FDA Approval vs FDA Oversight

Understanding the Difference

The terms "FDA-approved" and "FDA-regulated" are often confused, but they mean different things:

• FDA-approved: A finished drug product that has gone through rigorous clinical trials and been approved by the FDA for specific uses
• FDA-regulated/overseen: Facilities, ingredients, and processes that operate under FDA rules, even if the final product isn't FDA-approved

Both categories play important roles in your care, and your physician will explain which applies to any medication you're prescribed.

FDA-Approved Medications

These are finished drug products that pharmaceutical companies have submitted for FDA review and approval. The process includes:

• Multiple phases of clinical trials in humans
• Safety and efficacy data reviewed by the FDA
• Manufacturing facility inspections
• Approval for specific medical conditions (indications)
• Ongoing monitoring for safety signals

Examples include brand-name drugs like Ozempic (semaglutide) and Mounjaro (tirzepatide), as well as their FDA-approved generic equivalents.

Compounded Medications

Compounded medications are custom-prepared by licensed pharmacies for individual patient needs. They are:

• Not FDA-approved finished products
• Made from FDA-approved or FDA-recognized ingredients
• Prepared by FDA-registered pharmacies
• Subject to state and federal pharmacy regulations

Compounding allows physicians to prescribe medications that aren't commercially available or need to be customized for patient-specific needs.

→ Learn more about compounded medications

How the FDA Regulates Compounding

While compounded medications aren't "FDA-approved," the FDA still provides oversight:

• Facility registration: Compounding pharmacies must register with the FDA
• Ingredient standards: Active pharmaceutical ingredients (APIs) must meet FDA quality requirements
• Good Manufacturing Practices: 503B outsourcing facilities must follow cGMP standards
• Inspections: The FDA inspects 503B facilities; states oversee 503A pharmacies
• Adverse event reporting: Pharmacies must report safety concerns

Why Physicians Prescribe Compounded Medications

Your physician may recommend a compounded medication when:

• The FDA-approved version is unavailable or in shortage
• You need a different strength, form, or combination
• The commercial product contains an ingredient you're allergic to
• A customized formulation better fits your medical needs

This is a standard part of medical practice and has been for decades.

What About Off-Label Use?

Even FDA-approved medications can be prescribed "off-label"—meaning for uses not explicitly approved by the FDA. This is legal and common when:

• Strong clinical evidence supports the use
• Professional medical guidelines recommend it
• The FDA-approved indication is similar to the intended use

Your physician will explain if a medication is being used off-label and why it's appropriate for your care.

Quality Assurance

Whether FDA-approved or compounded, medications prescribed through Best Balance meet high-quality standards:

• Sourced from verified, FDA-registered suppliers
• Prepared in facilities that meet regulatory requirements
• Subject to sterility and potency testing
• Dispensed with clear labeling and instructions

What You Should Know

When receiving any medication:

• Ask your physician about the regulatory status (approved, compounded, off-label)
• Understand why that particular formulation is recommended for you
• Report any unusual symptoms or concerns
• Follow storage and administration instructions carefully