Md. Code Regs. 10.34.19.06

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.19.06 - Special Handling, Packaging, Labeling, and Beyond Use Dating

A. The pharmacy shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous sterile preparations, during handling and administration to the patient including:

(1) A reasonable effort to provide tamper-evident packaging if appropriate to setting;

(2) Proper in-transit storage consistent with preparation labeling; and

(3) Delivery to the patient within a reasonable time.

B. The dispensed container for any compounded sterile preparation shall include labeling according to Maryland law and regulations, in addition to the following information that is required by federal law:

(1) The date of preparation unless otherwise readily retrievable from prescription records;

(2) Time prepared, if applicable;

(3) The pertinent requirements for proper storage;

(4) The name of the prescriber, unless in an inpatient hospital setting;

(5) The name of the patient;

(6) Directions for use;

(7) The name of the base solution for infusion preparations;

(8) The name and concentration or amount of active drugs contained in the final sterile preparation;

(9) The name or identifying initials of the health care practitioner who checked or prepared the compounded sterile preparation unless otherwise readily retrievable from prescription records;

(10) The name, address, and telephone number of the sterile compounding facility unless in an inpatient hospital facility;

(11) The beyond-use/expiration dating and time of the compounded sterile preparation, and if no time is stated, the time is presumed to be at 11:59 p.m. of the stated beyond use date;

(12) Any ancillary and cautionary instructions as needed; and

(13) A pertinent warning consistent with applicable federal and State law that cytotoxic preparations are biohazardous, when applicable.

C. A sterile compounding facility compounding sterile infusion preparations shall provide a 24-hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its health care practitioners.

D. Expiration or Beyond-Use Dating. In the absence of direct testing evidence, as detailed in the Stability Criteria and Beyond Use Dating section of USP 795 Standards, the health care practitioner shall use "beyond-use dating" as determined by USP 797 Standards and reference materials as cited in Regulation .16 of this chapter.

Md. Code Regs. 10.34.19.06

Regulations .06 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .06A, D amended effective February 23, 2009 (36:4 Md. R. 354)
Regulation .06 amended effective 41:13 Md. R. 752, eff.1/1/2015; amended effective 43:2 Md. R. 127, eff.2/1/2016