Druggist License

Current through Register 1525, July 5, 2024
All applicants for a controlled substance registration shall be determined by the Board to be qualified to receive from the Board a pharmacy license, outsourcing facility registration, or wholesale druggist license before being issued a controlled substance registration.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.04 - Application for a Controlled Substance Registration

Current through Register 1525, July 5, 2024
Application for a controlled substance registration shall be made on a form provided by the Board. All applications submitted to the Board shall:
(1) be fully and properly completed; and
(2) be accompanied by a check or money order payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy" in the appropriate amount, which shall be non-refundable.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.05 - Separate Registration Required

Current through Register 1525, July 5, 2024
A separate controlled substance registration shall be required at each principal place of business where the licensee or registrant manufactures, distributes or dispenses controlled substances.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.06 - Expiration of a Controlled Substance Registration

Current through Register 1525, July 5, 2024
A controlled substance registration issued by the Board shall be valid as follows:
(1)
Pharmacy
. The controlled substance registration issued to a pharmacy shall be valid for two years beginning January 1st of each even-numbered year.
(2)
Outsourcing Facility
. The controlled substance registration issued to an outsourcing facility shall be valid for two years beginning January 1st of each even numbered year.
(3)
Wholesale Druggist
. The controlled substance registration issued to a wholesale druggist shall be valid for one year beginning on December 1st of each year.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.07 - Renewal of a Controlled Substance Registration

Current through Register 1525, July 5, 2024
(1) A registrant may renew a controlled substance registration on a renewal form provided by the Board. All renewal applications submitted to the Board shall:
(a) be submitted in a timely manner;
(b) be fully and properly completed; and
(c) be accompanied by a check or money order payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy" in the appropriate amount, which shall be non refundable.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.08 - Changes in the Name, Address and/or Status of Registrant

Current through Register 1525, July 5, 2024
(1) The controlled substance registration of any registrant shall automatically terminate and become invalid if:
(a) the pharmacy, outsourcing facility, or wholesale business named on the controlled substance registration ceases to exist;
(b) the name and/or address of the pharmacy, outsourcing facility, or wholesale business to which the controlled substance resignation was issued changes; or
(c) the pharmacy, outsourcing facility, or wholesale business to which the controlled substance registration was originally issued is sold.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.09 - Transfer or Assignment of a Controlled Substance Registration Prohibited

Current through Register 1525, July 5, 2024
A controlled substances registration issued by the Board, or any authority conferred thereby, shall not be assigned or transferred.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.10 - Wholesale Druggist Activities Limited

Current through Register 1525, July 5, 2024
A wholesale druggist which is registered to distribute a controlled substance or class of controlled substances shall be authorized to distribute only that controlled substance or class of controlled substances.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.11 - Inspection of Registered Premises

Current through Register 1525, July 5, 2024
The Board or its authorized agents may inspect, in accordance with 247 CMR, the establishment of a registrant or of an applicant for a controlled substances registration.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.12 - Revocation and Suspension of Registration; Grounds; Effect

Current through Register 1525, July 5, 2024
(1) The Board may suspend or revoke a controlled substance registration issued by it after a hearing pursuant to the provisions of M.G.L. c. 30A upon a finding that the registrant:
(a) has furnished false or fraudulent material information in any application filed under the provisions of M.G.L. c. 94C;
(b) has been convicted under any state or federal law of any criminal violation relating to his or her fitness to be registered under M.G.L. c. 94C;
(c) has had his or her state or federal controlled substance registration to manufacture, distribute, dispense, administer or possess controlled substances suspended or revoked, or has voluntarily surrendered said controlled substance registration;
(d) is, upon good cause, found to be unfit or unqualified to manufacture, distribute, dispense, or possess any controlled substance; or
(e) has violated any provision of M.G.L. c. 94C and/or any other applicable federal or state laws and regulations.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 11.00 - Registration Under The Controlled Substances Act (m.g.l. C.94c) › Section 11.13 - Summary Suspension of a Controlled Substance Registration

Current through Register 1525, July 5, 2024
(1) The Board may, without hearing, suspend or refuse to renew any controlled substance registration issued by it if it finds that there is an imminent danger to the public health or safety which warrants this action; provided, however, that the Board promptly affords the registrant an opportunity for a hearing in accordance with M.G.L. c. 30A, 801 CMR 1.01:
Formal Rules
and 247 CMR 10.00:
Disciplinary Proceedings
.
(2) Any suspension summarily imposed by the Board shall continue in effect until the conclusion of the final hearing on the merits of any Order to Show Cause issued by the Board in connection with its investigation of the pharmacy, outsourcing facility, or wholesale druggist, including judicial review thereof, unless sooner dissolved by a court of competent jurisdiction, or withdrawn by the Board.
(3) The procedure for summary suspension is as follows:
(a)
Closure of Pharmacy, Outsourcing Facility, or Wholesale Druggist
. Upon receipt by the Board of reliable information that a registrant is an imminent and serious threat to the public health or safety, the Board shall vote to take summary action on the registrant's controlled substances registration. Upon the Board's vote to summarily suspend such registration, Board Agents are authorized to:
1. immediately close the registrant's establishment or business;
2. at the registrant's expense, replace the locks on all doors to the registrant's establishment or business and retain the key(s);
3. conspicuously display at the entrance(s) to the registrant's establishment or business a sign, in letters no less than one inch in height and one inch wide, stating: "THE REGISTRATION OF THIS ESTABLISHMENT HAS BEEN SUSPENDED BY ORDER OF THE MASSACHUSETTS BOARD OF REGISTRATION IN PHARMACY."; and
4. conduct an inventory and audit of all drugs and record of drugs within the registrant's establishment or business.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 12.00 - Restricted Pharmacy › Section 12.01 - Authority

Current through Register 1525, July 5, 2024
The Board may, under authority granted to it by M.G.L. c. 112, § 39A, register a restricted pharmacy for the limited transaction of a drug business as defined in M.G.L. c. 112, § 37. A restricted pharmacy may furnish pharmacy services only to beneficiaries, as defined in M.G.L. c. 151D, § 1, of a trust, fund, pension plan, combination plan, or profit-sharing plan which is subject to the provisions of M.G.L. c. 151D.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 12.00 - Restricted Pharmacy › Section 12.02 - Limitation on the Functions and Operations of a Restricted Pharmacy

Current through Register 1525, July 5, 2024
Registration as a restricted pharmacy shall not authorize such a restricted pharmacy to function or operate as a retail pharmacy as defined in M.G.L. c. 112, § 39.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 12.00 - Restricted Pharmacy › Section 12.03 - Application for an Initial Registration

Current through Register 1525, July 5, 2024
(1) Application for an initial permit to operate as a restricted pharmacy shall be made by the plan administrator or trustee of the trust, fund, pension plan, combination plan, or profit-sharing plan on a form provided by the Board.
(2) A restricted pharmacy shall comply with the requirements for the issuance of a pharmacy permit as provided by 247 CMR 6.00.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 12.00 - Restricted Pharmacy › Section 12.05 - General Requirements for the Operation of a Restricted Pharmacy

Current through Register 1525, July 5, 2024
(1) A restricted pharmacy may, after written notice to the Board, limit its operation to a specific schedule of drugs.
(2) A restricted pharmacy shall be exempt from the application of 247 CMR 9.01(15).
(3) A restricted pharmacy shall be subject to all applicable provisions of 247 CMR except as specifically exempted by the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 13.00 - Registration Requirements And Minimal Professional Standards For Nuclear Pharmacies › Section 13.01 - Authority and Purpose

Current through Register 1525, July 5, 2024
247 CMR 13.00 is promulgated under the authority granted the Board by M.G.L. c. 112, § 39B to register an establishment for transacting business as a nuclear pharmacy as defined in M.G.L. c. 94C. The purpose of 247 CMR 13.00 is to establish minimum professional standards for the operation of a nuclear pharmacy in order to safeguard the public health and welfare.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 13.00 - Registration Requirements And Minimal Professional Standards For Nuclear Pharmacies › Section 13.03 - Requirements for the Issuance of Nuclear Pharmacy Permit

