Showing posts with label declaration. Show all posts
Showing posts with label declaration. Show all posts

Friday, July 10, 2015

Is Amazon a 3PL? – DC Velocity


Read the entire article: Is Amazon a 3PL? – DC Velocity:

"As for Amazon's competitive threat to existing 3PLs, those companies would be well advised to prepare for the possibility that Amazon will make a major push into their industry. As noted earlier, Jeff Bezos has often been quoted as saying that he is not sure whether retailing will continue to be Amazon's core business. If it's not retailing, then it may well be the logistics service industry."

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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

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.

Return Home:  The Designated Representative and Exemptee Blog

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 10, 2015

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

Updated August 18, 2021

The original link broke.

You can still read about the same topic here:

---  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):
     Florida:

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

     California (earn a training completion certificate):

Monday, June 8, 2015

CA Board of Pharmacy - Self-Assessment Forms

Updated May 13, 2025:

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
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):
     Florida:

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

     California (earn a training completion certificate):

Sunday, May 17, 2015

Is Your Pharmacy Ready for Drug Supply Chain Integrity? | The National Law Review

Read the full article: Is Your Pharmacy Ready for Drug Supply Chain Integrity? | The National Law Review:

"Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers.  The requirement stems from a 2013 federal law called the Drug Supply Chain Security Act (DSCSA), enacted as one component of the Drug Quality and Security Act."

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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):

Thursday, April 23, 2015

California Board of Pharmacy Issues Licensing Guidance for 3PLs | iwla1891

Read the full article: California Board of Pharmacy Issues Licensing Guidance for 3PLs | iwla1891:

"The California Board of Pharmacy issued guidance this week outlining the process for obtaining the licensing as third-party logistics providers or non-resident third-party logistics providers in the state. This requirement extends to all 3PLs that ship pharmaceuticals to or from California.

Prior to the Drug Supply Chain Security Act (DSCSA), 3PLs were required to obtain licensing as a wholesaler—now 3PLs and wholesalers are separate entities under California law." . . .

"Please see the complete guidance and visit www.pharmacy.ca.gov to access the online application."

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California Designated Representative 3PL Training Course - Board-approved online training program for third-party logistics providers. Earns a training affidavit to include in your license application.
California Designated Representative 3PL Training Course - Board-approved online training program for third-party logistics providers. Earns a training affidavit to include in your license application.


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, April 1, 2015

InBrief: HDMA Updates DSCSA Q&A - RxTrace

Read Dirk Rodgers' full update: InBrief: HDMA Updates DSCSA Q&A - RxTrace:

"This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law.  The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review."

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Reference:
HDMA Questions and Answers on the Drug Supply Chain Security Act (March 1, 2015) - Click to download the PDF

Return Home:  The Designated Representative and Exemptee Blog

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 12, 2015

Licensure Standards for DME Suppliers by Research and Markets

Updated December 1, 2025

The original link broke.

You might also be interested in:

DMEPOS Licensure Database - search by state and product
https://dominoapps.palmettogba.com/palmetto/npewest.nsf/DID/P4LF7PNQM8

---  the original post follows below  ---

Read the full announcement: Research and Markets: Licensure Standards for Durable Medical Equipment Suppliers | Business Wire:

"Research and Markets (http://www.researchandmarkets.com/research/h8n856/licensure) has announced the addition of the "Licensure Standards for Durable Medical Equipment Suppliers" report to their offering.

This report addresses the states that have relevant licensure requirements for suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). The report includes a listing of each state's oversight agency for DMEPOS suppliers, links to online applications, references to included statutes and regulations, and licensure requirements/guidelines."

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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):

Saturday, February 21, 2015

California Licenses Required For Third-Party Logistics Providers (3PLs) | The Best Designated Representative Training & Exemptee Training

Updated July 15, 2026

Licenses For California 3PLs

Read the full post with links: New CA Licenses Required For Third-Party Logistics Providers (3PLs) | The Best Designated Representative Training & Exemptee Training:

"Companies that do not own, but receive, store and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy."

