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Irish Regulators Recommend 34 Drugs for OTC Use

In mid-July, the Health Products Regulatory Authority (HPRA) of Ireland published a list of twelve active substances, currently classified as prescription only, which it considers could be safely switched from prescription to over the counter.

Comment Period Reopened During July on OTC Monograph System

FDA reopened the comment period on the functioning of the OTC monograph system during July to allow new and updated information to be submitted. A public hearing on the monograph system was held in March 2014.

FDA To Hold Hearings on OTC Overhaul Plan

FDA will hold public hearings on March 25-26 at its White Oak, MD campus on a plan to strengthen its oversight of OTC products and align it more closely with the prescription drug process. Comments will be accepted until May 12, 2014.

API Switch in OTC Cough Syrup Kills at Least 60 in Pakistan and India

The World Health Organization (WHO) reported in an “information exchange system alert” issued in late January that cough syrup manufactured in India using an incorrect raw material has resulted in the deaths of at least 60 people in Pakistan and India. The incidents occurred in November and December and were linked to cough syrup produced […]

Bolus of FDA Warning Letters to Foreign Manufacturers Spans Regions and Product Types

During a two-week period in late February and early March, FDA’s drug compliance office issued a bolus of six warning letters to foreign manufacturers that span across regions and product types, including two each on active pharmaceutical ingredients (APIs), over-the-counter (OTC) solutions and injectables....

TGA Releases Revised OTC Guidelines for Public Comment

Australia’s Therapeutic Goods Administration (TGA) has released guidelines for comment that revise its framework for the application and approval processes for over-the-counter (OTC) drugs.  Comments are due by February 11. The “Australian Regulatory Guidelines for Over-the-Counter Medicines” (ARGOM) is a set of documents that seeks to: ● provide information to help sponsors of OTC medicines […]

Consumer Complaints, FDA Inspection at Novartis Nebraska Plant Leads to Recalls and Temporary Manufacturing Shutdown

Consumer complaints of bottles containing mixed-up or damaged tablets and capsules and an extended FDA 483 focused on complaint handling at a Lincoln, Nebraska facility where they were made prompted Novartis to recall a handful of its over-the-counter (OTC) products and temporarily cease operations at the plant....

Deltex Injunction Follows History of Lab GMP and Unapproved Drug Compliance Problems

An injunction against Texas-based prescription and over-the-counter (OTC) drug contract manufacturer Deltex is forcing the firm to shut down operations and recall all products manufactured since it received an FDA warning letter in 2008....

McNeil Recalls Products for Cleaning Concerns Based on “Comprehensive Action Plan” Review

McNeil’s findings under its “Comprehensive Action Plan” (CAP) of cleaning issues at its Fort Washington, PA plant has resulted in another round of over-the-counter (OTC) product recalls....

FDA Re-inspection Findings at McNeil’s Fort Washington Plant Track Those at Las Piedras; Recall Problems Continue

A similar litany of concerns centering on the handling of complaints, deviations and recalls and their interrelationship was raised during FDA’s follow-up investigation at McNeil’s Fort Washington facility completed in mid-December as was found in the follow-up at its Las Piedras, Puerto Rico plant that ended a few weeks earlier....
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