[Pharmwaste] Question

Wed Jun 9 11:00:44 EDT 2010

Sherri/Gayle, is your question about regulations pertaining to
pharmaceuticals generated from a business facility or from a medicine
return / take-back program for households?  -Cheri

Cheri Grasso 

Pharmaceuticals Project 

Local Hazardous Waste Management Program in King County

130 Nickerson Street, Suite 100 | Seattle, WA  98109 | 206-263-3089

www.lhwmp.org

________________________________

From: Volkman, Jennifer (MPCA) [mailto:Jennifer.Volkman at state.mn.us] 
Sent: Tuesday, June 08, 2010 6:24 PM
To: Gayle Gray; pharmwaste at lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Question

The answer depends on a lot of factors from the type of collection
facility; event vs. permanent; the type of disposal and the state you
are in, among others. I don't think FDA has their finger in the pie if
the drugs are not going to be recycled or reused by manufacturers.  Each
agency has it's own set of regulations and there is not overlap between
them. Agencies don't have time to double regulate or argue over who has
precedence, so the roles are defined accordingly and you are stuck
working with at least five of them.  There are state and federal levels
of DEA, EPA and DOT and state and local govt. can be more restrictive
than the feds.  If you have state level programs in those areas, you
want to work with them vs. federal or regional offices.  To date there
has not been much specific guidance or federal level regulatory changes
to address collection of waste pharms. Here is a start, I think the
first 5 are the most important bases to hit:

DEA: regulate possession and end management of controlled substance
pharms only. The requirements, review and approval of collection
programs probably shouldn't, but do vary from state to state depending
on state/regional level of support for collection of HH pharms.

EPA/DEQ or state equivalent for RCRA: specifies which pharms are haz
waste and whether they are regulated federally and at the state level as
business waste; or at the state or local level as household haz waste.
Various management standards apply and these vary from state to state
for CESQG's and HH, with less or no variation for SQG and LQG's.

Boards of Pharmacy: regulate possession of legend pharmaceuticals and
those regulations vary state to state. Our Board Statutes were modified
during this past legislative session to allow for possession by certain
collection entities and HW transporters and facilities for the purpose
of proper disposal. Their regulations apply to Vet related pharms too.

DOT: regulates shipping of HW pharms or Haz Mat pharms. Don't regulate
non-haz mat pharms.

City or Regional Sewering authority: may have limitations on the types
or quantities of pharms that can be sewered.

Post Office: standards apply when using them for mail back programs. I
think a household can mail just about anything, but a business cannot
collect and mail any HW pharms with the USPS to an interim or end
disposal facility.

Board of Vet or Nursing: no pie for them, they defer to the Board of
Pharmacy. I am only 99% sure of that.

JCAHO: I'm not aware of anything that applies specifically to pharm
collections, because they don't generally occur at hospitals, but I'm
sure they cover in-house management of pharms.  I have not looked that
stuff up.

Rules governing hospitals....: covered above, I believe, between
RCRA/Board of Pharm/DOT/DEA

State Survey...: no idea what that's about, maybe a subpart of one of
the regulatory agencies above?

State Pharmacy Associations: MN's is very supportive of collection, but
don't have a regulatory role. 

Non-haz and non-controlled substance pharms have a much lower level of
regulation and they make up the majority of the volume, but since
collectors generally want to take in all pharms, they must comply with
the management standards for RCRA/DOT/DEA/Board. 

Many states have website areas devoted to the Health Care Industry, ours
is below, but we don't yet have our HH collection information done since
we are in the middle of revising guidance and end disposal options. I am
hoping we have info posted by Sept or so:
http://www.pca.state.mn.us/index.php/waste/waste-and-cleanup/waste-manag
ement/industry-specific-waste/health-care-industry.html

Hopefully that helps for starters.  I like the question, I saw some
things mentioned (JCAHO for one) that I hadn't thought about.

________________________________

From: pharmwaste-bounces at lists.dep.state.fl.us
[pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Gayle Gray
[rxrescuepack at gmail.com]
Sent: Tuesday, June 08, 2010 4:32 PM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] Question

I don't know if you have to start a new volume for this question, but
could you please list it. It would be very helpful. 

Thanks

Help!

Research has lead me to the understanding of how complicated
pharmaceutical disposal is.  Below is a list of the different agencies
that I know of that have "their finger in the pie" of pharmaceutical
waste.  

Does anyone know which rules and regulations facilities have to assure
that they are in full compliance with more than others? In other words
if they work to be in full compliance, for example, with local and Board
of Pharmacy rules and regulations would they be safe from repercussion
and consequences from the other governing agencies? This is considering
that the facilities hope that the rules and regulations for their local
and board of pharmacy rules and regulations would be the same of more
strict than the others, therefore if it complies with one it should
comply with all?

Does anyone know of other agencies that need to be on the list?  I just
don't want to miss any of the issues that each one addresses.

DEA

RCRA

DEQ

EPA

FDA

DOT

Hazardous Waste

US Post Office

Boards of Pharmacy/Medicine/Nursing

Boards of Veterinarian Medicine and anything surrounding Veterinarian
medicine.

JCAHO

State Survey for Health Care Facilities (will have tags that they will
survey for pharmaceutical waste processes and documentation)

Rules governing Hospitals, Nursing Homes, Assisted Living Centers, Home
Health, Hospice that state how medication must be disposed of.

Thanks for the assistance

Sherri Harward

Vice President of Research

Rx Rescue LLC

rxrescuepack at gmail.com <mailto:rxrescuepack at gmail.com> 

P.O. Box 190197

Boise, ID 86719-0197

877-408-5777

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