Understanding Personalized Compounded Medications
The words "FDA-approved," "generic" and "compounded" do not mean the same thing.
Understanding the difference is important when considering prescription treatment.
What Is a Personalized Compounded Medication?
Drug compounding generally involves preparing a medication for an individual patient under applicable legal and professional requirements.
Compounding can serve important medical needs in appropriate circumstances to accommodate specific patient requirements.
However, compounded drugs are different from FDA-approved drugs.
Are Personalized Compounded Medications FDA-Approved?
No.
Compounded medications are not FDA-approved.
They do not undergo FDA premarket review for safety, effectiveness or quality.
That distinction should be clearly communicated to patients. Compounding pharmacies in the United States are regulated by the board of pharmacy for sterile compounding and must follow United States Pharmacopeia standards. Medications are tested for strength and sterility according to sterile compounding regulations.
Is Personalized Compounded Medication the Same as a Generic Medication?
No.
An FDA-approved generic drug goes through an FDA approval process and must meet applicable FDA requirements.
A compounded medication is not an FDA-approved generic drug.
For that reason:
Compounded personalized semaglutide should not be described as "generic Ozempic" or "generic Wegovy."
Compounded personalized tirzepatide should not be described as "generic Mounjaro" or "generic Zepbound."
What Is a 503A Compounding Pharmacy?
Section 503A of the Federal Food, Drug, and Cosmetic Act establishes a framework under which qualifying traditional compounding pharmacies may compound patient-specific prescriptions when applicable requirements are met.
These pharmacies are subject to regulation by the board of pharmacy for sterile compounding and are required to follow United States Pharmacopeia standards for sterile compounding.
What Is a 503B Outsourcing Facility?
Section 503B establishes a separate framework for outsourcing facilities that elect to register with FDA and meet applicable federal requirements.
503A pharmacies and 503B outsourcing facilities are not the same. 503A pharmacies answer to the board of pharmacy for sterile compounding, and 503B facilities answer to the FDA.
Who Decides Whether Medication Is Appropriate?
The licensed healthcare provider.
Bodi Envi does not independently make prescribing decisions.
Who Compounds the Medication?
VialsRx, a licensed 503A pharmacy, compounds for Bodi Envi.
Bodi Envi does not manufacture or compound medication.
Who Dispenses the Medication?
VialsRx, a 503A licensed pharmacy, is responsible for dispensing prescribed medication.
What Should Patients Ask?
Patients considering personalized compounded medication may want to understand:
What medication has been prescribed?
Why is it being prescribed?
Is the product FDA-approved or compounded?
Which pharmacy is dispensing it?
What does the medication label say?
How should it be stored?
What side effects should be discussed?
Who should be contacted with questions?
Bodi Envi's Role
Bodi Envi provides telehealth technology and administrative support.
Licensed healthcare providers make clinical and prescribing decisions.
VialsRx, the compounding pharmacy, dispenses medication according to its own role and applicable requirements.
Continue Learning
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