November 21, 2011, Quality RX Returns Reply

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.
November 21, 2011, Quality RX Returns Reply

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.
November 21, 2011, Quality RX Returns Reply

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 
November 21, 2011, Quality RX Returns Reply

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
November 21, 2011, Quality RX Returns Reply

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.

2. 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.

3. 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.