Fillable Commonwealth of Massachusetts Pharmacy 797 Reporting Form

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Commonwealth of Massachusetts Pharmacy 797 Reporting Form

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The Commonwealth of Massachusetts Pharmacy 797 Reporting Form form is 5 pages long and contains:

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  • 422 check-boxes
  • 80 other fields

Country of origin: US
File type: PDF

U.S.A. forms for Commonwealth of Massachusetts

BROWSE COMMONWEALTH OF MASSACHUSETTS (MA) FORMS

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Instructions for filling out the Sterile Compounding Reporting Form
Step 1: Make sure the form is ‘enabled’
When the form is first opened it may, depending upon the version of Adobe Reader/Acrobat that you
are using, be in ‘protected mode’ – which is usually signaled by a message in a bar near the top of the
Adobe Reader/Acrobat window. If his happens, you need to ‘enable’ the form – which is usually
presented to you as an option in the same bar in which the ‘protected mode’ message us displayed.
Once the form is ‘enabled’, the fields that are open for data entry will appear shaded (again depending
upon which version of Adobe Reader/Acrobat you are using).
Step 2: Fill in the Pharmacy information on Page 1.
When you enter the Pharmacy name, the name will be replicated into the ‘running footer’ that appears
on each page. It may take a few seconds and be accompanied by the flickering ‘keyboard’.
Step 3: Fill in the rest of the form
On Page 2, select the first month of the reporting period from the dropdown box and then tab out of
the field. The remaining months of the reporting period will be filled in automatically.
Question 2 (Page 2) lists all of the states in which the pharmacy may hold a license. Note that the
license-status check boxes for a state will be exposed only if the state is selected.
Name of Pharmacy: ___________________________________________________________
1
STERILE COMPOUNDING REPORTING FORM
All pharmacies that are licensed by the Massachusetts Board of Registration in Pharmacy
(“Board”) and engage in compounding of sterile products are required to complete and submit
product, volume, and distribution data every six months pursuant to 247 CMR 6.15(5). The
completed form must be submitted to the Board on or before August 15 for the first half of the year
or February 15 for the second half.
Massachusetts licensed pharmacies that do not engage in sterile compounding, as
defined in USP <797>, are NOT required to submit this form to the Board. Institutional
sterile compounding pharmacies associated with hospitals or clinics are not required to submit this
form at this time.
The Sterile Compounding Reporting Form and the Excel Spreadsheet for CSP Prescriptions can
be found here: http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/dhpl/pharmacy/
mandated-reporting-forms-.html
Please Note: In addition to the CSP reporting form, the Excel Spreadsheet for CSP Prescriptions
must be electronically submitted using the Board provided template in Excel format only (e.g.,
not pdf versions) and sent to sterilecompoundingreportingforms@MassMail.State.MA.US
The Commonwealth of Massachusetts
Executive Office of Health and Human Services
Department of Public Health
Bureau of Health Professions Licensure
239 Causeway Street, Suite 500, Boston, MA 02114
Tel: 617-973-0800
TTY : 617-973-0988
www.mass.gov/dph/boards
CHARLES D. BAKER
Governor
KARYN E. POLITO
Lieutenant Governor
MARYLOU SUDDERS
Secretary
MONICA BHAREL, MD, MPH
Commissioner
Name of Pharmacy___________________________________________________________
Street Address______________________________________________________________
City/Town___________________________________ State ______ Zip Code _________
Tel. No______________________________ Fax No.______________________________
Pharmacy E-mail____________________________________________________________
MA Drug Store Permit Numbers:
Drug Store (DS No.)_________________ Exp. Date___________________
MA
Name of Pharmacy: ___________________________________________________________ 2
Answer all of the following questions for the current reporting period:
1. Indicate the total number of prescriptions dispensed by month and by risk-level category (low, medium,
high) in the table below.
Low Risk Compounding: single volume transfers of not more than 3 sterile dosage forms and not more
than 2 entries into a sterile container (e.g., hydrating solutions, irrigations, antibiotics and oncology
medications).
Medium Risk Compounding: the compounding process includes complex aseptic manipulations other
than single volume transfer (e.g., TPN, cardioplegia solutions, multiple sterile ingredient admixtures).
High Risk Compounding: non-sterile ingredients, including manufactured products not intended
for sterile routes of administration, are incorporated or a non-sterile device is employed before
terminal sterilization.
Note: The final product must be designated with the highest risk level of any individual
component of a CSP. For example, if one component is a non-sterile product that was made
sterile, then the final product must be designated as high-risk.
Total Number of Prescriptions / Orders
Risk Level
Month # Low # Medium # High Total
2. Identify all state(s) in which the pharmacy holds a license and indicate the status of each
license as: active, expired, on probation, restricted or revoked.
Active Expired Probation Restricted Revoked
Alaska Active Expired Probation Restricted Revoked
Arizona Active Expired Probation Restricted Revoked
Arkansas Active Expired Probation Restricted Revoked
California Active Expired Probation Restricted Revoked
Colorado Active Expired Probation Restricted Revoked
Connecticut Active Expired Probation Restricted Revoked
Delaware Active Expired Probation Restricted Revoked
D.C
Florida
Georgia
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Hawaii
Alabama
Home State
MA Pharmacies Only
# Dispensed
Out of State
% of
Total
January
0.00
0
0.00
0
0.00
0
0.00
0
0.00
0
0.00
Name of Pharmacy: ___________________________________________________________ 3
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Active Expired Probation Restricted Revoked
Home State
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Michigan
Minnesota
Mississippi
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Pennsylvania
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
Missouri
Active Expired Probation Restricted Revoked
Massachusetts
Other: ________
Other: ________
4
3. Identify all state(s) and jurisdictions to which the pharmacy dispenses.
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
D.C.
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Michigan
Minnesota
Mississippi
Missouri
4. For this reporting period, fill out the Excel Spreadsheet for CSP Prescriptions that is provided on the
Board’s website under Reporting Forms.
Attestation regarding compliance with laws and regulations:
I, _________________ (name), the Manager of Record (MOR) / Designated Pharmacist in Charge
(PIC) of ________________________ (name of pharmacy), attest under the pains and penalties of
perjury that ____________________ (name of pharmacy) is in compliance with all laws and
regulations pertinent to sterile compounding, including USP <797> Sterile Preparations.
_____________________ (name of pharmacy) will only dispense medication pursuant to a valid
prescription as defined in M.G.L. c. 94C, §19 for a single patient for any medications dispensed
into or from Massachusetts. The FAILURE of any Massachusetts licensed pharmacy that performs
sterile compounding to provide the requested information to the Board by the deadline may be
grounds for discipline under 247 CMR 10.03(q).
Print Name of MOR / PIC: ______________________ MA License Number: ____________
Signature of MOR / PIC: _______________________________ Date: _________________
Please send electronic (not pdf) versions of this reporting form along with the Excel Spreadsheet for
CSP Prescriptions to:
sterilecompoundingreportingforms@MassMail.State.MA.US
DO NOT send by mail or fax. Paper submissions will not be accepted. Thank you.
Name of Pharmacy: ___________________________________________________________
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
Other: _______
Other: _______
Massachusetts
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Commonwealth of Massachusetts Pharmacy 797 Reporting Form

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Completed 13 May 2020

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