Isomeric Pharmacy Solutions’ new state-of-the-art FDA-registered 503b Outsourcing Facility – Filling your drug shortage needs.
There have been increasingly frequent drug shortages in the U.S., causing numerous difficulties for clinicians, health care facilities and patients. Although certain types of drugs are more vulnerable to shortages than others, shortages of a variety of drugs have been reported—including heart drugs, pain medications, intravenous (IV) electrolytes, and many others.
The Institute for Safe Medication Practices (ISMP) conducted a national survey of 1,800 health care practitioners to assess the impact of drug shortages. The ISMP found that:
- 84% of the respondents said they had never received advance warning of a shortage from manufacturers or the FDA..
- 80% said they faced difficulty obtaining comparable drugs.
- 78% said there were significant costs to obtaining comparable drugs.
- 70% said they had been unable to find comparable alternatives.
- 64% believed that shortages posed a risk of adverse patient outcomes.
- respondents reported more than 1,000 adverse events and near-misses attributable to drug shortages.
Isomeric Pharmacy Solutions primary focus is patient safety and regulatory compliance — as an FDA-registered, 503b/cGMP facility, we adhere to stringent manufacturing controls, increased oversight and a commitment to the sterility, purity and integrity of our products.
Sterile Office Use Products
Isomeric Pharmacy Solutions’ new state-of-the-art Outsourcing Facility—Filling your sterile office use needs.
Isomeric Pharmacy Solutions is an FDA-registered, state-of-the-art 503b outsourcing facility for all your sterile and non-sterile compounding needs.
As a voluntarily registered outsourcing facility under Section 503b of the FDC Act, we adhere to all current good manufacturing practices (cGMP’s) related to sterility assurance of sterile drug products and the general safety of compounded drug products.
Q. What is a “sterile compounded preparation?”
A. “Sterile Compounding” means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797, must be prepared using aseptic techniques.
Q. What is an FDA Outsourcing Facility?
A. Federal law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of Section 503b (of the DQSA).
An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from current good manufacturing practice (cGMP) requirements.
Q. What requirements must an Outsourcing Facility meet?
A. An Outsourcing Facility:
- Must comply with cGMP requirements
- Will be inspected by FDA according to a risk-based schedule
- Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound
Contact our team to learn more about the purity and integrity of sterile office use products.