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United States Code
U.S.C. Title 21-FOOD AND DRUGS
CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V-DRUGS AND DEVICES
Part E-General Provisions Relating to Drugs and Devices

21 U.S. Code § 360bbb-7

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Notification

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21 U.S. Code § 360bbb-7. Notification

(a) Notification to SecretaryWith respect to a drug, the Secretary may require notification to the Secretary by a regulated person if the regulated person knows—

(1)

that the use of such drug in the United States may result in serious injury or death;

(2)

of a significant loss or known theft of such drug intended for use in the United States; or

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The United States Code on COSMOS is current through Public Law 118-64 (05/24/2024).

Part E-General Provisions Relating to Drugs and Devices

§360bbb Expanded access to unapproved therapies and diagnostics
§360bbb-0 Expanded access policy required for investigational drugs
§360bbb-0a Investigational drugs for use by eligible patients
§360bbb-1 Dispute resolution
§360bbb-2 Classification of products
§360bbb-3 Authorization for medical products for use in emergencies
§360bbb-3a Emergency use of medical products
§360bbb-3b Products held for emergency use
§360bbb-3c Expedited development and review of medical products for emergency uses
§360bbb-4 Countermeasure development, review, and technical assistance
§360bbb-4a Priority review to encourage treatments for agents that present national security threats
§360bbb-4b Medical countermeasure master files
§360bbb-5 Critical Path Public-Private Partnerships
§360bbb-5a Emerging technology program
§360bbb-6 Risk communication
§360bbb-7 Notification
§360bbb-8 Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
§360bbb-8a Optimizing global clinical trials
§360bbb-8b Use of clinical investigation data from outside the United States
§360bbb-8c Patient participation in medical product discussion
§360bbb-8d Notification, nondistribution, and recall of controlled substances

U.S. Code Popular Name Table

Popular Names

Americans with Disabilities Act 42 U.S.C. § 12101 et seq.

Anti-Kickback Statute 42 U.S.C. § 1320a–7b(b)

Clayton Act 15 U.S.C. § 12 et seq.

Clean Air Act 42 U.S.C. § 7401 et seq.

Commodity Exchange Act 7 U.S.C. § 1

Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) 42 U.S.C. § 9601 et seq.

Controlled Substances Act 21 U.S.C. § 801 et seq.

Emergency Medical Treatment and Labor Act (EMTALA) 42 U.S.C. § 1395dd

Fair Credit Reporting Act 15 U.S.C. § 1681

False Claims Act 31 U.S.C. § 3729 et seq.

Federal Food, Drug, and Cosmetic Act 21 U.S.C. § 301 et seq.

Federal Insecticide, Fungicide, and Rodenticide Act 7 U.S.C. § 136 et seq.

Federal Trade Commission Act 15 U.S.C. § 41 et seq.

Foreign corrupt Practices Act 15 U.S.C. § 78dd-1 et seq.

Fraud Enforcement and Recovery Act of 2009 (FERA) 18 U.S.C. § 27

Health Information Technology for Economic and Clinical Health Act (HITECH) 42 U.S.C. § 300jj et seq., 42 U.S.C. § 17901 et seq.

Health Insurance Portability and Accountability Act of 1996 (HIPAA) 42 U.S.C. § 201

National Environmental Policy Act (NEPA) 42 U.S.C. § 4321 et seq.

Patient Protection and Affordable Care Act 42 U.S.C. § 18001 et seq.

Physician Payments Sunshine Act 42 U.S.C. § 1320a–7h

Public Health Service Act 42 U.S.C. § 201 et seq.

Resource Conservation and Recovery Act (RCRA) 42 U.S.C. § 6901 et seq.

Robinson–Patman Act 15 U.S.C. § 13

Sarbanes-Oxley Act 15 U.S.C. § 7201 et seq.

Securities Act of 1933 15 U.S.C. § 77a et seq.

Sentencing Reform Act of 1984 18 U.S.C. § 3551 et seq.

Sherman Act 15 U.S.C. § 1 et seq.

Social Security Act 42 U.S.C. § 301 et seq.

Stark Law 42 U.S.C. § 1395nn

Toxic Substances Control Act 15 U.S.C. § 2601 et seq.

Notification

21 U.S. Code § 360bbb-7. Notification

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