Regulation .45 Acceptance of Non-Creditable Hazardous Waste Pharmaceuticals from Off Site.
Regulation .45 Acceptance of Non-Creditable Hazardous Waste Pharmaceuticals from Off Site.LinkCopy Citation
A.
This regulation establishes conditions under which a healthcare facility may accept non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that qualifies, under federal regulations, as a very small quantity generator (VSQG) of hazardous waste.
B.
Regulation .32F of this chapter specifies criteria that determine whether a generator of hazardous waste pharmaceuticals qualifies as a very small quantity generator of hazardous waste under federal regulations.
C.
A healthcare facility that does not have a permit or interim status that allows the facility to accept hazardous waste from off site may accept non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility if:
(1)
The off-site facility qualifies, under federal regulations, as a very small quantity generator (VSQG) of hazardous waste;
(2)
Either:
(a)
The receiving facility and the VSQG healthcare facility that is sending the non-creditable hazardous waste pharmaceuticals off site are under the control of the same person, as specified in §D of this regulation; or
(b)
The receiving facility has a contractual or other documented business relationship by which the receiving healthcare facility supplies pharmaceuticals to the VSQG healthcare facility; and
(3)
The receiving facility:
(a)
Is operating under the provisions of Regulations .32—.48 of this chapter for the management of the receiving facility’s non-creditable hazardous waste pharmaceuticals;
(b)
Manages the non-creditable hazardous waste pharmaceuticals that it receives from off site in compliance with the requirements of Regulations .32—.48 of this chapter; and
(c)
Keeps records of the non-creditable hazardous waste pharmaceuticals that the facility receives from off site for 3 years from the date that the shipment is received, except that the periods of retention of these records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity.
D.
For the purposes of this regulation:
(1)
“Person” has the meaning given by the definition in COMAR 26.13.01.03B; and
(2)
“Control”:
(a)
Means the power to direct the policies of the healthcare facility, whether by the ownership of stock, voting rights, or otherwise; and
(b)
Does not include the situation when a contractor operates healthcare facilities on behalf of a different person.