Articles — fda

Recently, the FDA has been providing much heavier guidance - and more Form 483s for objectionable conditions - with respect to the regulatory requirements of cGMP controlled raw materials. As a result, they are also providing more information on overall best practices for these materials. It is critical for those working in the pharmaceutical industry to understand the ever-changing requirements and best practices pertaining to cGMP. Regulations Guiding cGMP Controlled Raw Material are in FDA regulations 21 CFR 211.84 Subpart E: Testing and Approval or Rejection of Components, Drug Product Containers, and Closures Overview of the Regulation Section D of the FDA...

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of pharmaceuticals, biologics, and much more. It is one of the leading regulatory and compliance agencies that a compounding pharmacy will work alongside while developing products. The FDA is responsible for routine inspections, which many manufacturers know all too well! But, three little numbers - 483 - can come from the inspections, and they mean serious business. But there are two different types of terms associated with these numbers: "Observations" and "Warning Letters." Today, we'll look at the difference between...

How MediZap's Partnerships Help Compounding Pharmacies Many people depend on medications for their health. Often, multiple medications are necessary, and even specific combinations and dosages are required in order to maintain a condition.  Compounding pharmacies are able to combine multiple drugs into one effective medication, which is then chemically mixed to the exact dosage, strength, and combination needed. Using compounds in pharmaceuticals is meant to help alleviate some of the stress of taking multiple medications, and to make sure that the patient gets the best care possible. Especially in cases where a patient needs multiple drugs frequently during the day,...