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Notes

40 C.F.R. §§ 266.505–266.508

4 sections in range

§266.505. Prohibition on sewering hazardous waste pharmaceuticals.

40 C.F.R. § 266.505

All healthcare facilities—including very small quantity generators operating under § 262.14 of this subchapter in lieu of this subpart—and reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly-owned treatment works. Healthcare facilities and reverse distributors remain subject to the prohibitions in 40 CFR 403.5(b).
Notes, amendments, and revision history

Amendments

[88 FR 54113, Aug. 9, 2023]

Source

Source: 84 FR 5940, Feb. 22, 2019, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017, 6905, 6906, 6912, 6921, 6922, 6924-6927, 6934, and 6937.

Source

Source: 50 FR 666, Jan. 4, 1985, unless otherwise noted.

Amendments

[88 FR 54113, Aug. 9, 2023]

§266.506. Conditional exemption for hazardous waste pharmaceuticals that are also controlled substances and household waste pharmaceuticals collected by an authorized collector.

40 C.F.R. § 266.506

(a)
Conditional exemptions. Provided the conditions of paragraph (b) of this section are met, the following are exempt from 40 CFR parts 262 through 273:
(1)
Hazardous waste pharmaceuticals that are also listed on a schedule of controlled substances by the Drug Enforcement Administration in 21 CFR part 1308, and
(2)
Household waste pharmaceuticals that are collected by an authorized collector (as defined by the Drug Enforcement Administration) registered with the Drug Enforcement Administration that commingles the household waste pharmaceuticals with controlled substances from an ultimate user (as defined by the Drug Enforcement Administration).
(b)
Conditions for exemption. The hazardous waste pharmaceuticals must be:
(1)
Managed in compliance with the sewer prohibition of § 266.505; and
(2)
Collected, stored, transported, and disposed of in compliance with all applicable Drug Enforcement Administration regulations for controlled substances; and
(3)
Destroyed by a method that Drug Enforcement Administration has publicly deemed in writing to meet their non-retrievable standard of destruction or combusted at one of the following:
(i)
A permitted large municipal waste combustor, subject to 40 CFR part 62 subpart FFF or applicable state plan for existing large municipal waste combustors, or 40 CFR part 60 subparts Eb for new large municipal waste combustors; or
(ii)
A permitted small municipal waste combustor, subject to 40 CFR part 62 subpart JJJ or applicable state plan for existing small municipal waste combustors, or 40 CFR part 60 subparts AAAA for new small municipal waste combustors; or
(iii)
A permitted hospital, medical and infectious waste incinerator, subject to 40 CFR part 62, subpart HHH, or applicable state plan for existing hospital, medical and infectious waste incinerators, or 40 CFR part 60, subpart Ec, for new hospital, medical and infectious waste incinerators; or
(iv)
A permitted commercial and industrial solid waste incinerator, subject to 40 CFR part 62, subpart III, or applicable state plan for existing commercial and industrial solid waste incinerators, or 40 CFR part 60, subpart CCCC, for new commercial and industrial solid waste incinerators; or
(v)
A permitted hazardous waste combustor subject to 40 CFR part 63 subpart EEE.
Notes, amendments, and revision history

Amendments

[84 FR 5940, Feb. 22, 2019, as amended at 88 FR 54113, Aug. 9, 2023]

Source

Source: 84 FR 5940, Feb. 22, 2019, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017, 6905, 6906, 6912, 6921, 6922, 6924-6927, 6934, and 6937.

Source

Source: 50 FR 666, Jan. 4, 1985, unless otherwise noted.

Amendments

[84 FR 5940, Feb. 22, 2019, as amended at 88 FR 54113, Aug. 9, 2023]

§266.507. Residues of hazardous waste pharmaceuticals in empty containers.

40 C.F.R. § 266.507

(a)
Stock, dispensing and unit-dose containers. A stock bottle, dispensing bottle, vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose container (e.g., a unit-dose packet, cup, wrapper, blister pack, or delivery device) is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals have been removed from the stock bottle, dispensing bottle, vial, ampule, or the unit-dose container using the practices commonly employed to remove materials from that type of container.
(b)
Syringes. A syringe is considered empty and the residues are not regulated as hazardous waste under this subpart provided the contents have been removed by fully depressing the plunger of the syringe. At healthcare facilities operating under this subpart, if a syringe is not empty, the syringe must be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subpart and any applicable federal, state, and local requirements for sharps containers and medical waste.
(c)
Intravenous (IV) bags. An IV bag is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals in the IV bag have been fully administered to a patient, or if the IV bag held non-acute hazardous waste pharmaceuticals and is empty as defined in § 261.7(b)(1) of this subchapter. At healthcare facilities operating under this subpart, if an IV bag is not empty, the IV bag must be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subpart.
(d)
Other containers, including delivery devices. At healthcare facilities operating under this subpart, hazardous waste pharmaceuticals remaining in all other types of unused, partially administered, or fully administered containers must be managed as non-creditable hazardous waste pharmaceuticals under this subpart, unless the container held non-acute hazardous waste pharmaceuticals and is empty as defined in § 261.7(b)(1) or (2) of this subchapter. This includes, but is not limited to, residues in inhalers, aerosol cans, nebulizers, tubes of ointments, gels, or creams.
Notes, amendments, and revision history