Current through Register 1525, July 5, 2024
(1) An applicant for an initial permit to establish a nuclear pharmacy shall be made by submitting to the Board a fully and properly completed application form provided by the Board.
(2) An application for a nuclear pharmacy permit shall be accompanied by a check or moneyorder in the required amount payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy".
(3) No permit shall be issued to a proposed nuclear pharmacy unless there are maintained on the pharmacy premises the following publications:
(a) The most recent edition of the United States Pharmacopoeia, including the latest supplement thereto;
(b) the most recent edition of Remington's Pharmaceutical Sciences; and
(c) current texts on the practice of nuclear pharmacy and radiation safety.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 13.00 - Registration Requirements And Minimal Professional Standards For Nuclear Pharmacies › Section 13.04 - Renewal of a Nuclear Pharmacy Permit

Current through Register 1525, July 5, 2024
(1) Each nuclear pharmacy 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 nuclear pharmacy permit shall be made on a renewal application form provided by the Board. Such renewal form 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 13.00 - Registration Requirements And Minimal Professional Standards For Nuclear Pharmacies › Section 13.05 - General Requirements for Nuclear Pharmacies

Current through Register 1525, July 5, 2024
(1) A nuclear pharmacy registered pursuant to 247 CMR 13.00 shall comply with all applicable laws, regulations, and guidelines of the United States Nuclear Regulatory Commission, the United States Food and Drug Administration, and other appropriate federal and state agencies.
(2) No person other than a qualified nuclear pharmacist shall be employed by a nuclear pharmacy to direct and manage the pharmacy.
(3) Only designated qualified nuclear pharmacists shall conduct the radio pharmaceutical activities of a nuclear pharmacy, and at least one qualified nuclear pharmacist shall be in personal attendance at the pharmacy at all times.
(4) A nuclear pharmacy shall not dispense those radio pharmaceuticals which do not comply with acceptable professional standards of radiopharmaceutical quality assurance.
(5) A nuclear pharmacy shall maintain in readily retrievable form for at least three years detailed records of the acquisition and disposition of all radiopharmaceuticals. These records shall be available to the Board or its agents for inspection upon request.
(6) A nuclear pharmacy shall not prepare, compound, or dispense radiopharmaceutical drugs except upon a valid prescription from an authorized practitioner. In order to be valid, a prescription for radiopharmaceutical drugs shall contain the following information:
(a) the name, address, registration number and, in the case of a written prescription, the signature of the practitioner;
(b) the date of the prescription;
(c) the name, dosage unit, and strength per dosage unit of the radiopharmaceutical drug;
(d) the name and address of the patient; if the name of the patient is unknown at the time the prescription is received, the nuclear pharmacy shall obtain the name and address of the patient within 72 hours after dispensing the radiopharmaceutical drug; the address of the facility where the patient is being treated will be sufficient if his or her residential address is unavailable; and
(e) any specific instructions required.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 13.00 - Registration Requirements And Minimal Professional Standards For Nuclear Pharmacies › Section 13.06 - Edcation and Experience Requirements of a Qualified Nuclear Pharmacist

Current through Register 1525, July 5, 2024
A qualified nuclear pharmacist shall:
(1) Be currently registered under M.G.L. c. 112, § 24;
(2) have received 200 contact hours of formal academic training in the area of radio-pharmaceutical preparation and handling, with no more than 60 of said hours being acquired through laboratory training;
(3) have received, in addition to formal academic training, a minimum of three months of full-time, or 500 hours of actual on the job practical experience in the field of radioactive drugs and radiopharmaceutical services under the supervision of a qualified nuclear pharmacist in a nuclear pharmacy providing nuclear pharmacy services, or in a
structured
nuclear pharmacy training program of a Board-approved college/school of pharmacy; and
(4) submit a detailed affidavit of experience and training to the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 14.00 - Petition For Waiver › Section 14.01 - Petition for Waiver

