A Comprehensive Overview of the Biologics Control Act

Q: Is the Biologics Control Act still in effect?

While it has been replaced by newer laws, its principles still influence current regulations.

Q: Who oversees compliance with the Biologics Control Act?

The Food and Drug Administration (FDA) is responsible for overseeing compliance.

Definition & Meaning

The Biologics Control Act is a federal law enacted in 1902 that governs the production and regulation of biological products, including vaccines and antitoxins. This legislation was introduced in response to a tragic incident involving contaminated vaccines that resulted in the deaths of several children. The Act aimed to ensure the safety and efficacy of biological products by establishing standards for their production in hygienic laboratories. Although it was replaced by the Pure Food and Drugs Act in 1906, the Biologics Control Act laid the groundwork for modern regulations in the field of biotechnology and public health.

Table of content

Legal Use & context

The Biologics Control Act is significant in the realm of public health law and regulatory compliance. It is primarily used in the context of:

Public health and safety regulations
Biotechnology and pharmaceutical law
Compliance with federal standards for vaccine and antitoxin production

Users may encounter forms and procedures related to the production and approval of biological products, which can often be managed with the help of legal templates from US Legal Forms.

Key legal elements

Real-world examples

Here are a couple of examples of abatement:

One example of the Biologics Control Act in action is its role in the approval process for new vaccines. For instance, when a pharmaceutical company develops a new vaccine, it must comply with the standards set forth by the Act to ensure that the vaccine is safe for public use. This includes rigorous testing and quality control measures.

(Hypothetical example) A small biotech firm creates a new antitoxin to treat a specific disease. Before it can market this product, it must submit its production methods and safety data to the FDA, adhering to the regulations established by the Biologics Control Act.

Relevant laws & statutes

The primary statute relevant to this term is the Biologics Control Act of 1902. Additionally, the Pure Food and Drugs Act of 1906 and subsequent amendments to the Federal Food, Drug, and Cosmetic Act further shaped the regulatory landscape for biologics.

Comparison with related terms

Term	Definition	Key Differences
Biologics Control Act	A law regulating the production of biological products.	Focuses specifically on biologics, unlike general drug laws.
Pure Food and Drugs Act	A law that regulates food and drug safety.	Broader scope than the Biologics Control Act, which is specific to biologics.

Common misunderstandings

What to do if this term applies to you

If you are involved in the production or distribution of biological products, it is crucial to understand the regulations set by the Biologics Control Act. You should:

Consult legal resources or professionals to ensure compliance with federal regulations.
Explore US Legal Forms for templates and guidance on regulatory compliance.
Consider seeking professional legal assistance for complex matters or specific inquiries.

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Quick facts

Attribute	Details
Enacted	1902
Regulating Agency	Food and Drug Administration (FDA)
Focus	Biological products, including vaccines and antitoxins
Replaced By	Pure Food and Drugs Act (1906)