WEBVTT

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>> You should be here for
management

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standards for hazardous waste
pharmaceuticals.

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>> I

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will call up the presentation
materials.

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I will turn things over to the
first speaker.

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>> Thank you. Welcome everybody.

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We are glad you could join us
today I

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will start us off, you will also
hear from my

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colleagues, we know we are
running a

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little over one hour, and that
will be followed by the

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Q&A session.

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>> We have time to cover the

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final rule out an introductory
level, it will assume you had a
working

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knowledge of the current
regulations. There's

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not a lot of detail, it is
conceptual, big picture.

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>> In the coming months we will
do longer trainings

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that will take a deeper dive.

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Here is an outline of the
presentation.

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The book will be spent going
over the individual provisions
of Subpart

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P.

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>> The final rule was signed by
the

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administration or back in
December of 2018.

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we posted this on the
publication on our website, it

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wasn't published until February
22nd because of the shutdown.

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>> The publication,

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is important, it drives the
effective dates as well as the
state adoption

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deadlines.

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>> Some states are already in
the process of adopting the
final

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rule, I want to make them aware,
the office of the register made

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tweaks to the numbering's and
headings.

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>> So the FR version is the

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one that is different from the
prepublication.

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If you have any questions, you
can contact me.

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>> Before we

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get into the meat of the
discussion, I want to look at
things

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at the big picture level Ist.

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>> I think of the

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pharmaceutical rule as three
rules in one, the first,

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Subpart P, the second is the
reverse logistics

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policy, and the third is the
amendment to the nicotine
listing.

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>> Under Subpart P there are
things we are

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trying to do, we are trying to
create regulations that are a
better

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fit for the health care sector.

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Instead of applying the standard
regulation,

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we are trying to get a better
fit with some new

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regulations.

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>> We were trying to eliminate
the attentional sewer ring a
pharmaceuticals,

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we are reducing the overlapping
regulations

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with DEA and FDA.

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>> We are providing

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regulatory clarity and
consistency on how RCRA

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applies to reverse distribution
and logistics.

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The logistics policy is
something we committed to in
2016.

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we will get into the
distinctions,

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we are dealing with
pharmaceuticals as well as
non-pharmaceuticals,

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in pharmaceuticals that appears
in Subpart P.

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>> In

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part 261. we reevaluate whether
therapies should be regulated

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as acute hazardous waste. And
provide regulatory relief by
amending

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the listing so not every corner
pharmacy is

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an LPG. That would provide
relief to the community and to
the states.

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>> Let's focus on Subpart P.

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The bulk of what we will talk
about is Subpart P,

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that is the way specific and a
sector specific

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final rule. It is for the
management of hazardous waste
pharmaceuticals,

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it is applicable at healthcare
facilities and reverse

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distributors.

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>> Whether or not people are
aware of this, these hazardous
wastes

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and the sector are already
regulated under RCRA

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and they have been since the
beginning of RCRA.

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>> We are not newly applying the
regulations is pharmaceuticals

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at healthcare facilities, we are
changing how they are regulated

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under RCRA moving forward.

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>> Thank you.

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I want to talk about the
effective dates and state
adoption,

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at this point you might not be
familiar with all parts but we
want to do

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this up front so you are aware
of the components.

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>> This rule goes into effect on
August 21st of this year,

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there are three different parts
that have dates,

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those of the nicotine
amendments, and the sewer
prohibition.

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>> The effective date

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will differ depending whether or
not the state is authorized or
not

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authorized, there are two not
authorize states which are Iowa

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and Alaska.

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EPA will implement the
regulations in

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those states.

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>> All parts will go into effect
on August 21st.

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Starting with the nicotine
amendment, it will be effective

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federally on August 21st, the
rule goes into effect six months

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after the publication in the
Federal Register, the amendment
will be

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in effect and not authorize
states, Indian countries and

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the US

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>> Territories.

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>> The amendment modifies the
listing so that means

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it applies to all generators not
just healthcare facilities.

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>> In states that are
authorized,

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the amendment will be in effect
if and when that state chooses

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to adopt, this part is
considered to be less stringent,

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authorize states are not
required to adopt it, and there
are no corresponding

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deadlines.

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>> We expect most states will
eventually adopt the nicotine

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amendment.

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>> Moving on to Subpart P, this
will

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be in effect on August 21st, in
the authorize states,

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the state has to adopt the
before Subpart P goes into
effect,

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and that is more stringent.

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Eventually all states will have
to adopt it which means

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it will provide increased
consistency which was one of the
big

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requests.

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>> Because the rule was
published

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in the Federal Register, the
adoption clock is ticking,

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authorize states have until July
1st of 2021 to adopt Subpart P

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unless they require a statutory
amendment.

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They would get an extra year.

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>> We expect many states will
adopt sooner, particularly
Pennsylvania

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and New Jersey and Virginia and
Washington.

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>> The sewer prohibition is
different,

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as promulgated under authority
and the

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regulations going into effect
six months after publication,
regardless

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of whether or not the state is
authorized.

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So the sewer prohibition will go
into effect in all states

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on August 21st whether or not
the state is authorized.

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It applies to all healthcare
facilities and reverse
distributors

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regardless of the generator
category.

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The prohibition applies to all
facilities and distributors and

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that will start on August 21st.

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>> This is a representation of
what

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I went through.

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Moving on to the rule itself,
starting with the amendment,

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this part is separate from
subpart P,

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in a men's part 261. it

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applies to all generators.

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>> You may be aware, nicotine is
considered

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an acute hazardous waste when
discarded.

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>> What the amendment does, it
modifies the listing so

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replacement therapies will no
longer be included.

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During the rule, we considered
comments,

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we conducted reviews and we
concluded that nicotine patches,
and lozenges

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do not meet the criteria for
acute hazardous waste.

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>> Nicotine patches and
lozenges, they can now

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be discarded as nonhazardous
waste.

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>> Some commenters expressed
concern about

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people dumpster diving, we
included some recommended best
practices

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to prevent a listed diversion.

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>> We are calling these things
FDA approved so

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you will hear that again.

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When we say OGC, we mean

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replacement therapies.

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>> Even though we removed FDA
approved

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OGC, nicotine is considered an
acute hazardous

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waste. Other unused formulations
will still be considered

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P075 when discarded including
cartridges and vials,

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prescription drugs, they can be
managed under

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Subpart P, some things that
cannot be managed

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are legacy pesticides, nicotine
used in research and
manufacturing,

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those are not pharmaceuticals.

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They have to be managed under
part 262.

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>> We will talk about reverse
distribution

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and logistics.

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>> One of the goals of the final

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rule is to provide regulatory
clarity surrounding
distribution.

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>> The

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final rule, we have adopt the
terminology suggested to us by
commenters,

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it distinguishes between reverse
distribution and logistics.
Distribution

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refers to the process of
prescription pharmaceuticals

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and they are evaluated, reverse
logistics refers to the

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process for nonprescription
pharmaceuticals and other unsold
retail items.

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They are evaluated.

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>> Commenters told us, there

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is a difference for prescription
pharmaceuticals,

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and nonprescription
pharmaceuticals.

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Nonprescription pharmaceuticals
and other retail items,

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they are evaluated whether or
not they can be

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reused, liquidated, donated.

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In this rule we finalized the
nonprescription pharmaceutical,

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will not be considered waste, if
they have

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a reasonable expectation of
being reused or being reclaimed.

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>> This is a visual
representation of the

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process.

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If they will be donated,
recycled,

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they can be sent from the
healthcare facility to the
logistics center.

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And they are evaluated.

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>> If they decide the item
cannot

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be used or reused, they need to
be properly disposed

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of.

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On the other hand, if at the
healthcare facility,

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the nonprescription
pharmaceutical has no

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reasonable expectation of use or
reuse, they need to be disposed

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of as hazardous waste by the
healthcare facility.

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>> For the reverse logistics,
this is

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status quo, you can see similar
language in the preamble,

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nonprescription pharmaceuticals
and other retail items

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are sent through this logistics
centers to be reevaluated.

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They can be sent from the retail
store and facility

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to the center, and not be
considered waste until a
decision is

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made.

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>> Commenters

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confirm that prescription
pharmaceuticals, they are
evaluated

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Are not reused or reclaimed,
they are

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discarded.

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>> The rescreened that from

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healthcare facilities, the
unused pharmaceuticals,

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they are not liquidated, donated
or sent for

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reclamation, they are discarded.

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>> The final rule maintains the
position that

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we put forth in the proposed
rule.

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The fact that these
pharmaceuticals have value in
the form

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of manufacturer credit, has
allowed us to take a tailored
approach.

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>> This is a visual
representation

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of the flow process, a
healthcare facility

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is potentially credible, if they
have

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a reasonable expectation of
receiving credit. The healthcare

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facility distributor has to
manage these under

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the new standard.

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>> The reverse distributor
evaluates the pharmaceutical

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and if it needs to be sent to
another distributor for
evaluation, they

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are considered potentially
credible.

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>> On the

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other hand, if the healthcare

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facility generates a
prescription pharmaceutical

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that has no reasonable
expectation of receiving credit
These are considered

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non-credible.

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They must be stent to the
disposal.

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>> We want to hammer home the
point

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that in the final rule, we
recognize the key distinction

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in the industry between
distribution and logistics.

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>> The processes exist prior to
the rule,

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commenters told us about them.

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We build the structure around
these, we codify the policy on

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reverse distribution in Subpart
P, it will

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not be effective in
non-authorized states until six
months after publication.

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>> Reverse logistics,

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other unsold retail items, they
are evaluated

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to see if they can be reclaimed.

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In the final rule, we

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finalize that nonprescription
pharmaceuticals will not be
considered waste,

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they have an expectation of
being

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reclaimed. We codify this in
Subpart P, this affirms the
existing policy

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and is effective immediately at
the federal level.

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States have taken a variety of
positions on reverse logistics,
check

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with your state to confirm the
policy.

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We will move on to Subpart P, we
defined many new

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terms.

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>> This is a list of all the
terms defined and I will walk
through

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a few of them. In particular the
definition of pharmaceutical,

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and healthcare facility. Who can
operate, and what those folks

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are allowed to manage.

319
00:21:05.067 --> 00:21:10.067
>> First we derive the
definition of pharmaceutical,

320
00:21:10.067 --> 00:21:16.067
we included things

321
00:21:16.067 --> 00:21:21.067
we might not think of as a
pharmaceutical, like
supplements,

322
00:21:21.067 --> 00:21:26.000
personal equipment, these are
included

323
00:21:26.000 --> 00:21:31.000
because what facilities to
manage hazardous waste streams
under the

324
00:21:31.000 --> 00:21:34.000
same standard.

325
00:21:34.000 --> 00:21:42.000
>> Electronic cigarettes

326
00:21:42.000 --> 00:21:47.000
and vaping pens are not part of
the exception, but they are
included

327
00:21:47.000 --> 00:21:51.000
in the final definition of
pharmaceutical so facilities can
have the benefit

328
00:21:51.000 --> 00:21:57.067
of manage them under Subpart

329
00:21:57.067 --> 00:22:02.067
P.

330
00:22:02.067 --> 00:22:10.067
>> On the right-hand side,

331
00:22:10.067 --> 00:22:15.067
you can see the things that are
not included in the definition
of

332
00:22:15.067 --> 00:22:18.067
pharmaceutical.

333
00:22:18.067 --> 00:22:22.067
>> There is another EP rule on
water that addresses the

334
00:22:22.067 --> 00:22:25.000
first bullet point.

335
00:22:25.000 --> 00:22:29.000
>> The hazardous

336
00:22:29.000 --> 00:22:35.000
waste pharmaceutical is a
pharmaceutical that is a solid
waste

337
00:22:35.000 --> 00:22:39.000
and exhibits one or more
characteristics or is listed. A
nonprescription

338
00:22:39.000 --> 00:22:44.000
pharmaceutical is not a solid
waste, it

339
00:22:44.000 --> 00:22:50.000
has a reasonable expectation of
being legitimately reclaimed.

340
00:22:50.000 --> 00:22:59.067
>> There are three types of
pharmaceuticals,

341
00:22:59.067 --> 00:23:05.067
first non-credible,

342
00:23:05.067 --> 00:23:07.067
they are the hazardous
pharmaceuticals

343
00:23:07.067 --> 00:23:13.067
I have no expectation of
receiving credit, for example,

344
00:23:13.067 --> 00:23:18.067
cleanup material, contaminated
PPE, these are things

345
00:23:18.067 --> 00:23:22.067
that have no possibility of
getting manufacturers

346
00:23:22.067 --> 00:23:25.000
credit.

347
00:23:25.000 --> 00:23:29.000
>> You can see

348
00:23:29.000 --> 00:23:33.000
a comprehensive list of examples
on the slide.

349
00:23:33.000 --> 00:23:42.000
>> It must be sent for hazardous
waste disposable.

350
00:23:42.000 --> 00:23:48.000
Second is a potentially credible
pharmaceutical, it is

351
00:23:48.000 --> 00:23:52.000
a prescription that has a
reasonable expectation of
receiving

352
00:23:52.000 --> 00:23:55.000
manufacturers credit and these
can be sent to a distributor

353
00:23:55.000 --> 00:23:58.000
for evaluation.

354
00:23:58.000 --> 00:24:01.000
>> These have to have a
reasonable expectation of
receiving credit

355
00:24:01.000 --> 00:24:02.834
and they have to meet three

356
00:24:02.834 --> 00:24:06.000
criteria, and original
manufacturer packaging,

357
00:24:06.000 --> 00:24:12.000
they must be un-dispensed, and
unexpired.

358
00:24:12.000 --> 00:24:15.000
>> Is important to

359
00:24:15.000 --> 00:24:21.000
note that healthcare facilities
do not need to know when the
pharmaceuticals

360
00:24:21.000 --> 00:24:25.000
will get credit, the distributor
knows the policy

361
00:24:25.000 --> 00:24:27.000
of the manufacturer and can
determine which pharmaceuticals

362
00:24:27.000 --> 00:24:30.000
get credit.

363
00:24:30.000 --> 00:24:36.000
>> The non-credible
pharmaceutical

364
00:24:36.000 --> 00:24:41.000
they are the ones that the
healthcare facility knows will
not get credit

365
00:24:41.000 --> 00:24:47.000
for whatever reason, the cleanup
materials and the spills,

366
00:24:47.000 --> 00:24:52.000
you cannot get credit.

367
00:24:52.000 --> 00:25:00.067
>> The third type

368
00:25:00.067 --> 00:25:05.067
is the evaluated pharmaceutical,
after they

369
00:25:05.067 --> 00:25:10.067
received the pharmaceutical, and
evaluates them, and determines
whether

370
00:25:10.067 --> 00:25:15.067
credit should be issued, they
become evaluated. They need to
be managed

371
00:25:15.067 --> 00:25:21.067
as evaluated pharmaceutical
under Subpart P.

372
00:25:21.067 --> 00:25:26.000
>> If the distributor says they
need to be

373
00:25:26.000 --> 00:25:32.000
sent to another distributor,
they can submit a credible

374
00:25:32.000 --> 00:25:41.000
distributor.

375
00:25:41.000 --> 00:25:45.000
Under the final rule, the
definition of healthcare

376
00:25:45.000 --> 00:25:51.000
facility includes things such
as, hospitals, dentists,

377
00:25:51.000 --> 00:25:57.067
doctors offices, they include
things that we might not
traditionally

378
00:25:57.067 --> 00:26:00.067
think of, like a pharmacy.

379
00:26:00.067 --> 00:26:03.067
>> We want them to manage their
hazardous pharmaceuticals

380
00:26:03.067 --> 00:26:06.067
under Subpart P.

381
00:26:06.067 --> 00:26:11.067
>> We included wholesale
distributors, we want to make
sure they can continue

382
00:26:11.067 --> 00:26:16.067
to make pharmaceuticals through
a

383
00:26:16.067 --> 00:26:21.067
reverse distributor, the
healthcare facility does not
include

384
00:26:21.067 --> 00:26:26.000
pharmaceutical manufacturers,
reverse distributors or
logistics centers.

385
00:26:26.000 --> 00:26:32.000
>> The definition of long-term

386
00:26:32.000 --> 00:26:38.000
care facility, it includes
nursing homes,

387
00:26:38.000 --> 00:26:41.000
hospice facilities, it does not
include assisted living
facilities

388
00:26:41.000 --> 00:26:44.000
or independent living
communities.

389
00:26:44.000 --> 00:26:50.000
Originally, we included
assisted-living facilities

390
00:26:50.000 --> 00:26:52.000
in the definition, but we did
not include them in the final

391
00:26:52.000 --> 00:26:57.067
definition to be more consistent
with the definition

392
00:26:57.067 --> 00:27:00.067
that DEA uses.

393
00:27:00.067 --> 00:27:12.067
>> I talked about the functions

394
00:27:12.067 --> 00:27:18.067
of reverse distributor already,
the final rule defines this

395
00:27:18.067 --> 00:27:22.067
as a person receives
prescriptions pharmaceuticals
for

396
00:27:22.067 --> 00:27:28.000
facilitating credit, this can
include forward distributors

397
00:27:28.000 --> 00:27:32.000
and manufacturers, if they are
processing pharmaceuticals for
credit, they

398
00:27:32.000 --> 00:27:36.000
are considered a reverse
distributor under the rule.

