What must all medications sold in the United States comply with?

• A. State Pharmacy Laws
• B. National Drug Code Regulations
• C. United States Pharmacopeia and National Formulary Standards
• D. Consumer Protection Act Regulations

Answer: (C)

All medications sold in the United States must comply with the standards set forth by the United States Pharmacopeia (USP) and the National Formulary (NF). The USP establishes quality standards for medicines, which include both prescription and over-the-counter medications, ensuring their purity, strength, and consistency. The National Formulary complements the USP by providing standards for excipients and other ingredients used in drug formulations. These standards are essential for maintaining the safety and effectiveness of medications that patients rely on, ensuring that they meet the necessary criteria for public health protection.

While state pharmacy laws and National Drug Code regulations also play important roles in medication regulation, they are often governed by specific state and federal guidelines that may vary. The Consumer Protection Act focuses more on protecting consumers in general but does not specifically set the standards for medications. Thus, the compliance with USP and NF standards is foundational to the approval and sale of medications in the U.S. medical system.