The term prescription drug establishment refers to a business location, either in the United States or abroad, where prescription drugs are manufactured in their final dosage form. This establishment must consist of one or more buildings that are all located within five miles of each other. It is important to note that the term "manufactured" does not include the packaging of these drugs.
This term is primarily used in the context of pharmaceutical law and regulation. It is relevant to the Food and Drug Administration (FDA) and other regulatory bodies that oversee drug manufacturing practices. Understanding the definition of a prescription drug establishment is crucial for compliance with federal regulations, particularly those concerning the safety and efficacy of medications.
Users may encounter forms and procedures related to the registration and operation of these establishments, which can be managed using legal templates from US Legal Forms.
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company operates a facility in New Jersey where it produces tablets and capsules. All buildings are located within a five-mile radius, qualifying as a prescription drug establishment.
Example 2: A foreign manufacturer has multiple facilities in Canada that produce injectable medications, all located within the specified distance. This setup also qualifies under the definition of a prescription drug establishment. (hypothetical example)
The primary legal reference for the term prescription drug establishment is found in the Federal Food, Drug, and Cosmetic Act, specifically under 21 USCS § 379g (5). This statute outlines the definitions and regulations governing drug manufacturing and the responsibilities of establishments.
| Term | Definition | Key Differences |
|---|---|---|
| Pharmaceutical Manufacturer | A company that produces drugs. | Broader term; includes packaging and various forms of drug production. |
| Drug Distributor | A business that supplies drugs to retailers or healthcare providers. | Focuses on the distribution rather than manufacturing. |
If you are involved in the operation of a prescription drug establishment, ensure compliance with federal regulations. This may involve obtaining necessary licenses and adhering to safety standards. Users can explore US Legal Forms for templates that can assist in managing the legal requirements effectively. If your situation is complex, consider seeking professional legal advice.
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| Attribute | Details |
|---|---|
| Typical Fees | Varies by state and type of establishment. |
| Jurisdiction | Federal and state laws apply. |
| Possible Penalties | Fines, suspension of operations, or revocation of licenses for non-compliance. |
It is a business location where prescription drugs are manufactured in final dosage form, with all buildings within five miles of each other.