Compounded Medications: Safety & Oversight
Understanding how compounded medications are made, regulated, and monitored for quality.
What Is Compounding?
Compounding is the process of customizing medications for individual patient needs. Licensed pharmacists combine pharmaceutical-grade ingredients to create tailored formulations when commercially available options don't fit.
Compounding has been part of pharmacy practice for centuries and continues to serve important medical needs today.
Why Use Compounded Medications?
Compounded medications may be prescribed when:
- A medication is unavailable commercially or in shortage
- A patient needs a different strength or dosage form
- Alternative ingredients are needed due to allergies or sensitivities
- Combination therapy requires custom formulation
Types of Compounding Pharmacies
There are two primary categories of compounding facilities:
503A Compounding Pharmacies
- Traditional compounding pharmacies regulated by state boards of pharmacy
- Prepare medications based on individual prescriptions
- Must follow United States Pharmacopeia (USP) quality standards
- Subject to state inspections and oversight
503B Outsourcing Facilities
- Large-scale compounding facilities regulated directly by the FDA
- Produce medications in larger batches for distribution
- Must meet Current Good Manufacturing Practice (cGMP) standards
- Subject to regular FDA inspections
- Report adverse events to the FDA
Quality & Safety Standards
All compounding pharmacies we work with must meet strict quality requirements:
- FDA-registered facilities
- Use of pharmaceutical-grade ingredients from verified suppliers
- Adherence to USP sterility and quality standards
- Regular independent testing and sterility verification
- Environmental monitoring and cleanroom protocols
- Documented quality control procedures
Regulatory Oversight
Compounding pharmacies operate under a comprehensive regulatory framework:
- State Boards of Pharmacy: License and inspect 503A pharmacies
- FDA: Directly regulates 503B facilities and oversees ingredient safety
- USP Standards: Set quality benchmarks for sterile and non-sterile compounding
- Professional Organizations: Provide additional guidelines and best practices
How We Choose Our Pharmacy Partners
We work only with compounding pharmacies that demonstrate:
- Accreditation from recognized pharmacy accrediting bodies
- Regular third-party sterility and potency testing
- Clean inspection records
- Transparent quality documentation
- Responsive pharmacist support for patient questions
What You Should Know
When using compounded medications:
- They are not FDA-approved finished drug products
- They must be prescribed by a licensed healthcare provider
- Pricing is typically not covered by insurance, but may qualify for HSA/FSA
- You should receive clear instructions for storage and use
- Report any unusual symptoms or concerns to your physician
Important: All compounded medications dispensed through Best Balance come from FDA-registered U.S. compounding pharmacies that meet strict quality and safety standards. Your physician will only prescribe compounded medications when clinically appropriate and will monitor your response throughout treatment.