Tuesday, July 9, 2019

California Designated Representatives Can Renew Licenses By Credit Card

The California State Board of Pharmacy recently included this item in a July 1, 2019 Board of Pharmacy Update:

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California Designated Representative Training Course For Wholesalers. Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Course For Wholesalers. Earns a training affidavit accepted 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):

Thursday, June 27, 2019

California Board of Pharmacy Moving July 1, 2019

Board of Pharmacy Moving July 1

The California State Board of Pharmacy just sent out this June 26, 2019 email message:

"Beginning Monday, July 1, the California State Board of Pharmacy office will be at 2720 Gateway Oaks Drive, Suite 100, Sacramento, CA 95833.

Thursday and Friday this week, June 27-28, some regular office functions may be affected as movers begin disassembling and transporting files, furniture and other office equipment to the new location. We appreciate your patience during this transition.

The board’s office hours will remain 8 a.m. to 5 p.m. Monday through Friday during and after the move. The office is closed on state holidays.

Effective July 1, the new office phone number will be (916) 518-3100. The main fax number will remain the same: (916) 574-8618."

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California Designated Representative Training Courses. Earns a training affidavit accepted by the California State Board of Pharmacy. Separate courses specifically designed for: wholesalers, 3PL (third-party logistics providers); reverse distributors.
California Designated Representative Training Courses. Earns a training affidavit accepted by the California State Board of Pharmacy. Separate courses specifically designed for: wholesalers, 3PL (third-party logistics providers); reverse distributors.

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):

Tuesday, June 18, 2019

A Scary New Trend: Six-Year Lookback Audits - HME Business

The full article is a must read:  A SCARY NEW TREND: SIX-YEAR LOOKBACK AUDITS - Understanding another 'new normal' for HMEs from HHS OIG. - HME Business

"The Office of Inspector General (OIG) regularly performs audits and reviews as part of its normal functions. In June 2018, it released a scathing report entitled, “Most Medicare Claims for Replacement Positive Airway Pressure Device Supplies Did Not Comply With Medicare Requirements.”"  ... 
"In layman’s terms, suppliers either have to review every claim they have submitted for PAP supplies for the previous six years, or they must identify the universe of claims by taking a statistically valid random sample and extrapolating the results of the audit once the sample has been reviewed. They are asking suppliers to do something that requires the high-level skills and knowledge of an expert statistician."

#HMDRexemptee #HMDR #HME #DME #CPAP

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California Home Medical Device Retail Exemptee Online Training Certification Course - accepted by the California Department of Public Health (Food and Drug Branch)
California Home Medical Device Retail Exemptee Online 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):
     Florida:

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

     California (earn a training completion certificate):

Wednesday, June 12, 2019

ResMed study shows 170 million in Americas have sleep apnea - MassDevice.com

Read the full article:  ResMed study shows 170 million in Americas have sleep apnea - MassDevice.com

If you gasped, make sure you see the keyword, "Americas," in the plural.

"More than 170 million people in North and South America have sleep apnea, according to a new study released today by apnea device-maker ResMed"

"The figure represents 37% of adults on the two continents."

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training - online training certification class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch.
California HMDR Exemptee Training - online training certification class. Earns a course completion certificate 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):

Tuesday, June 4, 2019

Got a question? Ask an Inspector - California State Board of Pharmacy

California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor). Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor). Earns a training affidavit accepted by the California State Board of Pharmacy.

Telephone coverage hours have been expanded!

"Contact a board inspector if you have questions about pharmacy law or regulations. An inspector is available to answer telephone inquiries Monday through Thursday from 9 a.m. to 1 p.m." 
Contact them via phone, fax, or email. 
"Note: The board’s inspectors and staff cannot provide legal advice, but they will assist you by identifying statutory and regulatory sections that pertain to your questions. If you need legal advice, please contact a lawyer."

Source:  Got a question? Ask an Inspector - California State Board of Pharmacy

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor). Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor). Earns a training affidavit accepted 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):

Monday, May 13, 2019

Plan Ahead (June-July 2019) With The California State Board of Pharmacy


California Designated Representative Training Courses. Earns a training affidavit accepted by the California State Board of Pharmacy.
California Designated Representative Training Courses. Earns a training affidavit accepted by the California State Board of Pharmacy.

