Document ID: EPA-HQ-RCRA-2007-0932-0162
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-09-25T04:00Z

EPA Questions and Quality RX Returns Answers for Reverse Distributors

General Questions about the Returns Process
   1. Who initiates the return? Does the RD alert the healthcare facility that credit is available for certain pharmaceuticals or do health care facilities periodically go through inventory to return un-needed items?
   	The customer almost always initiates the return.  Most healthcare facilities have a scheduled 	interval for returning creditable merchandise.   For a hospital with over 1,000 acute care beds 	this can be as frequent as every other week.  For a very 	small hospital with less than 20 acute 	care beds this can be as infrequent as twice a year.  For most hospitals and retailers it is usually 	on a quarterly basis.  As a reverse distributor we use a sales and marketing team to remind 	customers that it has been 90 days since we last received their return goods.
   2. Does the RD have reps that go to healthcare facilities to pull and prepare pharmaceuticals for shipment to the RD?  If so, does the rep know which items will/will not receive credit?

Yes, some clients request this service, which is provided at extra charge.   Our field technicians are trained to exclude obvious wastes like repackaged items, patient labeled medications, and other wastes from certain manufacturers that do not issue credit (e.g. American Regent).  It is not practical from a time on the road perspective to actually have the field tech perform a full returnable analysis outside of our main facility.  

   3. Is credit received per container?  Per pill if container has been opened?
	This depends on the manufacturer's published return policy.   Some only issue credit for full 	sealed containers, some for partial containers with certain percentage of content thresholds 	(e.g. must be at least 50% full to receive any credit).  Partial creams, ointments, liquids are not 	ordinarily returnable.
   4. Do healthcare facilities return pharmaceuticals from the patient floors (e.g., drugs that have been re-packaged)? Are re-packaged pharmaceuticals creditable?
	Unless some special billing arrangement has been made between the hospital and/or GPO and 	the manufacturer, no.
   5. Once the shipment arrives at the RD facility, what is the timeframe for processing?  
	QRX will open the box and `process' (sort, count, input data into system, produce a report of 	returnable status, and generate packing slips) within 10 business days of receipt.

   6. Are generic brands creditable?
	Larger manufacturers of generics (Teva, Sandoz) usually issue credit for full sealed containers.  	Smaller 	manufacturers (Rugby, Major) frequently do not.
   7. Do expired items typically get credit?
	From a retail environment, 65% of the products are returnable.  For a hospital, it is usually less 	than 50%.  More items a hospital returns are from those aforementioned manufacturers that 	typically do not issue credit, for example on epinephrine syringes on crash carts.  A drug store 	doesn't carry an item like that.
   8. How is the RD paid for its services? Does the RD receive a percentage of the credit?  Is there a flat fee? Are there additional charges to the healthcare facility for waste management?
	We paid for a percentage of either the estimated credit or of the actual credit received 	(customer's choice).  There is sometimes a minimum daily charge for onsite service.  There may 	be additional charges for waste disposal and hazardous waste disposal.
   9. Under what circumstances would a healthcare facility return pharmaceuticals to a (forward) distributor in lieu of sending to a RD?  Do you process pharmaceuticals from (forward) distributors?
	It depends on the state pedigree laws (in Florida, for example, the hospital cannot do what you 	explained above over 30 days after receipt).  This would happen with a product that was 	mistakenly over ordered.  We do not currently process for any wholesaler forward distributors. 
   10. When pharmaceuticals are received at the RD, are they ever shipped to another RD's facility for crediting? 
	Yes, if there is another reverse distributor contracted to process for that manufacturer as part of 	an outsourcing agreement (like GSK with Stericycle).  Other manufacturers process their own 	returns (like Eli Lilly).
   11. Do you accept non-pharmaceutical products?
	We do not wish to, but sometimes non-pharmaceutical products, ranging from greeting cards to 	panty hose to Christmas decorations to OTC PCPs are sent to us.

   12. How long are pharmaceuticals kept on-site after providing credit?  How long are the pharmaceuticals that become hazardous wastes kept on-site?  On average how long does it take a pharmaceutical to cycle through your facility?
	This depends on the manufacturer's policy and procedure.  If the manufacturer does not require 	an authorization to return, we usually ship out product within five business days after 	determining it has credit value.  If a manufacturer requires a return authorization, and is slow to 	do so, a product could wait months to be returned.
	QRX is an EPA CESQG, but adheres to SQG rules in general and returns hazardous wastes every 	180 days or less.  P-listed wastes are returned when necessary to keep under the 1 kilo 	generator threshold.
	The average product is in our warehouse for 40 days.

