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In the U.S., if it's called a drug (claimed to treat or cure a disease or malady) it's regulated by the Food and Drug Administration. All drugs are regulated and have to meet standards set by the FDA in the Code of Federal Regulations. Drug manufacturer's are required to meet FDA mandates such as GMP's or Good Manufacturing Practices and are required to follow a 'Quality System' which involves a slew of factors and tons of documentation proving that they are in compliance with these laws.

Did you mean what is a controlled drug. That's a whole different question and involves substances that are addictive and not only is the FDA, but the DEA (Drug Enforcement Administration) scrutinized. There are different classes of controlled drugs.

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Q: What is a regulated drug?
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