Section Ph 2505.01 - Requirements for the Automated Systems in Remote Sites(a) A provider pharmacy may provide pharmacy services to remote sites properly licensed in New Hampshire through the use of an automated pharmacy system.(b) An automated dispensing system shall only be used to provide pharmacy services to an inpatient or a resident of the remote site.(c) The pharmacy shall have security to prevent unauthorized access. Such method shall include at least one of the following: (1) Electronic password(s);(2) Biometric identification (optic scanning or fingerprint); or(3) Other coded identification.(d) All the drug inventory stored in the automated pharmacy system shall be owned by the provider pharmacy.(e) An automated dispensing system shall be under the supervision of a licensed pharmacist or licensed advanced pharmacy technician employed by the provider pharmacy who does not need to be the individual need not be physically present at the remote site if the system is supervised electronically.(f) The pharmacist in charge and permit holder shall ensure that the automated dispensing system complies with RSA 318-B and 21 C.F.R., relating to the regulation of controlled substances, for each automated pharmacy system that contains a controlled substance.(g) The pharmacist in charge shall ensure that the use of an automated dispensing system does not compromise patient confidentiality.(h) A medicinal drug may be removed from an automated dispensing system for administration to a patient only after a prescription or order has been received and approved by a pharmacist at the provider pharmacy.(i) A pharmacist at the provider pharmacy shall control all operations of the automated dispensing system and approve release of the initial dose of a prescription or order.(j) A subsequent dose from an approved prescription or order may be released without additional approval of a pharmacist except that any change made in a prescription or order shall require a new approval by a pharmacist to release the drug.(k) A pharmacist at the provider pharmacy shall comply with the patient record requirements and prospective drug use review requirements in the Ph 700 rules for every drug delivered through an automated pharmacy system.(l) The stocking or restocking of a medicinal drug in an automated dispensing system at the remote site shall be completed by a pharmacist, licensed advanced pharmacy technician, certified pharmacy technician, registered pharmacy technician, or designated health care professional except as provided in (n) below.(m) If the automated dispensing system uses removable cartridges or containers to store the drug, the stocking or restocking of the cartridges or containers may occur at the provider pharmacy and be sent to the remote site to be loaded by personnel designated by the pharmacist if:(1) A pharmacist or licensed advanced pharmacy technician verifies the cartridge or container has been properly filled and labeled;(2) The individual cartridge or container is transported to the remote site in a secure, tamper-evident container; and(3) The automated pharmacy system uses bar code verification, electronic verification, or similar process to assure that the cartridge or container is accurately loaded into the automated dispensing system by pharmacist, a certified pharmacy technician, registered technician, licensed advanced pharmacy technician, or designated health care professional.(n) A medicinal drug that has been removed from the automated dispensing system shall not be replaced into the system unless a pharmacist or licensed advanced pharmacy technician has examined the medication, packaging, and labeling and has determined that reuse of the medication is appropriate.(o) If a provider pharmacy intends to store a controlled substance in an automated dispensing system: (1) No additional DEA registration shall be required outside of the dispensing pharmacy if used as an e-kit only in accordance with Federal Register 24128; and(2) It may utilize one DEA registration to include multiple automated pharmacy systems located at a single address.(p) Controlled substances shall only be released from the automated dispensing system to authorized personnel by a supervising pharmacist in compliance with provisions in 21 CFR 1306.11 and 21 CFR 1306.21.(q) A provider pharmacy shall only store a medicinal drug at a remote site within an automated dispensing system which is locked by a mechanism that prevents access to a drug or to data by unauthorized personnel.(r) Access to the drugs shall be limited to a pharmacist, certified pharmacy technician, registered pharmacy technician, licensed advanced pharmacy technician employed by the provider pharmacy, or licensed personnel in the facility or institution who are authorized to administer medications.(s) An automated dispensing system that contains a controlled substance shall prohibit simultaneous access to multiple drug entities, drug strengths, or dosage forms of controlled substances.(t) If an automated dispensing system is utilized for both a medication order for a specific patient and a non-controlled emergency medication for which the review of a pharmacist is not required the record shall include: (1) The name of the medication;(3) The name of the prescriber;(4) The name of the person who accessed the automated dispensing system; and(5) The date and time of the release.(u) The record of transactions with the automated dispensing system shall be maintained in a readily retrievable manner.(v) The record shall be available to a compliance investigator from the office of professional licensure and certification or the board of pharmacy.(w) The record shall include: (1) Name or identification of the patient or resident;(2) Name, strength, and dosage form of the drug product released;(3) Quantity of drug released;(4) Date and time of each release of a drug;(5) Prescription number or order number;(6) Name of prescribing practitioner;(7) Identity of the pharmacist who approved the prescription or order; and(8) Identity of the person to whom the drug was released.(x) Records of all transaction with the automated dispensing system shall be maintained for 4 years.N.H. Admin. Code § Ph 2505.01
Derived from Volume XLII Number 45, Filed November 10, 2022, Proposed by #13465, Effective 12/19/2022, Expires 12/19/2032