Drugs made by compounders, including those made at outsourcing facilities, are not FDA-approved. This means that they have not undergone the same premarket review as approved drugs.

Are you willing to take the risk?

See John Oliver, late night host, explain the dangers of compounding pharmacies

“There are some huge problems here because compounding pharmacies are subject to much less oversight than large drug manufacturers.”

Are you okay with buying, using, and administering drugs that are not proven safe or effective?

“Compounded drugs are NOT FDA approved”

Margaret Hamburg, former Commissioner of the U.S. Food and Drug Administration (FDA)

Did you know?

  • Compounding pharmacies voluntarily register with the FDA.[1] Less than one percent of them have chosen to voluntarily register.[2] These are known as outsourcing facilities.
  • Out of the 77 outsourcing facilities that were inspected as of December 1, 2020, 30 were the subject of an FDA action such as a warning letter or regulatory meeting, or conducted a recall. That’s more than one-third of the compounders registered as outsourcing facilities![3] Now imagine the conditions of the compounding pharmacies that didn’t volunteer to be registered. List of FDA-observed deviations potentially putting patients at risk – these varied in sterility issues, cleanliness, potency, safety issues – Click Here to read some inspection observations for outsourcing facilities.
  • Even though some compounders are being inspected, those that are not registered as outsourcing facilities are not subject to the same guidelines as manufacturers (cGMP).[1]