'via Blog this'

By the way:
On February 20, 2015, the California Board of Pharmacy announced that third-party logistics providers (3PLs) must obtain a third-party logistics provider license, as well as designate a responsible manager, and secure licensure of specialized employees who will serve as designated representatives-3PLs (DR-3PL). DR-3PL applicants must provide proof of DR-3PL training. SkillsPlus Intl Inc. now offers a DR-3PL training course:  California Designated Representative-3PL Certification Course - Buy Now!


California Designated Representative-3PL Training Course
Buy Now! Training program for California Designated Representative license applicants - Earn a training affidavit


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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, November 18, 2014

Expert cautions: DSCSA deadlines may cause drug shortages - in-Pharma Technologist

Updated December 13, 2025

The original link broke.

---  the original post follows below  ---

Read the full article: Expert cautions: DSCSA deadlines may cause drug shortages - in-Pharma Technologist:

"Supply chain consultant Dirk Rodgers wrote recently that wholesale distributors are having issues getting in touch with suppliers in order to meet one of the first deadlines of the DSCSA, which, after Jan. 1, 2015, requires all drugs transported through the supply chain to be accompanied by transaction information, transaction history and transaction statements.

“The real problem is that, despite many attempts by wholesale distributors to contact their suppliers to find out their ability to provide that information on that date, no response has been received from a significant percentage of those suppliers,” Rodgers says. "

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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):

Friday, April 18, 2014

California Board of Pharmacy - Fee Increases Effective July 1, 2014


Updated July 24, 2016

The Board changed the design of their website, and broke links in the original post.

Here's the Fee Schedule Webpage - CA Board of Pharmacy

- -  original post follows below  - -

If you are applying for new licenses or your renewals are coming up soon, be aware that the fees are going up on July 1, 2014.

Here are some annotated excerpts from the Fee Schedule - Adopted Text (PDF):

Title 16, California Code of Regulations - Amend Section 1749 - Fee Schedule changes go into effect July 1, 2014:

(h) The fee for the issuance or renewal of a wholesaler's license is seven hundred eighty dollars ($780) [six hundred dollars ($600)].

(j) The fee for the issuance of a license as a designated representative pursuant to Section 4053 of the Business and Professions Code shall be three hundred thirty dollars ($330) [two hundred fifty dollars ($250)]. ... The fee for the annual renewal of a license as a designated representative shall be one hundred ninety-five dollars ($195) [one hundred fifty dollars ($150)].

(k) The fee for the issuance or renewal of a license as a nonresident wholesaler is seven hundred eighty dollars ($780) [six hundred dollars ($600)].

The Board's Fee Schedule WebPage:
California Board of Pharmacy - Laws and Regulations - Regulations Approved in 2014 - Fee Schedule (webpage)

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Training intended for Designated Representative and Designated Representative-3PL license applicants


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

Wednesday, March 26, 2014

HDMA survey of specialty distribution: Sales to physicians' offices have dropped by 66% - Pharmaceutical Commerce

HDMA survey of specialty distribution: sales to physicians' offices have dropped by 66% - Pharmaceutical Commerce:

"A recap helps explain: Specialty pharmaceuticals differ from traditional pharma products in that they tend to be “high touch”—needing numerous ancillary services such as infusion, monitored dispensing, REMS, or followup care. As they tend to be expensive, the reimbursement / prior authorization / patient-support questions are also complex. Oncology products, in particular, have traditionally been purchased under a “buy and bill” model by physicians’ practices, but this is fading (as the HDMA date show) in place of sales to specialty pharmacies and health systems."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

- - -

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, March 12, 2014

Wholesaler Self-Assessment by the Designated Representative (California)

Updated February 4, 2026

Follow this link to the self-assessment forms:

Self-Assessment Forms


- - -  the original post follows below  - - -

Although wholesaler self-assessments are due in odd-numbered years, there are additional circumstances that require additional self-assessments.

