In State Outsourcing Facility
Obtaining Initial Registration or Transfer of Ownership as a Manufacturer, Wholesaler-Repacker and/or Wholesaler of Drugs and/or Devices
Section 6808 of the Education Law provides that no establishment shall operate as a Outsourcing Facility unless that establishment is registered by the New York State Education Department.
Procedure for Registering
- Complete the Application Form (OF100 39 KB), Information Form (OF111 43 KB). Respond to all applicable items on each form. All items must be typed or neatly printed.
- Submit Forms OF100, OF111 and any necessary documentation as indicated on Checklist (OF109 47 KB), and a check or money order for $825 (made payable to the New York Sate Education Department). Failure to submit all information will result in your application being returned or delayed.
- The Board will review the forms and the information. An evaluation will be made regarding the meeting of the requirements for registration. If the Board raises any questions, the Board will contact the applicant.
- After passing review, the Board will send the application to the Office of Professional Discipline with a request to conduct an on-site inspection. The applicant will be notified by letter to contact that office to arrange the inspection.
- At the time of inspection, the investigator will verify the information provided in the application materials. The investigator does not approve the registration.
- The Office of Professional Discipline will send its report to the Board of Pharmacy.
- If the report confirms that all requirements have been met, the Board will issue a registration number by mail. No registration numbers are issued by phone.
If it appears necessary, the Board may interview the Applicant and/or supervisor in order to ensure that the responsibilities associated with registration are fully understood.
The early submission of applications will allow the time necessary for processing. Allow 8 to 12 weeks for routine processing.
The information which follows will serve as a guide in the completion of the forms. Responses must be typed or neatly printed. Incomplete or illegible forms will be returned for clarification. Should any questions arise, call/write/e-mail the Board.
Completing the Application (OF100)
Name of Establishment: Name as it will appear on the registration certificate.
- Corporate title in case of a corporation.
- Names of all partners in a case of a partnership.
- Name of individual owner (if sole proprietor).
- Social Security numbers of all owners and officers.
- Federal Employer ID number.
Address of Establishment: Place where activities covered by this registration are to be conducted. (Note: Residences will not be registered.)
Clarification: For the purpose of the clarification of applicants under this registration, the following shall apply:
- Outsourcing Facility - means a facility that is engaged in the compounding of sterile drugs; is currently registered as an outsourcing facility with the Secretary of Health and Human Services; and complies with all applicable requirements of federal and state law, including the Federal Food, Drug and Cosmetic Act.
Type of Ownership: Check the applicable category.
Trade Name: Only trade names registered with the County Clerk or Secretary of State, and acceptable to the Board of Pharmacy, may be used.
Officers: Give names, titles, residences, Social Security and home telephone numbers.
Ownership: Give full name and residence of owner or owners. If a corporation, include names, titles, residences, Social Security and home phone numbers, and the percentage of stock owner by any principal stockholders, i.e., persons owning 10% or more stock in the corporation.
Scope of Operation: Check all applicable boxes.
Other Locations: If dispensing, manufacturing, repacking, outsourcing or wholesale operations are carried on by applicant at any other New York State location, so indicate. Also indicate if such site is currently registered with the Board of Pharmacy.
Supervision: Indicate the name and title of the individual who is designated as the supervisor. Every outsourcing facility shall be under the immediate supervision and management of a pharmacist licensed to practice in New York State.
NOTE: Applicants are urged to keep copies of all application materials for registration and these instructions for reference purposes.