Tag: Pharmaceutical regulation

In 2020, Medicaid spent $62.5 million on drugs marketed without FDA approval [1.9.2]. While federal law requires new drugs to be proven safe and effective, several categories of products exist outside this pre-market approval process. Understanding which drugs do not need an FDA approval is crucial for patient safety.

Did you know that in the U.S., the authority to determine drug classifications for controlled substances is shared between the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA)? This complex process, which involves assessing potential for abuse, medical utility, and dependence, is essential for regulating access to medications and preventing misuse.

According to the U.S. Drug Enforcement Administration (DEA), the active ingredient in Valtoco, diazepam, is classified as a Schedule IV controlled substance due to its potential for abuse and dependence. This classification places strict regulations on how the medication is prescribed, dispensed, and stored.

Ambroxol's regulatory status as an over-the-counter (OTC) medication varies significantly by country, with millions of people purchasing it without a prescription in Europe and other regions, while it remains unapproved in the United States. This difference highlights the importance of checking local pharmaceutical regulations before attempting to acquire this mucolytic drug.