In the bustling landscape of New York's pharmaceutical and healthcare industry, the Form MW111 emerges as a crucial document, designed and issued by The University of the State of New York, State Education Department, Office of the Professions, New York State Board of Pharmacy. This detailed form serves as an application and registration tool for businesses involved in the manufacturing, repacking, wholesaling, or handling of medical gases—an indispensable step for ensuring compliance with regulatory standards and safeguarding public health. Applicants, under the guidance of Lawrence H. Mokhiber, the Executive Secretary, are guided through an elaborate process that commences with providing basic identification details of the owner or corporation, followed by specifying the nature of their registration—be it for manufacturing, repacking, or wholesaling activities. Additionally, the form delves into operational aspects such as business hours, a breakdown of domestic versus foreign business dealings, and a comprehensive checklist covering the gamut from security measures to sanitation standards, underscoring the meticulous oversight aimed at maintaining the integrity of pharmaceutical and medical gas supply chains. With sections dedicated to outlining the premises, specifying supervision standards, and mandating an attestation of truthfulness and compliance with both state and federal regulations, Form MW111 epitomizes the intricate, yet essential, regulatory framework navigating the distribution of drugs and medical devices within New York State.
Question | Answer |
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Form Name | Form Mw111 |
Form Length | 4 pages |
Fillable? | No |
Fillable fields | 0 |
Avg. time to fill out | 1 min |
Other names | pharm mw111 how to fill out mw111 form |
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The University of the State of New York |
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THE STATE EDUCATION DEPARTMENT |
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Office of the Professions |
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New York State Board of Pharmacy |
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Lawrence H. Mokhiber |
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M/W |
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89 Washington Avenue |
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Executive Secretary |
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Albany, NY |
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INFORMATION |
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Phone: |
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FORM |
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REGISTRATION NUMBER: __________________________ |
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PART I (Print in Black Ink) |
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(check one): |
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Manufacturer |
Repacker of Drugs |
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Repacker of Medical Gases |
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Wholesaler |
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1 |
Name of owner/corporation under which registration has been issued or is sought: |
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2 |
Trade Name (if applicable): |
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3 |
M/W Address: |
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Street and Number |
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4 |
Complete ONE of the Following: |
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A. |
New Registration |
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Proposed date of opening: |
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B. |
Transfer of Ownership |
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Proposed date of transfer: |
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Name of previous registrant: _________________________________________________________________________ |
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Registration number: |
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C. |
Change of location |
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Proposed Date of change: |
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Previous address: __________________________________________________________________________________ |
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D. |
Renovation |
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Proposed date of renovation: |
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E. |
Update/Other _____________________________________________________________________________________ |
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5 |
Has the applicant applied for or been issued registration at any other location in this state by this department? |
Yes |
No |
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If yes, please list the address and registration number. Use additional paper if necessary. |
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_______________________________________________________________________________________ ______________________________ |
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Location and Address |
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Registration Number |
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Does this applicant have a New York State registered pharmacy? |
Yes |
No |
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6 List Supervisor of this establishment
_______________________________________________________________________________________________________________________
Form MW 111, Page 1 of 4, February 2006
7
A. Nature of registration: |
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Manufacturer/wholesaler |
Yes |
No |
Wholesaler only |
Yes |
No |
Repacker/wholesaler |
Yes |
No |
Medical gas repackager |
Yes |
No |
B.Daily schedule of hours the establishment will be opened. (list days of week and hours opened.)
