FDA recently alerted the public that Westminster Pharmaceuticals, LLC was recalling Levothyroxine and Liothyronine products in various strengths that were manufactured using active pharmaceutical ingredients from a deficient Chinese manufacturer.  According to the recall notice, the agency’s 2017 inspection of Sichuan Friendly Pharmaceutical Co., Ltd. identified Current Good Manufacturing Practices problems at the facility that “could represent the possibility of risk being introduced into the manufacturing process.”  While this recall highlights the potential threat to patients when drugs are manufactured using questionable Chinese-sourced APIs, other areas of potential interest to FDA should also be considered when such incidents occur.

For instance, an obvious first step is to establish whether the facility issuing the recall is registered with FDA. Surprisingly, not every labeler in FDA’s Electronic NDC Directory appears when conducting a search for that entity in FDA’s Drug Establishments Current Registration Site database. Although there may be a legitimate reason for this situation, it seems quite unusual for a drug labeler not to be registered with FDA as a manufacturer or a repackager. This is a significant concern because drugs are potentially misbranded under section 502 (o) the FD&C Act if they are manufactured in establishments that are not registered with FDA.

Further, manufacturer and repackager trading partners must be registered with FDA in order to be Authorized under the DSCSA. Trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) that engage in covered transactions with trading partners that are not Authorized are in potential violation of the Act.  Any person who violates a prohibited act provision in section 301 of the Act is subject to misdemeanor and felony penalties under section 303 of the Act.

Also, the recalled product may have a designation of “unapproved drug other” in FDA’s Electronic NDC Directory and the application number section for that particular drug may be blank.  These are two additional red flags for the agency.

Lastly, trading partners that provide transaction statements falsely attesting to their Authorized status under the DSCSA are likely supplying their customers with suspect products and illegitimate products. According to recent FDA guidance, the definition of fraudulent transaction, one element of the DSCSA’s definitions of suspect product and illegitimate product, involves a transaction “in which the transaction information, transaction history, or transaction statement contains falsified information.” Consequently, it is reasonable to conclude that any drug product sold by a manufacturer, wholesale distributor, or repackager is a suspect product if it is accompanied by a corresponding transaction statement in which the trading partner falsely attests to being Authorized under the DSCSA.

While the use of questionable Chinese-sourced APIs in the drug manufacturing process is at the heart of this recall notice, there are other less obvious, but still compelling, concerns that the agency should also be considering when evaluating its response to these types of incidents.