New Hampshire Administrative Code

(a) Compliance with USP 795 and all applicable USP chapters related to non-sterile compounding shall be followed. (b) There are 3 general categories of non-sterile compounding described in this section that require different levels of experience, training and physical facilities.…

(a) A compounder shall have and maintain a permit issued by the board that allows for the compounding of sterile products as defined by the board. (b) When a compounder prepares more than 50 dosage units for non-patient specific preparations the compounder shall be registered as …

(a) Each compounder shall maintain documentation that confirms staff training and competency related to proper garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures prior to compounding of any actual sterile product preparatio…

(a) Each compounder shall ensure there is sufficient space for the type and amount of compounding done. (b) Each compounder shall ensure there is appropriate space for orderly placement of equipment and materials to prevent mix-ups between ingredients, containers, labels, in-proc…

(a) Each compounder shall ensure the PEC, LAFW and BSCs provide ISO Class 5 air quality; (b) Each compounder shall ensure the buffer room maintains a minimum of an ISO Class 7 air quality; (c) Each compounder shall ensure the buffer room is designed to reduce the risk of contamin…

(a) Each compounder shall ensure that all personnel adhere to the following when they are in the LAFW or buffer areas: (1) No smoking, food, drink, or chewing gum shall be allowed in the buffer area at any time; (2) No jewelry shall be worn on the hands or wrists and there shall …

(a) Compounder shall maintain the following records related to compounding of sterile products for at least 4 years: (1) PEC certification records; (2) GAP analyses; and (3) Detailed formulation record of each sterile compounded preparation that includes: a. Name of preparation, …

(a) Pharmacies engaged in the practice of compounding and dispensing parenteral solutions shall have current reference materials located in or immediately available to the pharmacy. (b) In addition to Ph 702.07(a)(7)(8), such reference materials shall include information on: (1) …

All sterile pharmaceutical solutions and products compounded and distributed by licensed facilities located out of state shall be in compliance with Ph 404. Notes N.H. Admin. Code § Ph 404.11 #6181-B, eff 2-5-96, EXPIRED: 2-5-04 New. #8316, eff 3-26-05 The amended version of this…

The practice of nuclear pharmacy is hereby recognized as a specialty of pharmacy practice, regulated by the state board of pharmacy. As such, the following rules are included to address those areas specific or unique to this specialty practice. Notes N.H. Admin. Code § Ph 405.01 …

(a) "Authentication of product history" means identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical or other drug. (b) "Nuclear pharmacy" means a pharmacy which provides radiopharmaceutical services. (c) "Pra…

(a) A permit to operate a pharmacy which provides radiopharmaceutical services shall only be issued to a person who is, or who employs, a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs s…

The pharmacy shall have at least the following equipment: (a) A radionuclide dose calibrator; (b) A refrigerator; (c) A single or multiple channel scintillation counter with well-type NaI (Tl) or Ge (Li) detector; (d) A radiochemical fume hood and filter system with air sampling …

(a) The ethical standards set forth in this part shall bind all licensed pharmacists, and a violation of any such standard shall be a basis for the imposition of disciplinary sanctions. (b) A licensed pharmacist shall comply with the law and accept the following ethical principle…

(a) No person shall act as a limited retail drug distributor, as defined in RSA 318:1,VII-a, without first obtaining a license to do so from the board according to RSA 318:51-b. (b) No license shall be issued or renewed for a limited retail drug distributor unless the same shall …

(a) Applications for licensure of limited retail drug distributors may be obtained from and filed at the board office, identified in Ph 103.03. Notes N.H. Admin. Code § Ph 601.02 Amended by Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12335, Effective 7/22/2017, E…

(a) The applicant for licensure shall complete and submit a "Limited Retail Drug Distributor of Medical Gases and/or Medical Devices" form, form MM-1, revised June 2017. (b) The applicant shall also submit the following:(1) A scaled drawing of the facility; (2) A copy of the stat…

All applicants licensed under the provisions of RSA 318:51-b shall have a written contract with a pharmacist, licensed in NH, to serve as a consultant on all matters relating to procurement, storage and dispensing of prescription drugs as defined in RSA 318:1, XVII. Notes N.H. Ad…

The applicant shall notify the board, immediately, of any changes of information from that which was submitted on the original application pursuant to Ph 601.03. Failure to report changes shall result in the imposition of a $25 administrative fine. No license shall be issued unti…

(a) The license period shall be from July 1 thru June 30 of every odd-numbered year. (b) Applications for renewal of a license to operate as a limited retail drug distributor shall consist of prescribed fee as indicated in Ph 601.01(e) and the following appropriate application fo…

The temperature in any area wherein drugs are compounded shall, at all times, be in compliance with the standards established by the United States Pharmacopoeia as defined in Ph 701.02(s). Notes N.H. Admin. Code § Ph 601.07 #8572, eff 2-23-06 Amended by Volume XXXVII Number 32, F…

Any drug, which is adulterated as defined in Ph 701.02(a) or misbranded as defined in Ph 701.02(j), shall be removed from the routine stock and held in a specifically designated secure area of the facility pending proper and safe disposition. Notes N.H. Admin. Code § Ph 601.08 #8…

Drugs shall be housed in a well-lighted and ventilated room or department with clean and sanitary surroundings. Notes N.H. Admin. Code § Ph 601.09 #8572, eff 2-23-06 Amended by Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12335, Effective 7/22/2017, Expires 7/22/2…

(a) That portion of the facility where drugs are stored, compounded, or dispensed, shall be lockable so as to prevent entry into that area by any person or persons without the knowledge of the authorized individuals on duty, or when the facility is not open. (b) If the facility c…

