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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. xxxxxxxx Expiration Date: Xxxxxxx xx, 201x Drug Notification See PRA Statement on page 2. Refer to instruction.

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To comply with the notification requirements of the DQSA, trading partners – manufacturers, wholesale distributors, dispensers, and repackagers – should use Form FDA 3911 to notify FDA about illegitimate product and, for manufacturers, products that are at high risk of being illegitimate.

The FDA Form 1571 or '1571' is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND. The 1571 is a contractual agreement between the sponsor and the FDA.

The DQSA comprises two pieces of legislation: The Compounding Quality Act and the Drug Supply Chain Security Act (DSCSA).

If a pharmaceutical company agrees to supply the investigational treatment, the treating physician must next request permission to proceed from the FDA through a form FDA 3926, also known as the Individual Patient Expanded Access Investigational New Drug Application.

The Drug Quality and Security Act (H.R. 3204) is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.

“Failure to comply with DSCSA can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties.” “Penalties for a prohibited act include: Imprisonment for not more than one year and/or a fine of not more than $1,000.

The Drug Supply Chain Security Act (DSCSA) outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners).

Foreign Drug Establishment. Collection of GDUFA fees is initiated by industry by filling out a GDUFA cover sheet, (FDA Form 3794), for each of the following human generic drug user fees: ANDA and PAS (Note that a cover sheet is not required for all ANDA and PAS amendments)

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232