Showing posts with label prescription. Show all posts
Showing posts with label prescription. Show all posts

Friday, December 20, 2019

4 reasons Trump’s drug importation plan won’t work - Politico

Read the full article:  4 reasons Trump’s drug importation plan won’t work - Politico

Importers would need the cooperation of the Canadian government and the drug industry, both of which oppose it.

According to the article:
"President Donald Trump has promised that the plan his administration rolled out Wednesday to bring in cheaper prescription drugs from Canada will immediately lower medication costs. Experts say the plan won’t work — and many write it off as a political stunt. 
Under the proposal, importers would need the cooperation of the Canadian government and the drug industry, both of which oppose it. Importers would have to take many expensive and complicated steps to prove to the FDA that importation wouldn’t harm Americans, and to weave through complex regulations and the intricacies of the U.S. health delivery system."

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Board-approved California Designated Representative online training programs for wholesalers, 3PL, third-party logistics provider, reverse distributors. Earns a training affidavit.
Board-approved California Designated Representative online training programs for wholesalers, 3PL, third-party logistics provider, reverse distributors. Earns a training affidavit.

- - -

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

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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):

Friday, October 27, 2017

We just got another hint that Amazon could be getting into the prescription drug business - Business Insider


We just got another hint that Amazon could be getting into the prescription drug business.

Read the full article:   Amazon wholesale pharmacy licenses in at least 12 states - Business Insider:

"Samantha Liss at the St. Louis Post-Dispatch reports that Amazon has been approved for wholesale pharmacy licenses for at least 12 states. That's based on regulatory filings reviewed by the Post-Dispatch. "

'via Blog this'

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California Designated Representative Training Programs. Approved by the California State Board of Pharmacy.
California Designated Representative Training Programs. 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, May 18, 2017

What Amazon could do to the business of selling prescription drugs - The Washington Post

Read the full article:  What Amazon could do to the business of selling prescription drugs - The Washington Post:

"CNBC reported Tuesday that the online retail giant is considering wading into the complicated retail pharmacy market. The news organization reported that Amazon is hiring a general manager to lead a team to explore the idea but hasn’t made a final decision."

'via Blog this'

It'll be interesting to see how they tackle drug wholesale distribution  or 3PL in their supply chain.

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Training programs for California Designated Representative and Designated Representative-3PL license applicants


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

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     Florida:

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

     California (earn a training completion certificate):

Monday, November 7, 2016

Why prescription drugs costs so much - Business Insider

Read the full article with illustrations: Why prescription drugs costs so much - Business Insider:

"Don’t just blame drug companies for rising prescription prices. For all the outrage over Mylan increasing EpiPen prices by 500%, and insulin prices, which are up 300% over the past decade, drug prices are a lot more complicated than pointing the finger at a lone villain.

For a single prescription drug, there are often five companies involved, from development all the way to your medicine cabinet. Each company makes a tidy profit along the way. And as prices increase, so do those profits."

'via Blog this'

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Training for drug wholesaler Designated Representative license applicants


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

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Friday, June 3, 2016

California and the Future of the US Rx Pricing | Pharmaceutical Executive


Read the full article: California and the Future of the US Rx Pricing | Pharmaceutical Executive:

"First of all, what does the California proposition mandate?

 “The California Drug Price Relief Act” states that any prescription drug obtained by the State of California shall be purchased at the same “fixed price” that is accorded to the U.S. Veterans Administration, i.e., at about a 42% of average wholesale price. This is a really low price that is accorded to the VA as gesture of drug industry support for the armed services. It was never meant to be a market price point, but that is exactly what may happen if this California initiative passes on Nov. 8th."

'via Blog this'

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For CA Designated Representative & Designated Representative-3PL license applicants


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

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     California (earn a training completion certificate):

Saturday, March 23, 2013

Hamburg Says FDA Needs New Authorities to Regulate Pharmacy Compounding

Updated April 19, 2022

The original post didn't age well.

You can read more here:

---  the original post follows below  ---

FDA Must Have New Authorities to Regulate Pharmacy Compounding | FDA Voice:

"In the new framework, FDA believes that certain high-risk sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including . . .

And for all pharmacy compounding, FDA believes certain basic protections should be in place. These include . . ."

'via Blog this'

New Framework:
  • Require compliance with federal quality standards, appropriate for the compounding of riskier products & exposure of larger numbers of patients,
  • Require federal registration of the compounding facilities that will be subject to federal quality standards so FDA knows where they are and what drug products they are making.
  • Require those higher-risk compounding pharmacies to report to FDA serious adverse reactions to their drugs of which they become aware.
Basic Protections:
  • Grant clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law.
  • Prohibit compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. 

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Monday, December 3, 2012

Public Citizen to FDA - RE: Compounding Pharmacies

Updated June 6, 2024

Links in the original post broke.

You might also be interested in:

---  the original post follows below  ---

This is interesting reading for those of you who are following the role of the FDA in compounding pharmacy oversight.

Public Citizen to FDA: Reinspect Compounding Pharmacies Across the Country | The Legal Examiner Cleveland:

"In an 11-page letter to FDA Commissioner Margaret Hamburg, consumer watchdog group Public Citizen asked the agency to follow up on warning letters it issued to compounding pharmacies committing NECC-like violations.

Since 2003, the FDA has sent at least 18 warning letters to 16 compounding pharmacies, Public Citizen’s letter stated. In light of the 2012 fungal meningitis outbreak, the group would like the FDA to either reinspect those pharmacies or to verify that recent reinspections confirmed that those pharmacies cleaned up their act."

'via Blog this'

You might be interested in:
Public Citizen's Letter to the FDA re:  Compounding Pharmacies (PDF)

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Tuesday, June 5, 2012

New 2012 CA Rx Law - Security Prescription Forms for Controlled Substances

Updated November 20, 2025

The lawbook gets updated annually, so the page references change.

Here's the link to the current California Pharmacy lawbook:
http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf

HSC section 11162.1 is somewhere near page 743.

---  previous updates follow below  ---

Updated December 15, 2017

You might have also been looking for this, recently emailed out in a Nov 28, 2017 subscriber alert by the CA BOP.

"Background:

California Health and Safety Code section 11162.1 contains 14 elements that must appear on California Security Forms, the forms used to prescribe controlled substances in California*.  These elements were first enacted in 2003 when the triplicate prescription form was discontinued.  The law also requires that California Security Forms must be printed by CA Department of Justice licensed printers.  In 2006, the law was amended again to make several changes that took effect in January 2007.  Finally legislation enacted in 2011 required that the California Security Forms in use must be fully compliant with all requirements of the Health and Safety Code by July 1, 2012.

Here is a link to the required elements in the Health and Safety Code (go to page [718]):  http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf

In recent years, the board has continued to identify noncompliant California Security Forms in use that have been filled by California pharmacies, in violation of the Health and Safety Code requirements.  The board’s response upon identification of noncompliant forms having been used to dispense controlled drugs is to educate the licensee, and to cite and fine the pharmacy/pharmacists involved. Typically the licensing board for the prescriber is advised as well. 

Recently some pharmacies have begun to refuse to fill prescriptions written on noncompliant forms where item 11162.1(a)(10) is not fully compliant with the required elements.  One of these elements is “ Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered.”  There are also additional elements missing on some forms, including lack of a watermark on the reverse of the form.   

The board recently has received complaints from patients or prescribers whose patients have been denied medication from the pharmacy because of the noncompliant forms.

Interim Solutions
  • Prescribers and dispensers need to become familiar with the 14 required elements of the security prescription  forms.
  • Prescribers with noncompliant forms should reorder compliant forms from a DOJ-licensed security printer.
  • Prescribers with noncompliant forms should consider using e-prescribing for controlled substances."

- -  the original post follows below  - -

This was just sent out by the California State Board of Pharmacy.  It's important enough, that you should stop to read this, and make sure your policies and procedures are in compliance with the new laws.

According to the Board:

This is a reminder about a new law taking effect July 1, 2012 regarding the required elements for security forms for controlled substances:

Effective January 1, 2012, security prescription forms for controlled substances must include the preprinted address of the prescriber (Health and Safety Code section 11162.1). Security prescription forms that do not have the preprinted address of the prescriber can be dispensed by the pharmacist until July 1, 2012. Prescription forms not in compliance are invalid and cannot be accepted on or after July 1, 2012.

