Our Policies


Under the recently enacted 21st Century Cures Act in the US, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted for expanded access under section 561(b) of the US Federal Food, Drug, and Cosmetic Act.

As a company working toward scientific advancements in the treatment of diseases that have high unmet medical needs, the Company and its affiliates support the Cures Act and its provisions to speed the development of new treatments for patients. In accordance with the Cures Act, the following are the Company’s policies and procedures relating to how it will evaluate and respond to requests for expanded access to the Company’s investigational drugs to treat serious diseases:

Contact Information

The Company currently has no active clinical trials in the US. In the event that the Company begins a clinical trial involving a serious disease or condition in the US, this website and policy will be updated to notify the public whether the Company will consider accepting expanded access requests at that time. The following is the contact information at the Company for communications regarding expanded access requests as described above:

  • 1-888-292-0058 (please note that no expanded access program is available at this time)
Request Procedures

The Company currently has no active clinical trials in the US. In the event that the Company begins a clinical trial involving a serious disease or condition in the US, this website and policy will be updated to notify the public whether the Company will consider accepting expanded access requests at that time.

General Criteria

As noted above, the Company currently has no active clinical trials in the US. In the event that the Company begins a clinical trial involving a serious disease or condition in the US, this website and policy will be updated to notify the public whether the Company will consider accepting expanded access requests at that time. The following are the general criteria that the Company expects to use to evaluate any expanded access requests in the future:

  • The individual patient must suffer from a fatal or severely disabling condition for which no other effective treatment options exist.
  • There must be no other clinical trials underway, or the individual patient must be either categorically ineligible or disqualified from the clinical trials.
  • There must be clear and convincing evidence of safety of the investigational drug, demonstrated by a clinical trial.
  • There must be clear and convincing evidence that the investigational drug could be beneficial in the particular patient for whom the indication for which expanded access is sought.
  • There must be clear and convincing evidence that the risks associated with the use of the investigational drug are reasonable in light of the potential benefits.
  • There must be an open Investigational New Drug application (IND) in the US, under which clinical trials are to be conducted in the US.
  • The investigational drug must be used in clinical trials for the condition for which access is requested.
  • Any preapproval access to an investigational drug must always comply with the applicable local laws and regulations, including approvals from applicable regulatory bodies, and by an institutional review board or ethics committee for the treating hospital.
  • Qualified health professionals must be available to administer the investigational drug and monitor the patient under a study protocol.
  • There must be adequate supply of the investigational drug, beyond what is required for clinical trials.
  • In the event that the Company discontinues clinical development of the investigational drug, expanded access will be timely closed out as well for that investigational drug.
  • Once the US Food and Drug Administration (FDA) has approved the applicable drug for any indication, the expanded access program for that drug will be phased out, as the drug will then be commercially available.
  • The Company does not offer expanded access for an investigational drug which is in an early stage of testing since there are still lots of unknowns.
Anticipated Timing

The Company anticipates that it will acknowledge receipt of such request within five (5) business days of receipt of the applicable request.

Clinicaltrials.gov

The Company currently has no active clinical trials in the US. In the event the Company begins a clinical trial involving a serious disease or condition in the US that may qualify for expanded access under the US Federal Food, Drug, and Cosmetic Act, this website and policy will be updated to notify the public whether the Company will consider accepting expanded access requests at that time, and if so, with a hyperlink or other reference to the clinical trial record containing the required information about the expanded access for such drug.

Nothing herein shall prevent the Company from revising this policy at any time. The posting of this policy by the Company shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

I. Policy Statement

This United States Return Goods Policy (“Return Policy”) for Mitsubishi Tanabe Pharma America, Inc. ("MTPA") applies to any MTPA product (“Product”) sold in the United States and its territories. The terms of this Return Policy apply to expired Product and Product subject to a Product Quality Complaint (“PQC”) and/or potential Adverse Event (“AE”).

THIS RETURN POLICY IS SUBJECT TO CHANGE AT ANY TIME WITHOUT PRIOR NOTICE.

II. Return Designee

(A) Unless otherwise instructed, all MTPA Product returns should be sent to MTPA’s Authorized Return Goods Vendor at the address below:

Mitsubishi Tanabe Pharma America, Inc.
Attn: Returned Goods
15 Ingram Blvd, Dock 43
LaVergne, TN 37086

(B) MTPA incurs the cost for processing and destruction of Products properly returned to MTPA’s Authorized Return Goods Vendor. MTPA will not assume responsibility for charges incurred by customers using other means for processing returns and destruction.