399
00:27:36.000 --> 00:27:42.000
>> The definition of reverse
distributor differs from

400
00:27:42.000 --> 00:27:46.000
DEA's definition, under DEA,
they register with the DEA, and

401
00:27:46.000 --> 00:27:51.000
take control of controlled
substances for disposal

402
00:27:51.000 --> 00:27:56.067
and sent to a manufacturer.
Under DEA, a reverse distributor

403
00:27:56.067 --> 00:28:01.067
does not need a process
pharmaceutical for determining
credit.

404
00:28:01.067 --> 00:28:06.067
>> The main function is to
destroy

405
00:28:06.067 --> 00:28:12.067
the controlled substances. Under
EPA, the reverse distributor

406
00:28:12.067 --> 00:28:15.067
exempts credible pharmaceuticals
for the purpose of evaluating

407
00:28:15.067 --> 00:28:18.067
credit.

408
00:28:18.067 --> 00:28:23.000
>> That covers the main terms. I
will

409
00:28:23.000 --> 00:28:28.000
hand things back to talk about
applicable he.

410
00:28:28.000 --> 00:28:34.000
>> Thank you.

411
00:28:34.000 --> 00:28:40.000
As we move forward and discuss
the remaining slides,

412
00:28:40.000 --> 00:28:49.000
we have set things up with
definitions, our job is to fill
in this chart

413
00:28:49.000 --> 00:28:55.067
with provisions of Subpart P,
it's conceptual,

414
00:28:55.067 --> 00:29:00.067
some highlights of the rule to
give you a broad outline.

415
00:29:00.067 --> 00:29:04.067
>> You can see with the headers,
without any of the

416
00:29:04.067 --> 00:29:10.067
content, you can see the
regulations depend on two
things,

417
00:29:10.067 --> 00:29:14.067
the type of facility, one column

418
00:29:14.067 --> 00:29:18.067
is standards for healthcare
facilities and the other is for
the standards

419
00:29:18.067 --> 00:29:22.067
for reverse distributors, it
depends upon the type of
hazardous waste

420
00:29:22.067 --> 00:29:25.000
pharmaceutical your managing.

421
00:29:25.000 --> 00:29:31.000
>> There are the three types, it
depends on whether it

422
00:29:31.000 --> 00:29:46.000
is credible, on the whole,

423
00:29:46.000 --> 00:29:52.000
part 266 is considered more
stringent, it is

424
00:29:52.000 --> 00:29:56.067
not optional, for the states to
adopt, and not optional for the

425
00:29:56.067 --> 00:30:01.067
healthcare facilities and
reverse distributors. So the
pharmaceuticals

426
00:30:01.067 --> 00:30:07.067
must be managed under Subpart P
by all distributors,

427
00:30:07.067 --> 00:30:13.067
there is one big if, about
healthcare facilities, if

428
00:30:13.067 --> 00:30:18.067
they generate above

429
00:30:18.067 --> 00:30:24.000
VSQG amounts of hazardous waste,
that is subject to Subpart P.

430
00:30:24.000 --> 00:30:29.000
>> We estimate about 80% of
healthcare facilities generate
small enough

431
00:30:29.000 --> 00:30:36.000
amounts of hazardous waste to be
the VSQG.

432
00:30:36.000 --> 00:30:40.000
>> All healthcare facilities
that generate

433
00:30:40.000 --> 00:30:48.000
above VSQG amounts and
distributors must manage under
Subpart P. So

434
00:30:48.000 --> 00:30:51.000
Subpart P is a waste specific
and sector

435
00:30:51.000 --> 00:30:54.000
specific rulemaking.

436
00:30:54.000 --> 00:30:59.067
>> Subpart P applies when a
facilities and

437
00:30:59.067 --> 00:31:04.067
distributors manage
pharmaceuticals and

438
00:31:04.067 --> 00:31:06.067
both criteria must be met.

439
00:31:06.067 --> 00:31:12.067
>> If you see the first row
about healthcare facilities, if
they

440
00:31:12.067 --> 00:31:15.067
manage pharmaceuticals, Subpart
P applies but if they are
managing

441
00:31:15.067 --> 00:31:21.067
other wastes, then Subpart P
does not apply, they are still
hazardous

442
00:31:21.067 --> 00:31:25.000
wastes but they are under
different parts of RCRA.

443
00:31:25.000 --> 00:31:31.000
>> If you look at the second
row, other facilities that are

444
00:31:31.000 --> 00:31:37.000
not healthcare facilities,
Subpart P will apply even when

445
00:31:37.000 --> 00:31:43.000
managing pharmaceuticals, they
are generating waste,

446
00:31:43.000 --> 00:31:48.000
and they are subject to RCRA
just not this new part.

447
00:31:48.000 --> 00:31:54.000
>> Was

448
00:31:54.000 --> 00:31:58.067
the facility is subject to
Subpart P,

449
00:31:58.067 --> 00:32:01.067
there are no generator
categories.

450
00:32:01.067 --> 00:32:07.067
The categories that we're
familiar with, those under

451
00:32:07.067 --> 00:32:11.067
part 262. all facilities are
regulated the

452
00:32:11.067 --> 00:32:16.067
same for managing the
pharmaceuticals and distributors
are regulated

453
00:32:16.067 --> 00:32:19.067
the same.

454
00:32:19.067 --> 00:32:24.000
>> The good news about that
healthcare facilities and
distributors

455
00:32:24.000 --> 00:32:28.000
do not have to keep track of how
much hazardous

456
00:32:28.000 --> 00:32:33.000
waste pharmaceuticals they
generate per month. And they do
not have

457
00:32:33.000 --> 00:32:37.000
to segregate acute and nonacute
pharmaceuticals.

458
00:32:37.000 --> 00:32:43.000
>> We are hopeful this will
provide

459
00:32:43.000 --> 00:32:46.000
an incentive for healthcare
facilities to over

460
00:32:46.000 --> 00:32:52.000
manage the nonhazardous waste
pharmaceuticals as hazardous
without having to worry

461
00:32:52.000 --> 00:32:55.067
about popping up the generator
category.

462
00:32:55.067 --> 00:33:02.067
>> Healthcare facilities,

463
00:33:02.067 --> 00:33:05.067
once you are operating under
Subpart P, the regulations will
remain

464
00:33:05.067 --> 00:33:08.067
the same.

465
00:33:08.067 --> 00:33:23.000
>> What is new in the final
rule,

466
00:33:23.000 --> 00:33:28.000
we added a list of
pharmaceuticals that are not

467
00:33:28.000 --> 00:33:33.000
subject to regulation, we added
this for clarity.

468
00:33:33.000 --> 00:33:38.000
>> The first

469
00:33:38.000 --> 00:33:44.000
couple of ones, we have talked
about, they were already
included in the

470
00:33:44.000 --> 00:33:48.000
definition, we also address them
in the applicability

471
00:33:48.000 --> 00:33:53.000
of the rule, pharmaceuticals are
not solid waste because they are

472
00:33:53.000 --> 00:33:56.000
legitimately used or reclaimed.

473
00:33:56.000 --> 00:34:01.000
>> They are not subject to RCRA
regulations,

474
00:34:01.000 --> 00:34:03.000
we wanted to accommodate
donations which are

475
00:34:03.000 --> 00:34:06.000
rare.

476
00:34:06.000 --> 00:34:09.000
>> We hope they will

477
00:34:09.000 --> 00:34:12.000
increase.

478
00:34:12.000 --> 00:34:18.000
>> The second one is

479
00:34:18.000 --> 00:34:22.067
OTC pharmaceuticals, if

480
00:34:22.067 --> 00:34:28.000
you have a reasonable
expectation of being used,

481
00:34:28.000 --> 00:34:33.000
let's focus on the next three,
recall pharmaceuticals,

482
00:34:33.000 --> 00:34:38.000
pharmaceuticals under
preservation order, and
investigational

483
00:34:38.000 --> 00:34:41.000
new drugs.

484
00:34:41.000 --> 00:34:45.000
Also not subject to RCRA.

485
00:34:45.000 --> 00:34:51.000
>> In the case of all three, we
are different to other

486
00:34:51.000 --> 00:34:57.067
agencies primarily FDA, to avoid
duplicate of

487
00:34:57.067 --> 00:35:03.067
regulations, RCRA will apply
when the other

488
00:35:03.067 --> 00:35:04.067
agencies we've all.

489
00:35:04.067 --> 00:35:10.067
When the pharmaceuticals are
discarded, then RCRA will apply.

490
00:35:10.067 --> 00:35:14.067
>> Number six,

491
00:35:14.067 --> 00:35:22.067
the household waste
pharmaceuticals, household
disposal of waste is

492
00:35:22.067 --> 00:35:25.000
exempt federal.

