How is quality ensured?
Our dedicated quality department rigorously upholds the highest industry standards, underpinned by robust validated stability studies that promise the longest Beyond-Use Dates (BUDs) possible under United States Pharmacopeia (USP) guidelines.
PCAB-accredited
Dedicated quality department
Validated stability studies for longest possible BUDs
Robust systems to ensure quality ingredients
- Incoming raw material testing
- Material supplier quality audits
Compounding software with built-in quality controls
- Bar code scanning to confirm batch ingredients
- Integrated scales to assure correct ingredient amount
24-hour monitoring of critical environmental conditions
- Temperature
- Humidity
- Room pressurization
Continuous quality improvement systems
- Customer complaint tracking and trending software
- Root cause analysis, risk assessment, and corrective action process
Who regulates compounding pharmacies
Compounding pharmacies in the United States are regulated by several agencies and organizations, each playing a distinct role in overseeing different aspects of operations, standards, and compliance. These agencies ensure that compounding pharmacies adhere to the highest safety and quality standards to protect animal health.
SBoP
The Boards of Pharmacy of the States in which we are licensed are primarily responsible for regulating pharmacies including establishing and enforcing laws and regulations for production standards, licensing facilities and pharmacists, conducting inspections and addressing complaints.
FDA
The Food and Drug Administration establishes and enforces cGMP manufacturing and sanitary conditions standards, advertising guidelines related to claims of safety and efficacy and policies and procedures related to 503B outsourcing facilities.
USP
The United States Pharmacopeia sets standards for the identity, strength, quality, and purity of medicines, including compounded medications, ensuring public health and safety.
DEA
The Drug Enforcement Agency regulates controlled substances, including those used in compounding, to prevent addiction and illegal distribution.
