The Drug Supply Chain Security Act (DSCSA) creates a uniform, national standard for tracing pharmaceuticals through the supply chain. The DSCSA calls for implementing a new electronic, interoperable system for product tracking and tracing over a 10 year period for the date it was signed into law (11/23/13). The goal of the DSCSA is to enhance the US FDA ability to help protect consumers by detecting and removing potentially dangerous products from the pharmaceutical supply chain. In addition, the law’s immediate preemption provision eliminates the burdensome patchwork of state pedigree laws.

On December 24, 2014, the FDA released guidance for the requirement under the Drug Supply Chain Security Act (DSCSA) that requires information concerning the purchase and sale of prescription pharmaceutical products to be transmitted by the manufacturer to the wholesaler and from the wholesaler to the dispenser. The Act took effect January 1, 2015, and provides for a full implementation process over a period of 10 years. The Act imposes requirements on manufacturers, wholesaler drug distributors, repackagers and dispensers to verify that all pharmaceutical products are legitimate, utilizing identification and track and tracing procedures as well as maintaining systems that recognize and report suspect products.

The enforcement date of this requirement was moved to May 1, 2015 by the FDA. The previous effective date was January 1, 2015.

As of May 1, 2015, Pharmedix was compliant with its manufacturers and wholesale suppliers to receive and transmit data regarding the transaction history concerning the prescription products you purchase from Pharmedix™. However, depending on the vendor, prescription products purchased prior to May 1^st 2015 when DSCSA regulations took place, may have incomplete track and trace histories. 

As of July 1, 2015 the Drug Supply Chain Security Act (DSCSA) of 2013 was to require pharmacies, dispensing clinics and any other retail outlet that receive prescription pharmaceutical products to receive and maintain drug transaction records, including:

– Transaction History (TH): Details about which organizations have taken ownership of the product

– Transaction Information (TI): Details about the product, including but not limited to: product description, NDC and quantity, etc.

– Transaction Statement (TS): Statement attesting to the accuracy and integrity of the transaction data.

The FDA extended this effective date to Nov 1st 2015. Then on October 29th, 2015, the FDA announced that it did not intend to take enforcement action until March 1^st 2016 against dispensers of prescription drugs that do not capture and maintain the product tracking and tracing information as required by DSCSA.

Effective July 1^st 2015, Pharmedix ™ Company started providing access to the required Drug Supply Chain Security Act information (TH/TI/TS data)via email and our website for our clients transaction records for products purchased through the Pharmedix™. The information emailed andon the website is available in a printable PDF format.Track and trace documents will be emailed to the order person of record within 48 hours (Monday through Friday) following invoicing. Within 1 week following invoicing, your Track and Trace documents with also be available online at Pharmedixrx.com

Please contact customer service at 1-800 486-1811 to create an online account if you do not currently have access to our website. Please be aware that it istheresponsibilityof each user to retain this information for a period of 6 years and, if necessary, transmit the required information to your down-stream customers as required by the Drug Supply Chain Security Act. Your TH/TI/TS data will also be available online for as long as you are an active Pharmedix™ client. If your account becomes inactive for more than 12 months, Pharmedix™ will give you 30 days notice that your track and trace documents are being removed from the online database.

After that period of time there is a $250 charge to retrieve any archived track and trace documents.

There is something about a medication with a package insert the size of a small bible that doesn’t belong next to the potato chip isle.

Deaths by drug overdose have been on the rise in the United States, with a majority of states recording increases from 2009 to 2013, according to a study released on Wednesday.

As the Lorax said “They just keep on biggering and biggering and biggering”

Be careful who you dispense control substances to

http://www.pharmacytimes.com/news/22-Pharmacists-Doctors-Arrested-in-DEAs-Operation-Pilluted?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=PT%5FBreaking%5FNews%5F5%2D20%2D15

CVS to pay $22 million to settle illegal dispensing charges. And these guys want to control the pharmacy market. See Target story above.

http://drugtopics.modernmedicine.com/drug-topics/news/cvs-pay-22-million-settle-illegal-dispensing-charges

Wockhardt hit with new FDA concerns at banned plant
http://www.fiercepharmamanufacturing.com/story/wockhardt-hit-new-fda-concerns-banned-plant/2015-02-26?utm_medium=nl&utm_source=internal

http://www.fiercepharmamanufacturing.com/story/indian-regulator-lays-down-new-standards-its-inspectors/2014-08-13?utm_medium=nl&utm_source=internal