Section Ph 906.03 - Renewal Application Contents and When Filed Renewal applications shall be filed with the board in accordance with the following:
(a) Applications for renewal of a registration for a mail-order pharmacy shall be made by using the on-line form "License/Permit/Registration Renewal", revised edition 9/2014, located on the office of professional licensure and certification web site;(b) Documents to be submitted for renewal shall be received by the office no later than November 30th for the anticipated expiration date of December 30th.(c) An applicant who does not practice sterile or non-sterile compounding shall submit the following: (1) A copy of the pharmacy's home state permit; (2) A copy of the pharmacy's controlled substances permit if issued by the pharmacy's home state;(3) A copy of the DEA certificate;(4) A copy of the pharmacy's full, un-redacted inspection report created within the last 24 months, showing compliance with board rules, or a certificate of accreditation;(5) A copy of any responses to any violations or discipline and your company's plan of action to bring your facility into compliance. Such responses shall be signed and dated by the person that is responsible for the actions of the permit or pharmacist in charge; and(6) The application and the fee as specified in Plc 1000;(d) An applicant who practices sterile and non-sterile compounding shall submit the following to renew the pharmacy permit biennially:(1) A copy of an inspection report, created within the last 18 months, which documents compliance with the boardrules regarding sterile and non-sterile compounding in compliance with the United States Pharmacopoeia Chapter 797 and Chapter 795 pursuant to RSA 318:14-a, I performed by: a. The pharmacy's home state's board of pharmacy; c. Board approved third party entity;(2) A copy of the home state board of pharmacy permit; (3) The below attestation, signed and dated by the pharmacist in charge: "[] Sterile Compounded Drugs (Patient-Specific Only) [] If shipping Sterile Compounded Products to NH Residents, you must attach items 1-5; additionally, by signing this application you acknowledge that the pharmacy has item #6 on hand and available upon request:
1. Any and all GAP analysis reports related to the pharmacy done within the last twelve (12) months;2. Any and all certification documents on compounding equipment done within the last six (6) months;3. An inventory listing of any / all products shipped into the State of New Hampshire within the last six (6) months, including product, quantity, location of shipment, and date of shipment;4. Any Department of Health and Human Services, Food and Drug Administration Inspection Reports (Form FDA 483) issued within the last twelve (12) months and any responses submitted to these agencies by the pharmacy;5. Any state inspection reports issued within the last eighteen (18) months and any responses submitted to these agencies regarding the inspection reports by the pharmacy; and6. The pharmacy's policies and procedures on sterile compounding. (Do not attach - but must be available upon request);" (4) A hood certification inspection report completed under dynamic conditions, not at rest, within the last 6 months;(5) A Copy of the DEA permit;(6) An environmental monitoring report, dated within the last 6 months, that includes: a. Viable air and surface sampling; andb. HEPA filter performance testing;(7) If the facility does not have a clean report, the applicant shall submit the following as well:b. Identify the issue and explain in writing to the board;c. Explain what the corrective action plan is; andd. An indication whether this is in the SOP's and P & P Manual; and(8) Inventory list of last 6 months of sterile compounded products shipped into NH including: c. Location of shipment; andN.H. Admin. Code § Ph 906.03
#7474, eff 4-5-01; amd by 9139-B, eff 4-25-08; ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14
Ph 906.04 Failure to Comply. Failure to comply with any of the provisions of Ph 906 shall result in non-renewal of the pharmacy permit
Source. #10663, eff 9-3-14
Amended by Volume XLI Number 32, Filed August 12, 2021, Proposed by #13244, Effective 7/30/2021, Expires 7/30/2031.