Compound pharmacies produce special medication dosages, blends, and delivery systems for patients who need something different from standard pill manufacturers. If you can benefit from a specialized compound medication, you may wonder if they are safe. Due to increased safeguards, you can feel more confident than ever that these medications are well-regulated and safe to consume.
What's the DQSA?
In November of 2013, the Drug Quality and Security Act was enacted to establish additional safeguards concerning compound drugs due to several health scares throughout the nation. The law has several provisions, including one which establishes that compounding pharmacies can become registered outsourcing facilities. Those facilities who do register may qualify for some exemptions from FDA requirements, but they are expected to follow current good manufacturing practice, open themselves to regular FDA inspections, and report certain problematic events and other information to the FDA. In return, the facilities gain a reputation of compliance and safety that other facilities do not have.
Those compounders who do not register with the FDA will lose some exemptions and be expected to label their products with clear directions for the drugs' use. By imposing these requirements on compounders, the FDA can avoid any more tragedies such as the fungal meningitis outbreak that occurred after some contaminated medication was dispensed to more than 400 patients. The FDA legislation was partially enacted due to this incident and is designed to make certain such a tragedy never occurs again. And since compounding is vital for hospitals and those with special needs (e.g. those with allergies to certain medications), these reforms are good news.
How to Stay Safe
The FDA strongly recommends using a registered outsourcing facility to obtain your compounded medications. Ask your doctor to locate such a facility for you. You can also ask The American Society of Health-System Pharmacists (ASHP) to help you find a pharmacy or improve the regulations in your area. If your compounder is following all federal and state regulations, you can feel secure about getting your medications there. You can also talk with a place like Premier Custom Pharmacy for more information.
Compound medications are a blessing for many people who need individualized medications in order to get or stay healthy. Compounding can combine several medications or change their delivery method so that they are more effective. When compounders are careful and follow federal and state guidelines, you can feel secure that the medication will only help you be strong and well.