N.H. Admin. Code § Ph 2108.01

Current through Register No. 50, December 12, 2024

Section Ph 2108.01 - Inspections

(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.

N.H. Admin. Code § Ph 2108.01

Derived from Volume XL Number 19, Filed May 7, 2020, Proposed by #13028, Effective 4/11/2020, Expires 4/11/2030.