Wednesday, February 13, 2019

FDA Issues Warning Letter To McKesson For DSCSA Violations

Read the full article:  First Warning Letter Issued Under DSCSA - FDA sends McKesson a warning, highlighting issues with illegitimate product notification, quarantining and record-keeping - Healthcare Packaging

"According to the letter to McKesson, “The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.”  . . . 
The letter highlights two other examples in which the firm did not demonstrate proper quarantining of suspect product or provide records to show that requirements were met in identifying illegitimate product or subsequent requirements."

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Monday, February 11, 2019

Earn Your California Designated Representative Training Affidavit Through Board Approved Training

A Word About Independent Self-Study

We've started hearing about California Designated Representative license applicants trying to fulfill the training program requirement on their own. Specifically, applicants are reviewing specified subjects and topics outlined on the California Designated Representative Training Affidavit form, and claiming their self-study constitutes completion of a training program.

Studying the specified subjects and topics by oneself, that is, independent self-studying, would not be considered completing a training program.  Even if the independent self-study was considered a training program, such a self-study training program would still need to gain California State Board of Pharmacy ("Board") approval.

In general, the Board is unlikely to accept the submission of a California Designated Representative Training Affidavit signed by the applicant, or from a person or entity offering a training program that has not been approved by the Board. Sending in such a deficient Training Affidavit form is likely to delay license application processing.

California Designated Representative training programs must undergo an assessment and review by the Board before being considered for approval.  Approved California Designated training programs meet the Board's rigorous standards, ensuring the training provider covers all required subjects and topics, and that some form of assessment or grading (such as exams) is incorporated into the training program.

In Summary

Don't confuse independent self-study with Board approved training programs that are offered as an online course. In a nutshell, independent self-study isn't the same as self-study-paced online coursework in a Board approved training program, course, or class.

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California Designated Representative Training Courses (for wholesalers, 3PL, reverse distributors) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (for wholesalers, 3PL, reverse distributors) - Approved by the California State Board of Pharmacy

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Saturday, February 9, 2019

RE: DSCSA - Rx For Concern: Why I’m Getting Worried About Our Drug Dispensers - LSPediA

Read the full article:  Rx For Concern: Why I’m Getting Worried About Our Drug Dispensers - LSPediA

Wholesalers, distributors, and dispensers need to be paying attention to DSCSA rules.

"To help cope with the challenge, LSPediA created our own Dispensers DSCSA Checklist, which outlines the current and future compliance rules dispensers face. This simple web form takes just 30 seconds to complete: Do you know what a 2D barcode matrix is? Are you able to send electronic purchase verifications? Do you think a “serialized product” is something in the breakfast aisle at the grocery store? The results will show dispensers just where they stand and what they need to do to comply. 
What can we all do? If you’re a dispenser, check with your distributors to find out what they’re doing to meet DSCSA regulations, what that means for you, and how they expect you to interact with their solutions. If you’re a distributor, it’s time to start having this conversation with every dispensary in your network – so feel free to share our checklist and readiness test with them. 
LSPediA also publishes this handy Guide To DSCSA Compliance For Dispensers for you to download."

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California Designated Representative Training Course For Drug/Device Wholesalers (approved by the California State Board of Pharmacy)
California Designated Representative Training Course For Drug/Device Wholesalers (approved by the California State Board of Pharmacy)

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, February 8, 2019

Pilot Project Program Under the DSCSA - FDA Notice

"The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs as they are distributed within the United States."  
The "FDA is seeking pilot project participants from the pharmaceutical distribution supply chain (e.g., authorized manufacturers, repackagers, wholesale distributors, and dispensers) and other stakeholders. FDA expects potential participants to propose the design and execution of their pilot project in their submission to FDA; however, FDA intends to meet with selected pilot project participants to ensure that the learnings from the pilot project(s) will be complementary in informing all stakeholders in the development of the electronic, interoperable system that will go into effect in 2023."

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, February 7, 2019

Avoid These Common California HMDR Inspection Violations

Common California HMDR Inspection Violations

California HMDR (home medical device retailer) renewal inspections can take place annually, unannounced, at any HMDR facility during normal business hours. A customer complaint or other referral may trigger an inspection.

Be prepared. Be aware of these common violations.

Common violations include:
  • Dispensing prescription devices without a valid HMDR exemptee on the premise
  • Lack of dispensing records for prescription devices
  • Inadequate procedures for the cleaning and maintenance of rental devices
  • Inadequate staff training or patient/caregiver consultation
  • Inadequate quality assurance procedures and/or lack of documentation of quality assurance procedures.
Source:   California HMDR FAQs

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Health - Food and Drug Branch)
California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Health - Food and Drug Branch)

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Monday, February 4, 2019

What is the current number of licensed California Designated Representatives (EXC)?

Q.  What is the current number of licensed California Designated Representatives (EXC)?

A.  California Designated Representatives (EXC) work in the drug and device wholesale business.  According to California State Board of Pharmacy licensing statistics, in November 2018 there were 3,043 individuals holding a current California Designated Representative (EXC) license.  This number does not include other Designated Representative types (such as veterinary, 3PL, or reverse distributor).

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California Designated Representative Training Courses for wholesalers, 3PL, and reverse distributors (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses for wholesalers, 3PL, and reverse distributors (approved by the California State Board of Pharmacy)

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, February 1, 2019

Prescription Drug Wholesalers Reaped Windfall From Alleged Price-Fixing - The Washington Post

Read the full article:  Prescription drug wholesalers reaped windfall from alleged price-fixing - The Washington Post

"Multiple state attorneys general have joined forces in civil antitrust litigation against the makers of generic drugs. As part of the probe, they say wholesale distributors — who have not been named as defendants — should have held the line on anti-competitive behavior by manufacturers and alerted authorities to suspicious activity. 
Instead, end consumers paid a steep price as alleged price-fixing conspiracies boosted costs of common drugs as much as 1,000 to 4,000 percent."


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California Designated Representative Training Courses for wholesalers, 3PL, reverse distributors (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses for wholesalers, 3PL, reverse distributors (approved by the California State Board of Pharmacy)

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

New App Displays What Items Medicare Covers - HME Business

Read the full article:  New App Displays What Items Medicare Covers - HME Business 

"CMS has launched What’s Covered, a new smart phone app that lets beneficiaries with Original Medicare, caregivers and other healthcare professionals quickly check whether an item or service is covered by Medicare. 
What’s covered is intended to bypass what CMS predicts will be a gigantic avalanche of coverage questions in coming decades."

Get the What's Covered app for free:

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California HMDR Exemptee Training Certification Course for home medical device retailers (accepted by the California Department of Public Health - Food and Drug Branch)
California HMDR Exemptee Training Certification Course for home medical device retailers (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):
     Florida:

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

     California (earn a training completion certificate):

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