Current through Register 1525, July 5, 2024
(1) Unless otherwise prohibited by law, the Board may waive compliance with one or more regulatory requirements set in 247 CMR, if the Board finds:
(a) that there is a compelling public interest which would be served by granting the waiver;
(b) that the petitioner's adherence to the waived regulatory requirement(s) would be impractical and unduly burdensome; and
(c) that there are sufficient safeguards to protect the public health, welfare and safety without the petitioner's compliance with the waive regulatory requirements.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 15.00 - Continuous Quality Improvement Program › Section 15.01 - Definitions

Current through Register 1525, July 5, 2024
Continuous Quality Improvement Program
or
CQI Program
means a system of standards and procedures to identify and evaluate quality-related events and improve patient care.
Quality Related Event
or
QRE
means the incorrect dispensing of a prescribed medication that is received by a patient, including:
(a) a variation from the prescriber's prescription order, including, but not limited to:
1. dispensing an incorrect drug;
2. dispensing an incorrect drug strength;
3. dispensing an incorrect dosage form;
4. dispensing the drug to the wrong patient; or
5. providing inadequate or incorrect packaging, labeling, or directions; or
(b) a failure to identify and manage:
1. over-utilization;
2. therapeutic duplication;
3. drug-disease contraindications;
4. drug-drug interactions;
5. incorrect drug dosage or duration of drug treatment;
6. drug-allergy interactions; or
7. clinical abuse/misuse.
Pharmacy
, as referenced in 247 CMR 15.00, means 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.
Pharmacy Personnel
means pharmacist, pharmacy intern, pharmacy technician and pharmacy support personnel.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 15.00 - Continuous Quality Improvement Program › Section 15.02 - Continuous Quality Improvement Program

Current through Register 1525, July 5, 2024
(1)
Continuous Quality Improvement Program Requirements
. Each pharmacy shall establish a Continuous Quality Improvement (CQI) Program for the purpose of detecting, documenting, assessing and preventing Quality Related Events (QREs). At a minimum, a CQI program shall include provisions to:
(a) designate an individual or individuals responsible for monitoring CQI Program compliance with the requirements of 247 CMR 15.00;
(b) identify and document QREs;
(c) minimize impact of QREs on patients;
(d) analyze data collected in response to QREs to assess causes and any contributing factors;
(e) use the findings of the analysis to formulate an appropriate response and develop pharmacy systems and workflow processes designed to prevent QREs; and
(f) provide ongoing education at least annually in the area of CQI to pharmacy personnel.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 15.00 - Continuous Quality Improvement Program › Section 15.03 - Quality Related Event Discovery, Notification and Documentation

Current through Register 1525, July 5, 2024
(1)
QRE Discovery and Notification
. All pharmacy personnel shall be trained to bring any QRE to the attention of the pharmacist on duty or the pharmacist Manager of Record immediately upon discovery. The pharmacist who has discovered or been informed of a QRE shall immediately provide:
(a) notification to the patient or patient's representative, the prescriber (if indicated in the professional judgment of the pharmacist) and other members of the healthcare team;
(b) directions for correcting the error; and
(c) instructions for minimizing the negative impact on the patient.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 15.00 - Continuous Quality Improvement Program › Section 15.04 - Records

Current through Register 1525, July 5, 2024
(1) Each pharmacy shall maintain a written copy of its CQI Program description on the pharmacy premises. The CQI Program description shall be readily available to all pharmacy personnel.
(2) Each pharmacy shall maintain a record of all QREs for a minimum period of two years from the date of the QRE report.
(3) QRE records shall be maintained in an orderly manner and filed by date.
(4) QRE records may be stored at a site other than the pharmacy where the QRE occurred.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 15.00 - Continuous Quality Improvement Program › Section 15.05 - 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 in 247 CMR 6.14(1), within 15 business days of the pharmacy discovering or being informed of such improper dispensing, in accordance with the requirements of M.G.L. c. 112, § 39D and 247 CMR 6.00.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 16.00 - Collaborative Drug Therapy Management › Section 16.00 - Preface

