Regulatory Focus™ > News Articles > 2019 > 10 > FDA Warns California Drug Distributor for Listing Deficiencies

FDA Warns California Drug Distributor for Listing Deficiencies

Posted 08 October 2019 | By Zachary Brennan 

FDA Warns California Drug Distributor for Listing Deficiencies

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Orange, CA-based distributor NuCare Pharmaceuticals after the company failed to correct certain drug listings.

FDA said that since it first contacted NuCare in August 2017, some of the incorrect listings outlined in deficiency letters have been addressed and corrected, but many remain unresolved. 

The agency points to multiple incorrect carton labels or missing information on the strength of the active ingredient for certain submissions made from 2017 to this year. For instance, FDA notes in the warning letter that the carton label of one drug has an image of amoxicillin, but the listed drug is losartan potassium. Or the carton label image is of hydrocortisone cream, but the listed drug is ear wax removal drops, FDA says.

“Your firm failed to fulfill its listing obligations under Section 510(j) of the FD&C Act, which is a prohibited act under section 301(p) (21 U.S.C. 360[j] and 331[p]),” the warning letter, dated 26 September, notes. “In addition, your firm’s failure to fulfill its listing obligations misbrands the product under section 502(o) of the FD&C Act.”

FDA also says the company failed to address many of the listing deficiencies detailed in other letters in 2017 and 2018.

“Forty-five days after these FDA letters were sent, emails of data removal notifications were sent to your company and at that time, the listing data associated with these deficiencies were removed from the on-line NDC Directory. Prompt action must be taken to correct the remaining deficiencies,” the agency adds.

NuCare, which describes itself as a national distributor of generic drugs, prepackaged pharmaceuticals and supporting software, did not respond to a request for comment.

Warning Letter

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe