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FDA Issues New Guidance Document on Labeling of Heparin Devices
September 21, 2018 |FDA

The Food and Drug Administration on Sept. 20 issued a guidance document outlining “new expectations” for labeling of heparin-containing medical devices and combination products. Coming in response to a spate of heparin product overdose areas caused in part by expressions of drug strength on labels, FDA’s new guidance “addresses those safety concerns” by incorporating recent changes to United States Pharmacopeia drug substance monographs for Heparin Sodium, as well as drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection. The new guidance also includes safety testing recommendations.

FDA Amends Juice Labeling Requirements for Calcium and Vitamin D3
September 21, 2018 |FDA

The Food and Drug Administration is amending its food additive regulations to change requirements for vitamin D3 and calcium in fruit juices, in a final rule issued Sept. 20. In response to a petition filed by the Juice Products Association, FDA is replacing the current Reference Daily Intake percentage values of calcium in 100 percent fruit juice and fruit juice drinks with absolute values, and also updating the reference for vitamin D3 specifications. The final rule took effect Sept. 20, though objections may be submitted until Oct. 22.

FDA Issues Guidance on Qualified Facility Exemption From Food Preventive Controls Rules
September 21, 2018 |FDA

The Food and Drug Administration recently issued a new guidance document on partial exemptions for “qualified facilities” from regulations on preventive controls for human and animal food. The guidance explains the definition of a qualified facility under the two rules, and how to calculate whether a company qualifies for qualified facility status, which is generally limited to small businesses. Under the preventive controls regulations, qualified facilities are exempt from complying with the full range of requirements, and must instead notify FDA that they are addressing hazards through preventive controls and monitoring.

FDA VQIP Application Portal to Open Earlier Than Scheduled
September 19, 2018 |FDA

The Food and Drug Administration will open the Voluntary Qualified Importer Program portal on Oct. 1, some three months earlier than planned, the agency said in an email. Importers can use the portal to submit notices of intent to participate and VQIP applications "for the Fiscal Year 2020 benefit period," it said.