Compounding Quality Standards

Pharmacy Regulation

Pharmaceutical compounding is regulated by federal and state authorities to ensure patient safety and drug integrity. The U.S. Food and Drug Administration (FDA) sets the framework for what compounding pharmacies can make and the drugs/chemicals we’re able to work with, while state boards of pharmacy regulate acceptable compounding practices. To ensure the safety and quality of compounded medications regulatory agencies enforce stringent standards, including:

• United States Pharmacopeia (USP) Guidelines – Chapters <795> and <800> of the USP guidelines provide standards for non-sterile and hazardous drug compounding, respectively.
• State Board of Pharmacy Oversight – State pharmacy boards inspect compounding pharmacies and enforce compliance with USP guidelines, as well as other state regulations
• Environmental and Equipment Standards – Compounding facilities must maintain clean environments, use validated equipment, and adhere to proper storage and handling procedures.

Sourcing Pharmaceutical Ingredients

The quality of compounded medications begins with the sourcing of pharmaceutical ingredients. Both active pharmaceutical ingredients (APIs) and inactive ingredients (excipients) are obtained from trusted suppliers that adhere to stringent regulatory and safety standards. We source all APIs from FDA-registered manufacturers and distributors that comply with Current Good Manufacturing Practices (cGMP), supplying products that meet United States Pharmacopeia (USP), and/or National Formulary (NF) standards.

Understanding USP and NF Certifications

The United States Pharmacopeia (USP) and National Formulary (NF) set official standards for the quality, purity, strength, and consistency of drugs and their components. USP standards apply to active pharmaceutical ingredients (APIs), while NF standards regulate the inactive ingredients (bases such as creams or suspensions). These guidelines ensure that all pharmaceutical ingredients used in compounding meet the highest quality benchmarks. Compliance with these standards helps protect patients and ensure that our compounded medications contain verified ingredients that passed purity and potency testing.

Testing and Quality Assurance

Before being used in compounding, pharmaceutical ingredients undergo rigorous testing to confirm identity, potency, and purity. Each chemical has specific tests that must be performed to prove it meets USP standards. Some of the key safety and quality control tests include:

• Certificates of Analysis (CofAs): Suppliers are required to provide a CofA for each for each shipment of ingredients, detailing test results and compliance with USP/NF standards. A pharmacist here at Coastal Pharmacy verifies each CofA prior to its use in compounds.
• Microbial and Endotoxin Testing: Ingredients are tested for microbial contamination and endotoxins.
• Stability Testing: Active and inactive ingredients are evaluated to ensure they remain potent and stable under defined storage conditions.
• Heavy Metals and Impurities Testing: Analytical tests detect and quantify heavy metals and other impurities.

In-House Quality Protocols

In-House Quality Control Check
Individual compound units (capsules/troches/suppositories) are weighed using precision analytical balances to ensure precise, consistent, and accurate formulations. We capture and maintain a digital recording of every ingredient’s weight used in each batch.

Independent Potency Verification
Randomly selected compounds are sent to an accredited third-party laboratory for potency testing to ensure our processes result in accurate compounds.

Strict Cleaning Protocols
We follow rigorous, documented cleaning regimens to maintain a clean, controlled compounding environment at all times.

Continuous Environmental Monitoring
We continuously monitor temperature and humidity in all drug storage areas to ensure ingredients are maintained under optimal, USP-compliant conditions.

Controlled Laboratory Airflow
Our USP <800> compounding lab operates under maintained negative pressure with over 12 air changes per hour to reduce airborne contamination risk.

Routine Equipment Calibration & Digital Weight Capture
All critical devices—including pH meters, hot plates, and analytical balances—are calibrated regularly. Balances are calibrated daily and verified multiple times per year by a third-party scale certification company.

Barcode Verification of All Ingredients
Every ingredient used in compounding is barcode-scanned to verify correct lot number, expiration date, and potency, with complete records maintained for each compound.

Permanent, Traceable Batch Records
Every compound is documented with complete batch records, including ingredient weights/volumes, lot numbers, and expiration dates. These are stored indefinitely and retrievable instantly for full traceability.

Pharmacist Review of Every Compound
Each compounded medication is thoroughly reviewed by a licensed pharmacist prior to dispensing to ensure accuracy.

Annual Supplier Vetting & Supply Chain Verification
We conduct annual evaluations of our suppliers, including review of FDA inspections, to ensure the quality and reliability of our drug and ingredient supply chain.

Ongoing Compounding Staff Training
All compounders complete annual training to stay current with best practices, regulatory standards, and quality expectations.

Demonstrated Compounding & Cleaning Proficiency
Our compounders must routinely demonstrate proficiency in both compounding techniques and laboratory cleaning procedures.

Questions?

If you have additional questions, please reach out. We’re happy to address any concerns you have about compounded medication.