Compounded Drug Disclosure
⚠️ EXPLICIT COMPOUNDED DRUG DISCLAIMER
Compounded drugs are NOT FDA-approved. This means that the FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed for use.
1. What Compounded Medication Means
Drug compounding is the process of combining, mixing, or altering ingredients to create a tailored medication for an individual patient. My Pharma Supplies coordinates with licensed compounding pharmacies that prepare medications in response to a specific clinician's prescription.
2. Why Compounds are Used
Compounded medications may be prescribed when commercially available FDA-approved drugs are not appropriate for a patient (e.g., due to an allergy to an inactive ingredient) or when a drug is on the FDA’s drug shortage list.
3. Regulatory Oversight
While the compounded *product* is not FDA-approved, the pharmacies we partner with are licensed by their respective State Boards of Pharmacy and/or are registered with the FDA as outsourcing facilities (503B), which subjects them to specific quality standards (cGMP) and inspections.
4. Risks and Patient Acknowledgment
Compounded drugs carry risks that are different from FDA-approved drugs. By proceeding with treatment, you acknowledge that you have discussed these risks with your prescribing clinician and understand that the medication has not undergone the same FDA pre-market review as mass-produced drugs.
5. No Guarantee of Therapeutic Equivalence
Compounded drugs are not "generics" of FDA-approved drugs. They are unique preparations. Your clinician has determined that a compounded option is appropriate for your specific clinical needs.