Md. Code Regs. 10.34.19.03

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

Section 10.34.19.03 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Adverse event" means:

(a) Any adverse patient outcome related to the sterile compounding process; or

(b) Evidence of environmental contamination, including microbial contamination above the threshold set forth in USP 797 Standards.

(2) "Antineoplastic" means an agent that prevents the development, growth, or proliferation of malignant cells.

(3) "Anteroom" means the area, room, or rooms where personnel perform hand hygiene and garbing immediately adjacent to the designated clean room where the compounding of sterile preparations is performed.

(4) Batch.

(a) "Batch" means a preparation compounded in advance of receipt of a prescription, or a preparation compounded in a supply that will be used on more than one dispensing to a patient or patients or any preparation compounded in excess of the filling of an individual prescription.

(b) "Batch" includes a limited quantity of identical preparations compounded in a single, discrete process, by the same individuals, carried out during one limited time period.

(5) "Biological safety cabinet" means a containment unit:

(a) Suitable for work involving agents that pose higher risk of exposure to operators during compounding; and

(b) Used when there is a need for protection of the preparation, personnel, and environment.

(6) "Clean room" means a room with an International Standards Organization (ISO) Class 5 environment or an ISO Class 7 environment that meets USP 797 Standards, inside which compounding occurs within an ISO Class 5 engineering control device such as a laminar airflow workstation or a biological safety cabinet.

(7) "Closed system vial transfer device (CSTD)" means a closed system drug transfer device that mechanically, not by means of vents or filters, prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug aerosols or vapors into the environment.

(8) "Compounded sterile preparation" means sterile medication preparations, such as intravenous, epidural, and intraocular medications, compounded in the sterile compounding facility using currently accepted aseptic compounding techniques under acceptable compounding conditions.

(9) "Compounding" means the preparation, mixing, assembling packaging, or labeling of a drug:

(a) As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient relationship in the course of professional practice;

(b) For the purpose of or incidental to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device; or

(c) In anticipation of a prescription drug order based on routine, regularly observed prescribing patterns.

(10) "Compounding aseptic isolator" means an enclosed positive or negative pressure environment especially designed for sterile preparation compounding that maintains a physical barrier between the workspace and the operator.

(11) "Controlled environment" means a designated area for compounding sterile preparations that consists of a clean room and an anteroom.

(12) "Cytotoxic" means drug entities that are damaging or debilitating to cells, tissues, or organs.

(13) "Designee" means a public agency or private entity trained in:

(a) USP 797 Standards;

(b) FDA good manufacturing practices approved by the Board to conduct inspections of nonresident pharmacies that perform sterile compounding; or

(c) Both §B(13)(a) and (b) of this regulation.

(14) "Laminar air flow workstation" means an ISO Class 5 ("Class 100") laminar airflow hood inside which sterile compounding occurs.

(15) "Media fill verification" means a process of practical examination to verify the aseptic technique of personnel or an aseptic process by manual manipulation of microbiological growth media which simulates compounding processes and techniques used in actual compounding procedures.

(16) "Parenteral" means routes of drug administration or fluid administration other than via the gastrointestinal tract.

(17) "Pharmacist" means an individual who is licensed to practice pharmacy regardless of the location where the activities of practice are performed.

(18) "Pharmacy" means an establishment in which prescription or nonprescription drugs or devices are compounded, dispensed, or distributed.

(19) "Pyrogen testing" means an analysis of sterile preparations for the presence of cell material from microbiological organisms in sufficient quantity to elicit a febrile reaction.

(20) "Risk level" means a risk level of low, medium, or high as defined in USP 797 Standards.

(21) "Sterile" means free from living microorganisms or any other contaminants.

(22) "Sterile compounding" means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797 Standards, are prepared using aseptic techniques.

(23) "Total parenteral nutrition" means providing caloric needs by the parenteral route for a patient who is unable to ingest sufficient calories.

(24) "USP 795 Standards" means standards set forth in the US Pharmacopeia (USP) General Chapter 795 Pharmaceutical Compounding-Non-Sterile Preparations.

(25) "USP 797 Standards" means standards set forth in the U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding-Sterile Preparations.

Md. Code Regs. 10.34.19.03

Regulations .03 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .03B amended effective February 23, 2009 (36:4 Md. R. 354)
Regulation .03 amended effective 41:13 Md. R. 752, eff. 1/1/2015; amended effective 43:2 Md. R. 127, eff.2/1/2016