§726.606. Conditional Exemptions for Controlled Substances and Household Hazardous Waste Pharmaceuticals

a)         Conditional Exemptions.  Provided the conditions of subsection (b) are met, the following are exempt from 35 Ill. Adm. Code 722 through 733:

 

1)         Hazardous waste pharmaceuticals that are also listed on a schedule of controlled substances by DEA in 21 CFR 1308.11 through 1308.15, incorporated by reference in 35 Ill. Adm. Code 720.111; and

 

2)         Household waste pharmaceuticals that are collected in a take-back event or program, including those that are collected by a "collector", as defined in 21 CFR 1300.01, incorporated by reference in 35 Ill. Adm. Code 720.111, that is registered with DEA and that commingles the household waste pharmaceuticals with controlled substances from an "ultimate user", as defined in 21 USC 802(27), incorporated by reference in 35 Ill. Adm. Code 720.111.

 

BOARD NOTE:  Corresponding 40 CFR 266.506(a)(2) exempts from regulation as hazardous waste hazardous waste pharmaceuticals collected in a take-back event or program by "an authorized collector (as defined by the Drug Enforcement Administration) that is registered with the Drug Enforcement Administration".  DEA rules define "collector" in 21 CFR 130001.  The DEA registration rules are in 21 CFR 1301.

 

b)         Conditions for Exemption.  The following conditions apply to hazardous waste pharmaceuticals:

 

1)         The hazardous waste pharmaceuticals must be managed in compliance with the sewer prohibition of Section 726.605;

 

2)         The hazardous waste pharmaceuticals must be collected, stored, transported, and disposed of in compliance with all applicable DEA regulations for controlled substances in 21 CFR 1300 through 1317, incorporated by reference in 35 Ill. Adm. Code 720.111; and

 

3)         The hazardous waste pharmaceuticals must be rendered "non-retrievable", as defined in 21 CFR 1300.05, under 21 CFR 1317.90 and 1317.95, each incorporated by reference in 35 Ill. Adm. Code 720.111, by a DEA registrant using a method that complies with this DEA standard of destruction or combusted at one of the following facilities:

 

A)        A permitted large municipal waste combustor, subject to the standards of subpart FFF of 40 CFR 62 or applicable state plan for existing large municipal waste combustors, or subpart Eb of 40 CFR 60 for new large municipal waste combustors;

 

B)        A permitted small municipal waste combustor, subject to subpart JJJ of 40 CFR 62 or applicable state plan for existing small municipal waste combustors, or subpart AAAA of 40 CFR 60 for new small municipal waste combustors;

 

C)        A permitted hospital, medical and infectious waste incinerator, subject to subpart HHH of 40 CFR 62 or applicable state plan for existing hospital, medical, and infectious waste incinerators, or subpart Ec of 40 CFR 60 for new hospital, medical, and infectious waste incinerators;

 

D)        A permitted commercial and industrial solid waste incinerator, subject to subpart III of 40 CFR 62 or applicable state plan for existing commercial and industrial solid waste incinerators, or subpart CCCC of 40 CFR 60 for new commercial and industrial solid waste incinerators; or

 

E)        A permitted hazardous waste combustor subject to subpart EEE of 40 CFR 63.

 

BOARD NOTE:  Corresponding 40 CFR 266.506(b)(3) allows destruction by a method deemed in writing by DEA to render the pharmaceutical "non-retrievable".  USEPA was not aware of any DEA methods approvals when adopting the rule.  USEPA intended that destruction comply with applicable DEA requirements.  84 Fed. Reg. 5816, 5897 (Feb. 22, 2019); 21 CFR 1317.90(a) (2019); 79 Fed. Reg. 53520, 53541 (Sep. 9, 2014).  The entity performing the destruction must be a DEA registrant.  Management of controlled substances is authorized within the scope of DEA registration.  21 USC 822(b) (2018).

 

(Source:  Added at 44 Ill. Reg. 15427, effective September 3, 2020)