Current through Register 1525, July 5, 2024
St. 2008, c. 528 (amending M.G.L. c. 94C, §§ 7 and 9 and M.G.L. c. 112, §§ 24B½ and 24B¾) authorized pharmacists and physicians to engage in collaborative drug therapy management (CDTM) in the Commonwealth pursuant to collaborative practice agreements meeting the requirements of regulations adopted by the Boards of Registration in Pharmacy and Medicine. The Board of Registration in Pharmacy has promulgated 247 CMR 16.00 in accordance with M.G.L. c. 112, §§
2
4B½ and 24B¾. Board of Registration in Medicine regulations ( 243 CMR 2.12 ) include additional definitions and requirements applicable to pharmacists and physicians entering into collaborative practice agreements to practice CDTM in the Commonwealth.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 16.00 - Collaborative Drug Therapy Management › Section 16.01 - Purpose

Current through Register 1525, July 5, 2024
247 CMR 16.00 sets forth criteria applicable to pharmacists and pharmacies that engage in collaborative drug therapy management with physicians in accordance with M.G.L. c. 112, §§ 24½ and 24¾, including pharmacist qualifications, and requirements for practice settings and collaborative practice agreements.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 16.00 - Collaborative Drug Therapy Management › Section 16.02 - Pharmacist Qualifications

Current through Register 1525, July 5, 2024
(1) In accordance with M.G.L. c. 112, § 24B½, subsection (b), to qualify to enter into a collaborative practice agreement and engage in collaborative practice, a pharmacist must:
(a) hold a current unrestricted license in good standing to practice pharmacy in the Commonwealth and currently be engaged in pharmacy practice in the Commonwealth;
(b) maintain at least $1,000,000 (per occurrence) of professional liability insurance during the term of the agreement which specifically covers drug therapy management;
(c) have completed five years of experience as a licensed pharmacist or have satisfied one of the requirements in 247 CMR 16.02(1)(c)1. through 2.:
1. have earned a doctor of pharmacy degree and have entered into a collaborative practice agreement on or before June 30, 2017; or
2. have completed such other education or residency criteria that the Board determines to be the equivalent of five years experience as a licensed pharmacist;
(d) devote a portion of practice to the defined drug therapy area that the pharmacist shall co-manage;
(e) complete, in each year of the term of the agreement, at least five additional contact hours of Board-approved continuing education that address areas of practice generally related to the particular collaborative practice agreement; and
(f) if prescriptive practices are included in the collaborative practice agreement:
1. maintain a current controlled substance registration issued by the Department during the term of the agreement, pursuant to M.G.L. c. 94C, §§ 7 and 9 and 105 CMR 700.000:
Implementation of M.G.L. c. 94C
.
2. complete training required pursuant to M.G.L. c. 94C, § 18(e) prior to initially obtaining a controlled substance registration and at least biennially thereafter as a condition precedent to renewing his or her pharmacist license;
3. submit an attestation, signed under the pains and penalties of perjury, that the pharmacist participates in, or had applied to participate in, MassHealth as either a provider of services or for the limited purpose of ordering and referring services covered by MassHealth, in accordance with M.G.L. c. 112, § 24B½.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 16.00 - Collaborative Drug Therapy Management › Section 16.04 - Collaborative Practice Agreements - Required Agreement Terms for All Practice Settings; Duties; Biennial Renewal; Termination; Agreement to Be Filed in Primary Practice Setting; and Employment Relationships

