New Hampshire Administrative Code

All advanced practice pharmacy technician licenses shall expire biennially on March 31 in even numbered years. Notes N.H. Admin. Code § Ph 1806.01 Derived from Volume XLII Number 45, Filed November 10, 2022, Proposed by #13463, Effective 10/18/2022, Expires 10/18/2032

Applications for the renewal of a license for an advanced practice pharmacy technician may be obtained from, and shall be completed and filed with OPLC, identified in Ph 103.03. Notes N.H. Admin. Code § Ph 1806.02 Derived from Volume XLII Number 45, Filed November 10, 2022, Propo…

Renewal applications shall be filed with the board in accordance with the following: (a) Applicants for renewal of a licensed advanced practice pharmacy technician shall complete and submit a "Licensed Advanced Pharmacy Technician Renewal Form" PT-22 revised 7/2022; (b) The compe…

(a) All licensed advanced pharmacy technicians shall maintain their national certified status and stay up to date with all continuing education required by such certification demands. (b) Licensed advanced pharmacy technicians with duties involving sterile and non-sterile compoun…

Excess CEUs earned in one licensure period shall not be carried forward into the new licensure period for the purpose of fulfilling that year's continuing education prerequisite for licensure renewal. Notes N.H. Admin. Code § Ph 1806.05 Derived from Volume XLII Number 45, Filed N…

An advanced pharmacy technician whose license to practice in this state has been suspended, revoked, voluntarily surrendered, or allowed to lapse, and who wish to be reinstated shall: (a) File a reinstatement application with the board which shall include at the following: (1) Na…

Persons subject to these rules shall comply with the following: (a) Perform all functions under the supervision of a licensed pharmacist who is physically on premises and holds an unrestricted license issued by the board; (b) All licensed advanced pharmacy technicians shall wear …

(a) In addition to all the duties performed by a New Hampshire certified pharmacy technician, licensed advanced pharmacy technician duties shall include, but not limited to: (1) Product verification; and (2) Approval of drug preparation. (b) A licensed advanced pharmacy technicia…

(a) A New Hampshire licensed advanced pharmacy technician who seeks to engage in the administration of vaccines shall meet the requirements of RSA 318:16-b. (b) An advanced pharmacy technician who seeks to engage in the administration of vaccines shall hold current basic or highe…

(a) An advanced pharmacy technician who seeks to engage in the administration of influenza and COVID-19 vaccines, if available, to the general public shall file a completed "Pharmacist and Advanced Pharmacy Technician Application to Administer Vaccines" revised 7/2022. (b) An app…

The following documents shall be filed with the application described in Ph 1808.02(a): (a) Proof of possession of at least $1,000,000 of professional liability insurance coverage; and (b) Proof of having competed training specific to administration of the respective vaccines tha…

An advanced pharmacy technician who engages in the administration of influenza and COVID-19 vaccines shall comply with the following procedures: (a) The advanced pharmacy technician shall be under the supervision of an on-site immunizing pharmacist; (b) Provide the patient with a…

An advanced pharmacy technician who engages in the administration of vaccines shall, for a minimum of 4 years, keep a patient consent form that includes the: (a) Name and date of birth of the patient; (b) Name of the vaccine, manufacturer, lot number, and expiration date of the v…

The Plc 200 rules shall govern with regards to all procedures for: (a) The receipt and investigation of misconduct complaints; (b) The conduct of adjudicative and non-adjudicative proceedings; (c) Rulemaking submissions, considerations, and dispositions of rulemaking petitions; (…

(a) The board shall initiate a waiver of a substantive rule upon its own motion by providing affected parties with notice and opportunity to be heard, and issuing an order which finds that waiver would be necessary to advance the purpose of the rules of the board. (b) Individuals…

The purpose of these provisions is to regulate the licensing of outsourcing facilities, as defined and registered by the Food and Drug Administration pursuant to section 503B of the Federal Food, Drug and Cosmetic Act, codified as 21 USC 353b. Notes N.H. Admin. Code § Ph 2001 Der…

All terms used in these rules shall have the same meaning as in RSA 318:1, RSA 318-B:1, and RSA 541-A:1. Notes N.H. Admin. Code § Ph 2002.01 Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, Effective 7/22/2017, Expires 7/22/2027.

(a) "Outsourcing facility" means "outsourcing facility" as defined in RSA 318:1, XXX, namely, "a facility at one geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility, and complies with all of the re…

(a) Outsourcing facilities shall maintain a human drug compounding outsourcing facility registration from the United States Food and Drug Administration (FDA) when compounding or manufacturing drugs for sale in New Hampshire. (b) Outsourcing facilities shall be in compliance with…

(a) No person shall compound legend drugs or controlled drugs, as defined in RSA 318-B:1, VI, and no person acting as or employed by an outsourcing facility shall supply such drugs, without first having obtained a license from the board. No license shall be issued or renewed for …

(a) An "Application for Pemit - Bulk Sterile & Non-Sterile Compounders (Including FDA Registered 503B Outsourcing Facilities)", form Ph OF-1, revised June 2017, for a permit to license FDA registered 503B outsourcing facilities in New Hampshire may be obtained from the board or b…

(a) The applicant for a license to operate an outsourcing facility in New Hampshire shall complete and file the form described in Ph 2003.03. (b) The applicant shall indicate his or her title, and sign and date the application form under the following affirmation: "I affirm that …

In addition to the requirements imposed by Ph 2003.04, an applicant for an outsourcing facility license shall demonstrate that he or she is of good moral character or, if the applicant is an association or corporation, that the managing officers are of good moral character, as ev…

(a) If an applicant files an application, complete in all respects and demonstrates fulfillment of all requirements of these rules and RSA 318, the board shall issue a license which shall authorize the operation of an outsourcing facility in the location, and only under the name …

The person to whom a license to operate a 503B outsourcing facility has been issued in New Hampshire shall, within 30 days of that person's discovery of a change in any of the data contained in the application for an original or renewal permit, report that change to the board in …

An outsourcing facility licensed under these rules shall, within 30 days of any written warnings or disciplinary action from any state or federal licensing or enforcement agency, notify the board and provide a copy of the action to the board office, identified in Ph 103.03. Notes…

The person to whom a license to operate a 503B outsourcing facility has been issued shall renew that license by June 15 of every odd-numbered year. Notes N.H. Admin. Code § Ph 2005.01 Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, Effective 7/22/…

(a) Applications for the renewal of a license to operate a 503B outsourcing facility, "Renewal - Bulk Sterile & Non-Sterile Compounders (Including FDA Registered 503B Outsourscing Facilities)", form Ph OF-2, revised June 2017, may be obtained from the board's website at www.oplc.…

(a) Applications for renewal of a license to operate a 503B outsourcing facility shall consist of a completed renewal application form as described in Ph 2005.02 and the prescribed fee of $500.00. (b) Renewal applications as required pursuant to Ph 2005.01 shall be submitted to t…

The board shall notify the applicant in writing as to whom the application for renewal is deficient. The applicant may, within 10 days after the date of the notice of deficiency, correct the deficiency or file with the board a written request for an appeal. Notes N.H. Admin. Code…

(a) If an applicant shall timely file an application, complete in all respects, that demonstrates the fulfillment of all the requirements of these rules and RSA 318, the board shall issue a renewal permit. (b) An application which continues to fail to meet the requirements of the…

(a) Written policies and procedures shall be developed by management personnel to assure that the outsourcing facility prepares for, protects against, and handles crises situations that affect the security or operation of the facility. Such crises shall include fires, floods, or …

An outsourcing facility shall maintain a list of principals and persons in charge including officers, directors, or primary stockholders and their qualifications. Notes N.H. Admin. Code § Ph 2006.02 Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, …

An outsourcing facility shall maintain a procedure for the handling and disposal of returned goods. Notes N.H. Admin. Code § Ph 2006.03 Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, Effective 7/22/2017, Expires 7/22/2027.

(a) An outsourcing facility shall maintain a written policy for handling recalls and withdrawals for products. (b) Policies required by (a) above shall cover all recalls and withdrawals of compounded sterile products due to: (1) A voluntary action on the part of the compounder; (…

(a) The requirements of Ph 2006.05 shall be in addition to all record keeping and reporting requirements contained in all federal regulations and state rules. (b) Inventories and other records of transactions regarding the receipt and disposition of sterile compounded products sh…

(a) Outsourcing facilities shall be subject to inspections by the FDA on a risk-based schedule. (b) Information that is considered to contain trade secrets or which might be proprietary in nature shall be protected from public disclosure. Notes N.H. Admin. Code § Ph 2006.06 Deriv…

Compounded sterile drugs shall be dispensed in accordance with Ph 704. Notes N.H. Admin. Code § Ph 2007.01 Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, Effective 7/22/2017, Expires 7/22/2027.

(a) All outsourcing facilities licensed under this chapter shall comply with all applicable state and federal laws, rules, and regulations. (b) All outsourcing facilities licensed and doing business in New Hampshire, shall, before shipping or distributing any compounded sterile d…

All inspections shall be conducted as stated in Ph 2104, as part of an investigation process, and at the request of the various regulatory boards listed in RSA 318:8-a and RSA 318:9-a. Notes N.H. Admin. Code § Ph 2101.01 Derived from Volume XL Number 19, Filed May 7, 2020, Propos…

Registrants and licensees, including all pharmacists, pharmacies, and practitioners pursuant to RSA 318:8-a and RSA 318:9-a, shall permit the board investigators, board inspectors, and board commissioners to enter and inspect the premises and audit the records and operations for …

In addition to the definitions in RSA 318:1, the following definitions shall apply to this chapter: (a) "Clinics" means an institution, building, or part of a building devoted to the diagnosis and care of outpatient ambulatory patients. The term also includes public health clinic…

(a) All pharmacies shall be mailed, one to 3 months prior to inspection, a "Pre-Inspection Checklist" advising the pharmacist-in-charge or designated representative that the items listed in (b) below must be readily available to pharmacy board inspectors at the beginning of the i…

Inspections shall be: (a) For any facility involved in sterile compounding, scheduled up to one month in advance; (b) Unannounced for any other facility, notwithstanding the pre-inspection checklists sent to licensees in the quarter in which their inspection shall take place; (c)…

(a) Unless otherwise specified in this chapter, pharmacy board inspections shall be conducted at a minimum: (1) Annually for: a. Retail pharmacies; b. Institutional pharmacies; c. Compounding pharmacies; d. Public health clinics; and e. Methadone clinics.; (2) Every 3 years for: …

(a) Pharmacy inspections shall be conducted based on risk level as assigned by pharmacy board staff. (b) Risk level shall be assigned by the pharmacy board compliance staff following inspection and shall be reevaluated on a yearly basis or upon: (1) A review of previous inspectio…

(a) A self-inspection shall be conducted in accordance with, and documented upon, the self-inspection survey provided by the pharmacy board. (b) Upon a required self-inspection, the pharmacy board shall email to each licensee either: (1) A "Retail Self-Inspection Survey,# ph 538"…