M24003 BHPL NOO Board-Approved Inspectors Update 7-1.docx

THE COMMONWEALTH OF MASSACHUSETTS

EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

BUREAU OF HEALTH PROFESSIONS LICENSURE (BHPL)

NOTICE OF OPPORTUNITY (M24003)

I. Summary

Upon promulgation of the Massachusetts Board of Registration in Pharmacy’s (Board) draft regulations at 247 CMR 6.00 and 13.00, non-resident pharmacies will require licensure by the Board to dispense medications into the Commonwealth. As part of an application for new licensure or renewal of licensure, non-resident pharmacies will be required to provide evidence of a satisfactory inspection. A “satisfactory inspection” for non-resident pharmacies is defined as an on-site “Board-approved” pharmacy inspection revealing substantial compliance with required standards, provided that any identified deficiencies do not have an impact on patient safety and there is a documented plan of correction.

A. Non-Resident Drug Store Pharmacy (a.k.a. retail pharmacy) applicant(s) must submit an inspection report from a Board-approved inspector conducted within two years of the application submission date, prior to the issuance of a license.

B. Non-Resident Sterile Compounding Pharmacy License applicant(s) must submit a satisfactory Board inspection of the proposed non-resident sterile compounding pharmacy from a Board-approved inspector conducted within one year of the application submission date, prior to the issuance of a license, and then annually upon renewal. This license also requires the Non-Resident Drug Store Pharmacy inspection and associated license.

C. Non-Resident Complex Non-Sterile Compounding Pharmacy License applicant(s) must submit a satisfactory Board inspection of the proposed non-resident complex non-sterile compounding pharmacy from a Board-approved inspector conducted within one year of the application submission date, prior to the issuance of a license and then annually upon renewal. This license also requires the Non-Resident Drug Store Pharmacy inspection and associated license.

D. Non-Resident Nuclear Pharmacy License applicant(s) must submit a satisfactory Board inspection of the proposed non-resident nuclear pharmacy from a Board-approved inspector conducted within two years of the application submission date, prior to the issuance of a license and then biennially upon renewal.

The Board, through BHPL, seeks to identify qualified inspectional services vendors to serve as “Board-approved inspectors” for the purpose of conducting compliance inspections for the licensing of Non-Resident Drug Store Pharmacies, Non-Resident Sterile Compounding Pharmacies, Non-Resident Complex Non-Sterile Compounding Pharmacies, and Non-Resident Nuclear Pharmacies.

For the purposes of this Notice of Opportunity (NOO), a Board-approved inspector is a third-party vendor approved by the Board that provides inspections acceptable to the Massachusetts Board of Registration in Pharmacy. This NOO does not apply to U.S. Boards of Pharmacy (or designated governmental regulatory agencies).

II. Nature and Scope of the Project

The mission of the Massachusetts Board of Registration in Pharmacy is to promote, preserve, and protect the public health, safety, and welfare by fostering the provision of quality pharmaceutical care to the citizens of Massachusetts through the licensure of pharmacies and individuals, regulation of the practice of pharmacy, the operation of pharmacies, and the distribution of prescription drugs in the public interest.

The scope of this NOO is to identify qualified vendors that can provide inspectors to conduct non-resident pharmacy inspections for licensure. Qualified vendors applying to this NOO must have a proven track record of providing such inspections with expertise in general pharmacy compliance, USP <795>, <797>, <800>, and <825> standards, as applicable.

Vendors must utilize currently licensed U.S. pharmacists who are qualified and experienced in various pharmacy specialties, including: Retail Pharmacy, Sterile Compounding, Complex Non-Sterile Compounding, Hazardous Drug Compounding, and Nuclear Pharmacy. Vendors must ensure that the pharmacists have demonstrated skill and expertise in conducting pharmacy inspections as well as report writing experience in the area of pharmacy audits, inspections, and surveys.

The approval of vendors is not limited to a single vendor. The Board envisions a list of qualified vendors that may be utilized by pharmacy applicants for the purpose of conducting required inspections, when needed. Unless otherwise approved by the Board, inspections may not be conducted by subcontracted organizations of the vendor.

Approved vendor(s) shall be responsible for providing all resources for conducting licensure inspections including furnishing all labor, travel expenses, materials, supplies, and inspection forms/tools. Please note that all costs for Board-approved inspectors and inspections shall be paid by the pharmacy applicant(s). Fee collection is the responsibility of the vendor. No reimbursement, fees, or resources will be provided by the Commonwealth of Massachusetts.

The Board reserves the right to remove a vendor from the list of qualified vendors at any time. Approved vendor(s) must notify the Board in writing if they wish to no longer serve as an approved vendor under this NOO.

This NOO will expire in ten (10) years. The anticipated approval of vendors resulting from this NOO will have a maximum duration of ten (10) years based on the issue date of the NOO. For example, if a vendor applies to this NOO in five (5) years and is approved to be a Board-approved inspector, the vendor approval will only be valid for five (5) years.

III. Vendor Requirements

Eligible vendors must have at least seven (7) years of experience providing pharmacy inspections on behalf of U.S. Boards of Pharmacy (or designated governmental regulatory agencies). Individual inspectors employed by the vendors must have at least ten (10) years of experience as a U.S. licensed pharmacist with at least three (3) years of experience in the type of pharmacy inspection being conducted (e.g. sterile compounding, nuclear, etc.). CV’s / resumes and licensure details of individual pharmacist inspectors must be made available upon Board request.

Vendors must provide a copy of the inspection forms/tools to be utilized and are subject to Board-approval. Inspection forms/tools must be comprehensive to include standards for general pharmacy compliance as well as the most current chapters of USP <795>, <797>, <800>, and <825> standards, as applicable. Inspection of USP <800> standards must also occur if the pharmacy is engaged in sterile and/or non-sterile compounding of hazardous (HD) drugs.

Note: Massachusetts considers the compounding of non-sterile HD drugs to be Complex Non-Sterile Compounding

Additionally, approved vendors will be required to include any additional Massachusetts-specific inspectional criteria as part of the inspection forms/tools, as applicable. The Board requires that inspection forms/tools be continually updated to reflect any relevant changes to laws, regulations, or policies.

A demonstration / presentation of your organization’s services may be required.

IV. Application Requirements

Please provide a response to each of the following topics.

A. Indicate the type(s) of inspections you would like to perform (i.e., Drug Store Pharmacy, Sterile Compounding Pharmacy, Complex Non-Sterile Compounding Pharmacy, and/or Nuclear Pharmacy).

B. Provide a narrative of your organization’s experience in providing pharmacy inspectional services and types of inspections performed.

C. Describe in detail the process undertaken to conduct pharmacy inspections from the request to the “closing out” of an inspection including any involvement with the correction of identified deficiencies.

D. Describe the vetting process for pharmacist inspectors and how they meet the qualification and experience requirements of this NOO.

E. Provide copies of the inspection forms/tools to be utilized.

F. Provide a list of any certifications or accreditations that your organization has received.

There will be an opportunity to submit written questions. All questions must be submitted by April 16, 2024 at 5:00 PM to pharmacy.admin@mass.gov. Questions with answers will be posted on COMMBUYS with this Notice.

All applications to this Notice of Opportunity must be sent via email to pharmacy.admin@mass.gov with “NOO M24003” in the subject line. Applications will be accepted during this rolling procurement until June 30, 2033 at 5PM.