Current through Register 1525, July 5, 2024
(1) A collaborative practice agreement must be a written and signed agreement between an authorized pharmacist with training and experience relevant to the scope of the collaborative practice and a supervising physician that defines the collaborative practice in which the authorized pharmacist and supervising physician propose to engage. The collaborative practice must be within the scope of the supervising physician's practice. In the community pharmacy setting, the CDTM agreement shall include:
(a) a written referral of a specific patient from the supervising physician to an authorized pharmacist; and
(b) the written consent of the patient to the CDTM agreement.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 16.00 - Collaborative Drug Therapy Management › Section 16.05 - Authority of Board of Registration in Medicine

Current through Register 1525, July 5, 2024
Nothing in 247 CMR 16.00 shall limit the Board of Registration in Medicine's review, monitoring and investigation of its licensees' activities pursuant to 243 CMR 2.00:
Licensing and the Practice of Medicine
.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.02 - Outsourcing Facility Registration Requirements

Current through Register 1525, July 5, 2024
(1) Registration under 247 CMR 21.02 is limited to outsourcing facilities located in Massachusetts. Outsourcing facilities located outside Massachusetts shall register in accordance with 247 CMR 21.04.
(2) An application for an outsourcing facility registration shall be made on forms prescribed by, and available from, the Board.
(3) In support of an application for an outsourcing facility registration, the applicant shall submit:
(a) complete application forms;
(b) a complete application, available from the Board, for a Massachusetts controlled substance registration;
(c) check or money order made payable in the proper amount to the "Commonwealth of Massachusetts Board of Registration in Pharmacy";
(d) proof of a valid, current registration with the FDA pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act;
(e) proof of an inspection by the FDA in connection with the section 503B of the Federal Food, Drug, and Cosmetic Act registration within the two years immediately preceding the application;
(f) if the applicant is an entity:
1. a certificate of good standing and legal existence issued by the Secretary of State, or the equivalent, in the state in which the entity was organized or formed, and other information concerning ownership and control, as the Board may require;
2. a statement of the name and address of each officer, director, or partner of the entity and the position held;
3. the "doing business as" name of the entity;
4. if the corporation is not publicly owned, the total amount and type of stock issued to each stockholder and the names and addresses of said stockholder(s); and
(g) any additional information, as required by the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.03 - Provisional Outsourcing Facility Registration Requirements

Current through Register 1525, July 5, 2024
(1) A non-resident outsourcing facility is not eligible for a provisional outsourcing facility registration.
(2) In the event an applicant for an outsourcing facility registration was not inspected by the FDA within the two years immediately preceding the application, the Board may issue a provisional outsourcing registration, provided the applicant otherwise submitted a complete application for an outsourcing facility registration.
(3) An entity with a provisional outsourcing facility registration may compound sterile drug preparations, but may not distribute or dispense a sterile drug preparation within or outside the Commonwealth until it has been inspected by the FDA and received a Massachusetts outsourcing facility registration.
(4) A provisional outsourcing facility registration shall be valid until the earliest of the following events occurs:
(a) the Board converts the provisional outsourcing facility registration to an outsourcing facility registration;
(b) the provisional outsourcing facility registration is surrendered, suspended, or revoked; or
(c) the provisional outsourcing registration expires on December 31st of the first odd numbered year following the date of issuance.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.04 - Non-resident Outsourcing Facility Registration Requirements

Current through Register 1525, July 5, 2024
(1) In support of an application for a registration to operate a non-resident outsourcing facility, the applicant(s) shall submit:
(a) complete application forms;
(b) check or money order made payable in the proper amount to the "Commonwealth of Massachusetts Board of Registration in Pharmacy";
(c) proof of a valid, current registration with the FDA pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act;
(d) proof of an inspection by the FDA in connection with the section 503B of the Federal Food, Drug, and Cosmetic Act registration within the two years immediately preceding the application;
(e) if the applicant is an entity:
1. a certificate of good standing and legal existence issued by the Secretary of State, or the equivalent, in the state in which the entity was organized or formed, and other information concerning ownership and control, as the Board may require;
2. a statement of the name and address of each officer, director, or partner of the entity and the position held;
3. the "doing business as" (d/b/a) name of the entity; and
4. if the corporation is not publicly owned, the total amount and type of stock issued to each stockholder and the names and addresses of said stockholder(s);
(f) if the outsourcing facility is licensed or registered by the state in which it is located, proof of good standing from the licensing or registering authority in that state that was issued within three months; and
(g) any additional information, as required by the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.05 - Renewal of an Outsourcing Facility Registration and Non-resident Outsourcing Facility Registration

