Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 85 - BOARD OF MEDICINE › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF MEDICINE, OSTEOPATHIC MEDICINE, PODIATRY, AND CHIROPRACTIC › Part IX - Mixing, Diluting, or Reconstituting of Drugs for Administration › Section 18VAC85-20-400 - Requirements for immediate-use sterile mixing, diluting, or reconstituting

Current through Register Vol. 40, No. 24, July 15, 2024
A. For the purposes
				  of this chapter, the mixing, diluting, or reconstituting of sterile
				  manufactured drug products when there is no direct contact contamination and
				  administration begins within 10 hours of the completion time of preparation
				  shall be considered immediate-use with the exception of drugs in fat emulsion
				  for which immediate use shall be one hour. If manufacturers' instructions or
				  any other accepted standard specifies or indicates an appropriate time between
				  preparation and administration of less than 10 hours, the mixing, diluting, or
				  reconstituting shall be in accordance with the lesser time. No direct contact
				  contamination means that there is no contamination from touch, gloves, bare
				  skin, or secretions from the mouth or nose. Emergency drugs used in the
				  practice of anesthesiology and administration of allergens may exceed 10 hours
				  after completion of the preparation, provided administration does not exceed
				  the specified expiration date of a multiple use vial and there is compliance
				  with all other requirements of this section.
B. Doctors of medicine or osteopathic
				  medicine who engage in immediate-use mixing, diluting, or reconstituting shall:
1. Utilize the practices and principles of
				  disinfection techniques, aseptic manipulations and solution compatibility in
				  immediate-use mixing, diluting, or reconstituting;
2. Ensure that all personnel under their
				  supervision who are involved in immediate-use mixing, diluting, or
				  reconstituting are appropriately and properly trained in and utilize the
				  practices and principles of disinfection techniques, aseptic manipulations, and
				  solution compatibility;
3.
				  Establish and implement procedures for verification of the accuracy of the
				  product that has been mixed, diluted, or reconstituted to include a second
				  check performed by a doctor of medicine or osteopathic medicine or by a
				  physician assistant or a registered nurse who has been specifically trained
				  pursuant to subdivision 2 of this subsection in immediate-use mixing, diluting,
				  or reconstituting. Mixing, diluting, or reconstituting that is performed by a
				  doctor of medicine or osteopathic medicine or by a specifically trained
				  physician assistant or registered nurse or mixing, diluting, or reconstituting
				  of vaccines does not require a second check;
4. Provide a designated, sanitary work space
				  and equipment appropriate for aseptic manipulations;
5. Document or ensure that personnel under
				  his supervision document in the patient record or other readily retrievable
				  record that identifies the patient; the names of drugs mixed, diluted or
				  reconstituted; and the date of administration; and
6. Develop and maintain written policies and
				  procedures to be followed in mixing, diluting, or reconstituting of sterile
				  products and for the training of personnel.