Current through Register No. 40, October 3, 2024
(a) Inspections for pharmacy licensees, and
licensees of the boards included in
RSA 318:9-a
and
318:8-a,
shall include the certification listed in (d) and inspectors shall use the
following forms:
(1) For retail pharmacies,
all matter included in the "Retail Pharmacy-Inspection Form, #ph 511" revised
11/1/2018, available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(2) For institutional pharmacies, all matter
included in the "Institutional Pharmacy-Inspection Form, #ph 519" revised
11/1/2018, available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(3) For long term care pharmacies, all matter
included in the "Long Term Care Pharmacy-Inspection Form, #ph 516" revised
11/1/2018, available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(4) For methadone clinics, all matter
included in the "Methadone Clinic-Inspection Form, #ph 517" revised 11/1/2018,
available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(5) For manufacturers and wholesalers, all
matter included in the "Manufacturer/Wholesaler-Inspection Form, #ph 518"
revised 11/1/2018, available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(6) For practitioners and clinics, all matter
included in the "Practitioner/Clinic-Inspection Form, #ph 554" revised
11/1/2018, available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(7) For public health clinics, all matter
included in the "Public Health Clinic-Inspection Form, #ph 520" revised
11/1/2018, available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(8) For naturopathic practitioners and
clinics, all matter included in the "Naturopathic Practitioner/Clinic
Inspection Form, #ph 560" revised 11/1/2018, available on the pharmacy board's
website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(9) For facilities which maintain controlled
substances, all matter included in the "Controlled Substance-Inspection Form,
#ph 512" revised 11/1/2018 available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(10) For home infusion and sterile
compounding facilities, all matter included in the "Home Infusion/Sterile
Compounder-Inspection Form, #ph 513" revised 11/1/2018, available on the
pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(11) For prescription device and medical gas
distributors, all matter included in the "Inspection Form Prescription
Device/Medical Gas Distributors, form # ph 515," revised 11/1/2018, available
on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(12) For break policies involving
pharmacists, all matter included in the "Pharmacist Break Policy Supplemental
Inspection Form ph 553," revised 11/1/2018, available on the pharmacy board's
website at
https://www.oplc.nh.gov/pharmacy/compliance.htm.
and;
(13) For practitioners
offices, all matter included in the "Facilities performing IV infusion
according to Manufacturer Labeling or Aseptic Technique Form # ph 559" revised
11/1/2018, available on the pharmacy board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm.
(14) For compounding and dispensing
parenterals in an institutional setting USP 795/797 inspection form Ph 514
revised 11/1/18, available on the board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm.
(15) For compounding and dispensing
non-sterile preparations, compounding audit inspection form Ph 563 revised
11/1/19, available on the board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm.
(16) For compounding and dispensing sterile
preparations, compounding audit inspection form Ph 564, revised 11/1/19,
available on the board's website at
https://www.oplc.nh.gov/pharmacy/compliance.htm.
(b) Upon inspection,
all prescription and medication files requested by the investigator or
inspector shall be available on demand.
(c) If, during the course of an inspection,
the inspector identifies a violation of an administrative rule, the inspector
shall issue a minor or major violation notice to the licensee as stated in Ph
2200 and Ph 2109.
(d) The
inspection forms listed in (a) above shall require a representative's signature
on the following certification:
My signature acknowledges my awareness and understanding of
all entries and notations made on this report and my receipt of a copy thereof.
I also understand my responsibilities for corrective action as outlined
above.