Ala. Admin. Code r. 335-14-7-.16 - Hazardous Waste Pharmaceuticals
(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).
(2)
Standards for healthcare facilities managing non-creditable
hazardous waste pharmaceuticals
(a)
Notification and withdrawal
for healthcare facilities managing hazardous waste pharmaceuticals
1.
Notification. A
healthcare facility must notify the Department , using ADEM Form 8700-12
(Notification of Regulated Waste Activity), that it is a healthcare facility
operating under this subpart. A healthcare facility is not required to fill out
Schedule A part II.B (Characteristics of Nonlisted Hazardous Waste) and II.C
(Listed Hazardous Wastes) of the Notification of Regulated Waste Activity with
respect to its hazardous waste pharmaceuticals. A healthcare facility must
submit a separate notification (Notification of Regulated Waste Activity) for
each site or EPA identification number.
(i) A
healthcare facility that already has an EPA identification number must notify
the Department that it is a healthcare facility as part of its next
Notification of Regulated Waste Activity, if it is required to submit one; or
if not required to submit a Notification of Regulated Waste Activity, within 60
days of the effective date of
335-14-7-.16, or within 60 days
of becoming subject to
335-14-7-.16.
(ii) A healthcare facility that does not have
an EPA identification number must obtain one by notifying the Department that
it is a healthcare facility as part of its next Notification of Regulated Waste
Activity, if it is required to submit one; or if not required to submit a
Notification of Regulated Waste Activity, within 60 days of the effective date
of 335-14-7-.16, or within 60 days
of becoming subject to
335-14-7-.16.
(iii) A healthcare facility must keep a copy
of its notification on file for as long as the healthcare facility is subject
to 335-14-7-.16.
2.
Withdrawal. A healthcare facility that operated under
335-14-7-.16 but is no longer
subject to
335-14-7-.16, because it is a
very small quantity generator under
335-14-3-.01(4),
and elects to withdraw from
335-14-7-.16, must notify the
Department using ADEM Form 8700-12 (Notification of Regulated Waste Activity)
that it is no longer operating under
335-14-7-.16. A healthcare
facility is not required to fill out Schedule A part II.B (Characteristics of
Nonlisted Hazardous Waste) and II.C (Listed Hazardous Wastes) of the
Notification of Regulated Waste Activity with respect to its hazardous waste
pharmaceuticals. A healthcare facility must submit a separate notification
(Notification of Regulated Waste Activity) for each EPA identification number.
(i) A healthcare facility must submit the
Notification of Regulated Waste Activity notifying that it no longer intends to
operate subject to
335-14-7-.16 before it begins
operating under the conditional exemption of
335-14-3-.01(4).
(ii) A healthcare facility must keep a copy
of its withdrawal on file for three years from the date of signature on the
notification of its withdrawal.
(b)
Training of personnel
managing non-creditable hazardous waste pharmaceuticals at healthcare
facilities. A healthcare facility must ensure that all personnel
that manage non-creditable hazardous waste pharmaceuticals are thoroughly
familiar with proper waste handling and emergency procedures relevant to their
responsibilities during normal facility operations and emergencies.
(c)
Hazardous waste determination
for non-creditable pharmaceuticals. A healthcare facility that
generates a solid waste that is a non-creditable pharmaceutical must determine
whether that pharmaceutical is a hazardous waste pharmaceutical (i.e., it
exhibits a characteristic identified in
335-14-2-.03 or is listed in
335-14-2-.04) in order to
determine whether the waste is subject to
335-14-7-.16. A healthcare
facility may choose to manage its non-hazardous waste pharmaceuticals as
non-creditable hazardous waste pharmaceuticals under
335-14-7-.16.
(d)
Standards for containers used
to accumulate non-creditable hazardous waste pharmaceuticals at healthcare
facilities.
1. A healthcare
facility must place non-creditable hazardous waste pharmaceuticals in a
container that is structurally sound, compatible with its contents, and that
lacks evidence of leakage, spillage, or damage that could cause leakage under
reasonably foreseeable conditions.
2. A healthcare facility that manages
ignitable or reactive non-creditable hazardous waste pharmaceuticals, or that
mixes or commingles incompatible non-creditable hazardous waste pharmaceuticals
must manage the container so that it does not have the potential to:
(i) Generate extreme heat or pressure, fire
or explosion, or violent reaction;
(ii) Produce uncontrolled toxic mists, fumes,
dusts, or gases in sufficient quantities to threaten human health;
(iii) Produce uncontrolled flammable fumes or
gases in sufficient quantities to pose a risk of fire or explosions;
(iv) Damage the structural integrity of the
container of non-creditable hazardous waste pharmaceuticals; or
(v) Through other like means threaten human
health or the environment.
3. A healthcare facility must keep containers
of non-creditable hazardous waste pharmaceuticals closed and secured in a
manner that prevents unauthorized access to its contents.
4. A healthcare facility may accumulate
non-creditable hazardous waste pharmaceuticals and non-hazardous non-creditable
waste pharmaceuticals in the same container, except that non-creditable
hazardous waste pharmaceuticals prohibited from being combusted because of the
dilution prohibition of 40
CFR 268.3(c) [incorporated
by reference in
335-14-9-.01(3)]
must be accumulated in separate containers and labeled with all applicable
hazardous waste numbers (i.e., hazardous waste codes).
