[Pharmwaste] RE: Illinois Prohibits Health Facilities from Flushing
Meds
Terry Kilgore
terry at strongservices.com
Thu Aug 20 14:19:50 EDT 2009
It still comes back to the fact that a DEA Registrant cannot take back
controlled substances from an end user. Hospitals and Long Term Care
Facilities battle this issue daily. Below is the DEAs current response
to the problem. DEA is looking at methods to handle this but it is
part of the 21CFR and a law not a policy, so only congress can change
the law which means the DEAs hands are tied.
Secondly the possession of controlled substance without a prescription
is a Federal offense. The person giving the prescription to someone
else becomes a dispensing entity with out a DEA registration and the
receiver has possession of a controlled substance with out a
prescription in their name and therefore is involved in illicit drug
trade.
Question: Can an LTCF return a resident’s unused controlled substance
medication to a pharmacy?
Answer: No. There are no provisions in the Controlled Substances Act
for a DEA registrant (i.e., retail pharmacy) to acquire controlled
substances from a non-registrant (i.e., resident of an LTCF). Most
LTFCs are not licensed by their respective state to handle controlled
substances and, therefore, are not registered with DEA. LTCFs act in a
custodial capacity, holding controlled substances that, pursuant to a
prescription, have been dispensed to and belong to the resident of the
LTCF. Federal laws and regulations make no provisions for controlled
substances that have already been dispensed to patients, regardless of
the packaging method, to be returned to a pharmacy for further
dispensing or disposal.
http://www.deadiversion.usdoj.gov/faq/general.htm
(i) Under the "Federal Food, Drug, and Cosmetic Act," 52 Stat.
1040 (1938), 21 U.S.C.A. 301, as amended, the drug is required to bear
a label containing the legend "Caution: Federal law prohibits
dispensing without prescription" or any similar restrictive statement,
or the drug may be dispensed only upon a prescription.
The above is what I have been told during several conversations with
one of the DEA Associate Section Chiefs.
Terry Kilgore
SPS Program Manager
Strong Pharmaceutical Services,
a division of Strong Environmental Inc., a Stericycle company
770.409.1500 x141
770.409.1449 fax
TKilgore at StrongServices.com
Strong Pharmaceutical Services, a division of Strong Environmental, is
the leading provider of destruction services to the pharmaceutical
industry. Our experienced professionals manage and ensure the
appropriate witnessed destruction of DEA controlled substances, as
well as proper disposition of RCRA hazardous and non-hazardous
finished goods and manufacturing wastes. When we take control of waste
materials at your shipping dock, they become our full responsibility.
On Aug 20, 2009, at 12:08 PM, pharmwaste-request at lists.dep.state.fl.us
wrote:
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> 1. RE: Illinois Prohibits Health Facilities from Flushing Meds
> (Jeff Hollar)
> 2. Green OIl question (Gressitt, Stevan)
>
> From: "Jeff Hollar" <jhollar at pwaste.com>
> Date: August 20, 2009 12:06:10 PM EDT
> To: <TBadrick at aol.com>, <Deborah.DeBiasi at deq.virginia.gov>, <pharmwaste at lists.dep.state.fl.us
> >
> Subject: RE: [Pharmwaste] Illinois Prohibits Health Facilities from
> Flushing Meds
>
>
> Speaking of crawling through policies...
>
> From what I have read, it appears this regulation only restricts the
> disposal of “unused medications" that are in solid dosage forms –
> pills, tablets, capsules, and caplets.
>
> I suspect that there may be a few healthcare facilities in Illinois
> that received an OK from the POTW/DEA/EPA to dispose of RCRA DEA
> controls down the drain. A good example of a DEA control that is
> also RCRA waste when disposed of is Chloral Hydrate (U034). If this
> regulation restricts the disposal of Chloral Hydrate capsules and
> suppositories down the drain, I suspect these facilities will be
> scrambling around to find a licensed TSDF that is registered by the
> DEA to accept controlled substances for disposal. Although this is
> a viable option, the cost may raise some eyebrows.
>
> I know of at least two licensed TSDF’s that can accept DEA
> controlled substances for incineration.
>
> Jeff Hollar
> President
>
> PharmWaste Technologies, Inc.
> 4164 NW Urbandale Dr., Suite A
> Urbandale, IA 50322
> (P) 515-276-5302 Ext. 316
> (F) 480-393-5564
> (E) Jhollar at Pwaste.com
> (W) www.pwaste.com
>
> The unauthorized disclosure or interception of e-mail is a federal
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> From: TBadrick at aol.com [mailto:TBadrick at aol.com]
> Sent: Wednesday, August 19, 2009 8:51 PM
> To: Deborah.DeBiasi at deq.virginia.gov; pharmwaste at lists.dep.state.fl.us
> Subject: Re: [Pharmwaste] Illinois Prohibits Health Facilities from
> Flushing Meds
>
> Its unlikely you would see it in the drain effluent, but a complete
> no-brainer to come in and ask employees or review policies. Given
> there are RCRA regulated drugs...since oh say the 1970's you have an
> open door to come in and inspect by the State. My former employer
> had a 2 year old hospital with a catch basin where sharps were
> found...its not that hard to find mistakes if you know where to look
> and want to find them.
>
> Actually it wouldn't be that hard to sample a sink or hopper and
> find trace on the surface as evidence.
>
> If I were in Illinois I'd be crawling thru the policy manuals
> tonight...all of them to make sure nothing is missed. Having spent
> enough time in hospital committees changing policy in a healthcare
> system, you are looking at 6 months or more work at a minimum.
>
> I applaud the State of Illinois for doing this even though the bulk
> of pharm pollution does not come from healthcare settings. Its a
> start and one which will reverberate throughout the entire
> healthcare system, thus to customers.
>
>
> In a message dated 8/19/2009 1:04:49 P.M. Pacific Daylight Time, Deborah.DeBiasi at deq.virginia.gov
> writes:
> Unless someone is ‘caught in the act’ of flushing unused
> medications, I don’t know how they could monitor and enforce this
> given the amount of medications that are excreted. A positive
> result will be awareness along with better guidance and SOPs in
> health care facilities.
>
> ********
>
> http://wwn-online.com/articles/2009/08/17/illinois-prohibits-health-facilities-from-flushing-meds.aspx
>
> Illinois Prohibits Health Facilities from Flushing Meds
>
> Aug 17, 2009
>
> Illinois Gov. Pat Quinn on Aug. 10 signed several key environmental
> bills, including one that will prohibit health care institutions
> from flushing unused medications into public wastewater. Other
> legislation will track water usage by high capacity wells throughout
> the state.
>
> “This action is another important step in protecting our state’s
> precious natural resources,” said Quinn. “Keeping our water safe
> from unused medications and tracking water usage will help us
> preserve our waterways for future generations.”
>
> Senate Bill 1919 creates the Pharmaceutical Disposal Act and was
> sponsored by Sen. Susan Garrett (D-Lake Forest) and Rep. Karen May
> (D-Highwood). The new law provides that health care institutions may
> not discharge, dispose, flush, pour or empty any unused medication
> into a public wastewater collection system or septic system.
> Violators are subject to a fine.
>
> "For years, disposing unused or expired medicines in wastewater was
> common, even recommended practice. Today, we’re making clear how
> serious we are at stopping this practice before Illinois faces an
> environmental or community health crisis," said Sen. Garrett.
>
> The bill can be found here: http://www.ilga.gov/legislation/BillStatus.asp?DocNum=1919&GAID=10&DocTypeID=SB&SessionID=76&GA=96
>
> Deborah L. DeBiasi
> Email: Deborah.DeBiasi at deq.virginia.gov (NEW!)
> WEB site address: www.deq.virginia.gov
> Virginia Department of Environmental Quality
> Office of Water Permit Programs
> Industrial Pretreatment/Toxics Management Program
> PPCPs, EDCs, and Microconstituents
> Mail: P.O. Box 1105, Richmond, VA 23218 (NEW!)
> Location: 629 E. Main Street, Richmond, VA 23219
> PH: 804-698-4028
> FAX: 804-698-4032
>
>
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>
> From: "Gressitt, Stevan" <Stevan.Gressitt at maine.gov>
> Date: August 20, 2009 12:08:27 PM EDT
> To: <pharmwaste at lists.dep.state.fl.us>
> Subject: [Pharmwaste] Green OIl question
>
>
> A question has arisen over disposal of a bottle of Green Oil,
> probably manufactured in 1950 or earlier that comes from a now
> defunct pharmacy. Main active ingredient is chloroform, percentage
> unknown. Thoughts? Also legality as it does not appear to be a
> controlled drug…but not available for current purchase?
>
> Stevan Gressitt, M.D., Medical Director
> Office of Adult Mental Health Services
> Department of Health and Human Services
> Marquardt Building, 2nd Floor
> 11 State House Station
> 32 Blossom Lane
> Augusta, ME 04333-0011
> Ph: (207)287-4273
> Fax: (207)287-1022
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> E-Mail : stevan.gressitt at maine.gov
> http://www.maine.gov/dhhs/mh/
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