FDA Status of Medications

Medications With FDA-Approved Brand-Name Versions

These active ingredients exist in FDA-approved commercial products:

Semaglutide

Found in Ozempic, Wegovy, and Rybelsus

Tirzepatide

Found in Mounjaro and Zepbound

Historically FDA-Approved (Now Only Compounded)

Sermorelin

Formerly FDA-approved as Geref
Commercially discontinued for business reasons - not due to safety concerns.

Active Ingredients Without FDA-Approved Products (Compounded Only)

The following ingredients are used exclusively as compounded, research, or off-label options:

Glutathione
NAD+
BPC-157/TB-500
GHK-Cu
AOD-9604
MOTS-c
Semax/Selank

Why Compounded Medications Are Not Labeled "FDA-Approved"

1 - FDA Approval Applies To Commercial Products

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

FDA approval applies to specific, mass-produced products - such as a Wegovy 2.4mg injection pen. It does not apply to individualized compounded versions, even if the active ingredient is the same.

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

Under section 503A of federal law, patient-specific compounded medications are legally exempt from the standard of FDA approval pathway.

3 - Compounded Medications Are Patient Specific

A 503A pharmacy compounds a medication for one individual patient, often using a different:

Strength
Combination
Route of Administration
Volume or format

4 - No 503A Medication Is "FDA-Approved"

3 - Compounded Medications Are Patient Specific

Because of this exemption:

No compounded medication in the United States is labeled FDA-approved, regardless of its active ingredient.

This distinction is regulatory - not a statement about safety.

"Not FDA-Approved" Does NOT Mean "Unsafe"

"Not FDA-Approved" simply means the FDA has not reviewed that exact, patient-specific compounded for

it does not automatically imply:

unsafe
illegal
low-quality
unregulated

Where the Safety Actually Comes From

State-Licensed USP Compliant Pharmacies

Regulated by state boards of pharmacy
Must meet strict sterile-compounding standards
Facility controls
Sterility testing
Ingredient quality verification
Beyond-use dating

Medical Oversight

Licensed clinicians determine whether compounding is appropriate
Evaluate risks, history, and medications
Order and monitor labs
Adjust therapy as needed

Frequently Asked Questions

Why should I get a compounded version instead of the brand?

Compounded options allow the prescriber to customize the dose or format for an individual patient. Brand-name products are FDA-approved but may not always be available, affordable, or offered in the exact dosing a client needs. The clinician decides which option is most appropriate based on your history and goals.

Why should I trust this?

You are working with licensed clinicians, a regulated pharmacy, and a structured monitoring system.

Why isn't this FDA-approved?

Compounded medications are legally exempt from the FDA's approval process because they are patient-specific.

Is this safe?

Safety comes from:

Your clinician's evaluation
The pharmacy's sterile-compounding standards
Monitoring and follow-up

Is Semaglutide the same as Ozempic?

It contains the same active ingredient (Semaglutide), but your medication is compounded specifically for you.

Revitalize Health Revolution RX

FDA Status of Medications

Medications With FDA-Approved Brand-Name Versions

Historically FDA-Approved (Now Only Compounded)

Active Ingredients Without FDA-Approved Products (Compounded Only)

Why Compounded Medications Are Not Labeled "FDA-Approved"

1 - FDA Approval Applies To Commercial Products

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

3 - Compounded Medications Are Patient Specific

3 - Compounded Medications Are Patient Specific

3 - Compounded Medications Are Patient Specific

4 - No 503A Medication Is "FDA-Approved"

3 - Compounded Medications Are Patient Specific

3 - Compounded Medications Are Patient Specific

"Not FDA-Approved" Does NOT Mean "Unsafe"

"Not FDA-Approved" simply means the FDA has not reviewed that exact, patient-specific compounded for

Where the Safety Actually Comes From

Frequently Asked Questions

Medical Decisions & Clinical Oversight

FDA Status of Medications

Medications With FDA-Approved Brand-Name Versions

Historically FDA-Approved (Now Only Compounded)

Active Ingredients Without FDA-Approved Products (Compounded Only)

Why Compounded Medications Are Not Labeled "FDA-Approved"

1 - FDA Approval Applies To Commercial Products

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

2 - Compounded Medications Are Exempt From FDA's New Drug Approval Process

3 - Compounded Medications Are Patient Specific

3 - Compounded Medications Are Patient Specific

3 - Compounded Medications Are Patient Specific

4 - No 503A Medication Is "FDA-Approved"

3 - Compounded Medications Are Patient Specific

3 - Compounded Medications Are Patient Specific

"Not FDA-Approved" Does NOT Mean "Unsafe"

"Not FDA-Approved" simply means the FDA has not reviewed that exact, patient-specific compounded for

Where the Safety Actually Comes From

Frequently Asked Questions

Medical Decisions & Clinical Oversight

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