Expect Possible Delays With The California State Board of Pharmacy

Plan ahead. If you have license renewals coming up, or you're planning to submit license applications, try to get ahead of possible delays in the June-July 2019 timeframe, due to:

  • the end of the fiscal year (end of June 2019)
  • a Board office move July 2019

Return Home:  The Designated Representative and Exemptee Blog

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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):

Tuesday, May 7, 2019

AAHomecare Seeking Information on UnitedHealthcare Denied PAP Claims - HomeCareMag.com

Read the full article:  AAHomecare Seeking Information on UnitedHealthcare Denied PAP Claims - HomeCareMag.com

"AAHomecare has learned that providers are hearing mixed messages from UHC regarding appeals on these incorrect denials. Some providers have been told to submit denials as a claims project to UHC while others are being told not to resubmit and that UHC will be reprocessing the claims automatically."

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California HMDR Exemptee - Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. For home medical device retailers.
California HMDR Exemptee - Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. For home medical device retailers.

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):

Sunday, May 5, 2019

IDEAS FOR GROWTH - HME Business

Read the full article:  Ideas For Growth - HME Business  

"more than 30 tips that will hopefully help you widen your [oxygen] margins and bring in a win"

. . . "just in case you’ve missed a suggestion, HMEB consulted some industry experts for their advice on how to squeeze [oxygen] profits out of thin air. We’ve broken those suggestions down to bite-sized pieces so you can catch up on anything you’ve missed, or get started without getting overwhelmed."

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee online training certification class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers.
California HMDR Exemptee online training certification class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers.

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):

Tuesday, April 23, 2019

CMS bulks up PA program - HME News

Read the full article:  CMS bulks up PA program - HME News

"CMS has added seven codes for complex rehab power mobility devices and five codes for support surfaces to the national prior authorization program, AAHomecare reports. 
Additionally, CMS has added four codes for home oxygen therapy to the “master list” of codes potentially subject to prior authorization. Those codes are E1390, E0466, E0784 and L0650."

According to:

"This document announces the addition of four Healthcare Common Procedure Coding System (HCPCS) codes to the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment."

"This update reflects the addition of four new items that meet the updated Payment Threshold that are listed in an OIG or GAO report of a national scope or a CERT DME and/or DMEPOS Service Specific Report(s)."

"HCPCS  Description
E1390 Oxygen concentrator, single delivery port, capable of delivering 85 percent or greater oxygen concentration at the prescribed flow rate.
E0466 Home ventilator, any type, used with non-invasive interface, (e.g., mask, chest shell).
E0784 External Ambulatory infusion pump, insulin.
L0650 Lumbar-sacral orthosis, sagittal-coronal control, with rigid anterior and posterior frame/panel(s), posterior extends from sacrococcygeal junction to t-9 vertebra, lateral strength provided by rigid lateral frame/panel(s), produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated, off-the-shelf."

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Home medical device retailers. California HMDR Exemptee online training certification class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch.
Home medical device retailers. California HMDR Exemptee online training certification class. Earns a course completion certificate 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):

Tuesday, April 16, 2019

Dozens Charged in Massive DME Fraud Scheme Worth More than $1 Billion - HomeCareMag.com

Read the full article:  Dozens Charged in Massive DME Fraud Scheme Worth More than $1 Billion - HomeCareMag.com

"The defendants allegedly participated in health care fraud schemes involving more than $1.2 billion in loss. The Center for Medicare Services’ Center for Program Integrity also announced today that it took administrative action against 130 DME companies that had submitted more than $1.7 billion in claims, netting more than $900 million in payments."

Learn more about the fraud scheme:

Return Home:  The Designated Representative and Exemptee Blog

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For home medical device retailers - California HMDR Exemptee - Online training certification course. Earns a completion certificate accepted by the California Department of Public Health (Food & Drug Branch).
For home medical device retailers - California HMDR Exemptee - Online training certification course. Earns a completion certificate accepted by the California Department of Public Health (Food & 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, April 15, 2019

DMEPOS State License Directory - Palmetto GBA

Updated July 20, 2019

You might also be interested in the updated NSC State Licensure Map (DMEPOS State License Directory)

- - -  the original post follows below  - - -

DMEPOS State License Directory For California HMDR Exemptee License

This directory is a great resource that helps identify licenses you need.  I've selected this particular California page in the directory. Note that there are quite a number of California Home Medical Device Retailer (HMDR) Exemptee mentions. Most notable is ...

DMEPOS State License Directory - California:

"MUST HAVE a[n] EXEMPTEE HMDR , or a Pharmacist license, if providing the following items: Legend devices (RX only label), oxygen, TENS units, CPAP, Nutritional feeding kits (w/syringes), IV pumps. (Any item that has a caution (legend) that is only for sale by or by order of a physician. It is not an item that can be purchased over the counter but must be prescribed.) The EXEMPTEE or Pharmacist must be an employee and under full control of these items during dispensing of prescription devices."

