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 pharmacie s 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 intelli gence, 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 pharm acies 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 t ype of a pharmaceutical product and each NDC has a credit policy assigned by the manufacturer of that product. Inmar Pharmaceutical Services offers a com prehensive solution set for managing returns . MedTurn is a wholly owned subsi diary 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 settlem ent, 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 additiona l comments or inquires at: Keith.Anderson@Inmar.com o r 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? Gen erally, 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 fr om 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. P harmacies 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 establi sh 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 c ustomers. 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, T

exas operation.

4. I s credit received per container? In most cases, yes. All parameters for credit are established in polic i es 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 polic i es by the manufacturers of the pharmaceutical products.

5. Do healthcare facilities return pharmaceuticals from the patient floors (e.g., drugs that hav e 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 retu rned 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 polic i es by the manufactur

ers 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 pharmaceuti cal 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 va ries 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 separate ly from other pharmaceuticals? This varies by

customer. P

harmacies 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

s trict 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. N umerous states r egulat e 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 burde nsome 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 th e 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 fo r manufacturers. However, post

- destruction documentation is a more frequent requirement. For a non

- creditable pharmaceutical? Sam e 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. H istorically

, 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 direct ly disposed at any Inmar location.