Current through Register 1525, July 5, 2024
(1) An outsourcing facility registration and non-resident outsourcing facility registration shall expire on December 31st of each odd numbered year following the date of its issuance.
(2) Renewal of an outsourcing facility registration and non-resident outsourcing facility registration shall be made in the form and manner determined by the Board.
(3) In support of an application for a renewal of an outsourcing facility registration or a non-resident outsourcing facility registration, the applicant shall submit:
(a) proof of a valid, current registration with the FDA pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act;
(b) check or money order made payable in the proper amount to the "Commonwealth of Massachusetts Board of Registration in Pharmacy"; and
(c) any additional information, as required by the Board.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.06 - Grounds for Denial, Revocation, Suspension, and Non-renewal

Current through Register 1525, July 5, 2024
Grounds for denial of a registration, revocation or suspension of a registration, or non-renewal of a registration shall include, but shall not be limited to:
(1) failure to maintain a current, valid registration with the FDA pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act;
(2) an inspection by the FDA that results in a warning letter that prohibits commercial distribution by the registered facility of sterile drug preparations within or outside of the commonwealth;
(3) material misrepresentation, omission, or falsification of any information furnished to the Board;
(4) failure to comply with reporting requirements established by the Board with respect to registration with or inspections by the FDA;
(5) failure to adhere to the most current standards established under cGMP;
(6) the lack of suitability of the applicant or registrant; or
(7) in the case of outsourcing facilities located in Massachusetts, the failure to maintain a current, valid Massachusetts controlled substances registration.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.08 - Transfer of Ownership of an Outsourcing Facility

Current through Register 1525, July 5, 2024
(1)247 CMR 21.08 shall only apply to outsourcing facilities located in Massachusetts.
(2) At least 60 days prior to the transfer of ownership of an outsourcing facility, the registrant shall notify the Board of the proposed transfer of ownership. The outgoing registrant shall comply with 247 CMR 21.10 pertaining to the transfer of controlled substances.
(3) Within 60 days of a transfer of ownership, the proposed new registrant shall submit an application for a registration to operate an outsourcing facility in accordance with 247 CMR 21.02.
(4) In support of the application for a registration to operate an outsourcing facility, the proposed new registrant shall submit:
(a) a complete application pursuant to 247 CMR 21.02;
(b) an inventory report of controlled substances as required by 247 CMR 21.11; and
(c) any additional information, as required by the Board;
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.09 - Notifications

Current through Register 1525, July 5, 2024
A registrant shall notify the Board, within 14 days, in writing, of the following:
(1) any change in the d/b/a name of the entity accompanied by appropriate authorizing documentation;
(2) any change in the names of its officers or directors;
(3) any change in the ownership of the outsourcing facility representing more than 5% interest;
(4) an inspection by the FDA;
(5) receipt of an FDA Form 483 or Warning Letter; and
(6) any disciplinary or adverse action taken by the FDA or a state licensing or registering authority.
Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 21.00 - Registration Of Outsourcing Facilities › Section 21.10 - Closing of an Outsourcing Facility

Current through Register 1525, July 5, 2024
(1)247 CMR 21.10 shall only apply to outsourcing facilities located in Massachusetts.
(2) A registrant that intends to close a outsourcing facility 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 outsourcing facility;
(b) the outsourcing facility registration and controlled substance registration numbers;
(c) the date on which the intended closure shall take place;
(d) the intended procedures for closing the outsourcing facility;
(e) verification that adequate advance notice of the closure has been given to customers and patients of the outsourcing facility; and
(f) the intended procedures for disposal of controlled substances, or the intended procedures for transfer of controlled substance in accordance with 247 CMR 21.11.