New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 36 - COMPOUNDED STERILE PREPARATIONS › Section 16.19.36.15 - QUALITY ASSURANCE OF COMPOUNDED STERILE PREPARATIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. There shall be a documented, ongoing
				performance improvement control program that monitors personnel performance,
				equipment, and facilities:
(1) all aspects of
				sterile product preparation, storage, and distribution, including details such
				as the choice of cleaning materials and disinfectants and monitoring of
				equipment accuracy shall be addressed in policy and procedures;
(2) if non-sterile to sterile bulk
				compounding of more than 25 units of compounded sterile preparations is
				performed using non-sterile chemicals, containers, or devices, and the results
				of appropriate end product testing must be documented prior to the release of
				the product from quarantine; the test must include appropriate tests for
				particulate matter and pyrogens;
(3) there shall be documentation of quality
				assurance audits at regular, planned intervals, including infection control and
				sterile technique audits; a plan for corrective action of problems identified
				by quality assurance audits shall be developed which includes procedures for
				documentation of identified problems and action taken; a periodic evaluation as
				stated in the policy and procedures of the effectiveness of the quality
				assurance activities shall be completed and documented;
(4) the batch label of each sterile
				compounded product shall contain:
(a) drug
				product name(s), diluent names(s), and amount(s) of each;
(b) batch lot or control number;
(c) final concentration(s), and volume when
				appropriate, solution ingredient names and amounts;
(d) beyond use date, and time when
				applicable;
(e) route of
				administration when applicable;
(f)
				date of preparation;
(g) facility
				identifier; name or initials of person preparing the product and, if prepared
				by supportive personnel, the name or identifying initials and the name or
				initials of the pharmacist that completed the final check;
(h) when appropriate, ancillary instructions
				such as storage instructions orcautionary systems, including hazardous material
				warning labels and containment bags; and
(i) device instructions when needed.
(5) the patient specific
				label of a CSP shall contain:
(a) patient
				name;
(b) solution, ingredient
				names, amounts;
(c) beyond use
				date, and time when applicable;
(d)
				route of administration;
(e)
				directions for use, including infusion rates, specific times scheduled, when
				appropriate and applicable;
(f)
				identifier of person preparing the product and, if prepared by supportive
				personnel (i.e., pharmacist intern or pharmacy technician), the identifier of
				the pharmacist that completed the final check;
(g) when appropriate, ancillary instructions
				such as storage instructions or cautionary systems, including hazardous
				material warning labels and containment bags; and
(h) device instructions when
				needed;
(i) if dispensed for other
				than inpatient use, the label shall include all other required information.