COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS SUBSTANCES

Question 1

“Hazardous substances” shall mean:

Answer 1

those substances identified as hazardous by
the National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, Appendix A (2012 Edition)

Question 2

Pharmacies shall not:

Answer 2

prepare antineoplastic agents and other hazardous substances as immediate use compounded sterile preparations.

Question 3

A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity, respectively, consistent with the following:

Answer 3

1) Effective up until the day before the effective date of USP 800 (currently, November 30, 2019), for compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the PEC shall be placed in an ISO class 7 buffer room that is physically separated from other preparation areas and has not less than 0.01 inch water column negative pressure to adjacent positive pressure ISO class 7 or better ante room, thus providing inward airflow to contain any airborne drug. Effective on the effective date of USP 800 (currently, December 1, 2019), for compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the PEC shall be placed consistent with the standards set forth in USP 800

Question 4

Effective up until the day before the effective date of USP 800 (currently, November 30, 2019), for compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall be:

Answer 4

physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch water column and have a minimum of 12 air exchanges per hour. Effective on the effective date of USP 800 (currently, December 1, 2019), for compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall meet the standards set forth in USP 800

Question 5

The ante area shall have appropriate environmental control devices capable of maintaining:

Answer 5

ISO class 7 air quality conditions for hazardous drug compounding activities as provided in (b)1 above.

Question 6

Personnel who compound and dispense antineoplastic agents and other hazardous substances shall:

Answer 6

adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA’s Technical Manual on
Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA’s Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website

Question 7

Antineoplastic agents and other hazardous substances used to compound sterile preparations shall be:

Answer 7

stored separately from other inventory in a manner to prevent contamination and personnel exposure. Such storage is preferable within a containment area, such as a negative pressure room. The storage area shall have sufficient general exhaust, at least 12 air exchanges per hour to dilute and remove any airborne
contaminants. Antineoplastic agents and hazardous substances used to compound sterile preparations shall be handled with caution using appropriate chemotherapy gloves during distribution, receiving, stocking, inventorying, preparing for administration, and disposal.