What FDA-Approved Means and Why it Matters


Nov 7, 2023


Feb 2, 2022

Henry exclusively works with state and FDA registered facilities.

Doctor holding a green apple
Doctor holding a green apple
Doctor holding a green apple

Are you familiar with FDA-Approved?

You may have come across this term on a company website or in a commercial for a service or medication and had some questions. Questions like what does that term even mean? And how can you be certain that something that received FDA approval is safe in the first place? Some companies might even claim that their goods have FDA approval when that is not the case.

Stamp with FDA Approved on it

The FDA is in charge of safeguarding the public’s health by enforcing laws governing medical equipment, food (including animal food), cosmetics, tobacco products, but most importantly, pharmaceutical products and drugs.

Before being marketed commercially, new medicinal products for humans require FDA approval. It follows that a business must show that its medicine or biological product is both safe and efficient for the application intended and that it can be produced in accordance with federal quality standards. If the FDA approves a product, it implies that the agency has decided that the product’s advantages exceed its disadvantages for the intended application.

Compounded Drugs are not approved by the FDA

Compounded drugs are not approved by the FDA because they are made in small batches for a specific patient based on a prescription from a medical professional. Because compounds may vary in strength, ingredients, route of administration, and other variables, they cannot be individually analyzed by the FDA for safety or efficacy, as that would significantly delay the ability of patients to access compounds they critically need to manage a myriad of health conditions.

Instead of regulating the individual products coming out of compounding pharmacies, the government regulates the facilities themselves. 

Compounded drugs can only be legally produced in state Board of Pharmacy licensed pharmacies in accordance with section 503(a) of the Federal Food, Drug, and Cosmetic Act, or in FDA-registered outsourcing facilities under section 503(b) of the Federal Food, Drug, and Cosmetic Act. These facilities are strictly regulated to make sure they are following the laws and regulations around the practice of compounding.

Medical Facilities are not approved by the FDA

Physician offices and labs are examples of healthcare providers that the FDA does not “approve”. The FDA is authorized to conduct inspections of regulated facilities to ascertain whether or not they adhere to current good manufacturing practices.

How products get FDA approval

Products are not developed by the FDA before they are approved. Instead, FDA specialists carefully examine the outcomes of manufacturers’ clinical testing. Many biological products are subjected to lot-release testing by the FDA, which provides the agency with a real-time method for continuously monitoring product quality through review and testing. Compounded drugs do not go through this approval process, as they are regulated through a number of separate processes.

Supplements are not FDA-Approved

The FDA does not approve supplements or items not containing active pharmaceutical ingredients, as supplements are not intended to cure or relieve symptoms, like drugs or medication. Because of this distinction, the FDA does not certify the efficacy of supplements because they have no active pharmaceutical ingredients and are not proven to be effective to treat or cure any disease.

Suppliement label on bottle

Before putting their products on the market, dietary supplement manufacturers must make sure they are safe and that they also adhere to other labeling and quality standards, like good manufacturing practices. But outside of that they are not required to go through an approvals process.

The Henry Meds Promise

Henry Meds exclusively works with appropriately licensed 503(a) and 503(b) facilities. Though compounded drugs are not specifically approved by the FDA (as they are compounded individually on order from a licensed clinician), any compounded drug prescribed by a licensed healthcare provider on the Henry Meds platform is only prescribed when the expected benefits of the compounded medication outweigh the expected risk-profile, based on their clinical judgment.

Gloved hand taking a medical vial from tray of vials

If you are ever not sure if a product has been through the FDA-Approval process you can always go to the official FDA drug approvals and database page on their website.

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