CALIFORNIA CODE OF REGULATIONS - DIVISION 17, TITLE 16
1784. Self-Assessment of a Wholesaler by the Designated Representative-in-Charge
(a) The designated representative-in-charge of each wholesaler as defined under section 4160 of the Business and Professions Code shall complete a self-assessment of the wholesaler’s compliance with federal and state pharmacy law. The assessment shall be performed before July 1 of every odd-numbered year. The primary purpose of the self-assessment is to promote compliance through self-examination and education.
 (b) In addition to the self-assessment required in subdivision (a) of this section, the designated representative-in-charge shall complete a self-assessment within 30 days whenever:
(1) A new wholesaler permit is issued, or
(2) There is a change in the designated representative-in-charge. The new designated representative-in-charge of a wholesaler is responsible for compliance with this subdivision.
(3) There is a change in the licensed location of a wholesaler to a new address. ...

This text of Section 1784 has been truncated. Please refer to the Lawbook for the text in its entirety.

Authority cited:
Section 4005, Business and Professions Code. Reference: Sections 4022.5,4043, 4053, 4059, 4120, 4160, 4161, 4201, 4301 and 4305.5, Business and Professions Code.

Source:
2014 LAWBOOK FOR PHARMACY (California Board of Pharmacy) - PDF

You might also be interested in:
CA Board of Pharmacy - Applications & Forms - Wholesaler Self-Assessment (scroll down to this section)

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

Thursday, December 5, 2013

CA Designated Representative License Application - California Board of Pharmacy

California Designated Representative License Applications

Updated April 5, 2018

California Board of Pharmacy - Apply for a License: "Designated Representative (Exemptee)

Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations. The Designated Representative application forms may be obtained by download only."

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

Keywords & Phrases:
California Board of Pharmacy. California State Board of Pharmacy. Designated Representative. #license #application #CaliforniaDesignatedRepresentative #CaliforniaDesRep
#approved #accepted #recognized #certified #online #web #training #certification #affidavit #course #class #program #webinar #seminar #workshop #event #elearning #certificate #provider #vendor #seller #register #registration

Monday, November 11, 2013

Fingerprint Card Request - CA Board of Pharmacy

Updated March 1, 2026

The CA Designated Representative application process includes fingerprint requirements. The Board will only accept fingerprint cards from residents outside of California (... in contrast, the board will only accept Live Scan Service Forms from California residents. Live Scan will be accepted from residents of other states if the Live Scan service is performed in California.).

Follow the link below to request fingerprint cards from the California Board of Pharmacy . . .

Publications, Brochures and Fingerprint Card Request - Pharmacy Board:

"To request publications, brochures and fingerprint cards, please select the desired forms and complete your name and address. When the information is complete, please click on the submit button"

Return Home:  The Designated Representative and Exemptee Blog

- - -

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 14, 2013

Summer's Here! Complete Training Certification Before Vacation

It's Summer-time!

Don't let your Exemptee training or Designated Representative training hang over your head going into Summer.

Just get it done now, before:
  • the kids get out of school
  • you find yourself on vacation
Return Home:  The Designated Representative and Exemptee Blog

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Visit www.DREprof.com to learn more and buy California Exemptee Training, and California Designated Representative Training
Visit www.DREprof.com to learn more and buy California Exemptee Training, and California Designated Representative Training

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, February 28, 2012

What is a CA HMDR Exemptee license?

What Is A California HMDR Exemptee License?

Updated May 27, 2026

California HMDR Licensing Program Home Page

California HMDR Licensing Program Home Page:
"The Home Medical Device Retail Program's mission is to promote and improve the health and well-being of all California residents and to facilitate the growth and vitality of California home medical device retail product industries, while ensuring that products are not adulterated, misbranded or falsely advertised.

The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws.

For any questions, please contact us using the information on the left or email us as the following address: FDBMedDevice@cdph.ca.gov."

The California HMDR licensing program home page lists 3 helpful items:

  1. A category of several "Certificates and Licenses" forms
  2. A "Regulations and Statutes" link to an abstract of the California Sherman Food, Drug and Cosmetic Law that authorizes creation, regulation and licensing of HMDR firms and personnel, and 
  3. A "Frequently Asked Questions (FAQs)" link to a list of frequently asked questions is provided to guide the user through common occurrences during the HMDR licensing process.
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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):


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