493
00:35:25.000 --> 00:35:31.000
As with the DA regulations, when
collected,

494
00:35:31.000 --> 00:35:34.000
the healthcare facilities that
are DD registrants

495
00:35:34.000 --> 00:35:46.000
of Housel pharmaceuticals must
comply with conditions.

496
00:35:46.000 --> 00:35:50.000
>> As long as it is discarded by
the

497
00:35:50.000 --> 00:35:56.067
household, it is still exempt
but when collected,

498
00:35:56.067 --> 00:35:59.067
there are a few conditions.

499
00:35:59.067 --> 00:36:06.067
>> For the

500
00:36:06.067 --> 00:36:22.067
visual learners, we are diagram
the applicability.

501
00:36:22.067 --> 00:36:27.000
Let's talk about the
prescription pharmaceuticals

502
00:36:27.000 --> 00:36:30.000
first.

503
00:36:30.000 --> 00:36:35.000
>> Here are the three types of
pharmaceuticals.

504
00:36:35.000 --> 00:36:41.000
The non-credible, potentially
credible, evaluated.

505
00:36:41.000 --> 00:36:45.000
>> For prescription
pharmaceuticals

506
00:36:45.000 --> 00:36:50.000
in all cases, Subpart P will
apply to the management,

507
00:36:50.000 --> 00:36:55.067
when they are not credible, when
they are evaluated, reverse
distributors

508
00:36:55.067 --> 00:37:01.067
for them, the waste consist
exclusively

509
00:37:01.067 --> 00:37:06.067
of pharmaceuticals. So Subpart P
is the more appropriate

510
00:37:06.067 --> 00:37:09.067
regulatory scheme.

511
00:37:09.067 --> 00:37:23.000
>> With nonprescription
pharmaceuticals,

512
00:37:23.000 --> 00:37:28.000
it is a different situation.

513
00:37:28.000 --> 00:37:34.000
For the non-credible,
nonprescription, it is similar
to prescriptions,

514
00:37:34.000 --> 00:37:39.000
we will be applying Subpart P,
this will

515
00:37:39.000 --> 00:37:44.000
allow facilities to manage all
the waste pharmaceuticals both
prescription

516
00:37:44.000 --> 00:37:48.000
and nonprescription, the same
when they are destined directly
from

517
00:37:48.000 --> 00:37:53.000
the facility to a TSDF, so not
credible

518
00:37:53.000 --> 00:37:57.067
is the one type of hazardous
waste pharmaceutical that
includes prescription

519
00:37:57.067 --> 00:38:01.067
and nonprescription
pharmaceuticals.

520
00:38:01.067 --> 00:38:06.067
>> Otherwise, nonprescription
pharmaceuticals

521
00:38:06.067 --> 00:38:12.067
are not subject to Subpart P,
the stuff that is destined for

522
00:38:12.067 --> 00:38:18.067
the logistics center, the status
quo,

523
00:38:18.067 --> 00:38:20.067
Subpart P will not apply.

524
00:38:20.067 --> 00:38:23.000
It is not considered a solid
waste.

525
00:38:23.000 --> 00:38:29.000
>> Likewise, the stuff going
from reverse logistics

526
00:38:29.000 --> 00:38:35.000
centers to a TSDF, Subpart P
will not apply will continue

527
00:38:35.000 --> 00:38:39.000
to be regulated under part 262
of

528
00:38:39.000 --> 00:38:42.000
the regulations.

529
00:38:42.000 --> 00:38:48.000
>> Labor --

530
00:38:48.000 --> 00:38:53.000
they have different types of
hazardous waste besides
pharmaceuticals,

531
00:38:53.000 --> 00:38:56.067
without applying 266. excuse me,
262 is more

532
00:38:56.067 --> 00:38:59.067
appropriate.

533
00:38:59.067 --> 00:39:08.067
>> We will discuss the
standards.

534
00:39:08.067 --> 00:39:13.067
>> I will talk about

535
00:39:13.067 --> 00:39:19.067
some of your ministry
requirements, all

536
00:39:19.067 --> 00:39:23.000
facilities that are subject to
Subpart P have to submit a one
time notification

537
00:39:23.000 --> 00:39:34.000
that they are operating under
Subpart P,

538
00:39:34.000 --> 00:39:37.000
we have been working with the
data and reporting collects to
make sure

539
00:39:37.000 --> 00:39:40.000
the changes that are required
will be implemented in time for
the effective

540
00:39:40.000 --> 00:39:43.000
date.

541
00:39:43.000 --> 00:39:47.000
>> There are two different time
frames in which

542
00:39:47.000 --> 00:39:53.000
you have to notify, facilities

543
00:39:53.000 --> 00:39:59.067
that are not required to submit
BR has to notify within

544
00:39:59.067 --> 00:40:04.067
60 days, for non-authorized
states, notifications are due on
the 20th

545
00:40:04.067 --> 00:40:08.067
of October. Facilities that are
required to submit the

546
00:40:08.067 --> 00:40:13.067
BR to notify on the normal
cycle.

547
00:40:13.067 --> 00:40:18.067
>> And non-authorized states,
notifications

548
00:40:18.067 --> 00:40:24.000
will be due on March 1st.

549
00:40:24.000 --> 00:40:30.000
In some states, as

550
00:40:30.000 --> 00:40:35.000
TG is required to submit BR, if
you have to submit

551
00:40:35.000 --> 00:40:38.000
the BR report on the normal
reporting cycle.

552
00:40:38.000 --> 00:40:40.200
>> The training standards that

553
00:40:40.200 --> 00:40:43.000
we finalize, are
performance-based,

554
00:40:43.000 --> 00:40:48.000
they are not prescriptive, they
say, all personnel that manages

555
00:40:48.000 --> 00:40:52.000
hazardous waste pharmaceuticals
have to be familiar

556
00:40:52.000 --> 00:41:00.067
with the proper handling and
procedures relevant to their
responsibilities.

557
00:41:00.067 --> 00:41:15.067
>> This highlights

558
00:41:15.067 --> 00:41:19.067
the management standards for
pharmaceutical waste, when the

559
00:41:19.067 --> 00:41:24.000
fundamental aspects of Subpart P
is that facilities have to make

560
00:41:24.000 --> 00:41:30.000
determinations for all the
pharmaceuticals they generate,
facilities have

561
00:41:30.000 --> 00:41:34.000
to determine whether each
pharmaceutical waste is
hazardous and that applies

562
00:41:34.000 --> 00:41:40.000
to potentially credible and
noncritical pharmaceuticals.

563
00:41:40.000 --> 00:41:44.000
>> One of the flexibilities, is
to allow facilities to manage

564
00:41:44.000 --> 00:41:50.000
all the pharmaceuticals as
hazardous and if they do that,
then

565
00:41:50.000 --> 00:41:56.067
individual waste determinations
will not be necessary.

566
00:41:56.067 --> 00:42:04.067
>> It easy the compliance burden
and

567
00:42:04.067 --> 00:42:10.067
it also incentivizes facilities
to

568
00:42:10.067 --> 00:42:13.067
manage the waste as hazardous,
and that will keep them out of
landfills,

569
00:42:13.067 --> 00:42:20.067
that will reduce the
formidable's that are entering
the waterways.

570
00:42:20.067 --> 00:42:24.000
>> To go along with the
flexibility, we

571
00:42:24.000 --> 00:42:31.000
allow facilities to co-mingle
there waste, facilities may
actually

572
00:42:31.000 --> 00:42:36.000
hazardous and nonhazardous
pharmaceuticals in the same
container.

573
00:42:36.000 --> 00:42:45.000
>> I will talk quickly

574
00:42:45.000 --> 00:42:49.000
about the labeling standards,
containers that are used to
accumulate

575
00:42:49.000 --> 00:42:54.000
non-credible pharmaceuticals
have to be labeled with the
words, hazardous

576
00:42:54.000 --> 00:42:57.067
waste pharmaceuticals.

577
00:42:57.067 --> 00:43:02.067
>> It is allowed but not
required, the

578
00:43:02.067 --> 00:43:08.067
containers have to be
structurally sound, and will not
react

579
00:43:08.067 --> 00:43:13.067
with the contents.

580
00:43:13.067 --> 00:43:21.067
We want to make sure whatever is
in the container will not
corrode.

581
00:43:21.067 --> 00:43:25.000
The contents cannot react with
each other, whatever you put
inside

582
00:43:25.000 --> 00:43:32.000
the container cannot rightly act
with the other pharmaceutical.

583
00:43:32.000 --> 00:43:37.000
>> We included a security
requirement, continues have to

584
00:43:37.000 --> 00:43:43.000
remain closed in a manner that
prevents unauthorized access, we
want

585
00:43:43.000 --> 00:43:49.000
to prevent illicit the version,

586
00:43:49.000 --> 00:43:53.000
there is a one year accumulation
time limit from the date when
the

587
00:43:53.000 --> 00:43:55.000
accumulation began.

