Apply for, renew, or amend information for your facility MCSR

You must now apply for or renew your facility MCSR on the Health Professions Licensing Portal. If this is your first time using this new portal, please visit Health Professions Licensing System User Guide for information on how to get started.

What you need before applying for a new MCSR.

• Ambulance
  • Drug Security Policy
  • Current Hospital Affiliation Agreement
  • Current OEMS license
  • Federal Tax ID No.: (Required by M.G.L. c. 30A, s. 13A)
• Analytical Laboratory
  • Federal Tax ID No.: (Required by M.G.L. c. 30A, s. 13A)
• Clinic
  • Current Division of Health Care Facility Licensure and Certification license
  • Federal Tax ID No.: (Required by M.G.L. c. 30A, s. 13A)
• Drug Manufacturer or Drug Distributor
  • Federal Tax ID No.: (Required by M.G.L. c. 30A, s. 13A)
• Health Care Entity
  • Current Bureau of Substance Addiction Services License or Intent to Approve
  • Federal Tax ID No.: (Required by M.G.L. c. 30A, s. 13A)
• Hospital
  • Division of Health Care Facility Licensure and Certification
  • Federal Tax ID No.: (Required by M.G.L. c. 30A, s. 13A)
• School Health
  • A current Staffing Spreadsheet.
  • The Signature Page: Signatures must be within the last 12 months, can be scanned or electronic signatures, types signatures will not be accepted.
  • Two BU SHIELD Course Certificates: Medication Administration in a School Setting: School Nurse Practice in Massachusetts and Medication Administration in Schools: What School Nurse Managers Need to Know.  Both classes need to be taken every three years.
• Virtual Drug Manufacturer or Virtual Drug Distributor
  • Federal Tax ID No.: (Required by M.G.L. c. 30A, s. 13A)

Please note, any new facility application may require an inspection prior to issuing the MCSR. Please do not apply for the MCSR if your facility is under construction or not ready for inspection.

Important Information for Required Inspection

The following documents are required for inspection. Our inspector will reach out to you with more information.

Analytical Labs

• Business Overview
• High-Level Organizational Chart
• Location Overview, including:
  • Detailed Floor Plan and Square Footage
  • Hours of Operation
  • Visitor Policy
• Ordering and Receiving Policy (including supplier information)
• Controlled Substance Handling Policy
• Reverse Distribution/ Destruction Policy
• Record Retention Policy
• Security Standard Operating Procedures, including:
  • Controlled Substance Storage Information
  • Facility Access and Limited Areas (please note any individualized key cards, keys, etc.)
  • Alarm Company Information (if applicable, including POC for breach of security)
  • Further Security Measures (if applicable, including surveillance cameras, surveillance footage retention, motion sensors, glass-break sensors, contact switches, panic buttons, etc.)

Clinics

• Business Overview/ Services Offered
• High-Level Organizational Chart
• Location Overview, including:
  • Detailed Floor Plan and Square Footage
  • Hours of Operation
  • Visitor Policy
• Ordering and Receiving Policy (including supplier information)
• Dispensing and Administering Policy
• Reverse Distribution/ Destruction Policy
• Record Retention Policy
• Security Standard Operating Procedure, including:
  • Controlled Substance Storage Information
  • Facility Access and Limited Areas (please note any individualized key cards, keys, etc.)
  • Alarm Company Information (if applicable, including POC for breach of security)
  • Further Security Measures (if applicable, including surveillance cameras, surveillance footage retention, motion sensors, glass-break sensors, contact switches, panic buttons, etc.)

Hospitals

• Business Overview/ Services Offered
• High-Level Organizational Chart
• Location Overview, including:
  • Detailed Floor Plan and Square Footage
  • Hours of Operation
  • Visitor Policy
• Ordering and Receiving Policy (including supplier information)
• Dispensing and Administering Policy
• Reverse Distribution/ Destruction Policy
• Record Retention Policy
• Security Standard Operating Procedure, including:
  • Controlled Substance Storage Information
  • Facility Access and Limited Areas (please note any individualized key cards, keys, etc.)
  • Alarm Company Information (if applicable, including POC for breach of security)
  • Further Security Measures (if applicable, including surveillance cameras, surveillance footage retention, motion sensors, glass-break sensors, contact switches, panic buttons, etc.)

