DEA Proposes Removing Butalbital Products No Longer on the Market
/ 1 min read
Table of Contents
The Drug Enforcement Administration is proposing to remove certain prescription drug products from its list of exempted controlled substances. Specifically, the agency wants to take off 160 products containing butalbital, an intermediate-acting barbiturate, because they are no longer sold in the United States.
Why it matters: This action is primarily administrative cleanup. Since these 160 products are already off the market, removing them from the federal register does not change what patients can buy or how doctors prescribe currently available drugs. It simply updates the official record to reflect reality and prevents confusion for companies that might still be trying to navigate regulations for products that do not exist.
Who it affects
- Pharmaceutical manufacturers who may have listed inactive butalbital products on their regulatory filings
This is a proposed rule from the Drug Enforcement Administration published in the Federal Register; check the original document at regulations.gov for comment deadlines and full legal text.
Agency: Justice Department, Drug Enforcement Administration
Source: Federal Register — read the official document