(e)
Labeling containers used to
accumulate non-creditable hazardous waste pharmaceuticals at healthcare
facilities. A healthcare facility must label or clearly mark each
container of non-creditable hazardous waste pharmaceuticals with the phrase
"Hazardous Waste Pharmaceuticals."
(f)
Maximum accumulation time for
non-creditable hazardous waste pharmaceuticals at healthcare
facilities
1. A healthcare
facility may accumulate non-creditable hazardous waste pharmaceuticals on site
for one year or less without a permit or having interim status.
2. A healthcare facility that accumulates
non-creditable hazardous waste pharmaceuticals on-site must demonstrate the
length of time that the non-creditable hazardous waste pharmaceuticals have
been accumulating, starting from the date it first becomes a waste. A
healthcare facility may make this demonstration by any of the following
methods:
(i) Marking or labeling the container
of non-creditable hazardous waste pharmaceuticals with the date that the
non-creditable hazardous waste pharmaceuticals became a waste;
(ii) Maintaining an inventory system that
identifies the date the non-creditable hazardous waste pharmaceuticals being
accumulated first became a waste;
(iii) Placing the non-creditable hazardous
waste pharmaceuticals in a specific area and identifying the earliest date that
any of the non-creditable hazardous waste pharmaceuticals in the area became a
waste.
(g)
Land disposal restrictions for non-creditable hazardous waste
pharmaceuticals. The non-creditable hazardous waste
pharmaceuticals generated by a healthcare facility are subject to 335-14-9. A
healthcare facility that generates non-creditable hazardous waste
pharmaceuticals must comply with
335-14-9-.01(7),
except that it is not required to identify the hazardous waste numbers (i.e.,
hazardous waste codes) on the land disposal restrictions
notification.
(h)
Procedures for healthcare facilities for managing rejected
shipments of non-creditable hazardous waste pharmaceuticals. A
healthcare facility that sends a shipment of non-creditable hazardous waste
pharmaceuticals to a designated facility with the understanding that the
designated facility can accept and manage the waste, and later receives that
shipment back as a rejected load in accordance with the manifest discrepancy
provisions of
335-14-5-.05(3)
or 335-14-6-.05(3)
may accumulate the returned non-creditable hazardous waste pharmaceuticals on
site for up to an additional 90 days provided the rejected or returned shipment
is managed in accordance with
335-14-7-.16(2)(d) and
(e). Upon receipt of the returned shipment,
the healthcare facility must:
1. Sign either:
(i) Item 18c of the original manifest, if the
original manifest was used for the returned shipment; or
(ii) Item 20 of the new manifest, if a new
manifest was used for the returned shipment;
2. Provide the transporter a copy of the
manifest;
3. Within 30 days of
receipt of the rejected shipment, send a copy of the manifest to the designated
facility that returned the shipment to the healthcare facility; and
4. Within 90 days of receipt of the rejected
shipment, transport or offer for transport the returned shipment in accordance
with the shipping standards of
335-14-7-.16(8)
(a).
(i)
Reporting by healthcare
facilities for non-creditable hazardous waste pharmaceuticals
1.
Biennial reporting by
healthcare facilities. Healthcare facilities are not subject to
biennial reporting requirements under
335-14-3-.04(2),
with respect to non-creditable hazardous waste pharmaceuticals managed under
this subpart.
2.
Exception reporting by healthcare facilities for a missing copy of
the manifest.
(i)
For shipments from a healthcare facility to a designated
facility:
(I) If a healthcare
facility does not receive a copy of the manifest with the signature of the
owner or operator of the designated facility within 60 days of the date the
non-creditable hazardous waste pharmaceuticals were accepted by the initial
transporter, the healthcare facility must submit:
I. A legible copy of the original manifest,
indicating that the healthcare facility has not received confirmation of
delivery, to the Department ; and
II. A handwritten or typed note on the
manifest itself, or on an attached sheet of paper, stating that the return copy
was not received and explaining the efforts taken to locate the non-creditable
hazardous waste pharmaceuticals and the results of those efforts.
(II)
[Reserved]
(ii)
For shipments rejected by
the designated facility and shipped to an alternate facility.
(I) If a healthcare facility does not receive
a copy of the manifest for a rejected shipment of the non-creditable hazardous
waste pharmaceuticals that is forwarded by the designated facility to an
alternate facility (using appropriate manifest procedures), with the signature
of the owner or operator of the alternate facility, within 60 days of the date
the non-creditable hazardous waste was accepted by the initial transporter
forwarding the shipment of non-creditable hazardous waste pharmaceuticals from
the designated facility to the alternate facility, the healthcare facility must
submit:
I. A legible copy of the original
manifest, indicating that the healthcare facility has not received confirmation
of delivery, to the Department ; and
II. A handwritten or typed note on the
manifest itself, or on an attached sheet of paper, stating that the return copy
was not received and explaining the efforts taken to locate the non-creditable
hazardous waste pharmaceuticals and the results of those efforts.
(II)
[Reserved]
3.
Additional
reports. The Department may require healthcare facilities to
furnish additional reports concerning the quantities and disposition of
non-creditable hazardous waste pharmaceuticals.
(j)
Recordkeeping by healthcare
facilities for non-creditable hazardous waste pharmaceuticals.
1. A healthcare facility must keep a copy of
each manifest signed in accordance with
335-14-3-.02(4)(a)
for three years or until it receives a signed copy from the designated facility
which received the non-creditable hazardous waste pharmaceuticals. This signed
copy must be retained as a record for at least three years from the date the
waste was accepted by the initial transporter.
