N.J. Admin. Code § 13:39-11B.3 - Compounding antineoplastic agents and other hazardous products: sterile preparations

(a) Pharmacies shall not prepare antineoplastic agents and other hazardous substances as immediate use compounded sterile preparations.

(b) 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:

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 primary engineering control 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 primary engineering control shall be placed consistent with the standards set forth in USP 800.

2. 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 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.

(c) The ante area shall have appropriate environmental control devices capable of maintaining ISO class 7 air quality conditions for hazardous drug compounding activities as provided in (b)1 above.

(d) A pharmacy utilizing a compounding aseptic containment isolator not located in a cleanroom to compound antineoplastic agents and other hazardous substances shall comply with the requirements of (b)2 above.

(e) Effective up until the day before the effective date of USP 800 (currently, November 30, 2019), pharmacies shall compound antineoplastic agents and other hazardous substances only in:

1. A compounding aseptic containment isolator or a Class II or Class III biological safety cabinet in a negative pressure cleanroom. When handling volatile hazardous drugs, such devices shall be vented to the outside air; or

2. A compounding aseptic containment isolator located outside of a negative pressure cleanroom, consistent with N.J.A.C. 13:39-11.8. When handling volatile hazardous drugs, such devices shall be vented to the outside air.

(f) Effective on the effective date of USP 800 (currently, December 1, 2019), pharmacies shall compound antineoplastic agents and other hazardous substances consistent with the standards set forth in USP 800.

(g) Personnel who compound and dispense antineoplastic agents and other hazardous substances shall 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, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by NIOSH in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH Publication No. 2004-165 (2012 Edition) is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/. Effective on the effective date of USP 800 (currently, December 1, 2019), personnel shall also comply with the standards set forth in USP 800.

(h) Antineoplastic agents and other hazardous substances used to compound sterile preparations shall be 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.

(i) Effective on the effective date of USP 800 (currently, December 1, 2019), antineoplastic agents and other hazardous substances used to compound sterile preparations shall be stored and handled consistent with the standards set forth in USP 800.

Notes

N.J. Admin. Code § 13:39-11B.3

Amended by R.2019 d.007, effective 1/7/2019.
See: 50 N.J.R. 1468(a), 51 N.J.R. 91(a).
In (b)1, (b)2, and the introductory paragraph of (e), substituted "Effective up until the day before the effective date of USP 800 (currently, November 30, 2019)" for "Until June 30, 2018"; and in (b)1, (b)2, (f), (g), and (i), substituted "on the effective date of USP 800 (currently, December 1, 2019)" for "July 1, 2018".