588
00:43:55.000 --> 00:44:01.000
>> Potentially credible
pharmaceuticals do not have
standards,

589
00:44:01.000 --> 00:44:07.000
there is no labeling, no
container standards. The
preamble

590
00:44:07.000 --> 00:44:13.000
describes the rationale but we
believe there is incentive

591
00:44:13.000 --> 00:44:16.000
for facilities to manage them
properly and ship them off site
in a timely

592
00:44:16.000 --> 00:44:19.000
manner.

593
00:44:19.000 --> 00:44:26.000
>> This highlights the
differences

594
00:44:26.000 --> 00:44:32.000
between the standards for
non-credible and potentially
credible.

595
00:44:32.000 --> 00:44:37.000
The fourth line, individual
determinations,

596
00:44:37.000 --> 00:44:41.000
that is not required for either
one.

597
00:44:41.000 --> 00:44:50.000
>> The last line

598
00:44:50.000 --> 00:44:54.000
is included, hazardous waste
pharmaceuticals

599
00:44:54.000 --> 00:44:57.067
are not required on the BR for
both types.

600
00:44:57.067 --> 00:45:03.067
>> Here is a matrix,

601
00:45:03.067 --> 00:45:12.067
we will talk about VSQG
healthcare

602
00:45:12.067 --> 00:45:15.067
facilities.

603
00:45:15.067 --> 00:45:23.000
>> Healthcare facilities that
are

604
00:45:23.000 --> 00:45:29.000
VSQG are not subject to part 266
Subpart P,

605
00:45:29.000 --> 00:45:34.000
but there is an exception, and
that is the sewer band.

606
00:45:34.000 --> 00:45:40.000
>> So healthcare facilities,

607
00:45:40.000 --> 00:45:44.000
you have some choices, they can
choose to opt into Subpart

608
00:45:44.000 --> 00:45:50.000
P and comply with all the
provisions, or they

609
00:45:50.000 --> 00:45:55.067
have some optional provisions,
that they can use.

610
00:45:55.067 --> 00:46:03.067
>> The first one is

611
00:46:03.067 --> 00:46:09.067
a facility can continue to send
pharmaceuticals through

612
00:46:09.067 --> 00:46:18.067
a reverse distributor to receive
credit, the second one,

613
00:46:18.067 --> 00:46:25.000
is a variation of the new
consolidation provision,

614
00:46:25.000 --> 00:46:30.000
this allows the facility to send
its pharmaceuticals off-site to

615
00:46:30.000 --> 00:46:35.000
another facility provided the
receiving facility is either a
healthcare

616
00:46:35.000 --> 00:46:40.000
facility operating under part
266 and meet certain conditions

617
00:46:40.000 --> 00:46:45.000
or an elk UG operating under
part 262 and meets the
conditions

618
00:46:45.000 --> 00:46:48.000
for off-site consolidation.

619
00:46:48.000 --> 00:46:57.067
>> You have your choice

620
00:46:57.067 --> 00:47:04.067
of which consolidation you want
to comply with.

621
00:47:04.067 --> 00:47:13.067
>> The next options,

622
00:47:13.067 --> 00:47:18.067
they are specifically for
long-term

623
00:47:18.067 --> 00:47:23.000
care facilities, the first is a
long-term facility that

624
00:47:23.000 --> 00:47:28.000
is a VSQG that can dispose its
pharmaceuticals

625
00:47:28.000 --> 00:47:37.000
can use the on-site collection
receptacle,

626
00:47:37.000 --> 00:47:43.000
I'm not sure how many of these
exist,

627
00:47:43.000 --> 00:47:48.000
the way the DEA regulations are
written,

628
00:47:48.000 --> 00:47:57.067
the retail pharmacy has to
install the receptacle,

629
00:47:57.067 --> 00:48:03.067
in the event that they are

630
00:48:03.067 --> 00:48:09.067
in place, placement of the
pharmaceuticals

631
00:48:09.067 --> 00:48:14.067
is preferable.

632
00:48:14.067 --> 00:48:23.000
>> The second one,

633
00:48:23.000 --> 00:48:28.000
for the long-term care facility,
a facility with 20 beds

634
00:48:28.000 --> 00:48:34.000
or fewer will be presumed to be
a VSQG and not subject to
Subpart

635
00:48:34.000 --> 00:48:37.000
P.

636
00:48:37.000 --> 00:48:42.000
That is changing the burden on
the

637
00:48:42.000 --> 00:48:48.000
long-term care facility, so
facility with more than 20 beds
can be a

638
00:48:48.000 --> 00:48:51.000
VSQG but they will have to
continue to demonstrate

639
00:48:51.000 --> 00:48:56.067
that by monitoring the
generation.

640
00:48:56.067 --> 00:49:08.067
>> I will talk about three

641
00:49:08.067 --> 00:49:16.067
sections of the rule that apply
to facilities and distributors,

642
00:49:16.067 --> 00:49:20.067
healthcare facility standards
come first and the distributor
standards

643
00:49:20.067 --> 00:49:26.000
come last year.

644
00:49:26.000 --> 00:49:35.000
First, this rule finalizes the

645
00:49:35.000 --> 00:49:41.000
sewer prohibition, hazardous
waste pharmaceuticals may no
longer

646
00:49:41.000 --> 00:49:53.000
be placed in the sewer, you
cannot put them down the drain.

647
00:49:53.000 --> 00:49:57.067
The prohibition is the one thing

648
00:49:57.067 --> 00:50:02.067
that applies to all facilities,
regardless of generation
category,

649
00:50:02.067 --> 00:50:06.067
including those that are VSQG,
and it

650
00:50:06.067 --> 00:50:10.067
applies to all reverse
distributors.

651
00:50:10.067 --> 00:50:15.067
>> And applies to all hazardous
wastes that are DEA controlled

652
00:50:15.067 --> 00:50:18.067
substances, no exceptions.

653
00:50:18.067 --> 00:50:25.000
Including what DEA refers to as
waste,

654
00:50:25.000 --> 00:50:31.000
for example, they are left over
in syringes, they allow those to

655
00:50:31.000 --> 00:50:36.000
go down the drain. But we do
not.

656
00:50:36.000 --> 00:50:42.000
>> Although the rule technically
applies

657
00:50:42.000 --> 00:50:48.000
to hazardous waste
pharmaceuticals, and those
managed

658
00:50:48.000 --> 00:50:54.000
add healthcare facilities, we
discourage

659
00:50:54.000 --> 00:51:00.067
this by any entity with few
exceptions.

660
00:51:00.067 --> 00:51:04.067
The sewer prohibition, it is
part of Subpart P, the
prohibition

661
00:51:04.067 --> 00:51:10.067
will be effective in all states
on August

662
00:51:10.067 --> 00:51:13.067
21st, 2019.

663
00:51:13.067 --> 00:51:25.000
>> Long-term care facilities,
and some

664
00:51:25.000 --> 00:51:29.000
of the smaller facilities, they
have to be

665
00:51:29.000 --> 00:51:33.000
aware of this and get on top of
this.

666
00:51:33.000 --> 00:51:41.000
>> The second provision that
applies,

667
00:51:41.000 --> 00:51:47.000
are two new conditions, the

668
00:51:47.000 --> 00:51:52.000
first one, for the handful of
RCRA wastes

669
00:51:52.000 --> 00:52:01.067
that are DE controlled
substances, the second one is

670
00:52:01.067 --> 00:52:07.067
more narrow, it is to promote
takeback of pharmaceuticals,

671
00:52:07.067 --> 00:52:15.067
that is for household waste
pharmaceuticals that are
collected in the DEA

672
00:52:15.067 --> 00:52:20.067
you can find them in hospitals
and retail pharmacies, under

673
00:52:20.067 --> 00:52:25.000
the regulations, pharmacies and
hospitals that are already
registrants

674
00:52:25.000 --> 00:52:30.000
can amend the registration to
become collectors of
pharmaceuticals.

675
00:52:30.000 --> 00:52:35.000
>> DEA has the takeback days
twice

676
00:52:35.000 --> 00:52:40.000
a year, more collectors that
install these

677
00:52:40.000 --> 00:52:44.000
kiosks, the better we can move
to more permanent takeback of
household

678
00:52:44.000 --> 00:52:47.000
pharmaceuticals.

679
00:52:47.000 --> 00:52:54.000
>> Under the DEA regulations,
once the pharmaceuticals are
collected,

680
00:52:54.000 --> 00:53:00.067
they have to be destroyed to
meet the non-re-tradable
standards.

681
00:53:00.067 --> 00:53:06.067
Here is the hazardous waste

682
00:53:06.067 --> 00:53:10.067
that are DEA controlled
substances that we are aware of.