III. Returns of Expired Product

(A) AUTHORIZATION FOR RETURN:

  1. To initiate a Product return for expired Product that is not subject to a PQC or AE, the Authorized Distributor of Record shall contact MTPA’s Authorized Return Goods Vendor via email (GMB-SPS-ReturnRequests@cordlogistics.com) or by fax (615-652-0271) to obtain a Return Goods Authorization ("RGA"). To ensure consideration for reimbursement, all returned Products must be accompanied by a RGA and shipped pre-paid.
  2. Products not suitable for use, whether or not eligible for reimbursement (i.e. unexpired product), are to be returned to the Authorized Return Goods Vendor for evaluation, disposal and destruction and must include a RGA. NO REIMBURSEMENT WILL BE ISSUED FOR UNEXPIRED PRODUCT.
  3. All Product returns must be accompanied by a RGA.
  4. The RGA is valid for sixty (60) days from issuance. All Product must be returned to the Authorized Return Goods Vendor within sixty (60) days of the issuance of the RGA.
  5. To speak with MTPA’s Order/Returns Service, call: Toll Free Number – 844-529-8990
    Fax – 614-652-4374
  6. THE RETURN GOODS AUTHORIZATION IS ISSUED UPON UNCONFIRMED REPRESENTATIONS MADE TO MTPA’S AUTHORIZED RETURN GOODS VENDOR AND IS NOT INTENDED TO BE A GUARANTEE OF REIMBURSEMENT OR REPLACEMENT.
  7. MTPA will not assume any responsibility for charges incurred for Product returned to a facility other than MTPA’s Authorized Return Goods Vendor. Products shipped to the Authorized Return Goods Vendor without a prior issued RGA from MTPA will not be eligible for reimbursement.
  8. A Healthcare Provider (i.e. physician’s office, infusion center, clinic) shall initiate the return of Product by contacting the Authorized Distributor of Record from which it purchased the Product.
  9. Credit for a return shall be issued only to an Authorized Distributor of Record.

(B) RETURNING THE PRODUCT:

(1) Each return shipment of Product to the Authorized Return Goods Vendor must contain:

  1. Name, address, DEA # or HIN # and contact information for facility returning the Product
  2. Authorized Distributor of Record’s (entity Product was purchased from) name, address, and contact information
  3. Reference Number from the RGA
  4. Name and address of the customer’s current Authorized Distributor of Record to whom credit will be remitted
  5. List of Products, including quantity being returned, lot number, serialization number and expiration date of each
  6. Original Carton
  7. Debit Memo Number (see below)
  8. Reason for return
  9. Date of Return

(2) Only one (1) debit memo number/proof of purchase is allowed per return shipment. If a return shipment contains multiple boxes, a photocopy of the paperwork with debit memo number/proof of purchase must be placed in each box.

C. OUTDATED PRODUCTS NOT ELIGIBLE FOR REIMBURSEMENT:

No credit for a product return is available in the following circumstances:

  • Product not purchased directly from a MTPA Authorized Distributor of Record.
  • Product that is received more than six (6) months past the product’s expiration date.
  • Product damaged due to improper storage, handling, fire or catastrophe, unless otherwise qualifying as a returnable item.
  • Product destroyed or damaged from insurable causes.
  • Product distributed at no charge.
  • Product that has been sold expressly on a non-refundable basis.
  • Product obtained illegally or via diverted means.
  • Product purchased on behalf of other manufacturers, institutions, contract research organizations, or others for use in clinical trials or studies, Phase IV studies, or for charitable donations.
  • Product with a prescription label on either the bag or carton.
  • Product not in original containers.
  • Product with labels removed or illegible.
  • Product involved in salvage, bankruptcy or insolvency proceedings.
  • Private label or repackaged Products.
  • Product for which proof of purchase cannot be verified.
  • Partial bags.
IV. Shipping Errors/Damaged Shipments

(A) Product shipments received in error or damaged in transit from a MTPA Authorized Distributor of Record must be reported to the Authorized Distributor of Record.

(B) Product shipments received in error or damaged in transit from a pharmacy provider must be reported to the pharmacy provider.

(C) MTPA IS NOT RESPONSIBLE NOR LIABLE FOR PRODUCT SHIPMENTS RECEIVED IN ERROR FROM AN AUTHORIZED DISTRIBUTOR OF RECORD OR DAMAGED IN TRANSIT.

V. Returns Related To PQCs And/Or AEs

(A) For Product returns due to a PQC and/or AE, Authorized Distributors of Record, Healthcare Providers, and any others should follow the steps below to report PQCs or AEs and to obtain instructions to return the Product.

(1) Collect the following necessary information to report:

  • The name of the Product
  • The date of the incident, if available
  • The date that the complaint was received (i.e. awareness date)
  • Product identification information(s) (e.g. Lot number, NDC number, expiration date etc.)
  • Serialization number on the cartons and/or shipper
  • Defective quantity, total inventory for the lot at the site
  • The name, address, email and phone number of the reporter and the end-user (if different from the reporter and if available)

(2) Collect and report the details and circumstances of the incident or complaint, including but not limited to:

  • Details of any allegations of any adverse drug experience or health safety concerns (e.g. death, severe allergic reactions, serious injury or harm(s) caused by the Product etc.)
  • Document if the end user could not or did not provide any of the above information

(3) All complaints and related information shall be forwarded to the MTPA Medical Information call center (ProPharma) no later than one (1) business day of receipt of the information by using the following listed phone number or by fax:

PROPHARMA

Tel: 1-888-292-0058

Tel: 1-908-504-4060

(4) After the complaint and information is filed, MTPA or its representative will advise the Healthcare Provider, Authorized Distributor of Record, and/or other entity as to the return procedures for the Product.

VI. Terms For Product Returns

(A) MTPA will not be responsible for Product that is destroyed by any party other than MTPA’s Authorized Return Goods Vendor and proof of destruction will not be accepted in lieu of an actual return. All eligible Products shipped to MTPA must be shipped in a safe, secure, and reliable manner and in compliance with all applicable federal, state, and local laws, regulations and statutes. All shipments must be accompanied by a complete and accurate debit memo number and other required documentation as set forth in Section V hereof. MTPA is not responsible for shipments lost and/or damaged in transit. MTPA recommends that all customers insure return goods shipments.

(B) MTPA will audit the quantities of return goods and final reimbursement will be based on MTPA’s counts. The returned Products will be reimbursed based upon the actual selling price of such Product less any discounts or chargebacks. If the actual selling price of such Product is not able to be determined, MTPA will determine the reimbursement amount in its sole discretion. If the Healthcare providers initiating the return cannot be determined based on information supplied with the return or upon request, MTPA will deny any credit for the return. All reimbursements due for return goods to non-direct purchasing customers will be issued as a credit through the non-direct purchasing customers current Authorized Distributor of Record. Any credits that are issued by MTPA must be redeemed within six (6) months of issuance; otherwise, the credit may be voided or escheated in accordance with applicable law. If a customer cannot receive a credit via their current Authorized Distributor of Record, then the customer should contact MTPA’s Order/Returns Service at 844-529-8990 to determine an alternate method of reimbursement.

(C) Return goods shipments which are deemed to be outside of this Return Policy will not be returned to the customer and no reimbursement will be issued by MTPA for such Product unless state or local law requires otherwise.

(D) MTPA reserves the right to audit the amounts reimbursed for return goods for a period of up to three (3) years from when the payment or credit was issued. If the audit determines that a customer was paid/credited in excess of the amounts specified per this Return Policy then MTPA will be allowed at its election to either: (i) withhold payments/credits for future return goods, or (ii) invoice the customer for the amount of the return goods overpayment and the customer must make payment within thirty (30) days upon receipt of invoice.

(E) MTPA reserves the right to inspect all authorized returns and a credit memo will only be issued for Product that is returned in accordance with and meets the terms of this Return Policy.

(F) MTPA will only consider authorizing returns for Product that is purchased directly from MTPA or through a MTPA Authorized Distributor of Record. Product that has been purchased from sources outside of the United States or its territories or through unauthorized agents in the US will not be credited or refunded.

(G) MTPA reserves the right to require proof-of-purchase on any item returned for credit or refund.