NH Application for Non-Resident Pharmacy to Renew License--If shipping sterile compounded products to NH Residents--new requirements

Sterile Compounded Drugs * If shipping Sterile Compounded Products to NH Residents, you must attach items 1-5; additionally, by signing this renew

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; and

6. The pharmacy’s policies and procedures on sterile compounding. (Do not attach – but must be available upon request)

found here