A drug product refers to a finished dosage form, such as a tablet, capsule, or solution, that contains a drug substance. This drug substance may be combined with other ingredients, though this is not always necessary. Essentially, a drug product is what consumers receive when they purchase medication, and it is designed to deliver a specific therapeutic effect.
The term "drug product" is primarily used in the context of pharmaceutical regulation and law. It is relevant in areas such as:
Understanding drug products is essential for those involved in the manufacturing, distribution, and sale of medications. Users can manage related legal documents and processes through platforms like US Legal Forms, which provide templates drafted by licensed attorneys.
Here are a couple of examples of abatement:
Here are a couple of examples of drug products:
The regulation of drug products is primarily governed by:
| Term | Definition | Differences |
|---|---|---|
| Drug Substance | The active ingredient in a drug product that provides therapeutic effects. | A drug product includes the drug substance along with other ingredients, while a drug substance refers only to the active ingredient. |
| Pharmaceutical | A term that encompasses all aspects of drug products, including development, manufacturing, and marketing. | Drug product is a specific form of pharmaceutical, focusing on the finished dosage form. |
If you are involved in the development, distribution, or use of drug products, consider the following steps:
Browse our library of 85,000+ state-specific legal templates.
| Attribute | Details |
|---|---|
| Typical Fees | Varies based on regulatory requirements and product type. |
| Jurisdiction | Federal and state regulations apply. |
| Possible Penalties | Fines, product recalls, or legal action for non-compliance. |
A drug product includes the finished dosage form and may contain additional ingredients, while a drug substance refers only to the active ingredient.