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Understanding Bulk Drug Substance [Food and Drugs]: A Comprehensive Guide
Definition & Meaning
A bulk drug substance refers to any material intended for use in a drug that, during the manufacturing, processing, or packaging phases, becomes either an active ingredient or a finished dosage form of that drug. However, this term does not include intermediates, which are substances used in the synthesis of bulk drug substances. Understanding this definition is crucial for manufacturers and regulatory bodies involved in drug production and distribution.
Table of content
Legal Use & context
The term bulk drug substance is primarily used in the context of pharmaceutical law and regulation. It is relevant to the Food and Drug Administration (FDA) regulations, particularly in ensuring that drugs are manufactured according to safety and efficacy standards. Legal practitioners in the pharmaceutical field may encounter this term when dealing with compliance, registration, and quality assurance processes. Users can utilize legal templates from US Legal Forms to navigate the regulatory requirements concerning bulk drug substances.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company produces a bulk drug substance that is an active ingredient in a new medication for hypertension. This substance undergoes various manufacturing processes before it is packaged as a finished drug.
Example 2: A manufacturer creates a bulk drug substance for a vaccine. This substance is critical in the vaccine's formulation and must meet specific regulatory standards for safety and efficacy. (hypothetical example)
Relevant laws & statutes
Key regulations include:
21 CFR 207.3, which defines bulk drug substances and outlines the registration of drug producers.
21 CFR 210 and 211, which detail the current good manufacturing practices (cGMP) for drugs.
Comparison with related terms
Term
Definition
Difference
Active Ingredient
A component that provides the intended therapeutic effect in a drug.
Bulk drug substances can include active ingredients but also encompass the broader category of substances before they are formulated into a drug.
Intermediate
A substance produced during the synthesis of a bulk drug substance.
Intermediates are not classified as bulk drug substances, as they do not directly contribute to the final drug product.
Common misunderstandings
What to do if this term applies to you
If you are involved in the production or regulation of drugs, ensure compliance with relevant FDA regulations regarding bulk drug substances. Consider using US Legal Forms to access templates that can help you navigate the necessary documentation and procedures. If your situation is complex or unclear, seeking professional legal advice is recommended.
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