N.J. Admin. Code § 13:39-11A.9

Current through Register Vol. 56, No. 11, June 3, 2024

Section 13:39-11A.9 - Equipment and supplies

(a) A pharmacy shall possess equipment appropriate to the type of compounding performed at the pharmacy.

(b) Equipment used in compounding drug products shall be of appropriate design and capacity, and shall be suitably located to facilitate operations for the intended use, cleaning, and maintenance of the equipment.

(c) Equipment used in compounding drug products shall be of suitable composition. Equipment surfaces that contact components shall not be reactive, additive, or adsorptive, so as to alter the safety, identity, strength, quality, and purity of the compounded product.

(d) Equipment used in compounding drug products shall be thoroughly cleaned and sanitized after each use, and when necessary, prior to use, in order to prevent cross-contamination of ingredients and preparations.

(e) Equipment used in compounding drug products shall be stored in a manner to prevent cross-contamination of ingredients and preparations.

(f) Automated, mechanical, or electronic equipment may be used in compounding non-sterile preparations. All equipment utilized in compounding non-sterile preparations shall be inspected, maintained, and validated at appropriate intervals, consistent with manufacturer's recommendations, to ensure the accuracy and reliability of equipment performance.

N.J. Admin. Code § 13:39-11A.9

Amended by 49 N.J.R. 3761(a), effective 12/4/2017