Shipment 
   1. Are returned pharmaceuticals shipped to the RD via commercial mail carrier or USPS or private hauler?  Is the shipment tracked and is the healthcare facility notified by the RD that the shipment has been received?  Do healthcare facilities notify the RD that a shipment has been sent? 
	Common carrier, usually FedEx Ground, hauls QRX product.   For very large returns, an LTL truck 	service is used, as long as the return is palletized.  All shipments are tracked using a daily activity 	report provided by our contracted carrier.  Customer Service/Sales personnel notify the 	customer when the product is received.  Smaller customers typically do not inform us ahead of 	time, and we find out when we check our inbound shipping report from FedEx.
	One major exception to this is when there are DEA controlled substances involved; all parties 	are notified in advance of shipment, especially for DEA Class II drugs (e.g. Oxycontin).
   2. Does the board of pharmacy require RDs to keep an inventory of everything received at an RD? 
	While not required by the state of Tennessee, we do so anyway at QRX as part of our internal 	best practice.
   3. Are controlled substances shipped separately from other pharmaceuticals?  Can you explain more about the process of handling returned controlled substances?
	Controlled substances fall into two categories for us, Class II (e.g. Oxycontin, Cocaine, Fentanyl) 	and Class III-V (e.g. Ambien, Xanax, Phentermine).
	To return CII drugs, a DEA 222 form must accompany the shipment.  The customer requests our 	DEA 222 and we send it to them after verifying their request along with a separate shipping 	label that has an internal secret code so when the product is received, our receiving clerks know 	immediately that this is a CII controlled substance and it is locked up in our vault until such time 	that it is processed.   DEA rules require that the returned product and the request match 	absolutely exactly, so precision is key.
	The process for CIII-V is similar but not quite as stringent.  For example, there is an inventory 	form along with a bag to separate the CIII-V from the rest of the drugs in the box.  As soon as the 	box is open, the inventory form we supplied the customer, along with the drugs in question, are 	segregated in our DEA approved security cage.
   4. Have there been incidences where shipments have been lost or stolen?
	Fortunately for QRX, this has never happened to our company.
Waste Determination and Management 
   1. What percentage of returned pharmaceuticals is typically RCRA hazardous waste once it is determined credit will or will not be given?  Typically, do pharmaceuticals that meet RCRA's definition of a hazardous waste get credit?  Do you ever manage non-hazardous pharmaceuticals as RCRA hazardous waste?
	Approximately 5% of products returned meet some type of RCRA criteria.  However, only an 	item that is deemed non-returnable will be categorized as RCRA hazardous waste.  While it can 	be defined as off spec or expired, it still holds its original commercial value or a percentage 	thereof.  So the correct way to phrase this is that of the 40% of non-returnable product, 5% of 	that is RCRA.
	Again, in reference to my point above, if it is creditable it is not a `waste'.  However, we 	understand the point of the question being asked, and yes, many items like warfarin sodium 	(P001 when waste), especially brand name Coumadin from Bristol Myers-Squibb, and insulin 	(D009 when waste) from manufacturers like Eli Lilly and Novo Nordisk, do routinely receive 	credit.  However, there are other products like nicotine (P075) that are almost all OTC products 	and are for our purposes never creditable. 
	We do not manage items that do not meet RCRA definitions as hazardous.  However, we 	encourage our customers to ensure the following items are incinerated when waste whenever 	possible.  So while we do not manage non hazardous pharmaceuticals as RCRA because all of 	our waste is incinerated anyway, we encourage customer we might be using an autoclave or 	landfill for some of their waste streams to make sure some non-RCRA product is incinerated.  	Not necessarily at a RCRA incinerator, but at an incinerator instead of autoclave or landfill. 
                            ITEMS TO BE INCINERATED
   I.                RCRA Acutely Toxic Waste (RCRA INCINERATION) 
         a.                      COMMON EXAMPLES- Warfarin Sodium, Nicotine, Physostigmine, Phentermine
   II.                Mixed Infectious Hazardous Waste (RCRA INCINERATION)
         a.                      COMMON EXAMPLES- Crofab Antivenin, Intron Alfa 2B, Live Vaccines with Thimerosal Preservatives, Abraxane
   III.                RCRA Hazardous Pharmaceuticals (RCRA INCINERATION)
         a.                      COMMON EXAMPLES (U-list)  -  Lindane, Mitomycin, Daunorubicin, Cyclophosphamide
         b.                      COMMON EXAMPLES (D-list)  -  Flexible Collodion, Silver Sulfadiazine, Barium Sulfate, Selenium 
         c.                      COMMON EXAMPLES (Flammable Gases)  -  Epifoam, Protofoam, Granulex, Ethyl Chloride 
   IV.                D.O.T. Non-Flammable Gases require special transport placards and should be segregated for incineration.  Non-Flammable gases may be shipped with flammable gases.
         a.                      COMMON EXAMPLES  -  Ventolin, Maxair, Atrovent
   V.                E.P.A. Categories of Concern are products that may not yet be regulated, but we expect  regulatory action regarding these items.  
         a.                      E.P.A. Classified Greenhouse Gas
         b.                      COMMON EXAMPLE  -  Sevoflurane
         c.                      E.P.A. Contaminant Candidate List 3
         d.                      COMMON EXAMPLE  -  Estradiol
         e.                      E.P.A. Regulated Pesticide
         f.                      COMMON EXAMPLE  -  Permethrin
   VI.                Joint Commission Hazardous- The Joint Commission, the National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA) urge hospitals to prioritize safety and health protocols for the most hazardous drugs.  This category is a now combined entry of items found in the OSHA Technical Manual, Section VI, Chapter 2 listed drugs, NIOSH "Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings 2004", and the NIOSH "List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010",  from the Joint Commission Online, April 13, 2011.
   1. Is the manufacturer always contacted prior to disposal of a creditable pharmaceutical? For a non-creditable pharmaceutical?
	Yes, we always notify the manufacturer prior to destroying a creditable pharmaceutical; 	otherwise they might deny us and our customer our credit due.  If they have already denied 	credit either per policy or authorization, our duty to the manufacturer is complete and we 	destroy without notifying them.
   2. What percentage of returned pharmaceuticals is sent back to the manufacturer versus being disposed of directly by the RD?
	Approximately 60% of our product is returned, and 40% is destroyed.  This can vary from return 	company to return company based on my aforementioned explanation about different 	customer classes having different amounts of returnable product.