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Over-the-counter (OTC) drugs play a vital role in the U.S. healthcare market, allowing consumers to access safe and effective treatments without a prescription. To ensure public safety, the U.S. Food and Drug Administration (FDA) regulates OTC products under the OTC Drug Monograph system. Compliance with these monographs is mandatory for [...]
Importing Active Pharmaceutical Ingredients (APIs) and finished drug products into the United States requires strict compliance with U.S. Food and Drug Administration (FDA) and U.S. Customs & Border Protection (CBP) regulations. Any gaps in registration, labeling, or documentation can result in detention, refusal, or costly delays at U.S. ports of [...]
For FDA-regulated industries such as food, cosmetics, dietary supplements, and pharmaceuticals, preparing for an FDA inspection is essential to ensure uninterrupted market access. Inspections are designed to verify compliance with U.S. Food and Drug Administration (FDA) regulations, including cGMP (Current Good Manufacturing Practice), labeling requirements, and safety standards. Companies that [...]
The US FDA Drug Listing process is a mandatory compliance requirement for all human and veterinary drug products marketed in the United States. Under 21 CFR Part 207, every registered drug establishment must submit detailed information about each drug product they manufacture, repack, relabel, or distribute. This process ensures the [...]
Accurate and compliant drug labeling is one of the most critical requirements for marketing human and veterinary drugs in the United States. Under 21 CFR Part 201, the U.S. Food and Drug Administration (FDA) sets forth detailed labeling rules to ensure that healthcare providers and consumers have access to safe, [...]
A Drug Master File (DMF) is a confidential, detailed submission to the U.S. Food and Drug Administration (FDA) that provides information about the facilities, processes, and materials used in the manufacturing, processing, packaging, and storing of human drugs. While not legally required, DMFs are critical for companies that want to [...]
Compliance with controlled substances regulations is one of the most highly regulated areas in the U.S. pharmaceutical industry. Companies dealing with narcotics, psychotropics, or precursor chemicals must comply with both the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). Overlapping requirements make compliance complex, requiring detailed [...]
Launching a new drug in the United States requires rigorous compliance with FDA regulations, starting with the Investigational New Drug (IND) application. An IND is mandatory before beginning any clinical trials involving human subjects. It ensures that the investigational product is safe for testing and that the study design meets [...]
Compliance with Current Good Manufacturing Practices (cGMP) is mandatory for all pharmaceutical manufacturers, repackers, relabelers, and distributors who want to market drug products in the United States. Governed under 21 CFR Parts 210 and 211, cGMP regulations establish the minimum requirements for methods, facilities, and controls used in the manufacturing, [...]
For companies manufacturing, repacking, relabeling, or distributing human and veterinary drugs, annual and ongoing compliance with the U.S. Food and Drug Administration (FDA) is a mandatory responsibility. Non-compliance can lead to penalties, product recalls, import alerts, and loss of market access in the United States. XPRO America specializes in providing [...]