Regulation .47 Shipping Requirements — Non-creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals.
Regulation .47 Shipping Requirements — Non-creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals.LinkCopy Citation
A.
This regulation establishes requirements that apply to:
(1)
A healthcare facility shipping non-creditable hazardous waste pharmaceuticals off site; and
(2)
A reverse distributor shipping evaluated hazardous wastes pharmaceuticals off site.
B.
A person identified in §A of this regulation shall:
(1)
Ship the waste identified in §A of this regulation to a designated facility that is authorized to accept the specified hazardous waste by a hazardous waste facility permit, interim status authority, or other legal mechanism consistent with state and federal hazardous waste regulations; and
(2)
Ensure that the waste is transported by a transporter that has been issued a CHS Hauler Certificate in accordance with COMAR 26.13.04.01C.
C.
Pre-transport Requirements — Healthcare Facilities. A healthcare facility shall comply with the following requirements before transporting off site or offering for transport off site a non-creditable hazardous waste pharmaceutical:
(1)
Package the waste in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Parts 173, 178, and 180;
(2)
Label each package in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Part 172 Subpart E;
(3)
Mark each package of hazardous waste pharmaceuticals in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Part 172 Subpart D;
(4)
Mark each container of 119 gallons or less being used in the off-site shipment with the following words and information in accordance with the requirements of 49 CFR § 172.304:
(5)
Mark each lab pack container that will be incinerated in compliance with 40 CFR § 268.42(c) as follows:
(a)
Mark the container with EPA Hazardous Waste Numbers D004, D005, D006, D007, D008, D010, and D011, when applicable, by either:
(i)
Directly marking the applicable EPA Hazardous Waste Numbers on the container; or
(ii)
Using an electronic system for data capture, storage, and retrieval, such as bar coding or a radio frequency identification tag, if the electronic system allows the destination facility to be informed of the container's contents for the purposes of compliance with applicable hazardous waste management regulations; and
(b)
It is not necessary to mark the container with EPA Hazardous Waste Numbers other than those identified in §C(5)(a) of this regulation;
(6)
Placard the shipment or offer the initial transporter the appropriate placards according to U.S. Department of Transportation regulations for hazardous materials under 49 CFR Part 172, Subpart F.
D.
Pre-transport Requirements — Reverse Distributors. A reverse distributor shipping evaluated hazardous waste pharmaceuticals off site shall:
(1)
Comply with the requirements of §C of this regulation; and
(2)
Mark each container of 119 gallons or less that is being used in the off-site shipment with the EPA hazardous waste numbers of the wastes in the container by either:
(a)
Directly marking the applicable EPA Hazardous Waste Numbers on the container; or
(b)
Using a method described in §C(5)(a)(ii) of this regulation.
E.
Manifesting.
(1)
Except as specified in §E(2) of this regulation, a person identified in §A of this regulation shall comply with the manifest requirements of COMAR 26.13.03.04.
(2)
A healthcare facility shipping non-creditable hazardous waste pharmaceuticals:
(a)
Is not required to list all applicable hazardous waste numbers, also known as hazardous waste codes, in the “Waste Codes” section of the manifest form, item 13 of EPA Form 8700-22; and
(b)
Shall write either the code “PHRM” or the code “PHARMS” in the “Waste Codes” section of the manifest form, item 13 of EPA Form 8700-22.
F.
Export and Import Requirements.
(1)
A healthcare facility or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to COMAR 26.13.02.07.
(2)
Import Requirements.
(a)
A person that imports a non-creditable hazardous waste pharmaceutical or an evaluated hazardous waste pharmaceutical is subject to COMAR 26.13.02.07.
(b)
A healthcare facility or a reverse distributor may not accept an imported non-creditable hazardous waste pharmaceutical or an imported evaluated hazardous waste pharmaceutical unless the healthcare facility or reverse distributor has a permit or interim status that allows hazardous waste to be accepted from off site.