Fillable Defective Drug Form (Commonwealth of Massachusetts)

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Defective Drug Form (Commonwealth of Massachusetts)

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BROWSE COMMONWEALTH OF MASSACHUSETTS (MA) FORMS

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Pharmacy Report of Defective Drug Preparation
Pursuant to M.G.L c. 112, § 39D(e), pharmacies that are licensed with the Massachusetts Board of Registration in Pharmacy
(Board) shall report to the Board within seven days any defective drug preparation that is a compounded sterile product (CSP) or
complex non-sterile product (CNP) dispensed or distributed by the pharmacy into or from Massachusetts utilizing this form.
Please submit this information to the Board of Registration in Pharmacy at abnormalresults@massmail.state.ma.us
.
A
ny of the same drug preparation remaining in the possession of the pharmacy shall be segregated from active inventory and shall
not be distributed or dispensed. A defective drug preparation log documenting the recalled drug preparation shall be kept by the
pharmacy and submitted with this report.
F
or more information please reference the Board’s Pharmacy Requirement to Maintain Defective Drug Preparation Log, link
.
Section A: Pharmacy
Demographic Information
Please Enter All Information Clearly and Use One Form for Each Event
N
ame of Pharmacy:_________________ MA License Number: _________________
A
ddress: _________________ City: _________________ State: ____ Zip:_____
P
harmacy Tel. No.:____________ Pharmacy Fax No.: ______________________
Pharmacy Email: _________________________
Manager of Record (MOR): ___________________________ MA Lic. No.: _________________
Section B: Drug Preparation Information
Drug Preparation
Information
Prescribed
Dispensed
Compound name
Generic Drug Name(s)/
Ingredients
Potency/Strength/Concentration
(units)
Quantity (units)
Dosage Form
Instructions
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
For Board Use Only:
INV/ COMP #
Adopted: 6/15/17 Page 1 of 2
Date and Time Drug Compounded: _________________ Date and Time Drug Dispensed: _________________
Pr
escription Number(s): _________________ Batch/Lot Number (if applicable): _________________
☐ New Prescription or ☐ Refill Prescription or ☐ Other:
How was original prescription/order received? ☐ Written or ☐ Telephone/Verbal or ☐ Fax or ☐ Electronic
Reason for Recall:
Were r
ecipients of the defective drug preparation(s) contacted? ☐ Yes ☐ No (If no, explain below)
Was the defective drug
prepration retrieved from the patient(s)? ☐ Yes ☐ No
Was the compounded drug utilized by the patient(s)? ☐ Yes ☐ No
I
f yes, did the patient(s) experience any adverse event(s)? ☐ Yes ☐ No
Section C: Root Cause and Corrective Actions
De
scription of Root Cause(s) Identified:
Descr
iption of Corrective Action(s):
If the there was a serious adverse drug event related to the drug preparation in question, please immediately submit the
Board’s Pharmacy Report of Serious Reportable Event form, located on the Board’s website (Link), and submit.
I cert
ify that the foregoing information is correct to the best of my knowledge and belief. I further certify that I am the
individual listed below and that I completed this form.
_______________
________________ ____________________ ________________
Print Name of MOR or his/her designee Title Date
_______________
____________________________________ _____________________
Signature Contact Phone #
Adopted: 6/15/17 Page 2 of 2
Patient Name:
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Completed 27 July 2020

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