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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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  Who Offers Designated Representative Training?

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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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• 
  Who Offers Designated Representative Training?

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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Who Offers Exemptee Training?

• California HMDR Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch)

SkillsPlus International Inc. offers the highly respected California Home Medical Device Retailer (HMDR) Exemptee Course listed below. 

This training course is very popular for its convenience, and availability 24 hours a day & 7 days a week!  Buy now and gain immediate access to the course.

California HMDR Exemptee Training – Buy Now!

Learn more: Exemptee training taught by SkillsPlus International Inc.

Q & A:

Question: Who offers California HMDR Exemptee Training Certification?

Answer: SkillsPlus International Inc. is a highly recommended provider of California Exemptee certified training for home medical device retailers (HMDR).

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--------------

• California HMDR Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch)

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Authorities arrest 243 people in $712 million Medicare fraud | Reuters

Read the full article: UPDATE 2-Authorities arrest 243 people in $712 million Medicare fraud | Reuters:

"Many of the arrests were in Florida, long an epicenter of Medicare fraud. In Miami, 73 defendants were charged with offenses involving approximately $263 million in false billings.

Other cities involved include Houston, Dallas and McAllen, Texas; Los Angeles; Detroit; Tampa; Brooklyn, New York; and New Orleans."

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CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

Pharmacists discuss issues causing prescription drug problems | Health - WESH

• Florida CDR Training Course | Florida CDR Training Course
  Check out Florida Certified Designated Representative training for wholesalers by CDR Resource Center. Learn more today. Florida Certified Designated Representative (CDR) laws and rules examination preparation. Consulting expertise in prescription drug regulations and wholesale distribution compliance. State licensing support.
  

Patients having problems getting legitimate prescriptions filled was discussed at a recent Florida Board of Pharmacy meeting.

Read the full article:  Pharmacists discuss issues causing prescription drug problems | Health - WESH Home:

"Many also cited the restrictions on the volume of medication they can order as a major obstacle to serving patients, and they put that blame on the wholesalers."

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

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

• Register for a Board-approved California Designated Representative training course, for:
         Wholesalers | 3PL | Reverse Distributors

Updated August 18, 2021

The original link broke.

You can still read about the same topic here:

Track and trace: Is your pharmacy in compliance with the new law? - APhA Pharmacy Today

---  the original post follows below  ---

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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- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

CA Board of Pharmacy - Self-Assessment Forms

• California Designated Representative Training Courses (wholesaler, 3PL) - Approved by the California State Board of Pharmacy
• Buy a course now! For: wholesalers | 3PL | Reverse Distributors

Updated June 25, 2023:

CA Board of Pharmacy Self-Assessment Forms

Follow the Board's instructions on which versions of the forms posted on the Board's website that should be used:

CA Board of Pharmacy - Self-Assessment Forms

---  The original 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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-----------------

California Designated Representative Training Courses (wholesaler, 3PL) - Approved by the California State Board of Pharmacy

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute