(AGENPARL) – SILVER SPRING mer 15 marzo 2023

Human Compounding Fee Payment Instructions

When are fees incurred?
Beginning in fiscal year (FY) 2015, outsourcing facilities that register with the FDA may incur one or more of the fees listed below:

• Annual Establishment (Registration) Fee: Upon FDA determination that an entity has submitted complete registration information.
• Reinspection Fee: After completion of an FDA reinspection of a registered outsourcing facility.

How will I be notified of my fee obligation?
Once the fee is incurred, the agency will issue an invoice to the registrant via e-mail to the address indicated in the registration submission, or via regular mail if e-mail is not an option. This invoice will include the type of fee incurred, the amount of the fee and the date payment is due.

How do I make payment?
Payments can be made by check, bank draft, postal money order, or wire transfer. All payments must be made in U.S. currency, drawn on a U.S. financial institution. Instructions specific to the payment method are described in the table below:

Check, Bank Draft or U.S. Postal Money Order

• Make check/money order payable to the Food and Drug Administration.
• Reference the invoice number on the check
• Include a copy of the invoice
• Mail to the address listed below

  Food and Drug Administration P.O. Box 979033 St. Louis, MO 63197-9000	U.S. Bank Attn: Government Lockbox 979033 1005 Convention Plaza St. Louis, MO 63101 Important: For information on delivery by courier, contact U.S. Bank at (314) 418-4013.

Wire Transfer

• Verify the cost of the wire fee with your financial institution
• Ensure payment sent includes invoice amount plus wire fee
• Complete wire with information below

  Bank Address	33 Liberty Street, New York, NY 10045
  Account Number
  Routing Number
  SWIFT Code	FRNYUS33
  Beneficiary Name	FDA
  Beneficiary Address	8455 Colesville Rd, COLE-14-14253, Silver Spring, MD 20993-0002
  Reference	Invoice number XXXXXXXX

What happens if the FDA does not receive my payment by the due date?
Any entity that does not satisfy its annual establishment fee obligation for a given fiscal year will not be considered registered as an outsourcing facility under section 503B of the FD&C Act. Additionally, all drugs manufactured, prepared, propagated, compounded or processed by an entity that has not paid the full amount of the required annual establishment fee or any applicable reinspection fee will be deemed misbranded under section 502 of the FD&C Act until all fees owed by the outsourcing facility have been paid in full.

How do I know that my fee obligation is satisfied?
Entities that satisfy their annual establishment fee obligation will be notified that they are considered registered and will be added to FDA’s “Registered Outsourcing Facilities” list posted on our website. This list is generally updated weekly. Those whose obligations remain outstanding will be notified via e-mail at the address indicated in the registration submission.

What happens if the FDA does not receive my reinspection fee payment by the due date?
After the close of a reinspection, FDA will issue an invoice for the reinspection fee. Delinquent debt is subject to interest, administrative fees and penalties in accordance with Department of Health and Human Services claim collection regulations described in Title 45, Code of Federal Regulations, part 30. Accordingly, if payment is not received within 30 calendar days of the reinspection fee invoice due date, interest will be charged on the amount owed. Claims that are over 180 days delinquent are submitted to the U.S. Department of Treasury for collection action, in accordance with Title 31, United States Code, section 3711(g).

Whom should I contact with fee questions?
Inquiries should be directed to the Human Drug Outsourcing Facility User Fee staff at <a

What should I do if I receive a full or partial refund that I was not expecting?
If you do not know why you received a refund, contact the User Fee Helpdesk at <a or 301-796-7200.

Fonte/Source: http://www.fda.gov/industry/fda-user-fee-programs/human-drug-compounding-outsourcing-facility-fees