2. A healthcare facility must keep a copy of
each exception report for a period of at least three years from the date of the
report.
3. A healthcare facility
must keep records of any test results, waste analyses, or other determinations
made to support its hazardous waste determination(s) consistent with
335-14-3-.01(2),
for at least three years from the date the waste was last sent to on-site or
off-site treatment, storage or disposal. A healthcare facility that manages all
of its non-creditable non-hazardous waste pharmaceuticals as non-creditable
hazardous waste pharmaceuticals is not required to keep documentation of
hazardous waste determinations.
4.
The periods of retention referred to in this section are extended automatically
during the course of any unresolved enforcement action regarding the regulated
activity, or as requested by the Department .
5. All records must be readily available upon
request by an inspector.
(k)
Response to spills of
non-creditable hazardous waste pharmaceuticals at healthcare
facilities. A healthcare facility must immediately contain all
spills of non-creditable hazardous waste pharmaceuticals and manage the spill
clean-up materials as non-creditable hazardous waste pharmaceuticals in
accordance with the applicable requirements of
335-14-7-.16.
(l)
Accepting non-creditable
hazardous waste pharmaceuticals from an off-site healthcare facility that is a
very small quantity generator. A healthcare facility may accept
non-creditable hazardous waste pharmaceuticals from an off-site healthcare
facility that is a very small quantity generator under
335-14-3-.01(4),
without a permit or without having interim status, provided the receiving
healthcare facility:
1. Is under the control
of the same person (as defined in
335-14-1-.02) as the very small
quantity generator healthcare facility that is sending the non-creditable
hazardous waste pharmaceuticals off-site ("control" means the power to direct
the policies of the healthcare facility, whether by the ownership of stock,
voting rights, or otherwise, except that contractors who operate healthcare
facilities on behalf of a different person as defined in
335-14-1-.01(2)
shall not be deemed to "control" such healthcare facilities) or has a
contractual or other documented business relationship whereby the receiving
healthcare facility supplies pharmaceuticals to the very small quantity
generator healthcare facility;
2.
Is operating under
335-14-7-.16 for the management
of its non-creditable hazardous waste pharmaceuticals;
3. Manages the non-creditable hazardous waste
pharmaceuticals that it receives from off site in compliance with
335-14-7-.16; and
4. Keeps records of the non-creditable
hazardous waste pharmaceuticals shipments it receives from off site for three
years from the date that the shipment is received.
(3)
Standards for
healthcare facilities managing potentially creditable hazardous waste
pharmaceuticals.
(a)
Hazardous waste determination for potentially creditable
pharmaceuticals. A healthcare facility that generates a solid
waste that is a potentially creditable pharmaceutical must determine whether
the potentially creditable pharmaceutical is a potentially creditable hazardous
waste pharmaceutical (i.e., it is listed in
335-14-2-.04 or exhibits a
characteristic identified in
335-14-2-.03). A healthcare
facility may choose to manage its potentially creditable non-hazardous waste
pharmaceuticals as potentially creditable hazardous waste pharmaceuticals under
335-14-7-.16.
(b)
Accepting potentially
creditable hazardous waste pharmaceuticals from an off-site healthcare facility
that is a very small quantity generator. A healthcare facility may
accept potentially creditable hazardous waste pharmaceuticals from an off-site
healthcare facility that is a very small quantity generator under
335-14-3-.01(4),
without a permit or without having interim status, provided the receiving
healthcare facility:
1. Is under the control
of the same person , as defined in
335-14-1-.01(2),
as the very small quantity generator healthcare facility that is sending the
potentially creditable hazardous waste pharmaceuticals off site, or has a
contractual or other documented business relationship whereby the receiving
healthcare facility supplies pharmaceuticals to the very small quantity
generator healthcare facility;
2.
Is operating under
335-14-7-.16 for the management
of its potentially creditable hazardous waste pharmaceuticals;
3. Manages the potentially creditable
hazardous waste pharmaceuticals that it receives from off site in compliance
with 335-14-7-.16; and
4. Keeps records of the potentially
creditable hazardous waste pharmaceuticals shipments it receives from off site
for three years from the date that the shipment is received.
(c)
Prohibition. Healthcare facilities are prohibited from
sending hazardous wastes other than potentially creditable hazardous waste
pharmaceuticals to a reverse distributor.
(d)
Biennial reporting by
healthcare facilities. Healthcare facilities are not subject to
biennial reporting requirements under
335-14-3-.04(2)
with respect to potentially creditable hazardous waste pharmaceuticals managed
under this subpart.
(e)
Recordkeeping by healthcare facilities.
1. A healthcare facility that initiates a
shipment of potentially creditable hazardous waste pharmaceuticals to a reverse
distributor must keep the following records (paper or electronic) for each
shipment of potentially creditable hazardous waste pharmaceuticals for three
years from the date of shipment:
(i) The
confirmation of delivery; and
(ii)
The shipping papers prepared in accordance with 49 CFR part 172 subpart C, if
applicable.
2. The
periods of retention referred to in this rule are extended automatically during
the course of any unresolved enforcement action regarding the regulated
activity, or as requested by the Department .
3. All records must be readily available upon
request by an inspector.
(f)
Response to spills of
potentially creditable hazardous waste pharmaceuticals at healthcare
facilities. A healthcare facility must immediately contain all
spills of potentially creditable hazardous waste pharmaceuticals and manage the
spill clean-up materials as non-creditable hazardous waste pharmaceuticals in
accordance with
335-14-7-.16.
