“The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health…”
The FDASIA doesn’t seem to have a direct effect on this project, although they do define a UFI (unique facility identifier) managed by Dun & Bradstreet which may be a useful resource for us. “The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.” “The following are the major provisions of the Drug Supply Chain Security Act (DCSA). These provisions apply to manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers as noted below: - Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically. - Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market. - Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages. - Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous. - Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found. - Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database. -Third-party logistics provider licensing: Third-party logistics providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.” The product verification provision points to a similar system to what we’re discussing. The HP paper claims that these product verification technologies must be a “moving target” that stays ahead of counterfeiters, and that these organizations of counterfeiters and diverters are causing a revenue loss in the tens of billions of dollars. There’s some insight into the methods of counterfeiting that may be worth a read. Europe is the largest market for drug diversion. I’m inferring that in the USA the drug diversion activity is key in the opioid epidemic; buyers know they are getting goods outside of the regulated supply chain. This paper discusses 2D barcodes and RFID in terms of “track-and-trace”. The Global Data Synchronization Network (GDSN) and EPCglobal Network are mentioned as supply chain database providers. Security printing is discussed. This paper is to sell HP’s solution to the problem. It looks like we’d be competing with them, although their website link is gone. I suggest reading this paper. The FedEx paper didn’t have anything obviously interesting for us. The web article is much more recent than these other sources. They claim that USA packages were required to have the unique serial number by November 27 2017. 40 other countries have pharmaceutical tracing efforts in flight. In Europe there’s the Falsified Medicines Directive (FMD) with a February 2019 labeling deadline. There are “vendors of serialization equipment” out there. There’s a machine type to check barcode quality after printing. This is another article worth reading in addition to the HP paper. While our labeling approach may have unique characteristics, I don’t think we’re going to compete with commercial companies already tied into regulation in these many countries with recent legislation. What do you think? How do we add value? Matt On Friday, January 5, 2018 at 6:45:04 PM UTC-6, matthe...@gmail.com wrote: > > From > https://www.pharmamanufacturing.com/experts/contract-manufacturing-management-supply-chain-management-/show/71/ > > In the US: Food and Drug Administration Safety and Innovation Act > (FDASIA), Drug Supply Chain Security Act (DSCSA) > > Don mentions the term "end-to-end security program". > > Here's a paper on pharmaceutical product tracking and authentication: > ftp://ftp.hp.com/pub/services/manufacturing/info/pta_59830764en.pdf > > A paper from FedEx: > http://images.fedex.com/us/supply-chain/services/healthcare-shared-network/HSN-End-to-End-security.pdf > > An article on the state of these activities in 2017: > http://pharmaceuticalcommerce.com/supply-chain-logistics/2017-product-security-report/ > > I'll read these in detail and report any significant information. > > Matt > > On Friday, December 29, 2017 at 4:27:52 PM UTC-6, KLR wrote: >> >> >> EU has also been at it >> https://ec.europa.eu/health/sites/health/files/files/counterf_par_trade/doc_publ_consult_200803/114_b_efpia_en.pdf >> >> El domingo, 24 de diciembre de 2017, 17:38:57 (UTC+1), Frank Davidson >> escribió: >>> >>> A few weeks ago, I saw this report on the PBS NewsHour: >>> >>> >>> https://www.pbs.org/newshour/show/fighting-the-public-health-threat-of-counterfeit-drugs >>> >>> <https://www.google.com/url?q=https%3A%2F%2Fwww.pbs.org%2Fnewshour%2Fshow%2Ffighting-the-public-health-threat-of-counterfeit-drugs&sa=D&sntz=1&usg=AFQjCNED32vXuXXyv80iowZldCg5SxLYSw> >>> >>> I have just (as in haven't even started putting code in GitHub yet) >>> started to work on an app which I was thinking might help deal with this >>> and truly help folks out, worldwide. It also could help with drugs bought >>> over the internet as well, I would think. >>> >>> The idea is to use aztec bar codes to encode a manufacturer's ECDSA >>> signature and a UUID and possible some other metadata on the label of a >>> bottle of pharmaceuticals. >>> >>> An Android and iOS app would then allow an individual or small pharmacy >>> to scan that bottle, verifying the signature against a manufacturer's >>> website, where there would be verification against their public key and >>> also their cert with their cert authority. Smartphones and the Internet are >>> fast becoming ubiquitous even in the developing world. >>> >>> I'm working on the code right now and I'll post things as I progress. >>> >>> I'm not looking for any money at all because I think the programming >>> task isn't really too hard, but, I was thinking that the greater Go >>> community might also have an interest. >>> >>> I'm not sure if there's a charitable team or group or anything, but I >>> thought I'd check it out. I'd like to make this totally OSS with a >>> non-profit backing it (if it gets to that state eventually). I've >>> registered verx.codes as a domain. >>> >>> I'm not totally sure yet if this is feasible in the real world or if the >>> pharmaceutical companies could be persuaded to buy in, but I would think it >>> could also be good for their brands and give them a way to track individual >>> bottles and provide authenticated info to users like expiration dates and >>> extensive use instructions once a person successfully scans and verifies a >>> code and then gets passed to the company's website. >>> >>> Anyway, totally just beginning and I'd welcome any thoughts, comments, >>> and/or critisms! >>> >>> Merry Christmas and Happy Holidays to all the Go community! >>> >>> Frank >>> >> -- You received this message because you are subscribed to the Google Groups "golang-nuts" group. To unsubscribe from this group and stop receiving emails from it, send an email to golang-nuts+unsubscr...@googlegroups.com. For more options, visit https://groups.google.com/d/optout.
