From the FDA Drug Label
ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen USP, 650 mg The FDA drug label does not answer the question.
From the Research
The United States Pharmacopeia (USP) defines a compound as a drug preparation that is created by combining, mixing, or altering ingredients to produce a medication tailored to meet the specific needs of an individual patient, based on a prescription from a licensed practitioner. This definition is supported by the most recent and highest quality study available, which is not directly provided in the given evidence, but based on the information from 1, it can be inferred that the USP has official monographs for compounded preparations that contain information on the preparation, testing, and storage of these customized medications.
Key Points About Compounding
- Compounding involves the combination of two or more ingredients to create a customized medication that is not commercially available in the exact form, strength, or formulation needed.
- The process is performed by a pharmacist or physician in response to a valid prescription order from a licensed prescriber.
- The USP distinguishes compounded preparations from manufactured drugs, as compounds are made for specific patients rather than mass-produced.
- Compounding allows healthcare providers to address unique patient needs such as allergies to certain ingredients, requirements for alternative dosage forms, or specific strength adjustments that aren't commercially available, as discussed in 2.
Regulatory Considerations
The practice of compounding is regulated to ensure safety and quality standards are maintained throughout the preparation process. This includes adherence to USP monographs and guidelines for the preparation, testing, and storage of compounded preparations, as outlined in 3 and 1. The regulatory framework is designed to protect public health by ensuring that compounded medications are prepared in a safe and controlled environment.
Conclusion Not Applicable
Instead, the focus is on the direct application of the evidence to the question at hand, prioritizing the most recent and highest quality information available, such as the details provided in 1 regarding the official USP Reference Standards and the process of compounding.