(4)
Healthcare
facilities that are very small quantity generators for both hazardous waste
pharmaceuticals and non-pharmaceutical hazardous waste.
(a)
Potentially creditable
hazardous waste pharmaceuticals. A healthcare facility that is a
very small quantity generator for both hazardous waste pharmaceuticals and
nonpharmaceutical hazardous waste may send its potentially creditable hazardous
waste pharmaceuticals to a reverse distributor.
(b)
Off-site collection of
hazardous waste pharmaceuticals generated by a healthcare facility that is a
very small quantity generator. A healthcare facility that is a
very small quantity generator for both hazardous waste pharmaceuticals and
non-pharmaceutical hazardous waste may send its hazardous waste pharmaceuticals
off-site to another healthcare facility, provided:
1. The receiving healthcare facility meets
the conditions in
335-14-7-.16(2)(l)
and 335-14-7-.16(3)(b),
as applicable, or
2. The very small
quantity generator healthcare facility meets the conditions in
335-14-3-.01(4)(a)5.(viii)
and the receiving large quantity generator meets the conditions in
335-14-3-.01(7)(f).
(c)
Long-term care
facilities that are very small quantity generators. A long-term
care facility that is a very small quantity generator for both hazardous waste
pharmaceuticals and non-pharmaceutical hazardous waste may dispose of its
hazardous waste pharmaceuticals (excluding contaminated personal protective
equipment or clean-up materials) in an onsite collection receptacle of an
authorized collector (as defined by the Drug Enforcement Administration) that
is registered with the Drug Enforcement Administration provided the contents
are collected, stored, transported, destroyed and disposed of in compliance
with all applicable Drug Enforcement Administration regulations for controlled
substances.
(d)
Long-term care facilities with 20 beds or fewer. A
longterm care facility with 20 beds or fewer is presumed to be a very small
quantity generator subject to
335-14-3-.01(4)
for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste
and not subject to
335-14-7-.16, except for
335-14-7-.16(5)
and 335-14-7-.16(7)
and the other optional provisions of
335-14-7-.16(4).
The Department has the responsibility to demonstrate that a long-term care
facility with 20 beds or fewer generates quantities of hazardous waste that are
in excess of the very small quantity generator limits as defined in
335-14-1-.02(1).
A long-term care facility with more than 20 beds that operates as a very small
quantity generator under
335-14-3-.01(4)
must demonstrate that it generates quantities of hazardous waste that are
within the very small quantity generator limits as defined by
335-14-1-.02(1).
(5)
Prohibition of
sewering hazardous waste pharmaceuticals. All healthcare
facilities-including very small quantity generators operating under
335-14-3-.01(4)
in lieu of
335-14-7-.16 -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) (1).
(6)
Conditional exemptions for
hazardous waste pharmaceuticals that are also controlled substances and
household waste pharmaceuticals collected in a take-back event or
program.
(a)
Conditional exemptions. Provided the conditions of
335-14-7-.16(6)(b)
are met, the following are exempt from 335-14-3 through 335-14-11:
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 in a take-back event or program, including those 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
335-14-7-.16(5);
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.
(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
335-3-3-.05 for new commercial
and industrial solid waste incinerators.
(v) A permitted hazardous waste combustor
subject to 40 CFR part 63 subpart EEE.
(7)
Residues of
hazardous waste pharmaceuticals in empty containers.
(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. 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. 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, unless the IV bag held non-acute hazardous
waste pharmaceuticals and is empty as defined in
335-14-2-.01(7)(b)
1.
(d)
Other
containers, including delivery devices. 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
335-14-2-.01(7)(b)1.
or 2. This includes, but is not limited to, residues in inhalers, aerosol cans,
nebulizers, tubes of ointments, gels, or creams.
(8)
Shipping non-creditable
hazardous waste pharmaceuticals from a healthcare facility or evaluated
hazardous waste pharmaceuticals from a reverse distributor.
(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.
(I) 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;
(II) 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.
Healthcare Facility's or Reverse distributor's Name and Address ______________________________
Healthcare Facility's or Reverse distributor's EPA Identification
Number_________________________.
Manifest Tracking Number _____________________.
(III) Lab packs that will be incinerated in
compliance with
335-14-9-.04(3)
are not required to be marked with EPA Hazardous Waste Number(s), except D004,
D005, D006, D007, D008, D010, and D011, where applicable. A nationally
recognized electronic system, such as bar coding or radio frequency
identification, may be used to identify the EPA Hazardous Waste
Number(s).
(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
335-14-3-.02, except that:
(i) A healthcare facility shipping
non-creditable hazardous waste pharmaceuticals is not required to list all
applicable hazardous waste numbers (i.e., hazardous waste codes) in Item 13 of
EPA Form 8700-22 (Uniform Hazardous Waste Manifest).
(ii) A healthcare facility shipping
non-creditable hazardous waste pharmaceuticals must write the word "PHARMS" in
Item 13 of EPA Form 8700-22 (Uniform Hazardous Waste Manifest).
(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
335-14-3-.09.
(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 335-14-3-.09. 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.
(9)
Shipping potentially
creditable hazardous waste pharmaceuticals from a healthcare facility or a
reverse distributor to a reverse distributor.
