Pharmaceuticals

FDA Issues Testing Guidance: Testing of Ethanol and Isopropyl Alcohol FDA Guidance Overview:  The US FDA has issued guidance on the testing of Ethanol and Isopropyl Alcohol for Methanol. At the time of publication, it was intended for immediate implementation. The guidance focused on the potential health hazards associated with alcohol (ethanol and isopropyl alcohol) contaminated with methanol. The potential public health hazards of methanol became apparent as the COVID-19 pandemic increased awareness, the demand for and the subsequent exposure to hand sanitizers. Both ethanol and isopropyl alcohol are widely used ingredients in pharmaceutical and natural health [...]

FDA Issues Testing Guidance: Drug Products Containing Carbomers FDA Guidance Overview:  The US FDA has recently (December 2023) issued immediate implementation guidance focusing on the reformulation of drug products containing carbomers manufactured with benzene. This guidance prioritizes safety considerations and outlines recommendations for testing, documentation, and submission types to facilitate compliance with cGMP requirements. Key Recommendations and Requirements The recommendations align with International Council for Harmonization (ICH) guidelines and cover various dosage forms, including semisolid dosage forms, immediate-release and modified-release solid oral dosage forms, and oral suspensions. Implementation Without Prior Public Comment: Given the urgency of addressing [...]

On May 26, 2021, Health Canada extended the timelines for activities related to Nitrosamines Risk Assessment in consideration of the on-going COVID-19 pandemic and challenges associated. To mitigate the risk of presence of nitrosamine impurities, Health Canada has requested that Market Authorization Holders (MAHs) follow a three-step process for assessing and controlling the nitrosamine impurities in all human pharmaceutical products (prescription and non-prescription (over-the-counter)) containing chemically synthesized active pharmaceutical ingredients (APIs). The initial deadline to complete the risk assessment (Step 1) was extended to March 31, 2021. On April 14, 2021, Health Canada issued a follow up letter [...]

What you need to know about Health Canada’s Regulatory Amendments for Non-Prescription Drug Products (GUI-0001) Health Canada's regulatory amendment to the Food and Drugs Regulations Guidance Document GUI-0001 came into effect on July 1st as part of the Canada-United States-Mexico Agreement (CUSMA) and replaces the previous 2018 edition. The new amendments emphasize finished product testing of non-prescription drug products and directly affects importers and distributors and requires reviewing and updating of certain documents and agreements. Non-Prescription Drug Products The new expectations from the regulatory amendments are an effort to streamline and provide flexibility to the importation and [...]