Additionally, licensed health care facilities or clinics exempt under Section 1206 (those having 25 or more licensed physicians or surgeons preprinted on the form) are not required to preprint the category of licensure and license number of their facility or clinic (Health and Safety Code 11162.1[c][2]).

View all changes in Pharmacy Law that took effect in 2012 by using this link: http://www.pharmacy.ca.gov/laws_regs/new_laws.pdf

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     California (earn a training completion certificate):


Saturday, March 24, 2012

Role of the pharmacist in preventing distribution of counterfeit meds - Amer Pharmacists Assoc

Counterfeit drugs
Counterfeit drugs (Photo credit: Wikipedia)
American Pharmacists Association - Article: - Role of the pharmacist in preventing distribution of counterfeit meds

"Summary: The taskforce recommends that pharmacists (1) purchase medications from known, reliable sources; (2) warn patients of the dangers of purchasing medications over the Internet; (3) confirm with distributors that products were purchased from manufacturers or other reliable sources; (4) monitor counterfeit product alerts; (5) examine products for suspicious appearance; (6) work with the pharmaceutical industry, distributors, and the Food and Drug Administration (FDA) to close gaps in the supply chain, especially for drugs in short supply; (7) use scanning technology in the pharmacy as part of a prescription verification process; (8) educate themselves, coworkers, and patients about the risks of counterfeit medications; and (9) report suspicious medications to FDA, the distributor, and the manufacturer.

Conclusion: The consequence of a patient receiving a counterfeit medication in the United States could be catastrophic, and pharmacists must play an active role in preventing such an event from occurring."

'via Blog this'

Source:
Journal of the American Pharmacists Association
Issue: Volume 52, Number 2 / March-April 2012
Pages: 195 - 199

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Sunday, March 11, 2012

E-Pedigree Agenda Item - CA Pharmacy Board Meeting 3-21-2012

Updated 4/19/2012 with the following:

The CA Board of Pharmacy just emailed this out:

"On behalf of the Board of Pharmacy, the Department of Consumer Affairs today added to its website the webcast of its March 21, 2012 Enforcement Committee/e-Pedigree Meeting.  At this meeting, presentations were made by FDA and multiple supply chain members.  . . .

To view the webcast of the March 21, 2012 meeting go to:
http://www.dca.ca.gov/publications/multimedia/pharm_20120321.wmv  "


Note:  I hope you've got patience with the wmv download.  I didn't have 2 hours worth of patience to wait for the download.

- - - - original post follows - - - -

According to this California Board of Pharmacy NOTICE OF MEETING AND AGENDA - Enforcement Committee and E‐Pedigree Public Meeting - March 21, 2012:

Here's what's listed under this agenda item, Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication:

a. Discussion about the Presence of Counterfeit Avastin in California Physician Offices
b. Presentation and Discussion of a Proposal for Federal Legislation by the Pharmaceutical Distribution Security Alliance
c. Presentation by Connie T. Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Center for Drug Evaluation and Research, US Food and Drug Administration
d. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule 1. Kimberly Fleming, Senior Manager, Product Security, EMD Serono, Inc, 2. Robert Celeste, Director, Healthcare, GS1 US 3. Other Companies, Associations and Other Entities Wishing to Address the Committee on E‐Pedigree Issues
e. General Discussion
f. Discussion and Possible Action to Develop Regulation Requirements Specifying a Unique Identification Number for Prescription Medication Pursuant to California’s E‐Pedigree Requirements
f. Discussion and Possible Action to Develop “Grandfathering” Provisions for Non‐Pedigreed Dangerous Drugs Pursuant to section 4163.2 of the Business and Professions

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

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Thursday, November 3, 2011

Florida Pharmacists Must Check Database Before Prescribing Some Painkillers

Updated November 5, 2021

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

Florida pharmacists required to check database before dispensing painkillers - News:  'via Blog this'

Florida's "drug database took a leap forward Monday by requiring pharmacists to check it to see whether a patient is illegally 'doctor shopping' for powerful painkillers."

And "pharmacists said requests for the painkillers have been dropping off since they started having to enter the prescriptions in the database beginning Sept. 1."

