Sage is registered as a U.S. FDA OTC-approved manufacturer
What is an OTC drug?
According to the FDA, “Over-the-counter medicine is also known as OTC or nonprescription medicine. All these terms refer to medicine that you can buy without a prescription. They are safe and effective when you follow the directions on the label and as directed by your health care professional.”
Conditions for an establishment to receive approval include being in compliance with GMP (Good Manufacturing Practice) standards and being registered. Sage complies, specifically with ISO 22716 GMP. Other conditions are to comply with the suggested label contents and for the “drug facts” label to be completely factual. Advertising for the product prescribes, recommends, or suggests its use only under the conditions stated on the label. It must contain only suitable inactive ingredients that are safe in the amounts administered and do not interfere with their effectiveness. Among others, the product’s container must also meet its requirements.
Sage Pharmaceuticals, Inc. strictly complies with all application conditions and specifications, and was approved by the US FDA and successfully registered as an approved manufacturer of OTC over-the-counter drugs.
Source:https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-330/subpart-A/section-330.1