(a)
Shipping potentially
creditable hazardous waste pharmaceuticals. A healthcare facility
or a reverse distributor who transports or offers for transport potentially
creditable hazardous waste pharmaceuticals off-site to a reverse distributor
must comply with all applicable U.S. Department of Transportation regulations
in 49 CFR part 171 through 180 for any potentially creditable hazardous waste
pharmaceutical that meets the definition of hazardous material in
49 CFR
171.8. For purposes of the Department of
Transportation regulations, a material is considered a hazardous waste if it is
subject to the Hazardous Waste Manifest Requirements of 335-14-3. Because a
potentially creditable hazardous waste pharmaceutical does not require a
manifest, it is not considered hazardous waste under the Department of
Transportation regulations.
(b)
Delivery confirmation. Upon receipt of each shipment
of potentially creditable hazardous waste pharmaceuticals, the receiving
reverse distributor must provide confirmation (paper or electronic) to the
healthcare facility or reverse distributor that initiated the shipment that the
shipment of potentially creditable hazardous waste pharmaceuticals has arrived
at its destination and is under the custody and control of the reverse
distributor.
(c)
Procedures for when delivery confirmation is not received within 35
days. If a healthcare facility or reverse distributor initiates a
shipment of potentially creditable hazardous waste pharmaceuticals to a reverse
distributor and does not receive delivery confirmation within 35 calendar days
from the date that the shipment of potentially creditable hazardous waste
pharmaceuticals was sent, the healthcare facility or reverse distributor that
initiated the shipment must contact the carrier and the intended recipient
(i.e., the reverse distributor) promptly to report that the delivery
confirmation was not received and to determine the status of the potentially
creditable hazardous waste pharmaceuticals.
(d)
Exporting potentially
creditable hazardous waste pharmaceuticals. A healthcare facility
or reverse distributor that sends potentially creditable hazardous waste
pharmaceuticals to a foreign destination must comply with the applicable
sections of
335-14-3-.09, except the
manifesting requirement of
335-14-3-.09(4),
in addition to
335-14-7-.16(9) (a) through
(c).
(e)
Importing potentially
creditable hazardous waste pharmaceuticals. Any person that
imports potentially creditable hazardous waste pharmaceuticals into Alabama
from outside the United States is subject to
335-14-7-.16(9)(a) through
(c) in lieu of
335-14-3-.09. Immediately after
the potentially creditable hazardous waste pharmaceuticals enter Alabama from
outside the United States, they are subject to all applicable requirements of
335-14-7-.16.
(10)
Standards for the
management of potentially creditable hazardous waste pharmaceuticals and
evaluated hazardous waste pharmaceuticals at reverse distributors.
A reverse distributor may accept potentially creditable hazardous waste
pharmaceuticals from off site and accumulate potentially creditable hazardous
waste pharmaceuticals or evaluated hazardous waste pharmaceuticals on site
without a hazardous waste permit or without having interim status, provided
that it complies with the following conditions:
(a)
Standards for reverse
distributors managing potentially creditable hazardous waste pharmaceuticals
and evaluated hazardous waste pharmaceuticals.
1.
Notification. A
reverse distributor must notify the Department , using ADEM Form 8700-12
(Notification of Regulated Waste Activity), that it is a reverse distributor
operating under
335-14-7-.16.
(i) A reverse distributor that already has an
EPA identification number must notify the Department , using ADEM Form 8700-12,
that it is a reverse distributor, as defined in
335-14-1-.02(1),
within 60 days of the effective date of
335-14-7-.16, or within 60 days
of becoming subject to
335-14-7-.16.
(ii) A reverse distributor that does not have
an EPA identification number must obtain one by notifying the Department , using
ADEM Form 8700-12, that it is a reverse distributor, as defined in
335-14-1-.02(1),
within 60 days of the effective date of
335-14-7-.16, or within 60 days
of becoming subject to
335-14-7-.16.
2.
Inventory by the
reverse distributor. A reverse distributor must maintain a current
inventory of all the potentially creditable hazardous waste pharmaceuticals and
evaluated hazardous waste pharmaceuticals that are accumulated on site.
(i) A reverse distributor must inventory each
potentially creditable hazardous waste pharmaceutical within 30 calendar days
of each waste arriving at the reverse distributor.
(ii) The inventory must include the identity
(e.g., name or national drug code) and quantity of each potentially creditable
hazardous waste pharmaceutical and evaluated hazardous waste
pharmaceutical.
(iii) If the
reverse distributor already meets the inventory requirements of
335-14-7-.16(10)(a)2.
because of other regulatory requirements, such as Alabama Board of Pharmacy
rules, the facility is not required to provide a separate inventory pursuant to
this rule.
3.
Evaluation by a reverse distributor that is not a
manufacturer. A reverse distributor that is not a pharmaceutical
manufacturer must evaluate a potentially creditable hazardous waste
pharmaceutical within 30 calendar days of the waste arriving at the reverse
distributor to establish whether it is destined for another reverse distributor
for further evaluation or verification of manufacturer credit or for a
permitted or interim status treatment, storage, or disposal facility.
(i) A potentially creditable hazardous waste
pharmaceutical that is destined for another reverse distributor is still
considered a potentially creditable hazardous waste pharmaceutical and must be
managed in accordance with
335-14-7-.16(10)(b).
(ii) A potentially creditable hazardous waste
pharmaceutical that is destined for a permitted or interim status treatment,
storage or disposal facility is considered an "evaluated hazardous waste
pharmaceutical" and must be managed in accordance with
335-14-7-.16(10)(c).
4.
Evaluation by a
reverse distributor that is a manufacturer. A reverse distributor
that is a pharmaceutical manufacturer must evaluate a potentially creditable
hazardous waste pharmaceutical to verify manufacturer credit within 30 calendar
days of the waste arriving at the facility and following the evaluation must
manage the evaluated hazardous waste pharmaceuticals in accordance with
335-14-7-.16(10)(c).
5.
Maximum accumulation time for
hazardous waste pharmaceuticals at a reverse distributor.
(i) A reverse distributor may accumulate
potentially creditable hazardous waste pharmaceuticals and evaluated hazardous
waste pharmaceuticals on site for 180 calendar days or less. The 180 days start
after the potentially creditable hazardous waste pharmaceutical has been
evaluated and applies to all hazardous waste pharmaceuticals accumulated on
site, regardless of whether they are destined for another reverse distributor
(i.e., potentially creditable hazardous waste pharmaceuticals) or a permitted
or interim status treatment, storage, or disposal facility (i.e., evaluated
hazardous waste pharmaceuticals).
(ii)
Aging
pharmaceuticals. Unexpired pharmaceuticals that are otherwise
creditable but are awaiting their expiration date (i.e., aging in a holding
morgue) can be accumulated for up to 180 days after the expiration date,
provided that the unexpired pharmaceuticals are managed in accordance with
335-14-7-.16(10)(a)
and the container labeling and management standards in
335-14-7-.16(10)(c)4.(i) through
(vi).
6.
Security at the reverse
distributor facility. A reverse distributor must prevent unknowing
entry and minimize the possibility for the unauthorized entry into the portion
of the facility where potentially creditable hazardous waste pharmaceuticals
and evaluated hazardous waste pharmaceuticals are kept.
(i) Examples of methods that may be used to
prevent unknowing entry and minimize the possibility for unauthorized entry
include, but are not limited to:
(I) A
24-hour continuous monitoring surveillance system;
(II) An artificial barrier such as a fence;
or
(III) A means to control entry,
such as keycard access.
(ii) If the reverse distributor already meets
the security requirements of
335-14-7-.16(10)(a)6.
because of other regulatory requirements, such as Drug Enforcement
Administration or Alabama Board of Pharmacy rules, the facility is not required
to provide separate security measures pursuant to this section.
7.
Contingency plan
and emergency procedures at a reverse distributor. A reverse
distributor that accepts potentially creditable hazardous waste pharmaceuticals
from off-site must prepare a contingency plan and comply with the other
requirements of
335-14-3-.14.
8.
Closure of a reverse
distributor. When closing an area where a reverse distributor
accumulates potentially creditable hazardous waste pharmaceuticals or evaluated
hazardous waste pharmaceuticals, the reverse distributor must comply with
335-14-3-.01(7)(a)8.(ii) and
(iii).
9.
Reporting by a reverse
distributor.
(i)
Unauthorized waste report. A reverse distributor must
submit an unauthorized waste report if the reverse distributor receives waste
from off site that it is not authorized to receive (e.g., nonpharmaceutical
hazardous waste, regulated medical waste). The reverse distributor must prepare
and submit an unauthorized waste report to the Department within 45 calendar
days after the unauthorized waste arrives at the reverse distributor and must
send a copy of the unauthorized waste report to the healthcare facility (or
other entity) that sent the unauthorized waste. The reverse distributor must
manage the unauthorized waste in accordance with all applicable regulations.
The unauthorized waste report must be signed by the owner or operator of the
reverse distributor, or its authorized representative, and contain the
following information:
(I) The EPA
identification number, name and address of the reverse distributor;
(II) The date the reverse distributor
received the unauthorized waste;
(III) The EPA identification number, name,
and address of the healthcare facility that shipped the unauthorized waste, if
available;
(IV) A description and
the quantity of each unauthorized waste the reverse distributor
received;
(V) The method of
treatment, storage, or disposal for each unauthorized waste; and
(VI) A brief explanation of why the waste was
unauthorized, if known.
(ii)
Additional
reports. The Department may require reverse distributors to
furnish additional reports concerning the quantities and disposition of
potentially creditable hazardous waste pharmaceuticals and evaluated hazardous
waste pharmaceuticals.
10.
Recordkeeping by reverse
distributors. A reverse distributor must keep the following
records (paper or electronic) readily available upon request by an inspector.
The periods of retention referred to in this section are extended automatically
during the course of any unresolved enforcement action regarding the regulated
activity, or as requested by the Department .
(i) A copy of its notification on file for as
long as the facility is subject to this subpart;
(ii) A copy of the delivery confirmation and
the shipping papers for each shipment of potentially creditable hazardous waste
pharmaceuticals that it receives, and a copy of each unauthorized waste report,
for at least three years from the date the shipment arrives at the reverse
distributor;
(iii) A copy of its
current inventory for as long as the facility is subject to this
subpart.
(b)
A dditional standards for reverse distributors managing potentially
creditable hazardous waste pharmaceuticals destined for another reverse
distributor. A reverse distributor that does not have a permit or
interim status must comply with the following conditions, in addition to the
requirements in
335-14-7-.16(10)(a),
for the management of potentially creditable hazardous waste pharmaceuticals
that are destined for another reverse distributor for further evaluation or
verification of manufacturer credit:
1. A
reverse distributor that receives potentially creditable hazardous waste
pharmaceuticals from a healthcare facility must send those potentially
creditable hazardous waste pharmaceuticals to another reverse distributor
within 180 days after the potentially creditable hazardous waste
pharmaceuticals have been evaluated or follow
335-14-7-.16(10)(c)
for evaluated hazardous waste pharmaceuticals.
2. A reverse distributor that receives
potentially creditable hazardous waste pharmaceuticals from another reverse
distributor must send those potentially creditable hazardous waste
pharmaceuticals to a reverse distributor that is a pharmaceutical manufacturer
within 180 days after the potentially creditable hazardous waste
pharmaceuticals have been evaluated or follow
335-14-7-.16(10)(c)
for evaluated hazardous waste pharmaceuticals.
3. A reverse distributor must ship
potentially creditable hazardous waste pharmaceuticals destined for another
reverse distributor in accordance with
335-14-7-.16(9).
4.
Recordkeeping by reverse
distributors. A reverse distributor must keep the following
records (paper or electronic) readily available upon request by an inspector
for each shipment of potentially creditable hazardous waste pharmaceuticals
that it initiates to another reverse distributor, for at least three years from
the date of shipment. The periods of retention referred to in this rule are
extended automatically during the course of any unresolved enforcement action
regarding the regulated activity, or as requested by the Department .
(i) The confirmation of delivery;
and
(ii) The DOT shipping papers
prepared in accordance with 49 CFR part 172 subpart C, if applicable.
(c)
Additional standards for reverse distributors managing evaluated
hazardous waste pharmaceuticals. A reverse distributor that does
not have a permit or interim status must comply with the following conditions,
in addition to the requirements of
335-14-7-.16(10)(a),
for the management of evaluated hazardous waste pharmaceuticals:
1.
Accumulation area at the
reverse distributor. A reverse distributor must designate an
on-site accumulation area where it will accumulate evaluated hazardous waste
pharmaceuticals.
2.
Inspections of on-site accumulation area. A reverse
distributor must inspect its on-site accumulation area at least once every
seven days, looking at containers for leaks and for deterioration caused by
corrosion or other factors, as well as for signs of diversion.
3.
Personnel training at a
reverse distributor. Personnel at a reverse distributor that
handle evaluated hazardous waste pharmaceuticals are subject to the training
requirements of
335-14-3-.01(7)(a)7.
4.
Labeling and
management of containers at on-site accumulation areas. A reverse
distributor accumulating evaluated hazardous waste pharmaceuticals in
containers in an on-site accumulation area must:
(i) Label the containers with the words,
"hazardous waste pharmaceuticals";
(ii) Ensure the containers are in good
condition and managed to prevent leaks;
(iii) Use containers that are made of or
lined with materials which will not react with, and are otherwise compatible
with, the evaluated hazardous waste pharmaceuticals, so that the ability of the
container to contain the waste is not impaired;
(iv) Keep containers closed, if holding
liquid or gel evaluated hazardous waste pharmaceuticals. If the liquid or gel
evaluated hazardous waste pharmaceuticals are in their original, intact, sealed
packaging; or repackaged, intact, sealed packaging, they are considered to meet
the closed container standard;
(v)
Manage any container of ignitable or reactive evaluated hazardous waste
pharmaceuticals, or any container of commingled incompatible evaluated
hazardous waste pharmaceuticals so that the container does not have the
potential to:
(I) Generate extreme heat or
pressure, fire or explosion, or violent reaction;
(II) Produce uncontrolled toxic mists, fumes,
dusts, or gases in sufficient quantities to threaten human health;
(III) Produce uncontrolled flammable fumes or
gases in sufficient quantities to pose a risk of fire or explosions;
(IV) Damage the structural integrity of the
container of hazardous waste pharmaceuticals; or
(V) Through other like means threaten human
health or the environment; and
(vi) Accumulate evaluated hazardous waste
pharmaceuticals that are prohibited from being combusted because of the
dilution prohibition of
335-14-9-.01(3)
(e.g., arsenictrioxide (P012)) in separate containers from other evaluated
hazardous waste pharmaceuticals at the reverse distributor.
5.
Hazardous waste
numbers. Prior to shipping evaluated hazardous waste
pharmaceuticals off site, all containers must be marked with the applicable
hazardous waste numbers (i.e., hazardous waste codes). A nationally recognized
electronic system, such as bar coding or radio frequency identification, may be
used to identify the EPA Hazardous Waste Number(s).
6.
Shipments. A
reverse distributor must ship evaluated hazardous waste pharmaceuticals that
are destined for a permitted or interim status treatment, storage or disposal
facility in accordance with the applicable shipping standards in
335-14-7-.16(8)(a) or
(b).
7.
Procedures for a reverse
distributor for managing rejected shipments. A reverse distributor
that sends a shipment of evaluated hazardous waste pharmaceuticals to a
designated facility with the understanding that the designated facility can
accept and manage the waste, and later receives that shipment back as a
rejected load in accordance with the manifest discrepancy provisions of
335-14-5-.05(3)
or 335-14-6-.05(3),
may accumulate the returned evaluated hazardous waste pharmaceuticals on site
for up to an additional 90 days in the on-site accumulation area provided the
rejected or returned shipment is managed in accordance with
335-14-7-.16(10) (a) and
(c). Upon receipt of the returned shipment,
the reverse distributor must:
(i) Sign
either:
(I) Item 18c of the original
manifest, if the original manifest was used for the returned shipment;
or
(II) Item 20 of the new
manifest, if a new manifest was used for the returned shipment;
(ii) Provide the transporter a
copy of the manifest;
(iii) Within
30 days of receipt of the rejected shipment of the evaluated hazardous waste
pharmaceuticals, send a copy of the manifest to the designated facility that
returned the shipment to the reverse distributor; and
(iv) Within 90 days of receipt of the
rejected shipment, transport or offer for transport the returned shipment of
evaluated hazardous waste pharmaceuticals in accordance with the applicable
shipping standards of
335-14-7-.16(8)(a) or
(b).