683
00:53:10.067 --> 00:53:16.067
>> What do we mean by
exemptions? In

684
00:53:16.067 --> 00:53:20.067
both cases, the hazardous waste
pharmaceuticals are exempt from

685
00:53:20.067 --> 00:53:26.000
RCRA provided they meet the
following conditions,

686
00:53:26.000 --> 00:53:30.000
they are related to the
treatment and destruction
methods that are

687
00:53:30.000 --> 00:53:33.000
allowed.

688
00:53:33.000 --> 00:53:38.000
Because of the sewer
prohibition, they cannot be
placed in the sewer,

689
00:53:38.000 --> 00:53:47.000
we are deferring to DEA
regulations, they have to comply

690
00:53:47.000 --> 00:53:51.000
with regulations, they have the
option of destroying the

691
00:53:51.000 --> 00:53:57.000
collective pharmaceuticals by a
method that the DEA has deemed
to

692
00:53:57.000 --> 00:54:03.000
meet the standard, the DEA is
not done this, chances

693
00:54:03.000 --> 00:54:11.000
are they will be combusted, they
have to be combusted at one

694
00:54:11.000 --> 00:54:16.000
of the following types of
permitted facilities, initially
we proposed

695
00:54:16.000 --> 00:54:21.000
large or small combusted, we
have expanded

696
00:54:21.000 --> 00:54:24.000
the list, we have added others
to the

697
00:54:24.000 --> 00:54:27.000
list.

698
00:54:27.000 --> 00:54:33.000
>> Finally the third provision
that

699
00:54:33.000 --> 00:54:38.000
applies to healthcare facilities
and distributors relates to

700
00:54:38.000 --> 00:54:41.000
empty containers.

701
00:54:41.000 --> 00:54:47.000
>> The new container standards
apply.

702
00:54:47.000 --> 00:54:51.000
They are developed for the

703
00:54:51.000 --> 00:54:57.067
types of containers that are
found in the healthcare
facilities, we

704
00:54:57.067 --> 00:55:03.067
have heard about this as being a
problem.

705
00:55:03.067 --> 00:55:04.901
New empty container standards

706
00:55:04.901 --> 00:55:08.067
apply to containers with
hazardous pharmaceuticals

707
00:55:08.067 --> 00:55:14.067
that are IQ and nonacute,

708
00:55:14.067 --> 00:55:19.067
they apply to healthcare
facilities and distributors

709
00:55:19.067 --> 00:55:23.000
that are subject to Subpart P
and they apply to anybody else
with

710
00:55:23.000 --> 00:55:27.000
containers of hazardous
pharmaceuticals, we

711
00:55:27.000 --> 00:55:34.000
had provisions in Subpart P and
we amend the existing
regulations.

712
00:55:34.000 --> 00:55:39.000
>> The resident is remaining in

713
00:55:39.000 --> 00:55:45.000
empty containers are no longer
regulated as hazardous waste,

714
00:55:45.000 --> 00:55:50.000
the new standard can be used

715
00:55:50.000 --> 00:55:54.000
to determine whether a
healthcare facility is subject
to Subpart P,

716
00:55:54.000 --> 00:56:00.067
it is possible a small facility
that is on the bubble,

717
00:56:00.067 --> 00:56:05.067
may remain if you can use the

718
00:56:05.067 --> 00:56:08.067
new empty container standards.

719
00:56:08.067 --> 00:56:12.067
>> There are four different
standards for

720
00:56:12.067 --> 00:56:16.067
the containers found in a
healthcare facility,

721
00:56:16.067 --> 00:56:25.000
we tried to make the standard
straightforward and easy to
implement,

722
00:56:25.000 --> 00:56:31.000
the welcome change is triple
rinsing

723
00:56:31.000 --> 00:56:37.000
of containers is not required
anymore.

724
00:56:37.000 --> 00:56:47.000
>> We will go through

725
00:56:47.000 --> 00:56:59.067
the containers, let's start with
the dispensing bottles,

726
00:56:59.067 --> 00:57:07.067
we're talking about individual
packets, Dixie cups,

727
00:57:07.067 --> 00:57:12.067
is a new standard for these for
acute and nonacute
pharmaceuticals,

728
00:57:12.067 --> 00:57:17.067
you have to remove the contents.

729
00:57:17.067 --> 00:57:21.067
>> You can remove those gauche
you can dispense

730
00:57:21.067 --> 00:57:30.000
the pharmaceutical to a patient,
the patient refuses, you can

731
00:57:30.000 --> 00:57:33.000
empty the container into a
container.

732
00:57:33.000 --> 00:57:42.000
>> The second type

733
00:57:42.000 --> 00:57:48.000
of container are syringes, we
have a new standard,

734
00:57:48.000 --> 00:57:53.000
in order to be empty you have to
fully depress the plunger,

735
00:57:53.000 --> 00:57:56.067
for both acute and nonacute.

736
00:57:56.067 --> 00:58:01.067
>> The syringe can become empty
by

737
00:58:01.067 --> 00:58:07.067
administering the contents to a
patient or emptying

738
00:58:07.067 --> 00:58:11.067
leftover into

739
00:58:11.067 --> 00:58:14.067
the container.

740
00:58:14.067 --> 00:58:19.067
>> You may not make that syringe

741
00:58:19.067 --> 00:58:25.000
empty by squirting the remaining
contents down the sink.

742
00:58:25.000 --> 00:58:30.000
If you have remaining contents,
the contents have to go

743
00:58:30.000 --> 00:58:33.000
in a container not down the
sink.

744
00:58:33.000 --> 00:58:41.000
>> If the syringe is RCRA empty,
then

745
00:58:41.000 --> 00:58:47.000
RCRA will not apply to the
syringe anymore,

746
00:58:47.000 --> 00:58:50.000
other regulations may apply.

747
00:58:50.000 --> 00:58:55.067
If it is empty, RCRA will not
apply.

748
00:58:55.067 --> 00:59:01.067
If you cannot depress the
plunger, and you have to put

749
00:59:01.067 --> 00:59:10.067
it in a container that meets
regulations,

750
00:59:10.067 --> 00:59:16.067
then it is medical regulation.

751
00:59:16.067 --> 00:59:22.067
Let's talk about IV bags, there
is a new standard,

752
00:59:22.067 --> 00:59:27.000
to render them empty, you have
to most of the contents

753
00:59:27.000 --> 00:59:30.000
of the bag to be empty.

754
00:59:30.000 --> 00:59:34.000
If it is nonacute, if you cannot

755
00:59:34.000 --> 00:59:40.000
fully minister the contents we
allow the old standard.

756
00:59:40.000 --> 00:59:46.000
>> You can use the existing
regulations to demonstrate it is

757
00:59:46.000 --> 00:59:50.000
empty, if it is an acute
pharmaceutical, and you

758
00:59:50.000 --> 00:59:56.067
cannot fully minister the
contents, the IV bag

759
00:59:56.067 --> 01:00:05.067
is not RCRA empty.

760
01:00:05.067 --> 01:00:12.067
Finally, the fourth type of
container, other containers.

761
01:00:12.067 --> 01:00:21.067
>> These are inhalers,
nebulizers,

762
01:00:21.067 --> 01:00:25.000
there is no new standard, what
we allow you

763
01:00:25.000 --> 01:00:31.000
to use, is the existing --
standard

764
01:00:31.000 --> 01:00:35.000
in the existing regulations.

765
01:00:35.000 --> 01:00:41.000
>> For acute pharmaceuticals,
there is

766
01:00:41.000 --> 01:00:47.000
no new standard and there is no
old standard. These things
cannot

767
01:00:47.000 --> 01:01:01.067
be considered RCRA empty they
must be managed.

768
01:01:01.067 --> 01:01:05.067
They must be managed as
hazardous waste pharmaceuticals.

769
01:01:05.067 --> 01:01:16.067
>> The shipping standards are
divided

770
01:01:16.067 --> 01:01:20.067
by the type of pharmaceutical
you are dealing with.

771
01:01:20.067 --> 01:01:28.000
For non-credible
pharmaceuticals, items that no
have potential value,

772
01:01:28.000 --> 01:01:35.000
they have to be sent to a TSDF
for disposal.

773
01:01:35.000 --> 01:01:40.000
They have to be sent using the
transporter, for the healthcare

774
01:01:40.000 --> 01:01:47.000
facilities that are shipping
non-credible ways, they are not
required to use

775
01:01:47.000 --> 01:01:53.000
all codes, they have to use this
new waste code,

776
01:01:53.000 --> 01:01:57.067
that will go in item 13.

777
01:01:57.067 --> 01:02:04.067
>> Additional codes are allowed
but not required.

778
01:02:04.067 --> 01:02:09.067
The new code will be
pre-populated, you can

779
01:02:09.067 --> 01:02:13.067
use the search function to find
that and you can select that and

780
01:02:13.067 --> 01:02:19.067
that will be in place in time
for the August 21st effective
date.

