[Pharmwaste] Question

Tue Jun 8 21:23:30 EDT 2010

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-management/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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