8.
Land disposal
restrictions. Evaluated hazardous waste pharmaceuticals are
subject to the land disposal restrictions of 335-14-9. A reverse distributor
that accepts potentially creditable hazardous waste pharmaceuticals from
off-site must comply with the land disposal restrictions in accordance with
335-14-9-.01(7).
9.
Reporting by a reverse
distributor for evaluated hazardous waste pharmaceuticals.
(i)
Biennial reporting by a
reverse distributor. A reverse distributor that ships evaluated
hazardous waste pharmaceuticals off-site must prepare and submit a single copy
of a biennial report to the Department by March 1 of each even numbered year in
accordance with
335-14-3-.04(2).
(ii)
Exception reporting by a
reverse distributor for a missing copy of the manifest.
(I)
For shipments from a reverse
distributor to a designated facility,
I. If a reverse distributor does not receive
a copy of the manifest with the signature of the owner or operator of the
designated facility within 35 days of the date the evaluated hazardous waste
pharmaceuticals were accepted by the initial transporter, the reverse
distributor must contact the transporter or the owner or operator of the
designated facility to determine the status of the evaluated hazardous waste
pharmaceuticals.
II. A reverse
distributor must submit an exception report to the Department if it has not
received a copy of the manifest with the signature of the owner or operator of
the designated facility within 45 days of the date the evaluated hazardous
waste pharmaceutical was accepted by the initial transporter. The exception
report must include:
a. A legible copy of the
manifest for which the reverse distributor does not have confirmation of
delivery; and
b. A cover letter
signed by the reverse distributor, or its authorized representative, explaining
the efforts taken to locate the evaluated hazardous waste pharmaceuticals and
the results of those efforts.
(II)
For shipments rejected by
the designated facility and shipped to an alternate facility,
I. A reverse distributor that does not
receive a copy of the manifest with the signature of the owner or operator of
the alternate facility within 35 days of the date the evaluated hazardous waste
pharmaceuticals were accepted by the initial transporter must contact the
transporter or the owner or operator of the alternate facility to determine the
status of the hazardous waste. The 35-day time frame begins the date the
evaluated hazardous waste pharmaceuticals are accepted by the transporter
forwarding the hazardous waste shipment from the designated facility to the
alternate facility.
II. A reverse
distributor must submit an Exception Report to the Department if it has not
received a copy of the manifest with the signature of the owner or operator of
the alternate facility within 45 days of the date the evaluated hazardous waste
pharmaceuticals were accepted by the initial transporter. The 45-day timeframe
begins the date the evaluated hazardous waste pharmaceuticals are accepted by
the transporter forwarding the hazardous waste pharmaceutical shipment from the
designated facility to the alternate facility. The Exception Report must
include:
(A) A legible copy of the manifest
for which the generator does not have confirmation of delivery; and
(B) A cover letter signed by the reverse
distributor, or its authorized representative, explaining the efforts taken to
locate the evaluated hazardous waste pharmaceuticals and the results of those
efforts.
10.
Recordkeeping by a reverse
distributor for evaluated hazardous waste pharmaceuticals.
(i) A reverse distributor must keep a log
(written or electronic) of the inspections of the on-site accumulation area,
required 335-14-7-.16(10)(c)2.
This log must be retained as a record for at least three years from the date of
the inspection.
(ii) A reverse
distributor must keep a copy of each manifest signed in accordance with
335-14-3-.02(4)(a)
for three years or until it receives a signed copy from the designated facility
that received the evaluated hazardous waste pharmaceutical. This signed copy
must be retained as a record for at least three years from the date the
evaluated hazardous waste pharmaceutical was accepted by the initial
transporter.
(iii) A reverse
distributor must keep a copy of each biennial report for at least three years
from the due date of the report.
(iv) A reverse distributor must keep a copy
of each exception report for at least three years from the submission of the
report.
(v) A reverse distributor
must keep records to document personnel training, in accordance with
335-14-3-.01(7)(a)7.(iv).
(vi) All records must be readily available
upon request by an inspector. The periods of retention referred to in this
section are extended automatically during the course of any unresolved
enforcement action regarding the regulated activity, or as requested by the
Department .
(d)
When a reverse distributor
must have a permit
. A reverse distributor is an operator of a
hazardous waste treatment, storage, or disposal facility and is subject to the
requirements of 335-14-5, 335-14-6, and the permit requirements of 335-14-8, if
the reverse distributor:
1. Does not meet the
conditions
335-14-7-.16;
2. Accepts manifested hazardous waste from
off site; or
3. Treats or disposes
of hazardous waste pharmaceuticals on site.
Notes
Author: Sonja B. Favors; Brent A. Watson; Jonah L. Harris
Statutory Authority: Code of Ala. 1975, §§ 22-30-10, 22-30-11, 22-30-12, 22-30-14, 22-30-15, 22-30-16, 22-30-19, 22-30-20.
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