The Food and Drug Administration issued guidance on how exporters of milk and milk products, seafood, infant formula and formula for young children can meet new establishment certification requirements required for export to China, it said (here). The revised guidance document, which previously covered only milk, “explains how establishments should apply to be included on FDA’s lists of exporters to China, how FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how FDA intends to update this information,” the agency said. FDA recently signed a memorandum of understanding with China establishing a formal registration process after the Chinese government issued a decree requiring “certification of compliance with the relevant standards, laws, and regulations of China” as of June 15 for milk and milk products, seafood, infant formula and formula for young children. FDA will use the information it receives from exporters “to establish and update a list of eligible exporters in a manner consistent with the MOU, and the agency will update the list of establishments and products four times per year,” it said.
The Food and Drug Administration intends to give drug manufacturers a one-year grace period to implement product identifier marking requirements under the Drug Supply Chain Security Act, it said in a draft guidance document posted June 30 (here). A requirement to “affix or imprint a product identifier to each package and homogenous case of a product” takes effect Nov. 27, 2017, but FDA does not intend to take action against manufacturers that do not do so until Nov. 26, 2018, it said. “FDA also does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level” before that date, it said. FDA will also allow a grace period for verification, wholesale distributor and dispenser verification requirements under the Drug Supply Chain Security Act, it said. Comments on the draft guidance document are due Sept. 1, FDA said (here).
The Food and Drug Administration is amending its color additive regulations to allow for the use of spirulina extract to “seasonally color” hard-boiled eggs “at levels consistent with good manufacturing practice,” it said (here). The change was requested by McCormick & Company. The final rule takes effect Aug. 3, 2017.
The Food and Drug Administration issued an updated draft guidance document on current good manufacturing practices for medical gases, it said (here). The updated guidance provides additional information “regarding the application of certain regulations to medical gases,” FDA said in the draft (here). “This guidance is expected to reduce the regulatory compliance burden for the medical gas industry by providing clear, up-to-date, detailed recommendations regarding CGMP issues that have been the subject of industry questions,” it said. The document supersedes draft guidance on CGMPs for medical gases issued by FDA in 2003. Comments are due Aug. 28.
On June 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for June 21 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.
On June 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: