Pharmaceutical compounding as we know today has grown exponentially since its origin – creating greater complexities than ever before. Drug compounding was once the job of local community pharmacists – preparing personalized medications based on patient-specific needs. More recently, the industry experienced a growth in mass production of compounded drugs due an increase in cost. As a result, today, drugs are primarily compounded on a much larger scale – focusing on given formulas. This drive for larger-scale production decreases individual prescription cost, yet leads to concerns of drug quality standards and patient safety.
Compounded drugs developed by both compounding pharmacies and outsourcing facilities must meet Federal quality standards. Sections 503A and 503B of the FDCA are in place to ensure product quality is met.
According to section 503A of the FDCA, bulk compounded drugs must be made at an FDA-registered facility and be accompanied by a Certificate of Analysis (COA). The conditions of section 503A states that bulk compounded drugs must:
- include components of FDA-approved drugs
- be the subject of a USP monograph or
- appear on a list of bulk drugs developed by FDA of bulk drug substances acceptable for compounding.
Compounding pharmacies registered as “outsourcing facilities,” under section 503B of the FDCA, are exempt from select FDA standards which are common to other outsourcing facilities, such as FDA approval and labeling products requirements. However, the one FDA standard in which no compounding outsourcing facility may be exempt from is compliance with CGMP. These outsourcing facilities must meet the following FDA conditions:
- Compliance with CGMP by or under the direct supervision of a licensed pharmacist in a registered facility
- Inspections by FDA according to a risk-based schedule
- Reporting adverse events and providing FDA with required product information (ie. source of the ingredients used to compound)
- Records of all production within the last 6 months
Whether a compounding facility is registered as an outsourcing facility or not, it is critical for the organization to comply with FDA regulations. For non-registered compounding pharmacies, drugs must be approved – following FDA regulations. For registered outsourcing facilities, CGMP compliance, FDA inspections and accurate tracking of assets are critical to the organization’s success. With an enterprise asset management system (EAM), such as Blue Mountain RAM, all compounding pharmacies can have the means necessary to properly track equipment. An EAM that leverages the calibration and maintenance of assets involved in the large-scale production of the compounded drugs, can ensure GMP compliance, while increasing product quality and patient safety.