- 2001-01: RE: Board Interpretation of USP Beyond Use Date Requirement
- 2001-02: Massachusetts Board of Pharmacy ("Board") Guidelines for Pilot Project Approval - Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy
DRAFT POLICY 2001-01
RE: Board Interpretation of USP Beyond Use Date Requirement
It is the policy of the Board that pharmacists repackaging prescription drugs in unit-dose and single-unit dose packaging follow the Board of Registration In Pharmacy ("Board") guidelines and USP requirements for determining an appropriate beyond-use date.
The Board Regulations state: "A registered pharmacist shall at all times conduct professional activities in conformity with federal, state and municipal laws, ordinances and/or regulations, including the regulations of the Board"[247 CMR � 9.01(1)]; and, "A pharmacist shall observe the standards of the current United States Pharmacopoeia"[247 CMR � 9.01(3)].
Effective January 01, 2000, the United States Pharmacopoeia (USP) revised the beyond-use dating requirement for nonsterile solid and liquid dosage forms packaged in single-unit and unit-dose containers to make them more consistent with the requirements for multi-unit containers. The First Supplement of the USP 24-National Formulary 19 (USP-NF) now states that the beyond-use date for these products shall be one year or less, unless the stability data or the manufacturer's labeling indicates otherwise; provided that the facility where the drug is repackaged is at controlled room temperature and provided further that the plastic material used provides better protection against moisture than polyvinyl chloride (PVC).
In the opinion of the Board the use of a one year beyond-use date on the label of a prescription container of a single-unit or unit-dose container is acceptable, provided that the actual expiration date of the drug dispensed is not less than one year from the date of dispensing; the stability data or the manufacturer's label does not indicate otherwise; and provided use of a beyond-use date is not prohibited by any federal, state or municipal law.
The Board of Pharmacy and Department of Public Health considers a bingo card to be a tamper-evident, multiple unit container dispensed to a patient. The beyond-use date of one year or less according to the time remaining on the expiration date is acceptable if the bingo card is filled with a drug product from the same or different lots with the same expiration date. If the bingo card is filled with a drug product from different lots with different expiration dates than the beyond use-date would be the earlier of one year or the time remaining on the shortest expiration date.
Authority G.L. c 112 � 42 (A)
Amended August 08, 2001
Proposed for vote February 20, 2001
Adopted March 13, 20011
Massachusetts Board of Pharmacy ("Board") Guidelines for Pilot Project Approval
Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy
(A) Purpose. The purpose of this section is to specify the procedures to be followed in applying for approval of a pilot or demonstration research project for innovative applications in the practice of pharmacy. In reviewing projects, the board will give priority to projects that expand pharmaceutical care services which contribute to positive patient outcomes.
(B) Scope of pilot or demonstration research projects and the board' s approval of such projects.
(1) Pilot or demonstration research projects may not:
(a) expand the definition of the practice of pharmacy as provided in G.L. c 112, Sections 24(A)-42(A); or
(b) include therapeutic substitution or substitution of medical devices used in patient care.
(2) The boards approval of pilot or demonstration research projects may include the granting of an exception to the rules adopted under 247 CMR, but may not include an exception from any law relating to the practice of pharmacy. Such exception to the rules shall be for a specified period of time and such period may not exceed 18 months.
(C) Procedures for applying for approval of pilot or demonstration research projects. A person who wishes the board to consider approval of a pilot or demonstration research project shall submit to the board a petition for approval which contains at least the following information:
(1) name, address, telephone number, and pharmacist s license number of the pharmacist responsible for overseeing the project;
(2) specific location and, if a pharmacy, the pharmacy license number where the proposed pilot or demonstration project will be conducted;
(3) a detailed summary of the proposed pilot or demonstration project which includes:
(a) the goals, hypothesis, and/or objectives of the proposed a project;
(b) a full explanation of the project and how it will be conducted;
(c) the time frame for the project including the proposed start date and length of study. Such time frame may not exceed 18 months;
(d) background information and/or literature review to support the proposal;
(e) the rule(s) that will have to be waived in order to complete the project and a request to waive the rule(s);
(f) procedures to be used during the project to ensure that the public s health and safety are not compromised as a result of the rule waiver.
(D) Review and approval or denial of the proposed projects.
(1) On receipt of a petition for approval of a pilot or demonstration research project, board staff shall initially review the petition for completeness and appropriateness. If the petition is incomplete or inappropriate for board consideration for any reason, staff shall return the petition with a letter of explanation. Such review shall be completed within 30 working days of receipt of the petition.
(2) Once board staff has determined that the petition is complete and appropriate, a task force composed of board staff, at least one board member and, if deemed necessary, resource personnel appointed by the board president, shall review the petition and make a written recommendation to the board regarding approval. Such recommendation shall be presented to the board at the next regularly scheduled meeting of the board that occurs at least three weeks after completion of the review and written recommendation.
(3) A copy of the recommendation shall be provided to the petitioner and the board at least two weeks prior to the board meeting.
(4) Both the petitioner and a representative of the task force shall be given equal time for presentations to the board.
(5) Upon hearing the presentations, the board shall either approve or deny the petition. If the board approves the petition, the approval:
(a) shall be specific for that project and for a specific time period; and
(b) may include conditions or qualifications, if deemed appropriate by the board.
(6) The board, its Quality Assurance Surveyor or its representatives shall be allowed to inspect and review the project documentation and site at any time during the review process and after the project is approved.
(E) Presentation of results to the Board.
(1) The pharmacist responsible for overseeing the project shall forward to the board a summary of the results of the project and conclusions drawn from the results within three months after completion of the project.
(2) A task force composed of board staff, at least one board member and, if deemed necessary, resource personnel appointed by the board president, shall review the results and make written recommendations to the board regarding the results of the project.
(3) The board will receive the report of the task force at the next regularly scheduled meeting of the board that occurs at least three weeks after the task force has completed its review and issued written recommendations.
(4) A copy of the task force recommendation shall be provided to the petitioner and the board at least two weeks prior to the board meeting.
(5) Both the petitioner and a representative of the task force shall be given equal time for presentations to the board.
Authority G.L. c 112, Section 42(A)
Adopted by the Board: March 13, 2001
This information is provided by the Division of Health Professions Licensure within the Department of Public Health.
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