A drug substance is an active ingredient that provides pharmacological effects or other direct impacts on diagnosing, curing, mitigating, treating, or preventing diseases. It can also influence the structure or function of the human body. However, it does not include intermediates used in the synthesis of such ingredients.
The term "drug substance" is primarily used in the context of pharmaceutical law and regulatory frameworks. It is relevant in areas such as:
Individuals or companies involved in drug development may need to complete specific forms and comply with regulations set by the Food and Drug Administration (FDA). Users can manage these processes effectively with legal templates available through US Legal Forms.
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company develops a new drug for treating high blood pressure. The active ingredient in this drug is classified as a drug substance because it has a direct effect on the body's cardiovascular system.
Example 2: A manufacturer creates a new vaccine. The active components that stimulate an immune response are considered drug substances. (hypothetical example)
The definition and regulation of drug substances are primarily governed by:
| Term | Definition | Difference |
|---|---|---|
| Drug Product | A finished dosage form that contains a drug substance. | A drug substance is the active ingredient, while a drug product includes the drug substance and other components. |
| Active Pharmaceutical Ingredient (API) | The substance in a pharmaceutical drug that is biologically active. | API is synonymous with drug substance, but "drug substance" is a broader term that includes regulatory context. |
If you are involved in drug development or regulation, ensure you understand the classification of drug substances. You may want to:
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A drug substance is the active ingredient, while a drug product includes the drug substance and other components that make up the final formulation.