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Thursday, September 1, 2011

Prescription Drug Monitoring Program: Florida's Prescription Drug Monitoring Program slated to launch today - OrlandoSentinel.com

Updated July 30, 2026

You might have been looking for this:
- - -

Updated Dec 31, 2015:

You might also be interested in this Florida E-FORCSE Program post:

"Physicians that are not treating patients for chronic nonmalignant pain are not required to register as controlled substance prescribers." - "The Department has received numerous calls in recent weeks from physicians expressing concerns that some pharmacists are not filling controlled substance prescriptions if the physician is not listed as a controlled substance prescriber on the practitioner profile on Department of Health’s website. . . ."

- -  original post follows below  - -



Prescription Drug Monitoring Program: Florida's Prescription Drug Monitoring Program slated to launch today - OrlandoSentinel.com:  'via Blog this'

Hello!  Doctors in Florida bought 89 percent of all the Oxycodone sold in the country last year. There's current thinking that the illegal sale of prescription drugs, and Oxycodone in particular, boomed in Florida because of the absence of a widely used prescription drug monitoring system and lax state regulations

In a nutshell:
The roughly 4,000 pharmacies permitted in Florida will be required to participate in the new database and monitoring program. So anytime a prescription is dispensed for controlled substances, the doctor and the patient's name will be entered into Florida's database

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Tuesday, July 5, 2011

Phantom Pharmacy Scams Exploding

Updated February 7, 2026

The original link broke.

You might also be interested in this book:

PHANTOM BILLING, FAKE PRESCRIPTIONS, AND THE HIGH COST OF MEDICINE
Health Care Fraud and What to Do about It:
https://library.oapen.org/bitstream/handle/20.500.12657/62116/9780801460807.pdf

---  the original post follows below  ---

Federal officials are watching as "a new fraud is spreading through the health care system. Criminal enterprises posing as pharmacies are billing Medicare, Medicaid and private insurers for fake prescriptions and bilking health care out of millions of dollars," reports this CNN Money article, Phantom pharmacy - A growing health care fraud.

You're probably reading this because you have an interest in CA or FL. The article also says, "scammers typically target Florida and California because they have large Medicare and Medicaid populations."

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Tuesday, June 14, 2011

California - Guidance On Controlled Substance e-Prescribing

The California State Board of Pharmacy just publicized this guidance document on the e-prescribing of controlled substances that describes DEA requirements, California State Board of Pharmacy and Medical Board of California - Transmission and Receipt of Electronic Controlled Substance Prescriptions (pdf).

It provides an overview of the federal requirements, as they apply to:
  1. Prescribers
  2. Pharmacies
  3. Application Providers
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Tuesday, August 18, 2009

Alert - Drug Wholesale Conviction - Don't be next

Updated May 19, 2022

The original link broke.

You can still read about the topic here:

---  the original post follows below  ---

According to this US Attorney's Office press release, MIAMI PRESCRIPTION DRUG WHOLESALER CONVICTED:
A significant portion of the Serostim that Segredo distributed through these two companies originated from California-based AIDS patients who sold their Serostim supplies secured from the Medi-Cal Medicaid program

This drives home the point that it's essential to avoid non-standard and fraudulent distribution methods. 

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Thursday, June 11, 2009

CA Man Sentenced For Prescription Drug Diversion

Updated May 17, 2022

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

Uh-oh. Don't get caught like this. Read this Department of Justice (DOJ) news release to see what I mean, California Man Sentenced For Prescription Drug Diversion. According to the release, the Californian man was "was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork." Here's what this means to you, "The Prescription Drug Marketing Act (“PDMA”) requires wholesale distributors of prescription drugs to be licensed by the states in which they operate. Pursuant to the PDMA, the FDA enacted minimum state guidelines for state licensing of wholesale distributors of prescription drugs. The PDMA generally requires wholesale distributors of prescription drugs to provide to the recipient of the drugs a statement indicating each prior sale of the drug including the names of all parties to the transactions. This statement is generally referred to as the “Drug Pedigree.” The minimum state guidelines and the drug pedigree requirement are designed to eliminate potential risks to the public health by protecting the integrity of the drug distribution system." 


- - -

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

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