Compounding Pharmacies plus Farris Labs equal a partnership for success
Compounding pharmacies customize drug formulations to satisfy the unique needs of their patients. With this specialized role comes inherent complexities in daily operations, which affect all compounding pharmacy owners and operators, as well as pharmacists and technicians in the United States.
As a compound pharmacy owner or operator, how can you successfully navigate these complexities?
Compounding pharmacies can’t navigate it all in a siloed manner. It takes partnerships to comply with increasingly stringent federal regulations, set your business up for operational success, and be prepared to handle the challenges inherent in the industry.
The complexities of drug packaging and formulation directly affect patient safety, making drug sterility, purity, and strength top priorities to support patients and prevent injury or death.
Partnering with a trusted producer and manufacturer of sterilized medical office supplies can help your pharmacy operate legally, efficiently, cost-effectively, and with a superior level of safety in packaging and operations.
Compound pharmacies have faced increasingly stringent federal compliance mandates when it comes to sterility and integrity in drugs and packaging. To ensure pharmacies can operate as smoothly as possible without interference, compound pharmacies must:
- Understand and comply with pharmacy best practices
- Record written standard operating procedures (SOPs)
- Designate areas specifically for compounding equipment and processing
- Partner with a trusted medical supplies distributor
- Employ quality assurance procedures
- Maintain master formula records
- Deploy processes to report recalls or complaints to protect your business reputation
How Farris Labs works with Compound Pharmacies
Farris Labs works hand in hand with compound pharmacies to provide FDA-approved, top rated packaging components that are pre-sterilized and ready-to-use.
Save time and costs associated with in-facility sterilization and increasingly more rigorous FDA testing by letting Farris Labs provide dependable, sterilized components for your drug packaging needs.
When pharmacies take sterilization in-house, costs and risks rise, quality assurance procedures are multiplied, and there’s simply more to manage while stakes become higher. Farris Labs is a trusted source for providing sterile empty and filled clear and amber vials and supplies for all of your compounding pharmacy needs.
The challenges you may be facing as a compound pharmacy
Compound pharmacies are consistently facing new challenges when it comes to packaging, sterilization, compliance, operations, and reputation. Well-known cases like the meningitis outbreaks of 2012 resulting from compounding pharmacy errors have attracted attention from the public as well as government agencies. So, more rigorous compliance regulations have been enacted, bringing ever-evolving new challenges to pharmacies.
Pharmacies must also comply with the Compounding Quality Act (CQA) and Compounding Clarity Act (CCA), among other legal mandates. This means you’re facing more challenges now than ever before.
The importance of good compounding practices
Poor compounding practices can lead to serious problems in drug efficacy and integrity, resulting in patient injury or death.
Good compounding practices are key to protecting the health and safety of patients. Compounding pharmacy owners and operators’ top priority is to provide patients with quality, effective customized medications free of contaminants. To do so, good compounding practices are outlined in order to establish:
- General principles
- Quality assurance systems and documentation
- Personnel standards and practices
- Practices for the premises, equipment, and facility
- Compounding processes
- Quality control
- Navigating complaints and recalls
Good compounding practices promote patient health and safety by outlining quality assurance protocol, providing written standard operating procedures, and preparing all workers at a compounding facility to work within established safety standards.
All compounding personnel, from technicians to pharmacists, must be aware of and comply with good compounding practices to uphold standards of manufacturing and distribution, and ensure safe drugs are dispensed to patients.
How Farris Labs helps ensure Packaging Sterility for Compounding Pharmacies
Packaging sterility for compounding pharmacies is a top consideration for the Food and Drug Administration.
Compounding pharmacies are increasingly partnering with medical supply manufacturers and suppliers that can provide quality sterile medical grade packaging solutions as an alternative to in-facility sterilization.
In recent years, the FDA enacted new compliance requirements for sterilizing drug packaging components in compounding pharmacies. The FDA has advised the use of qualifying container closure systems and ready-to-use packaging as alternatives to sterilizing in-facility. This presents new challenges for what 503B compounding pharmacies need to do to comply.
Previously, compounding pharmacies could purchase ready-to-sterilize (RS) packaging and sterilize packaging at their facilities. However, with new legislation and guidance from the FDA, compounding pharmacies should instead purchase ready-to-use (RU) packaging to reduce risk to patients and their businesses.
Sterilization at compounding facilities now requires more stringent protocol and stronger oversight by regulatory agencies. So, the better solution is to use ready-to-use packaging. Ready-to-use components not only streamline sterilization and quality assurance processes, but they provide peace-of-mind protection for compounding pharmacies nationwide.