CFR
- Title 1 - General Provisions
- Title 2 - Grants and Agreements
- Title 3 - The President
- Title 4 - Accounts
- Title 5 - Administrative Personnel
- Title 6 - Domestic Security
- Title 7 - Agriculture
- Title 8 - Aliens and Nationality
- Title 9 - Animals and Animal Products
- Title 10 - Energy
- Title 11 - Federal Elections
- Title 12 - Banks and Banking
- Title 13 - Business Credit and Assistance
- Title 14 - Aeronautics and Space
- Title 15 - Commerce and Foreign Trade
- Title 16 - Commercial Practices
- Title 17 - Commodity and Securities Exchanges
- Title 18 - Conservation of Power and Water Resources
- Title 19 - Customs Duties
- Title 20 - Employees' Benefits
- Title 21 - Food and Drugs
- Title 22 - Foreign Relations
- Title 23 - Highways
- Title 24 - Housing and Urban Development
- Title 25 - Indians
- Title 26 - Internal Revenue
- Title 27 - Alcohol, Tobacco Products and Firearms
- Title 28 - Judicial Administration
- Title 29 - Labor
- Title 30 - Mineral Resources
- Title 31 - Money and Finance: Treasury
- Title 32 - National Defense
- Title 33 - Navigation and Navigable Waters
- Title 34 - Education
- Title 35 - Panama Canal
- Title 36 - Parks, Forests, and Public Property
- Title 37 - Patents, Trademarks, and Copyrights
- Title 38 - Pensions, Bonuses, and Veterans' Relief
- Title 39 - Postal Service
- Title 40 - Protection of Environment
- Title 41 - Public Contracts and Property Management
- Title 42 - Public Health
- Title 43 - Public Lands: Interior
- Title 44 - Emergency Management and Assistance
- Title 45 - Public Welfare
- Title 46 - Shipping
- Title 47 - Telecommunication
- Title 48 - Federal Acquisition Regulations System
- Title 49 - Transportation
- Title 50 - Wildlife and Fisheries
601.5—Revocation of license.
(a)
A biologics license shall be revoked upon application of the manufacturer giving notice of intention to discontinue the manufacture of all products manufactured under such license or to discontinue the manufacture of a particular product for which a license is held and waiving an opportunity for a hearing on the matter.
(b)
(1)
The Commissioner shall notify the licensed manufacturer of the intention to revoke the biologics license, setting forth the grounds for, and offering an opportunity for a hearing on the proposed revocation if the Commissioner finds any of the following:
(i)
Authorized Food and Drug Administration employees after reasonable efforts have been unable to gain access to an establishment or a location for the purpose of carrying out the inspection required under § 600.21 of this chapter ,
(ii)
Manufacturing of products or of a product has been discontinued to an extent that a meaningful inspection or evaluation cannot be made,
(iv)
The establishment or any location thereof, or the product for which the license has been issued, fails to conform to the applicable standards established in the license and in this chapter designed to ensure the continued safety, purity, and potency of the manufactured product,
(v)
The establishment or the manufacturing methods have been so changed as to require a new showing that the establishment or product meets the requirements established in this chapter in order to protect the public health, or
(vi)
The licensed product is not safe and effective for all of its intended uses or is misbranded with respect to any such use.
(2)
Except as provided in § 601.6 of this chapter, or in cases involving willfulness, the notification required in this paragraph shall provide a reasonable period for the licensed manufacturer to demonstrate or achieve compliance with the requirements of this chapter, before proceedings will be instituted for the revocation of the license. If compliance is not demonstrated or achieved and the licensed manufacturer does not waive the opportunity for a hearing, the Commissioner shall issue a notice of opportunity for hearing on the matter under § 12.21(b) of this chapter.
Code of Federal Regulations
Tips