781
01:02:19.067 --> 01:02:25.000
>> RDs that ship

782
01:02:25.000 --> 01:02:31.000
pharmaceuticals to a TSDF they
have to list all the codes

783
01:02:31.000 --> 01:02:33.000
on the manifest.

784
01:02:33.000 --> 01:02:40.000
There are few shipping
requirements for credible
pharmaceuticals,

785
01:02:40.000 --> 01:02:42.000
they have the potential value.

786
01:02:42.000 --> 01:02:47.000
>> Potentially credible
pharmaceuticals can be sent

787
01:02:47.000 --> 01:02:54.000
from a facility to a
distributor, we are

788
01:02:54.000 --> 01:02:59.067
not requiring the use of a
hazardous waste manifest or
transporter.

789
01:02:59.067 --> 01:03:04.067
Common parcel carriers are okay
to use,

790
01:03:04.067 --> 01:03:08.067
we require the shipper has
received delivery confirmation
from the distributor

791
01:03:08.067 --> 01:03:11.067
within 35 days.

792
01:03:11.067 --> 01:03:16.067
>> The electronic tracking
system that carriers use

793
01:03:16.067 --> 01:03:22.067
will be sufficient to meet the
standard.

794
01:03:22.067 --> 01:03:30.000
>> We want to make sure the
package

795
01:03:30.000 --> 01:03:35.000
is not just left outside of the
building unattended.

796
01:03:35.000 --> 01:03:40.000
The facility that initiates the
shipment has to keep records for

797
01:03:40.000 --> 01:03:43.000
three years.

798
01:03:43.000 --> 01:03:47.000
>> We want to make sure

799
01:03:47.000 --> 01:03:52.000
shipments do not get lost or
stolen in transit, that was a
big concern

800
01:03:52.000 --> 01:03:57.000
for many of the commenters, that
is because pharmaceutical waste

801
01:03:57.000 --> 01:04:03.000
is unique, it has the potential
for illicit diversion.

802
01:04:03.000 --> 01:04:11.000
>> Here is the summary matrix.

803
01:04:11.000 --> 01:04:17.000
We have added the shipping
requirements.

804
01:04:17.000 --> 01:04:30.000
>> As I mentioned earlier,

805
01:04:30.000 --> 01:04:40.000
we finalized the standards,
under the final rule,
distributors

806
01:04:40.000 --> 01:04:46.000
are considered a new management
facility,

807
01:04:46.000 --> 01:04:51.000
they don't need a permit, but
there are no

808
01:04:51.000 --> 01:04:56.067
generator categories, they are
the same thing under Subpart P.
The

809
01:04:56.067 --> 01:05:01.067
standards are similar, but with
a few additions, such as

810
01:05:01.067 --> 01:05:04.067
inventory and security
requirements.

811
01:05:04.067 --> 01:05:13.067
>> We finalized the maximum
number

812
01:05:13.067 --> 01:05:19.067
of transfers to prevent and was
transfers.

813
01:05:19.067 --> 01:05:25.000
The potential pharmaceutical can
go to multiple distributors but

814
01:05:25.000 --> 01:05:29.000
they must go to a TSDF
ultimately.

815
01:05:29.000 --> 01:05:35.000
>> As long as the credit

816
01:05:35.000 --> 01:05:41.000
is verified, they are considered
credible

817
01:05:41.000 --> 01:05:47.000
health waste pharmaceuticals.
Because the potentially
pharmaceutical has

818
01:05:47.000 --> 01:05:52.000
value, we can take a later touch

819
01:05:52.000 --> 01:05:55.067
for the credible pharmaceutical.

820
01:05:55.067 --> 01:06:03.067
>> On the other hand,

821
01:06:03.067 --> 01:06:08.067
once the credit has been
verified, they are evaluated. At
this point

822
01:06:08.067 --> 01:06:11.067
the value has been realized.

823
01:06:11.067 --> 01:06:20.067
The regulation becomes robust.

824
01:06:20.067 --> 01:06:26.000
We increased the accumulation
time,

825
01:06:26.000 --> 01:06:32.000
once the distributor receives
the pharmaceutical

826
01:06:32.000 --> 01:06:36.000
they have to inventory and
evaluate each one within 30

827
01:06:36.000 --> 01:06:39.000
days.

828
01:06:39.000 --> 01:06:45.000
>> The 180 day accumulation time
limit

829
01:06:45.000 --> 01:06:50.000
does not begin until it is
evaluated, they can accumulate

830
01:06:50.000 --> 01:06:54.000
a total for 210 days.

831
01:06:54.000 --> 01:07:10.067
>> For potentially credible
pharmaceuticals,

832
01:07:10.067 --> 01:07:17.067
there are no specific labeling
standards, they do

833
01:07:17.067 --> 01:07:20.067
not need to be included on the
report.

834
01:07:20.067 --> 01:07:23.000
Once they become evaluated, the
more robust regulations kick

835
01:07:23.000 --> 01:07:26.000
in.

836
01:07:26.000 --> 01:07:32.000
>> For evaluated pharmaceuticals
that are destined for TSDF,

837
01:07:32.000 --> 01:07:37.000
there needs to be an
accumulation area and conduct
weekly inspections.

838
01:07:37.000 --> 01:07:42.000
For personal handling, the
training standards are

839
01:07:42.000 --> 01:07:45.000
the same.

840
01:07:45.000 --> 01:07:51.000
>> The pharmaceuticals need to
be labeled and the containers

841
01:07:51.000 --> 01:07:54.000
need to be in good condition.

842
01:07:54.000 --> 01:08:00.067
The codes are required prior to
transport off-site.

843
01:08:00.067 --> 01:08:05.067
>> The

844
01:08:05.067 --> 01:08:10.067
reason the pharmaceuticals do
not need to be included on the
report,

845
01:08:10.067 --> 01:08:16.067
we do not want these
pharmaceuticals to be double
counted.

846
01:08:16.067 --> 01:08:24.000
There are going to another
distributor where they will be
evaluated.

847
01:08:24.000 --> 01:08:33.000
>> Here is the summary matrix
for

848
01:08:33.000 --> 01:08:36.000
the standards.

849
01:08:36.000 --> 01:08:48.000
The potentially credible
pharmaceuticals, they are
evaluated.

850
01:08:48.000 --> 01:08:54.000
>> Here is another matrix

851
01:08:54.000 --> 01:09:10.067
that shows the accumulation
times for reverse distributors.

852
01:09:10.067 --> 01:09:25.000
>> Thank you for bearing with
us.

853
01:09:25.000 --> 01:09:30.000
We want to leave you with a
reminder,

854
01:09:30.000 --> 01:09:36.000
and go back to the authorization
and adoption. The final rule

855
01:09:36.000 --> 01:09:41.000
is out and it is published, you
must be patient you cannot use
it

856
01:09:41.000 --> 01:09:47.000
yet. It is not effective until
August. The effective date

857
01:09:47.000 --> 01:09:52.000
will vary by state, we will have
maps on our website tracking

858
01:09:52.000 --> 01:09:55.067
the adoption.

859
01:09:55.067 --> 01:09:58.067
Stay tuned.

860
01:09:58.067 --> 01:10:04.067
>> Here

861
01:10:04.067 --> 01:10:06.067
are the effective dates.

862
01:10:06.067 --> 01:10:12.067
When it comes to the nicotine
exemption,

863
01:10:12.067 --> 01:10:17.067
August.

864
01:10:17.067 --> 01:10:25.000
Authorized states have to adopt
it,

865
01:10:25.000 --> 01:10:31.000
there is the more stringent
aspect, the

866
01:10:31.000 --> 01:10:36.000
sewer prohibition will be
effective everywhere. As for the
rest of Subpart

867
01:10:36.000 --> 01:10:52.000
P, it is effective in
non-authorized states.

868
01:10:52.000 --> 01:11:03.067
The state does not require
legislative session. If they
require

869
01:11:03.067 --> 01:11:08.067
a session, it has to be adopted
by July 1st, 2022.

870
01:11:08.067 --> 01:11:24.067
>> Here is our contact
information.

871
01:11:24.067 --> 01:11:35.000
We will have a Q&A session.

872
01:11:35.000 --> 01:11:45.000
We cannot get to every question
immediately.

873
01:11:45.000 --> 01:11:52.000
The questions we do not get to
today, we will develop an FAQ
that we will

874
01:11:52.000 --> 01:11:55.067
put on our website.

875
01:11:55.067 --> 01:12:11.067
>> There is confusion

876
01:12:11.067 --> 01:12:27.067
with the generator category.

877
01:12:27.067 --> 01:12:39.000
>> By a large

878
01:12:39.000 --> 01:12:43.000
they are not subject to the
rule, with the exception of the
sewer

879
01:12:43.000 --> 01:12:49.000
prohibition, and they have the
optional provisions that they
can take advantage

880
01:12:49.000 --> 01:12:52.000
of.

881
01:12:52.000 --> 01:12:58.067
Healthcare facilities there is
currently a VSQG would

882
01:12:58.067 --> 01:13:03.067
be subject to Subpart P, the

883
01:13:03.067 --> 01:13:09.067
generator category is not
relevant when it comes to
hazardous

884
01:13:09.067 --> 01:13:25.067
waste pharmaceuticals. So the
VSQG is still relevant.

885
01:13:25.067 --> 01:13:39.000
>> Where are the training
standards

886
01:13:39.000 --> 01:13:42.000
located?

887
01:13:42.000 --> 01:13:54.000
>> For the healthcare facilities

888
01:13:54.000 --> 01:14:00.000
that manage non-credible, their
26650 (b).

889
01:14:00.000 --> 01:14:05.000
There is nothing prescriptive.

890
01:14:05.000 --> 01:14:09.000
It says you have to be familiar
with the waste and how to handle

891
01:14:09.000 --> 01:14:12.000
that.

892
01:14:12.000 --> 01:14:18.000
>> The standards for reverse
distributors are in

893
01:14:18.000 --> 01:14:27.000
266.510 (c).

894
01:14:27.000 --> 01:14:29.000
They need to be trained in the
proper

895
01:14:29.000 --> 01:14:32.000
handling.

896
01:14:32.000 --> 01:14:41.000
>> When shipping

897
01:14:41.000 --> 01:14:47.000
credible medications to a
reverse distributor,

898
01:14:47.000 --> 01:14:53.000
[ Inaudible ] >>

899
01:14:53.000 --> 01:15:09.067
There is no manifest required.

900
01:15:09.067 --> 01:15:19.067
>> There is tracking

901
01:15:19.067 --> 01:15:25.000
required but it is not in the
form of a manifest,

902
01:15:25.000 --> 01:15:29.000
there is tracking requirement
and shipping confirmation, it
has to

903
01:15:29.000 --> 01:15:35.000
go back to the shipper, there is
tracking

904
01:15:35.000 --> 01:15:40.000
that mimics the manifest, but it
is not a manifest.

905
01:15:40.000 --> 01:15:46.000
>> Under

906
01:15:46.000 --> 01:15:52.000
the new empty container rule,
will cartridges

907
01:15:52.000 --> 01:15:56.067
-- will they be considered

908
01:15:56.067 --> 01:15:59.067
unit though

909
01:15:59.067 --> 01:16:05.067
>> Containers?

910
01:16:05.067 --> 01:16:10.067
We got this question before, we
are developing an answer

911
01:16:10.067 --> 01:16:14.067
that will appear in the FAQs on
the website.

912
01:16:14.067 --> 01:16:18.067
>> We got some questions on

913
01:16:18.067 --> 01:16:23.000
different types of things that
are not regulated. Has the
management

914
01:16:23.000 --> 01:16:26.000
of warfarin changed with the
regulation?

915
01:16:26.000 --> 01:16:32.000
>> Yes.

916
01:16:32.000 --> 01:16:40.000
Some concentrations, no, nothing
changes other than

917
01:16:40.000 --> 01:16:45.000
the empty container standards
for warfarin. Was pharmacies

918
01:16:45.000 --> 01:16:51.000
will have black dispensing
bottles that had warfarin in
them

919
01:16:51.000 --> 01:16:56.067
they no longer have to triple
rinse them to make

920
01:16:56.067 --> 01:17:01.067
them empty.

921
01:17:01.067 --> 01:17:07.067
>> As long as the pills are
removed,

922
01:17:07.067 --> 01:17:12.067
the containers are considered
period empty.

923
01:17:12.067 --> 01:17:24.000
>> For facilities covered

924
01:17:24.000 --> 01:17:29.000
by 262. instead of 263.
pharmaceuticals

925
01:17:29.000 --> 01:17:33.000
be accumulated and sadly
accumulation areas?

926
01:17:33.000 --> 01:17:41.000
>> Hazardous waste
pharmaceuticals,

927
01:17:41.000 --> 01:17:45.000
there are no satellite
accumulation areas.

928
01:17:45.000 --> 01:17:50.000
There is no central accumulation
area anymore. Nothing that
prohibits

929
01:17:50.000 --> 01:17:55.067
you from putting that into a
central accumulation area, but
we eliminated

930
01:17:55.067 --> 01:18:10.067
some of the language around
satellite areas.

931
01:18:10.067 --> 01:18:15.067
You cannot necessarily install a
satellite area in any hospital

932
01:18:15.067 --> 01:18:19.067
room, you might have to go to
the nurses station.

933
01:18:19.067 --> 01:18:22.067
We eliminated that language.

934
01:18:22.067 --> 01:18:38.067
>> Can you revisit the
definition

935
01:18:38.067 --> 01:18:54.067
of pharmaceutical?

936
01:18:54.067 --> 01:19:04.701
>> The definition of
pharmaceutical,

937
01:19:04.701 --> 01:19:19.501
it is pretty broad. It includes
all of these examples.

938
01:19:19.501 --> 01:19:33.801
We use the definition of drug to
form our definition

939
01:19:33.801 --> 01:19:48.834
of pharmaceutical, who wanted to
include a lot of other

940
01:19:48.834 --> 01:19:55.701
things that are commonly

941
01:19:55.701 --> 01:20:06.033
managed, they can
have the benefits

942
01:20:06.033 --> 01:20:13.067
of managing all of these.

943
01:20:13.067 --> 01:20:18.067
>> In order

944
01:20:18.067 --> 01:20:23.000
to operate under Subpart P, you
have to be a healthcare facility

945
01:20:23.000 --> 01:20:39.000
and manage hazardous
pharmaceuticals.

946
01:20:39.000 --> 01:20:46.000
>> We

947
01:20:46.000 --> 01:20:51.000
excluded items on the bottom
right-hand side.

948
01:20:51.000 --> 01:20:59.067
>> There were DEA controlled
substances

949
01:20:59.067 --> 01:21:02.067
as well. What guidance can you
provide?

950
01:21:02.067 --> 01:21:08.067
>> Controlled substances are
regulated by the DEA

951
01:21:08.067 --> 01:21:13.067
not by EPA. There are a handful
of pharmaceuticals

952
01:21:13.067 --> 01:21:18.067
that are also DEA controlled
substances.

953
01:21:18.067 --> 01:21:23.000
We can only speak to the ones
that are hazardous waste.

954
01:21:23.000 --> 01:21:35.000
>> What do you have to do to
prove

955
01:21:35.000 --> 01:21:39.000
the VSQG status?

956
01:21:39.000 --> 01:21:50.000
>> The current regulation,

957
01:21:50.000 --> 01:22:05.067
the rule redefines the
categories, and clarifies the
categories.

958
01:22:05.067 --> 01:22:10.067
It talks about what you have to
count towards

959
01:22:10.067 --> 01:22:14.067
your status, it doesn't really
say exactly how one has to

960
01:22:14.067 --> 01:22:17.067
determine that.

961
01:22:17.067 --> 01:22:25.000
>> It is not new to the rule
that

962
01:22:25.000 --> 01:22:30.000
one has to determine whether you
are a VSQG were not.

963
01:22:30.000 --> 01:22:38.000
>> Any sort of facility
assessment

964
01:22:38.000 --> 01:22:47.000
required?

965
01:22:47.000 --> 01:22:51.000
>> No.

966
01:22:51.000 --> 01:23:00.067
>> Can

967
01:23:00.067 --> 01:23:06.067
you clarify, is there an
accumulation weight

968
01:23:06.067 --> 01:23:09.067
limit after August 21st?

969
01:23:09.067 --> 01:23:25.067
>> We did the one kilogram,

970
01:23:25.067 --> 01:23:36.000
no.

971
01:23:36.000 --> 01:23:41.000
We did not do that, the
satellite

972
01:23:41.000 --> 01:23:45.000
is different from generation
status.

973
01:23:45.000 --> 01:23:53.000
>> I'm

974
01:23:53.000 --> 01:23:56.000
not sure what the question was.

975
01:23:56.000 --> 01:24:04.000
>> Another question,

976
01:24:04.000 --> 01:24:10.000
do pharmaceutical areas require
weekly inspection?

977
01:24:10.000 --> 01:24:15.000
>> There is no inspection
requirements at

978
01:24:15.000 --> 01:24:21.000
a healthcare facility.

979
01:24:21.000 --> 01:24:37.000
>> Thank you.

980
01:24:37.000 --> 01:24:42.000
>> [ Event has exceeded
scheduled

981
01:24:42.000 --> 01:24:47.000
time. Captioner must proceed to
captioner's next scheduled
event.

982
01:24:47.000 --> 01:24:52.000
Disconnecting at 5:01 ET ]