Achieve Compliance with the Help of Blue Harbors
In the United States, counterfeit prescription pharmaceuticals are increasingly being added into authentic drug distribution channels. It is becoming more difficult to distinguish the authentic prescription drugs from the counterfeit. As a result, the State of California has passed the most wide-ranging anti-counterfeiting and anti-deviation legislation in the United States. This law bans manufacturers, wholesalers and pharmacies from selling, trading or transferring a prescription drug without initially presenting a pedigree.
You might be wondering, what does this mean for you and your business? What products does this law cover? What products are exempt? How, exactly, have the laws changed? What do you need to do to remain compliant? How much time do you have left before these laws take effect? That’s exactly where Blue Harbors will help you. Our expert team of consultants will help you achieve compliant status for your piece of mind.
Each pedigree tracks individually identified and labeled prescription drugs and records all changes of the drug’s ownership. To achieve compliance with California pedigree laws, your company is required to employ an electronic system that is compatible in all distribution channels. This system must be capable of tracking all sellable items’ production, distribution to pharmacies, and returns. The deadline for the first 50% of your inventory must be serialized by January 1, 2015. DO NOT wait until it’s too late.
All prescription medication distributed into and within the State of California must observe the specified dates of compliance:
January 1, 2015 – First 50% of manufacturers’ products serialized
January 1, 2016 – Remaining 50% of manufacturers’ products serialized
July 1, 2016 – California wholesalers are required to obtain pedigrees before sale
July 1, 2017 – California pharmacies are required to obtain pedigrees before sale
To learn more about the California’s ePedigree laws & compliance strategies, call us at (415) 375-0756, send us an email at firstname.lastname@example.org, or CONTACT US HERE to schedule a meeting.