Alabama Administrative Code › Title 335 - ALABAMA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT › LAND DIVISION - HAZARDOUS WASTE PROGRAM › Chapter 335-14-7 - STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTES AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES › Section 335-14-7-.16 - Hazardous Waste Pharmaceuticals

Current through Register Vol. 42, No. 9, June 28, 2024
(1)
Applicability
(a) A healthcare facility that is a very
				small quantity generator when counting all of its hazardous waste, including
				both its hazardous waste pharmaceuticals and its nonpharmaceutical hazardous
				waste, remains subject to
				335-14-3-.01(4)
				and is not subject to
				335-14-7-.16, except for
				335-14-7-.16(5)
				and 335-14-7-.16(7)
				and the optional provisions of
				335-14-7-.16(4).
(b) A healthcare facility that is a very
				small quantity generator when counting all of its hazardous waste, including
				both its hazardous waste pharmaceuticals and its nonpharmaceutical hazardous
				waste, has the option of complying with 335-141-7-.16(1)(d) for the management
				of its hazardous waste pharmaceuticals as an alternative to complying with
				335-14-3-.01(4)
				and the optional provisions of
				335-14-7-.16(4).
(c) A healthcare facility or reverse
				distributor remains subject to all applicable hazardous waste regulations with
				respect to the management of its non-pharmaceutical hazardous waste.
(d) With the exception of healthcare
				facilities identified in
				335-14-7-.16(1)(a),
				a healthcare facility is subject to the following in lieu of 335-14-3 through
				335-14-6:
1. Sections
				335-14-7-.16(2)
				and 335-14-7-.16(5)
				through 335-14-7-.16(8)
				with respect to the management of:
(i)
				Non-creditable hazardous waste pharmaceuticals, and
(ii) Potentially creditable hazardous waste
				pharmaceuticals if they are not destined for a reverse distributor. 2.
				335-14-7-.16(2)(a),
				335-14-7-.16(3),
				335-14-7-.16(5)
				through 335-14-7-.16(7)
				and 335-14-7-.16(9)
				with respect to the management of potentially creditable hazardous waste
				pharmaceuticals that are prescription pharmaceuticals and are destined for a
				reverse distributor.
(e) A reverse distributor is subject to
				335-14-7-.16(5)
				through 335-14-7-.16(10)
				in lieu of 335-14-3 through 335-14-6 with respect to the management of
				hazardous waste pharmaceuticals.
(f) Hazardous waste pharmaceuticals generated
				or managed by entities other than healthcare facilities and reverse
				distributors (e.g., pharmaceutical manufacturers and reverse logistics centers)
				are not subject to this subpart. Other generators are subject to 335-14-3 for
				the generation and accumulation of hazardous wastes, including hazardous waste
				pharmaceuticals.
(g) The following
				are not subject to 335-14-1 through 335-14-11, except as specified:
1. Pharmaceuticals that are not solid waste,
				as defined by
				335-14-2-.01(2)
				because they are legitimately used/ reused (e.g., lawfully donated for their
				intended purpose) or reclaimed.
2.
				Over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs
				that are not solid wastes, as defined by
				335-14-2-.01(2),
				because they have a reasonable expectation of being legitimately used/reused
				(e.g., lawfully redistributed for their intended purpose) or
				reclaimed.
3. Pharmaceuticals being
				managed in accordance with a recall strategy that has been approved by the Food
				and Drug Administration in accordance with 21 CFR part 7 subpart C. This
				subpart does apply to the management of the recalled hazardous waste
				pharmaceuticals after the Food and Drug Administration approves the destruction
				of the recalled items.
4.
				Pharmaceuticals being managed in accordance with a recall corrective action
				plan that has been accepted by the Consumer Product Safety Commission in
				accordance with 16 CFR part 1115 . This subpart does apply to the management of
				the recalled hazardous waste pharmaceuticals after the Consumer Product Safety
				Commission approves the destruction of the recalled items.
5. Pharmaceuticals stored according to a
				preservation order, or during an investigation or judicial proceeding until
				after the preservation order, investigation, or judicial proceeding has
				concluded and/or a decision is made to discard the pharmaceuticals.
6. Investigational new drugs for which an
				investigational new drug application is in effect in accordance with the Food
				and Drug Administration's regulations in 21 CFR part 312 . This subpart does
				apply to the management of the investigational new drug after the decision is
				made to discard the investigational new drug or the Food and Drug
				Administration approves the destruction of the investigational new drug, if the
				investigational new drug is a hazardous waste.
7. Household waste pharmaceuticals, including
				those that have been collected by an authorized collector (as defined by the
				Drug Enforcement Administration), provided the authorized collector complies
				with the conditional exemption in
				335-14-7-.16(6)(a)2.
				and 335-14-7-.16(6)(b).