___________________________________________________________________________________________________________________
C.List percent of business done with the following (must equal 100%):
8
9
Domestic __________ % |
Foreign __________ % |
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Check ALL items distributed at this location. |
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Prescription required drugs (human) |
Medical Devices |
Prescription required drugs (animal) |
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Hypodermic syringes and needles |
Controlled substances |
Compressed medical gases/liquid |
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Over the counter drugs |
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Cosmetics |
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Other ___________________________________________________________________________________________________________ |
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Building/Space Requirements |
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Has the following been adequately provided for? (check yes or no) |
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Adequate lighting |
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Yes |
No |
Appropriate sanitation |
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Yes |
No |
Adequate space |
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Yes |
No |
Necessary equipment |
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Yes |
No |
Appropriate security |
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Yes |
No |
Secure quarantine area |
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Yes |
No |
Orderly stock control |
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Yes |
No |
Free from insects, rodents, birds or vermin |
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Yes |
No |
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Drug areas secure from unauthorized entry |
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Yes |
No |
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Outside access well controlled and kept to a minimum |
Yes |
No |
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Outside perimeter well lighted |
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Yes |
No |
Alarm system for after hours |
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Yes |
No |
Security system against theft and diversion |
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Yes |
No |
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Computer and electronic system security against theft and diversion |
Yes |
No |
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Temperature control |
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Yes |
No |
Humidity control |
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Yes |
No |
Written policies and procedures for distribution/recalls etc. |
Yes |
No |
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Hot and cold running water |
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Yes |
No |
Recording equipment used for temperature/humidity (check each): |
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Manual |
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Yes |
No |
Electromagnetic |
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Yes |
No |
Electronic |
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Yes |
No |
Neighborhood (check type): |
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Commercial |
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Yes |
No |
Residential |
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Yes |
No |
Both |
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Yes |
No |
Pharmacy Guide to Practice, Reference books, etc. |
Yes |
No |
FOR MANUFACTURERS AND REPACKERS ONLY
10
Supervision |
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Will all manufacturing and/or repacking be done under the personal supervision of a licensed pharmacist? |
Yes |
No |
Supervisor’s who are not pharmacists shall meet the requirements as outlined in Section 63.6 (c)(1) of the regulations for registration and operation and of the establishments.
11
Do you have storage or manufacturing facilities for drug products at an address other than that indicated? |
Yes |
No |
If your answer is “Yes,” indicated locations and explain: |
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_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
Form MW 111, Page 2 of 4, February 2006
PART II
•Draw to scale the proposed establishment, indicating all dimensions. Show all doors and walls.
•Indicate areas for storage of drugs (drug bays).
•In red pen, indicate R for refrigerator.
•In red pen indicate S for sink that is located in the compounding and dispensing area.
•Outline the registered area in yellow.
•Indicate the premises adjacent to the buildings, offices and public thoroughfares.
•Name the adjacent businesses.
•DO NOT SEND A BLUEPRINT, IT WILL BE DISCARDED.
Form MW111, Page 3 of 4, February 2006
PART III
Contact person to clarify information provided on this application:
Name: _______________________________________________________________________________________________________
Phone: _______________________________________________________________________________________________________
Fax: _________________________________________________________________________________________________________
Email address: ________________________________________________________________________________________________
PART IV: ATTESTATION
I affirm that all information submitted to the Board of Pharmacy is true. I am familiar with the Pharmacy Guide to Practice and the laws which govern the distribution of drugs and/or devices in New York State and with the Title 21 Code of Federal Regulations Part 205. I further understand that manufacturers, repackers and wholesalers may only sell drugs and/or devices to those purchasers authorized by law to receive them, and that records of the receipt and disposition of all drugs and/or devices shall be maintained for a period of five years and shall be available to the Department or any other authorized State or Federal agency for a period of not less than five years.
____________________________________________________________________________ |
______________________________ |
Signature of applicant (Individual owner, partner, corporate officer, or *other authorized person) |
Date |
____________________________________________________________________________ |
______________________________ |
Print Name |
Date |
*Power of attorney must be submitted for “other authorized person” |
|
PART V: INSPECTION
Investigator’s Comments:
_____________________________________________________________________________________________________________
_____________________________________________________________________________________________________________
_____________________________________________________________________________________________________________
_____________________________________________________________________________________________________________
____________________________________________________________________________ |
______________________________ |
Signature – Investigator Office of Professional Discipline |
Date |
____________________________________________________________________________ |
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Print name |
|
Form MW111, Page 4 of 4, February 2006