N.H. Admin. Code § Ph 2301.05

Current through Register No. 50, December 12, 2024

Section Ph 2301.05 - Drug Security

The institution drug security protocols shall be detailed in the institution's policies and procedures and shall include, but not be limited to, the following:

(a) Drugs stored in any area or department of the facility shall be labeled and kept secure and shall be accessible only to authorized personnel;

(b) When controlled drugs are stored in authorized areas other than in the pharmacy, special locked storage for all controlled substances requiring additional security shall be used;

(c) When using an automated medication supply system, a secure system shall be developed to assign, discontinue, or change personnel access codes;

(d) The institution shall have a pharmacy labeling, inspection, and inventory management system that ensures that outdated, mislabeled, or otherwise unusable medications shall not be available for patient use. Inspections by the institutional pharmacy shall be periodically performed but, at a minimum, no less than every 90 days; and

(e) A retrievable record of each inspection specified in (d) above shall be maintained in the pharmacy for at least 2 years and shall be available to the board upon request;

(f) Significant controlled drug losses shall be reported to the pharmacy within 24 hours and resolved within 72 hours. If the drug is determined to be missing or unaccounted for, it shall be reported to the board and DEA as specified by 21 CFR § 1301.76 -b.

(g) A pharmacy shall consider a controlled drug loss to be significant when:

(1) The percentage of dosage units of a specific drug exceeds 2% of monthly dispensing volume; or

(2) Fifteen or more dosage units are not accounted for.

(h) The written report referenced in (a) shall contain at least the following:

(1) Date of discovery;

(2) Identity of the person making the discovery;

(3) Name and location of the pharmacy from which the drug is missing;

(4) Name, strength, dosage form, NDC, and quantity of the missing drug(s); and

(5) Cause of the controlled drug loss as determined by the investigation.

N.H. Admin. Code § Ph 2301.05

Derived from Volume XLII Number 6, Filed February 10, 2022, Proposed by #13323, Effective 1/5/2022, Expires 1/5/2032