Submitted Electronically

December 2, 2011

Fitzgerald.Kristin@epa.gov

Environmental Protection Agency

Arlington, VA

Subject: Questions about reverse distribution

Dear Ms. Fitzgerald, 

Inmar, Inc. (“Inmar”) appreciates the opportunity to provide written responses to the EPA’s questions about 

reverse distribution. Inmar applauds the EPA for soliciting comments to learn more about this invaluable 

service industry to the nation’s pharmacies and healthcare system. 

Inmar connects trading partners through consulting, software services, and operations. Our solutions make 

the connections that improve quality, efficiency and collaboration in supply chain, consumer marketing, 

business intelligence, financial settlement and risk management. We are a trusted partner focused on 

driving sales and bottom line performance through a combination of technology and people. We serve over 

1,200 retailers, wholesalers, manufacturers and 32,000 retail pharmacies by processing billions 

of returned/recalled products, promotional transactions and pharmacy claims each year. 

To help put this into perspective; Inmar’s current database of NDC’s (National Drug Codes) exceeds 

330,000 separate entries. Each entry represents one package type of a pharmaceutical product and each 

NDC has a credit policy assigned by the manufacturer of that product. Inmar Pharmaceutical Services 

offers a comprehensive solution set for managing returns. MedTurn is a wholly owned subsidiary of Inmar 

and is registered with DEA as a reverse distributor. Inmar’s MedTurn facility provides pharmacies with 

controlled substance pharmaceutical returns processing for CII-V, List 1, prescription drugs, over the 

counter products, financial settlement, hazardous waste destruction, pedigree compliance and Web-based 

pharmacy inventory automation tools.

We again would like to thank the EPA for the opportunity to comment and participate in this process. 

Please feel free to contact me for any additional comments or inquires at: Keith.Anderson@Inmar.com or 

by telephone: 336-770-3567.

Best regards, 

Keith Anderson

Senior Director, Regulatory Compliance

cc: Lisa Lauer Lauer.Lisa@epa.gov, 

Jessica Young Young.Jessica@epa.gov

2601 Pilgrim Court

Winston Salem, NC 27041

www.inmar.com
EPA’s Questions for Reverse Distributors

General Questions about the Returns Process

1. Who initiates the return? Generally, Inmar’s clients will initiate the return of prescription products. 

Each client has a predetermined process for returning prescription products to Inmar. These 

processes are similar, but vary from client to client.

2. 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? This 

practice varies from client to client. Direction may be given from a pharmacy’s corporate or regional 

office directing them to return products, or this may be at the discretion of the individual pharmacy. 

The items shipped to Inmar are close to expiration, and/or are damaged. The EPA should not 

presume that returned items are un-needed. Pharmacies will replace these returned products with 

products that have a longer expiration date and are not damaged. Most of Inmar’s clients have 

knowledge of their returns policies. As such, the clients work with Inmar to establish business rules 

that will procure credit eligibility to the manufacturer’s policy. 

3. Does the RD have reps that go to healthcare facilities to pull and prepare pharmaceuticals 

for shipment to the RD? Inmar performs this service for some of our hospital customers. If so, 

does the rep know which items will/will not receive credit? No. All credit decisions are made 

after the pharmaceutical product has been received and evaluated against the manufacturers’ 

policy at the Inmar Ft. Worth, Texas operation.

4. Is credit received per container? In most cases, yes. All parameters for credit are established in 

policies by the manufacturers of the pharmaceutical products. So, these practices may vary. Per 

pill if container has been opened? In some cases, yes. This is referred to as a ‘partial return’. 

Again, all parameters for credit are established in policies by the manufacturers of the 

pharmaceutical products. 

5. Do healthcare facilities return pharmaceuticals from the patient floors (e.g., drugs that have 

been re-packaged)? Inmar receives very little returned pharmaceuticals from healthcare facilities. 

Based upon our limited receipts, Inmar is not able to answer this question. Are re-packaged 

pharmaceuticals creditable? Inmar receives very little returned pharmaceuticals from healthcare 

facilities. Based upon our limited receipts, Inmar is not able to answer this question.

6. Once the shipment arrives at the RD facility, what is the timeframe for processing? 

Pharmaceutical returns are typically processed within 30 days once they have been received. For 

some clients, this is a longer process and can last as long as 90 days.

7. Are generic brands creditable? In most cases, yes. All parameters for credit are established in 

policies by the manufacturers of the pharmaceutical products.