Amendments

[84 FR 5940, Feb. 22, 2019, as amended at 88 FR 54113, Aug. 9, 2023]

Source

Source: 84 FR 5940, Feb. 22, 2019, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017, 6905, 6906, 6912, 6921, 6922, 6924-6927, 6934, and 6937.

Source

Source: 50 FR 666, Jan. 4, 1985, unless otherwise noted.

Amendments

[84 FR 5940, Feb. 22, 2019, as amended at 88 FR 54113, Aug. 9, 2023]

§266.508. Shipping non-creditable hazardous waste pharmaceuticals from a healthcare facility or evaluated hazardous waste pharmaceuticals from a reverse distributor.

40 C.F.R. § 266.508

(a)
Shipping non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. A healthcare facility must ship non-creditable hazardous waste pharmaceuticals and a reverse distributor must ship evaluated hazardous waste pharmaceuticals off-site to a designated facility (such as a permitted or interim status treatment, storage, or disposal facility) in compliance with:
(1)
The following pre-transport requirements, before transporting or offering for transport off-site—
(i)
Packaging. Package the waste in accordance with the applicable Department of Transportation regulations on hazardous materials under 49 CFR parts 173, 178, and 180.
(ii)
Labeling. Label each package in accordance with the applicable Department of Transportation regulations on hazardous materials under 49 CFR part 172 subpart E.
(iii)
Marking.
(A)
Mark each package of hazardous waste pharmaceuticals in accordance with the applicable Department of Transportation (DOT) regulations on hazardous materials under 49 CFR part 172 subpart D;
(B)
Mark each container of 119 gallons or less used in such transportation with the following words and information in accordance with the requirements of 49 CFR 172.304:

HAZARDOUS WASTE—Federal Law Prohibits Improper Disposal. If found, contact the nearest police or public safety authority or the U.S. Environmental Protection Agency.

(C)
Lab packs that will be incinerated in compliance with § 268.42(c) of this subchapter are not required to be marked with EPA hazardous waste numbers (i.e., hazardous waste codes), except D004, D005, D006, D007, D008, D010, and D011, where applicable. A nationally recognized electronic system, such as bar coding or radio frequency identification tag, may be used to identify the applicable EPA hazardous waste numbers (i.e., hazardous waste codes).
(iv)
Placarding. Placard or offer the initial transporter the appropriate placards according to Department of Transportation regulations for hazardous materials under 49 CFR part 172 subpart F.
(2)
The manifest requirements of 40 CFR part 262 subpart B, except that—
(i)
A healthcare facility shipping noncreditable hazardous waste pharmaceuticals is not required to list all applicable EPA hazardous waste numbers (i.e., hazardous waste codes) in Item 13 of EPA Form 8700-22.
(ii)
A healthcare facility shipping non-creditable hazardous waste pharmaceuticals must write the word “PHRM” or “PHARMS” in Item 13 of EPA Form 8700-22. A healthcare facility may also include the applicable EPA hazardous waste numbers (i.e., hazardous waste codes) in Item 13 of EPA Form 8700-22.
(b)
Exporting non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. A healthcare facility or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to 40 CFR part 262 subpart H.
(c)
Importing non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. Any person that imports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to 40 CFR part 262 subpart H. A healthcare facility or reverse distributor may not accept imported non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals unless they have a permit or interim status that allows them to accept hazardous waste from off site.
Notes, amendments, and revision history

Amendments

[84 FR 5940, Feb. 22, 2019, as amended at 88 FR 54113, Aug. 9, 2023; 88 FR 84713, Dec. 6, 2023; 89 FR 99732, Dec. 11, 2024]

Source

Source: 84 FR 5940, Feb. 22, 2019, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017, 6905, 6906, 6912, 6921, 6922, 6924-6927, 6934, and 6937.

Source

Source: 50 FR 666, Jan. 4, 1985, unless otherwise noted.

Amendments

[84 FR 5940, Feb. 22, 2019, as amended at 88 FR 54113, Aug. 9, 2023; 88 FR 84713, Dec. 6, 2023; 89 FR 99732, Dec. 11, 2024]