The Food and Drug Administration issued its weekly Enforcement Report for Jan. 11 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 Jan. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Jan. 10 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 a new guidance document (here) on current good manufacturing practices (CGMP) for combination products, it said (here). The guidance is intended to explain FDA’s January 2013 final rule that set CGMP requirements for combinations of drug, device and biologics products (see 13011824). The guidance also “includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios,” FDA said.

The Food and Drug Administration on Jan. 10 released two guidance documents on labeling of over-the-counter drug products. Guidance on over-the-counter acetaminophen-containing drug products (here) says FDA “does not intend to take action against the marketing of single- and combination-ingredient, acetaminophen-containing,” over-the-counter “drug products bearing a warning as described in the guidance alerting consumers that the use of acetaminophen may cause severe skin reactions,” it said (here). A draft guidance document on the recommended statement for over-the-counter products that contain aspirin (here) encourages “drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for ... secondary prevention” of heart-related events, FDA said (here).

On Jan. 9 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The Food and Drug Administration issued a draft guidance document (here) on annual reporting requirements under the Drug Supply Chain Security Act for prescription drug wholesale distributors and third-party logistics providers, it said (here). The questions and answers document clarifies that the reporting requirements apply only to 3PLs “that provide or coordinate warehousing, or other logistics services” for “human prescription drugs in finished dosage form.” If a 3PL facility “handles only bulk drug substances that are free form active pharmaceutical ingredients (API) and have yet to undergo manufacturing, processing, or packaging to become the finished dosage form of the drug, the 3PL facility does not need to report,” FDA said. Comments are due March 13.

On Jan. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Jan. 5 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 Jan. 4 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.