Manufacturer

• Business Overview
• High-Level Organizational Chart
• Supply Chain Diagram
• Location Overview, including:
  • Detailed Floor Plan and Square Footage
  • Hours of Operation
  • Visitor Policy
• Quality Control and Destruction Policies
• cGMP Standard Operating Procedures and Policies
• Recordkeeping and Retention Policy
• Returned Goods Policy
• Pest Control Policy
• Security Standard Operating Procedure, including:
  • Controlled Substance Storage Information
  • Facility Access and Limited Areas (please note any individualized key cards, keys, etc.)
  • Alarm Company Information (if applicable, including POC for breach of security)
  • Further Security Measures (if applicable, including surveillance cameras, surveillance footage retention, motion sensors, glass-break sensors, contact switches, panic buttons, etc.)

Distributor

• Business Overview
• High-Level Organizational Chart
• Supply Chain Diagram
• Location Overview, including:
  • Detailed Floor Plan and Square Footage
  • Hours of Operation
  • Visitor Policy
• Drug Product List
• Ordering, Receiving, and Distributing Policies (please include supplier information)
• Reverse Distribution/ Destruction Policy
• Recordkeeping and Retention Policy
• Returned Goods Policy
• Pest Control Policy
• Security Standard Operating Procedure, including:
  • Controlled Substance Storage Information
  • Facility Access and Limited Areas (please note any individualized key cards, keys, etc.)
  • Alarm Company Information (if applicable, including POC for breach of security)
  • Further Security Measures (if applicable, including surveillance cameras, surveillance footage retention, motion sensors, glass-break sensors, contact switches, panic buttons, etc.)

Virtual Distributor and/or Virtual Manufacturer

• Business Overview
  • Including CMO and 3PL
• High-Level Organizational Chart
• Supply Chain Diagram
• Location Overview
  • Detailed Floor Plan and Square Footage
  • Hours of Operation
  • Visitor Policy
• Returned Product Policy
  • Storage Area Information for Returned Product (If Applicable)
• Record Retention Policy
• Security Standard Operating Procedure, including:
  • Facility Access and Limited Areas (please note any individualized key cards, keys, etc.)
  • Alarm Company Information (if applicable, including POC for breach of security)
  • Further Security Measures (if applicable, including surveillance cameras, surveillance footage retention, motion sensors, glass-break sensors, contact switches, panic buttons, etc.)

Health Care Entity

• BSAS Letter of Intent to Approve
• Detailed Floor Plan
• Square footage of room in which controlled substances will be stored
• Hours of Operations
• High-Level Organizational Chart
• Business Overview
• Security SOPs/Policies and Procedures
• Visitor Policy
• Access to the facility (ex. Individualized key card, keys, etc.)
• Access to limited areas within facilities (ex. Individualized key card, keys, etc.)
• Facility Security SOPs/Policies and Procedures
• Surveillance Cameras (are they inside and/or outside of facility? How many inside and how many outside? How long is the footage kept?)
• Location of safe(s) and its/their security (ex. motion sensors, vibration sensors, contact switches, etc., who has access?)
• Panic Buttons (How many? Where are they located?)
• Outside Alarm Company (Who is the alarm company? Who will they contact if breach occurs?)
• Use of Controlled Substances
  • Policies on administration and dosing hours
  • Will patients be allowed to bring in their prescribed medications on in-take? If so, where will they be stored? Will they be administered by staff or stored until departure?
• Ordering and Receiving Process
• Reverse Distribution/ Destruction Process
• Record keeping Process

You must also acquire a DEA registration. If you have any questions regarding the DEA security requirements or regulations for this activity, you may contact the Boston DEA Office Duty-Line at 571-362-9171. This number is a voicemail, and a Boston diversion investigator should return your call within 24 hours.