Current through Register No. 40, October 3, 2024
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;
b. The NABP;
or
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; and
6. 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;
and
b. HEPA filter performance
testing;
(7) If the
facility does not have a clean report, the applicant shall submit the following
as well:
a. CAPA report;
b. Identify the issue and explain in writing
to the board;
c. Explain what the
corrective action plan is; and
d.
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:
a. Product name;
b. Quantity;
c. Location of shipment; and
d. Date of shipment.
#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
