As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." Recently, the U.S. Food and Drug Administration (FDA) has issued a draft Guidance for Industry for implementing the DSCSA with respect to identification of suspect products and notification thereof.
Starting January 1, 2015, trading partners and manufacturers are required to "notify FDA and immediate trading partners (that they have reason to believe may have received [or possess] the illegitimate product) not later than 24 hours after making the determination."
The Guidance sets up the following specific scenarios that could increase the risk of a suspect product entering the distribution chain, such as:
- receiving unsolicited sales offers from unknown sources;
- purchasing products from a new source, from an unknown source on the Internet or from a source known or which the trading partner believes has transacted business involving suspect products (e.g., the source has a history of problematic or potentially false transaction histories or pedigrees or is reluctant to provide such information; where transaction information, statements and/or histories are incomplete or suspicious);
- products that are in high demand, have high sales volumes or prices, previously or currently are being counterfeited or diverted, are subject to a shortage, are the subject of an illegitimate product notification or are the subject of an FDA counterfeit or cargo theft alert;
- products that arrive in suspicious packaging or containers (e.g., the label contains misspellings or incorrect colors, fonts, images, etc.);
- packages that use foreign terms or are missing information and/or anti-counterfeiting technology; or
- dosage formulations that seem suspicious (e.g., different shape or color, different or unusual imprint, odorous, contains chips or cracks or has smeared ink imprint).
The Guidance recommends being aware of the following situations, which may help in identifying suspect products:
- products offered at very low prices;
- packages and containers that have been compromised, have been changed for unexplained reasons, are missing inserts or contain inserts that do not correspond to the product or come from unexpected foreign sources;
- labels that are missing information, have altered information, contain misspelled words, are bubbling on the surface, do not have an Rx symbol, contain foreign language, have a different product name from the FDA-approved drug, have the foreign version of the product name and are transported in an unexpected case or tote; or
- lot numbers and expiration dates on the product do not match those on the outer container.
The process for notifying the FDA of an illegitimate product requires the trading partner to access the FDA's drug notification website and submit a completed copy of Form FDA 3911, which is also attached as Attachment A to the Guidance.
In order to terminate a notification in consultation with the FDA, a trading partner is required to access the drug notification website and compete a copy of Form FDA 3911, including "an explanation about what actions have taken place or what information has become available that make the notification no longer necessary to FDA." The FDA will then review and consult with the trading partner regarding termination of the notification. Although the response time for a request to terminate a notification will depend on the circumstances, the FDA intends to respond within 10 business days of the submission. Should a trading partner believe that exigent circumstances exist that require expedited review, a description of those circumstances must be included in the termination request. Once the FDA has responded with a determination that notification is no longer necessary, the trading partner "must promptly notify immediate trading partners that the notification has been terminated." This section of the Guidance relating to termination of notification will have a binding effect once this Guidance is finalized.