(a) Drugs shall be dispensed only by or in the presence of and under the supervision of a pharmacist, physician, advanced registered nurse practitioner, physician assistant, or registered nurse as identified in RSA 318:42 (a),VII, in compliance with state and federal pharmacy-rel…

(a) All drug order deliveries containing prescription drugs shall be delivered only when a licensed practitioner is on the premises in order to secure such drug orders. (b) In the case of methadone maintenance/detoxification facilities, drug deliveries may be accepted only by the…

(a) Only the pharmacist, physician, advanced registered nurse practitioner, physician assistant or registered nurse, as identified in RSA 318:42 shall have access to the drug supply. (b) In the case of methadone maintenance/detoxification facilities, access to the drug storage ar…

(a) A readily retrievable record, completed by the nursing or medical staff, shall be made of all administration or dispensing of prescription drugs from the facility. (b) The record, as specified in (a) above, shall be separate from the patient's medical record and include: (1) …

(a) Whenever an authorized practitioner dispenses a controlled drug, as defined in RSA 318-B:1-a and b, or a non-controlled prescription drug, as defined in RSA 318:1, XVII, he/she shall affix to the container in which such drug is dispensed, a label showing at least:(1) Name and…

The labeling requirements, as specified in Ph 601.15, shall be exempted when medication is being administered for immediate consumption, such as in a methadone maintenance/detoxification facility. Notes N.H. Admin. Code § Ph 601.16 #8572, eff 2-23-06 Amended by Volume XXXVII Numb…

Any person who distributes legend drugs according to RSA 318:51-b and the provisions of Ph 600, shall be subject to disciplinary action as provided in RSA 318:29. Notes N.H. Admin. Code § Ph 601.17 #8572, eff 2-23-06 Amended by Volume XXXVII Number 32, Filed August 10, 2017, Prop…

Pursuant to Ph 601.06, every person, or corporate entity that is not a licensed pharmacy, engaged in supplying medical gases to the consuming public, or to a patient or a patient's agent, in the state of New Hampshire, shall renew biennially with the board as a limited retail dru…

(a) The limited retail drug distributor license shall be posted in a conspicuous place in the wholesaler's place of business for which it is issued. (b) A medical gas supplier shall not: (1) Supply prescription medications, except medical gases, without appropriate licensure as a…

The provisions of this chapter shall apply to, and impose duties upon, all pharmacists, pharmacies, manufacturers, wholesalers and distributors holding licenses issued by the board. Notes N.H. Admin. Code § Ph 701.01 #1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss by #2914, eff 1…

Except where the context makes another meaning manifest, the following words mean: (a) "Adulterated drug" means any drug:(1) That is contaminated, decomposed, deteriorated, sub-potent, super-potent, or otherwise unsafe for administration to humans or other animals; (2) Which has …

(a) Persons subject to these rules shall comply with the following regulations and statutes as cited: (1) RSA 146, Purity and Branding of Foods and Drugs; (2) RSA 318, Pharmacists and Pharmacies; (3)RSA 318-B, the New Hampshire Controlled Drug Act; (4)21 USC Sections 300 through …

(a) The requirements of Ph 703 shall be in addition to all record keeping and reporting requirements contained in all federal and state rules and regulations. (b) Hard copies of prescription records and reports shall not be required to be maintained if they can be reproduced on d…

(a) Drugs shall be prepackaged in quantities suitable for internal distribution only by a pharmacist or by supportive personnel under the direct supervision of a pharmacist. (b) The label of a prepackaged unit shall indicate the:(1) Brand name and strength of the drug, or if no b…

(a) The pharmacist-in-charge or pharmacist on duty shall report to the board in writing, any theft or significant loss of controlled substances within one business day. The pharmacist-in-charge shall complete a New Hampshire Drug Loss Form (revised 5/2015) or DEA 106 Form and mai…

All pharmacies shall have an automated data processing system to be used for the storage of original, faxed or written prescriptions and the retrieval of refill information for all prescription orders including, but not limited to, controlled substances in schedules II, III, IV, …

All used DEA #222 order forms or any successor forms shall be maintained on the premises to which the forms and the corresponding DEA permit number were issued. In the case of on-line ordering of CII drugs, all records of such shall be maintained on said premises and be readily r…

The current compliance inspection report of the licensed location, conducted by the board, shall be kept on file in the prescription department. Notes N.H. Admin. Code § Ph 702.06 #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96 New. #6181-B, eff 2-5-96, E…

(a) Permit holders shall provide that every pharmacy shall have contained therein, at all times, the following: (1) Prescription labels showing the name, address, telephone number and DEA number of the pharmacy; (2) All equipment, supplies and drugs that are relevant to the pract…

(a) No pharmacist shall work more than 8 hours without a rest break of 30 minutes. Breaks shall be scheduled as close as possible to the same time each day so that patients may become familiar with the approximate break times. (b) Whenever the prescription department is staffed b…

All cough syrups containing codeine shall require a valid prescription. Notes N.H. Admin. Code § Ph 703.02 #1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96 New. #6181-B, eff 2-5-…

(a) All schedule III through V controlled substance prescription drug orders, as described in RSA 318-B:1-b, and transmitted by facsimile or as an electronic prescription, shall include: (1) The name and address of the patient; (2) The name, strength, and quantity of the drug pre…

Original prescription drug order information for drugs may be transferred between pharmacies for the purpose of refill dispensing subject to the following: (a) The transfer of controlled drug prescriptions shall be communicated between 2 licensed pharmacists, or a pharmacist and …