When the FDA Office of Compliance, generally the central point for enforcement of the Drug Supply Chain Security Act (DSCSA), issued “immediate implementation” guidance that the looming Jan. 1 deadline for having a functioning system for transmitting transaction information from manufacturers to trading partners was postponed to May 1, it seemed merely to confirm an expectation that FDA had to give the industry more time. Informal assessments had indicated that roughly three-quarters of the pharma supply chain would be ready by Jan. 1 for the DSCSA deadline; that indicated that pallets of undocumented product could start stacking up at distributors’ loading docks and, as one major wholesaler put it, “We will not be building new warehouses to handle quarantined [undocumented] product.”
The Healthcare Distribution Management Assn., for one, had sent letters to FDA cautioning that full industry readiness had not yet been achieved. The next deadline in the 10-year process of full DSCSA compliance is to be a July 1 date for retail and other pharmacies to have the transaction information available to FDA inspectors; allowing two months between complete manufacturer-distributor data exchange, and subsequent data exchange with retailers, seems problematic at this point, but FDA wants to keep the pressure on to keep DSCSA compliance moving forward.
“Issuing the traceability guidance in November, expecting a January 1 implementation, was unrealistic,” says David DeJean, president and CEO at Systech International (Cranbury, NJ), one of the leading IT vendors working in the area. “Even so, most major biopharmas have their implementations in place, and are working toward the next deadline in 2017.” (In that time frame, the first steps toward item-level traceability will be taken.)
Case in point: EMD Serono, which announced in November that it is already doing individual serialization for all four of its major brands: Serostim and Saizen (both somatropins); Rebif (interferon beta-1a); and Gonal-f (follitropin alfa). For many of its products, EMD Serono already has a limited pharmacy network that it interacts with directly to ensure safe and appropriate dispensing. Serialization is carried out with 2-D barcodes (and linear codes on cases). Layered on top of this is a new smartphone app, brandnamed Check My Meds, that allows patients to record and then authenticate their dosages with a central database maintained by EMD Serono.
Although such traceability has significant implications for supply chain visibility, Kimberly Fleming, associate director of product security and outbound logistics, says that Check My Meds is “data push, not data pull”—the company will not be collecting patient data such as locations or lookup frequency. Once a patient does perform the smartphone verification, there is an option to link into the company’s patient support services, but that’s at the patient’s option.
The international timelines for traceability initiatives are also pushing the industry along; in the best-case scenario, a manufacturer would install a traceability solution that, with as little modification as possible, could be adapted to the US’ and other countries’ rules. That reality is bringing QAD (Santa Barbara, CA) into the life-sciences traceability scene: the major enterprise resource planning (ERP) vendor has developed a traceability solution to meet the requirements of a UK manufacturer, Aesica Pharmaceuticals, shipping into China (whose system involves the China FDA sending designated serial numbers out to manufacturers to apply to pharma packages); the company is also active in the Unique Device Identifier (UDI) program being implemented by med device manufacturers in the US.
“Compliance is the immediate priority of our life sciences customers, but we see important added value in managing financial elements like chargebacks, product returns and the like with our traceability module,” says Bart Reitter, director of marketing for life sciences at the firm.
Yet another guidance document issued by FDA in late 2014 requires both wholesalers and third-party logistics providers (3PLs) to file state licensure information (if it exists for 3PLs) by March 31, 2015. Wholesalers are to begin filing after Jan. 1; 3PLs were to begin immediately. Each facility address is also required information. Wholesalers are to provide the name of a contact person for FDA; this is recommended but not required for 3PLs. All these data are to be updated annually.
Only a few states currently license 3PLs for healthcare products, so the new regulations will be bringing a host of 3PLs into the FDA scope. Also, it’s not widely recognized, but usually when a pharma manufacturer buys finished drug products from another manufacturer, it is acting as a wholesaler. Further, many wholesalers also act as 3PLs, and FDA is instructing them to file under both categories. (The FDA definition of a 3PL is an entity that “provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.”)
FDA’s goal, as specified in DSCSA, is to “make a database of authorized wholesale distributors available to the public on FDA’s website [and] to make information about 3PLs available … because having the license status of 3PLs in one publicly available database would be helpful for FDA, trading partners and other stakeholders.”
The Drug Supply Chain Security Act of 2013, which is the source of all of these new regulations, has a timeline out to 2023 for additional rules and practices. IT, manufacturing, supply chain and compliance managers are going to be busy for years to come.