[Pharmwaste] FW: Sample prescription drugs

[Jeff Hollar]

Laura, Charlotte, All,

 

One would think that a manufacturer would not distribute samples of a
product that is considered a RCRA hazardous waste when discarded, but it
does happen.  Example: Jantoven (Warfarin Sodium), EPA Waste Code = P001.

 

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

 

The unauthorized disclosure or interception of e-mail is a federal crime.
See 18 U.S.C. SEC 2517(4). This e-mail is intended for the use of those whom
it is addressed and may contain information that is privileged,
confidential, and exempt from disclosure under the law. If you have received
this e-mail in error, do not distribute or copy it. Please return it
immediately to the sender with attachments, if any, and notify the sender by
telephone.

From: Charlotte A. Smith [mailto:csmith at pharmecology.com] 
Sent: Tuesday, October 14, 2008 7:35 PM
To: Tenace, Laurie; pharmwaste at lists.dep.state.fl.us
Cc: ayoungblut at cvmspc.com
Subject: RE: [Pharmwaste] FW: Sample prescription drugs

 

I'm not sure about the Florida statute, but the FDA Prescription Drug
Marketing Act prohibits manufacturers' representatives from picking up
samples once they have been distributed. I believe the rep can assist the
clinic in packaging them up for return to the manufacturer, but
realistically, that doesn't happen. It's important to remember that any
clinic that generates pharmaceutical waste of any type has the
responsibility of determining if the waste drugs are RCRA hazardous waste.
While most samples would not be listed drugs, since it is newer drugs that
are sampled and the regulations have not been updated, it is possible that
the samples could exhibit one of the characteristics of hazardous waste. It
is not therefore appropriate for businesses to use the landfill option
without reviewing their drugs first. It is also not a best management
practice. Clinics should check with their regulated medical waste vendors
and see if disposal of non-hazardous pharmaceutical waste by incineration is
an option for them. If they do have RCRA hazardous waste, they will need a
hazardous waste vendor also. 

 

I hope this helps. 

 

Best regards,

 

 

Charlotte A. Smith, R. Ph., M.S., HEM

President

PharmEcology Associates, LLC

12229 W. North Ave., Suite 2

Wauwatosa, WI 53226

414-292-3959

414-915-4026 (cell)

csmith at pharmecology.com

www.pharmecology.com

  _____  

From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Tenace,
Laurie
Sent: Tuesday, October 14, 2008 1:52 PM
To: pharmwaste at lists.dep.state.fl.us
Cc: ayoungblut at cvmspc.com
Subject: [Pharmwaste] FW: Sample prescription drugs

 

Can anyone help this person?

 

This question comes up a lot for me. A Florida Statute says, "All
out-of-date drug samples must be returned to the manufacturer or distributor
of that drug sample." (Ch. 499.028(9), F.S.) However every drug rep I've
asked (just while waiting to see doctors at various times) has never heard
this and insists that they do not take back samples. 

 

Thanks!

Laurie

 

Laurie J. Tenace
Environmental Specialist
Florida Department of Environmental Protection
2600 Blair Stone Road, MS 4555
Tallahassee, Florida 32399-2400
PH: (850) 245-8759
FAX: (850) 245-8811
Laurie.Tenace at dep.state.fl.us 

Mercury web pages:
http://www.dep.state.fl.us/waste/categories/mercury/default.htm

Unwanted Medications web pages:
http://www.dep.state.fl.us/waste/categories/medications/default.htm




Please Note:  Florida has a very broad public records law.  Most written
communications to or from state officials regarding state business are
public records available to the public and media upon request.  Your e-mail
is communications and may therefore be subject to public disclosure.





 

The Department of Environmental Protection values your feedback as a
customer. DEP Secretary Michael W. Sole is committed to continuously
assessing and improving the level and quality of services provided to you.
Please take a few minutes to comment on the quality of service you received.
Simply click on this link to the DEP Customer Survey
<http://survey.dep.state.fl.us/?refemail=Laurie.Tenace@dep.state.fl.us> .
Thank you in advance for completing the survey.

From: Angie Youngblut [mailto:AYoungblut at cvmspc.com] 
Sent: Tuesday, October 14, 2008 2:39 PM
To: pharmwaste at lists.dep.state.fl.us
Subject: FW: Sample prescription drugs

 

I have been trying to get one clear answer- and haven't had much success. I
have tried EPA, DNR, Iowa Board of Pharmacy, local landfill and others. I
have expired sample prescription drugs to dispose of and I don't want to
break any regulations, however I have been told I am a "waste generating
facility" and therefore have different rules. It has been recommended to me
to mix them with undesirable substances and put in regular trash and that
they are not considered hazardous.

I do not have the option of giving them to a charitable organization because
they will only take them( in the Iowa Drug Repository program) with a year
left on the expiration and our offices keep them until they expire. 

Is there any clear guideline federally or in Iowa that I have missed? 

Angie Youngblut RN, BS 
Clinical Practice Manager 
Cedar Valley Medical Specialists, P.C. 
4150 Kimball Avenue 
Waterloo, Iowa 50701 
Phone 319-235-5390 
Fax 319-287-9249 
ayoungblut at cvmspc.com 

-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://lists.dep.state.fl.us/pipermail/pharmwaste/attachments/20081014/fcdf3466/attachment.html