8. Do expired items typically get credit? In most cases, yes. Expiration dating is an established 

parameter identified by manufacturers in their credit policies. 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? Our clients pay on varying pricing 

models, including per unit and percentage of creditable value models, and some of our contracts

include a provision for a waste management fee.
9. Under what circumstances would a healthcare facility return pharmaceuticals to a (forward) 

distributor in lieu of sending to a RD? Returning product to a forward distributor could be a 

parameter of a returns policy or program. Do you process pharmaceuticals from (forward) 

distributors? Yes. Inmar processes product returns from forward distributors.

10. When pharmaceuticals are received at the RD, are they ever shipped to another RD’s facility 

for crediting? Yes. This occurs as a condition of the manufacturer’s returns policy.

11. Do you accept non-pharmaceutical products? Yes. 

12. How long are pharmaceuticals kept on-site after providing credit? This time period varies. 

How long are the pharmaceuticals that become hazardous wastes kept on-site? Once a 

product has been determined to be waste, the item is stored on site for less than 90 days. On 

average how long does it take a pharmaceutical to cycle through your facility? Under normal 

circumstances, product would typically reside in our facility about 60 days. There are many 

exceptions that would create longer time frames.

Shipment 

1. Are returned pharmaceuticals shipped to the RD via commercial mail carrier or USPS or 

private hauler? Both commercial mail carriers and USPS. 

2. Is the shipment tracked and is the healthcare facility notified by the RD that the shipment 

has been received? Pharmacies are notified through the carriers that a package has been 

received through online package tracking. This information is also posted on our company’s 

website for our client.

3. Do healthcare facilities notify the RD that a shipment has been sent? Notification of shipment 

to Inmar by a client varies with each client.

4. Does the board of pharmacy require RDs to keep an inventory of everything received at an 

RD? An inventory is kept for all products received at the Inmar pharmaceutical processing location. 

5. Are controlled substances shipped separately from other pharmaceuticals? This varies by 

customer. Pharmacies may ship controlled substances in the same package as non-controlled 

pharmaceutical products. 

6. Can you explain more about the process of handling returned controlled substances? The 

processing of controlled substances complies with the DEA regulations, including the execution of

Form 222. This is a detailed process.

7. Have there been incidences where shipments have been lost or stolen? There have been 

incidences of theft or loss. These incidences are documented to DEA on a Form 106 (Report of 

Theft or Loss). These incidents are very rare due to the heightened security measures and 

security/surveillance equipment in place at the Inmar processing location. Also, Inmar has a very 

strict no-pilfering policy and executes random locker, and clothing checks of personnel as additional 

deterrents to employee theft.
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? On average, less than 3% of pharmaceutical 

products that are processed by Inmar are disposed as RCRA hazardous waste. This percentage 

can vary. New pharmaceutical products are introduced each year, and a product recall can skew 

this percentage. Numerous states regulate expired pharmaceuticals as hazardous waste, which 

impacts this percentage. Additionally, pharmacies are not eligible to utilize the valuable services of 

a Reverse Distributor due to burdensome state regulations. Typically, do pharmaceuticals that 

meet RCRA’s definition of a hazardous waste get credit? In most cases, yes. Again, all

parameters for credit are established in policies by the manufacturers of the pharmaceutical 

products. So, these practices may vary. However, we do not see policies that are different for a 

hazardous product as compared to a non-hazardous product by the same manufacturer. Do you 

ever manage non-hazardous pharmaceuticals as RCRA hazardous waste? Only in the 

circumstance where a state regulation requires that a non-hazardous pharmaceutical product be 

managed as a state-regulated hazardous waste.

2. Is the manufacturer always contacted prior to disposal of a creditable pharmaceutical? The 

manufacturers provide the reverse distributor with the credit policies for their products. Any 

additional notification from the reverse distributor to the manufacturer will be detailed as a part of 

this credit policy. Pre-destruction communication is not a common requirement for manufacturers. 

However, post-destruction documentation is a more frequent requirement. For a non-creditable 

pharmaceutical? Same as for a creditable pharmaceutical.

3. What percentage of returned pharmaceuticals is sent back to the manufacturer versus being 

disposed of directly by the RD? This percentage will vary upon the manufacturer and the 

particular returned product. Historically, Inmar returns approximately 25% of returned 

pharmaceuticals to the manufacturer. In the case of Inmar, the disposal of pharmaceutical products 

is performed off-site at permitted incinerator disposal facilities. Inmar contracts with these permitted 

disposal facilities for the compliant disposal of non-hazardous and hazardous waste. No 

pharmaceutical products are directly disposed at any Inmar location.