According to a recently filed bill in the United States Congress, the FDA might soon be cracking down on compounding pharmacy growth and regulations. A new law (H.R. 3204) aims on changing the way compounding pharmacies operate. Both Republicans and Democrats supported the bill.
Growing concerns about the security and safety of the US medication supply chain sway view. The legislation will provide FDA with increased enforcement jurisdiction over compounding pharmacies. Democrat Senator Tom Harkin of Iowa, the bill’s author, said its passage “would increase control of high-risk medication compounding” and assure that fake and stolen drugs remain out of the drug supply” if approved.
By providing national serial numbers for prescription pharmaceuticals, the law will establish a system for tracking them along the supply chain.
To comply with the FDA’s quality control and oversight rules, companies that use “non-traditional” compounding (mass production rather than patient-specific) must register as “outsourcing facilities.” Companies not registered will continue to produce under a narrow compounding explanation: combining medicines for persons based on a prescription or creating limited quantities prior to a prescribing period.
Patients who are unable to be treated with FDA-approved medication benefit from compounding services provided by Frontier Medicine. Patients around the world benefit greatly from well-tailored chemicals. This includes those needing drugs for pain management, hormone replacement, pediatrics, dermatology, dental, and allergies.
Because of escalating costs and dwindling drug supplies, many hospitals outsource their drug combination to large-scale “Nonconventional” compounding pharmacies. this helps keep up with expanding demand. It allows those compounding pharmacies to exploit a system that solely applies to state law. They circumvent more stringent FDA rules, such as the disclosure of information and reporting problems.
A recent FDA statement claimed that “Nontraditional” compounding must, due to the higher risk offered, be subject to a greater degree of monitoring. When allowing sterile items transported over state lines without a prescription, they should be subject to the greatest level of FDA-mandated controls, which are in line with cGMP guidelines for traditional pharmaceutical producers.
International Academy of Compounding Pharmacists, one of the bill’s most vocal opponents concerns are several. Concerns exist that the bill in its current form will contribute to the shortfall of needed medications. It would grant the FDA sweeping and unprecedented authority on determining what pharmacies can mix.
Here at Frontier Medicine, we follow the guidelines of this compound pharmacy while selling medical marijuana. We are open 24 hours in OKC.
**Disclaimer: This content is not the advice of a doctor; no product promoted herein is approved by the FDA to treat, cure, or prevent any disease.