Section Ph 2003.04 - Application Contents(a) The applicant for a license to operate an outsourcing facility in New Hampshire shall complete and file the form described in Ph 2003.03.(b) The applicant shall indicate his or her title, and sign and date the application form under the following affirmation: "I affirm that I am the person authorized to sign this application for licensure and affirm that this application (including any accompanying documents) has been examined by me and to the best of my knowledge and belief is a true, correct and complete application, and if the registration herein applied for is granted, I hereby agree to and do submit to the jurisdiction of the New Hampshire Board of Pharmacy and to the laws and rules of this State. I understand that as an outsource facility I am required to comply with current Good Manufacturing Practice (cGMP) standards. I have read and understand the testing requirements required for shipping compounded products into New Hampshire."
(c) The applicant shall submit the following documents with the application form:(1) If shipping controlled drugs, a copy of the facility's current DEA registration;(2) If licensed by the applicant's home state, a copy of the current license; and(3) If applicable, a copy of the most recent inspection report from the applicant's home state; and(4) If applicable, a copy of: a. The most recent FDA inspection report;b. The FDA issued Form 483; andc. The applicant's response to the Form 483.(d) The applicant shall submit scale drawings of the facility, detailing usage of all space.(e) The applicant shall supplement the application with any certificates, affidavits, plans, documents, or other information sufficient to show full compliance with all of the requirements for licensure.(f) If the applicant is a corporation, or if the outsourcing facility will be operated under a corporate name, the applicant shall submit a certificate from the secretary of state attesting to the documents creating the corporate person and any amendment(s) thereof to the certificate of incorporation, or authorizing it to do business in the State of New Hampshire under the corporate name.(g) The application shall be filed with the prescribed fee of $500.00.N.H. Admin. Code § Ph 2003.04
Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, Effective 7/22/2017, Expires 7/22/2027.Amended by Volume XL Number 46, Filed November 12, 2020, Proposed by #13117, Effective 10/15/2020, Expires 10/15/2030