Ohio Admin. Code 3745-266-501 - Applicability - hazardous waste pharmaceuticals
(A)
A healthcare
facility that is a very small quantity generator when counting all of the
generator's hazardous waste, including both hazardous waste pharmaceuticals and
non-pharmaceutical hazardous waste, remains subject to rule 3745-52-14 of the
Administrative Code and is not subject to rules 3745-266-500 to 3745-266-510 of
the Administrative Code, except for rules 3745-266-505 and 3745-266-507 of the
Administrative Code and the optional provisions of rule 3745-266-504 of the
Administrative Code.
(B)
A healthcare facility that is a very small quantity
generator when counting all of the generator's hazardous waste, including both
hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, has the
option of complying with paragraph (D) of this rule for the management of the
hazardous waste pharmaceuticals as an alternative to complying with rule
3745-52-14 of the Administrative Code and the optional provisions of rule
3745-266-504 of the Administrative Code.
(C)
A healthcare
facility or reverse distributor remains subject to all applicable hazardous
waste regulations with respect to the management of non-pharmaceutical
hazardous waste.
(D)
With the exception of healthcare facilities identified
in paragraph (A) of this rule, a healthcare facility is subject to the
following in lieu of Chapters 3745-52, 3745-53, 3745-54 to 3745-57, 3745-65 to
3745-69, 3745-205, and 3745-256 of the Administrative Code:
(1)
Rules
3745-266-502 and 3745-266-505 to 3745-266-508 of the Administrative Code with
respect to the management of both of the following:
(a)
Non-creditable
hazardous waste pharmaceuticals.
(b)
Potentially
creditable hazardous waste pharmaceuticals if the potentially creditable
pharmaceuticals are not destined for a reverse distributor.
(2)
Paragraph (A) of rule 3745-266-502 and rules
3745-266-503, 3745-266-505 to 3745-266-507, and 3745-266-509 of the
Administrative Code 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 rules 3745-266-505 to 3745-266-510 of the
Administrative Code in lieu of Chapters 3745-52, 3745-53, 3745-54 to 3745-57,
3745-65 to 3745-69, 3745-205, and 3745-256 of the Administrative Code 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 rules 3745-266-500 to
3745-266-510 of the Administrative Code. Other generators are subject to
Chapter 3745-52 of the Administrative Code for the generation and accumulation
of hazardous wastes, including hazardous waste pharmaceuticals.
(G)
The following are
not subject to Chapters 3745-50, 3745-51, 3745-52, 3745-53, 3745-54 to 3745-57,
3745-65 to 3745-69, 3745-205, 3745-256, 3745-266, and 3745-273 of the
Administrative Code, except as specified:
(1)
Pharmaceuticals
that are not "waste," as defined in rule
3745-51-02 of
the Administrative Code, because the pharmaceuticals are legitimately used or
reused (e.g., lawfully donated for the pharmaceuticals' intended purpose) or
reclaimed.
(2)
Over-the-counter pharmaceuticals, dietary supplements,
or homeopathic drugs that are not "wastes," as defined in rule
3745-51-02 of
the Administrative Code, because the items have a reasonable expectation of
being legitimately used or reused (e.g., lawfully redistributed for the items'
intended purpose) or reclaimed.
(3)
Pharmaceuticals
being managed in accordance with a recall strategy that has been approved by
the food and drug administration (FDA) in accordance with 21 C.F.R. Part 7
subpart C. Rules 3745-266-500 to 3745-266-510 of the Administrative Code do
apply to the management of the recalled hazardous waste pharmaceuticals after
the FDA 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 C.F.R.
Part 1115. Rules 3745-266-500 to 3745-266-510 of the Administrative Code 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 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 FDA's regulations in 21 C.F.R. Part 312. Rules
3745-2636-500 to 3745-266-510 of the Administrative Code apply to the
management of the investigational new drug after the decision is made to
discard the investigational new drug or the FDA 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 paragraphs (A)(2) and (B) of rule 3745-266-506 of the
Administrative Code.
Notes
Promulgated Under: 119.03
Statutory Authority: 3734.12
Rule Amplifies: 3734.12
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.