Tuesday, June 30, 2015

FDA To Dispensers - Guidance on DSCSA July & Nov Timelines

The FDA published a new guidance:

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry - FDA (PDF)

In a nutshell:

"The product tracing requirements in sections 582(d)(1) of the FD&C Act take effect for
dispensers on July 1, 2015. ... "

"FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept
ownership of product without receiving the product tracing information, as required by section
582(d)(1)(A)(i) of the FD&C Act."

There's a whole lot more in the guidance, so you'll want to review it, in its entirety.

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Wednesday, June 24, 2015

Pharmacy Groups Ask FDA to Delay Enforcement of ‘Track & Trace’ Requirement - Pharmacy Practice News

Read the full article: Pharmacy Practice News - Pharmacy Groups Ask FDA to Delay Enforcement of ‘Track & Trace’ Requirement:

"The organizations asked that the FDA use its enforcement discretion to delay the July 1 product tracing deadline for dispensers to forestall potential disruptions in the pharmaceutical supply chain."

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Tuesday, June 23, 2015

California Man Pleads Guilty in Prescription Drug Diversion Scheme | OPA | Department of Justice

Read the full article: California Man Pleads Guilty in Prescription Drug Diversion Scheme | OPA | Department of Justice:

"According to court documents, from May 2010 through December 2012, Vin Nguyen, 45, and others conspired to distribute illegally-diverted prescription drugs while concealing the true, illicit sources of the drugs.  Nguyen purchased prescription drugs, including HIV medications, anti-psychotic medications and other brand name drugs, from various unlicensed and illegal sources in California and Florida.  Working with co-conspirators, Nguyen then sold the drugs to other drug diverters without the statutorily required pedigree documents stating the origin of the drugs.  Nguyen and his co-conspirators sold more than $6.5 million worth of diverted drugs. "

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Thursday, June 18, 2015

Wednesday, June 10, 2015

Track and trace: Is your pharmacy in compliance with the new law? | American Pharmacists Association

Read the full article: Track and trace: Is your pharmacy in compliance with the new law? | American Pharmacists Association:

"Is your pharmacy ready for the new track-and-trace law? Under the Drug Supply Chain Security Act, January 1 and July 1 are the key dates in 2015 for new requirements for pharmacies.

Per the new law, as of January 1, 2015, pharmacies shall only accept drug products from authorized trading partners. Also, pharmacies are required to have processes in place to identify, quarantine, and investigate suspect products and determine whether products are illegitimate. By July 1, 2015, pharmacies must be able to capture and maintain transaction information (TI), transaction history (TH), and a transaction statement (TS)—sometimes referred to as “the three Ts”—for each drug product received for 6 years from the date of the transaction."

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Monday, June 8, 2015

CA Board of Pharmacy - Self-Assessment Forms

Updated April 26, 2016:

Use the latest version of the forms posted on the Board's website:

CA Board of Pharmacy - Self-Assessment Forms

---  The post below is outdated --- 

Go to the links for all forms: Board of Pharmacy - Applications and Forms - California Board of Pharmacy:

"Self-Assessment Forms

Board regulations require that all licensed pharmacies and wholesalers complete a Self-Assessment by July 1 of every odd-numbered year.

The board is in the process of updating the Self-Assessment forms through a formal rulemaking.  The updates include references to statutory and regulatory changes that occurred between 2011 and 2015.  The last time the forms were formally updated and approved by the Office of Administrative Law was 2011.

Current regulation requires a pharmacy or wholesaler to complete the 2011 version of the Self-Assessment form.  Please be advised, however, the board will accept completion of either the 2011 version OR the 2014 version.  The latter version is likely to be a more helpful assessment to the pharmacy or wholesaler completing it."

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