'via Blog this'

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

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):

Tuesday, April 2, 2019

Supply chain group sets out model for DSCSA governance - SecuringIndustry.com

Read the full article:  Supply chain group sets out model for DSCSA governance - SecuringIndustry.com

"A consortium of pharmaceutical supply chain partners in the US has come up with a proposed system of governance for data generated in a traceability scheme due to come into effect in 2023." 
"Now, the Pharmaceutical Distribution Security Alliance (PDSA) – a group which includes manufacturers, distributors, dispensers and third-party logistics (3PL) companies – has kicked off the development of its own suggested governance framework that it hopes could serve as a model for discussions going forward."

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California Designated Representative Training Courses (for wholesalers, or 3PLs) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (for wholesalers, or 3PLs) - 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):

Monday, March 25, 2019

Study: US oxygen fatalities far outnumber those in England - HME News

Read the full article:  Study: US oxygen fatalities far outnumber those in England - HME News

"Home oxygen fatalities in the US are nearly twenty times than in England, according to new research from BPR, a medical gas specialist. 
BPR used data from local health service organizations (clinical commissioning groups) in England to compare how many incidents and fatalities were recorded in that country between 2013 and 2017 to that same time period in the US."

Go to the BPR (a medical gas specialist) research report

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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):

Friday, March 15, 2019

SAP blockchain service helps fight counterfeit drugs - TechTarget

Read the full article:  SAP blockchain service helps fight counterfeit drugs - TechTarget

"SAP is working to combat counterfeit drugs. The company has released a blockchain offering that is aimed at authenticating drugs in the supply chain. 
The SAP blockchain application for the pharmaceutical industry is designed to ensure that any drugs returned to a wholesaler from hospitals and pharmacies are validated before they are resold, according to SAP. The blockchain was developed in the SAP Information Collaboration Hub for Life Sciences, a public cloud network involving several large pharmaceutical wholesalers and manufacturers, which SAP launched in November 2017."

It's getting competitive.  Looks like a lot of companies are trying to offer a DSCSA blockchain solution.

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers or third-party logistics providers (3PL)
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers or third-party logistics providers (3PL)

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, March 14, 2019

TraceLink proposes blockchain system for DSCSA pilot - SecuringIndustry.com

Updated May 18, 2019:


- - -  original post follows below  - - -

Read the full article:  TraceLink proposes blockchain system for DSCSA pilot - SecuringIndustry.com

"TraceLink says that its offering – called Trace Histories – is built on its digital supply network which is already widely used in the pharma supply chain. Adding blockchain means that it can now offer a system that is “designed specifically to help pharmaceutical manufacturers, wholesale distributors, pharmacies, and hospitals securely exchange information and satisfy the 2023 DSCSA requirement.”"

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers, third-party logistics providers (3PL), or reverse distributors
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers, third-party logistics providers (3PL), or reverse distributors

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, March 11, 2019

Self-Assessment Forms Answer Legal Questions (for pharmacy operations in California)

Self-Assessment Forms Answer Legal Questions - The Script (March 2019)

"In the late 1990s, the Board established requirements for community and hospital pharmacies to complete self-assessment forms. Since then, assessment forms also have been developed for wholesalers and sterile compounding pharmacies. 
The forms provide a compilation of pharmacy law that can be used to assess pharmacy operations for compliance with laws and regulations. This self-evaluation can highlight areas needing improvement and enable corrective actions. 
Self-assessment forms contains references to specific laws. If you have a pharmacy law question, there is good chance it can be answered by checking the self-assessment form."

Source:  Self-Assessment Forms Answer Legal Questions - The Script (March 2019 page 11) - California State Board of Pharmacy

Resources:  Self-Assessment Forms on the California State Board of Pharmacy website

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California Designated Representative Training Course For Wholesalers (approved by the California State Board of Pharmacy)
California Designated Representative Training Course For 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, March 8, 2019

Real World Product Serialization: Report from the Warehouse - LSPedia

Read the full article:  Real World Product Serialization: Report from the Warehouse - LSPedia

"Even though manufacturers have invested lots of time and money into DSCSA serialization compliance, the LSPediA team found that many products still won’t scan up to standards."

The article points out that serialization efforts are making slow progress, and implemented barcodes can contain errors or fail scans.

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers

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):

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."

Return Home:  The Designated Representative and Exemptee Blog

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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):

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