Showing posts with label counterfeit. Show all posts
Showing posts with label counterfeit. Show all posts

Wednesday, October 21, 2015

Drug Firms Use Tor to Shop for Dark Web Fakes - Bloomberg Business


Read the full article: Big Pharma's Darknet Drug Deal - An Ex-Detective Is Tracking Down Knock-Offs To Counter A Dangerous Trade -  Drug Firms Use Tor to Shop for Dark Web Fakes - Bloomberg Business:

"For the $300 billion pharmaceutical industry, the rapid growth of such marketplaces is a serious threat to profits and reputations. For regular folks who turn to the darknet because they’re uninsured or their coverage won’t pay for expensive medications, the choice can be lethal. Counterfeit drugs bought online have been shown to include everything from gypsum and rat poison to heavy metals and household cleaners."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 


Friday, June 6, 2014

This Graphic of Counterfeit, Poison-Laced Pills Is Horrifying | TIME


How did I miss World Anti-Counterfeiting Day (June 5)?

Read the full article: This Graphic of Counterfeit, Poison-Laced Pills Is Horrifying | TIME:

"Rat poison, wall paint, antifreeze, paint thinner and a few other ingredients that have slipped into the $75 billion a year market for counterfeit pills

Today the world celebrates Anti-Counterfeiting Day, and by world, we mean a little-known coalition of regulators and lawyers celebrating their quiet battle against counterfeit drug makers."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Wednesday, March 20, 2013

FDA Says, Be Safe - Know Your Online Pharmacy

The FDA is raising awareness of the dangers of buying prescription medicines from fake online pharmacies. Their BeSafeRx campaign provides the resources to help consumers.

The following short video explains why you should care, and how to protect yourself.



You might also be interested in:


Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Friday, February 15, 2013

IOM Suggests Other Alternatives To The Word "Counterfeit" re: Drugs

FDA Law Blog: Don’t Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs:

"IOM recommended excluding the use of the term “counterfeit.”  There is disagreement in the international regulatory community as to whether “counterfeit” refers broadly to something that is “not what it claims to be,” or whether the narrower, legal definition, which focuses on trademark infringement, is applicable.  The IOM report forgoes the use of the term “counterfeit,” and instead encourages the use of the terms “substandard,” “falsified,” and “unregistered.”  “Substandard” drugs are “those that do not meet the specifications given in the accepted pharmacopeia or in the manufacturer’s dossier.” "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 




Friday, November 30, 2012

More fake drugs now using active ingredients

SecuringIndustry.com - Many more fake drugs now using real APIs, US official says:

"The US Department of Commerce reports that more and more counterfeit pharmaceuticals are using real APIs to trick patients.

Globalisation of the active pharmaceutical ingredient (API) supply chain means raw materials are more readily available in countries where counterfeit manufacturing takes place.

The trend has helped counterfeiters change the composition of their products, Security Management reports.

"Twenty years ago most counterfeit medicines did not contain any medicinal ingredients. They had ground up dry wall, sawdust, anything to make the product look real," said Jeffrey Gren, director, Office of Health and Consumer Goods at the US Department of Commerce, said."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training - for Pharma & Biotech
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 


Thursday, February 16, 2012

Roche Says Counterfeit Cancer Drug Avastin Being Investigated by FDA

Roche Says Counterfeit Cancer Drug Avastin Being Investigated by U.S. FDA - Bloomberg:


"Roche and the Food and Drug Administration are seeking to prevent the fake cancer drug, which doesn’t include the active ingredient bevacizumab, from being distributed further, the company’s Genentech unit said in an e-mail late yesterday. The FDA notified the company about the issue in December, said Edward Lang, a spokesman for Roche’s South San Francisco, California-based unit.

“We’re working with the FDA, as well as with law enforcement authorities to aid in their investigation,” Lang said today in an interview. “We’ve analyzed some of the vials, we found no therapeutic protein there. So there’s no Avastin, there’s no generic form of Avastin.”"

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

--------

Tuesday, January 31, 2012

Counterfeit Medicine - On the FDA Website

The FDA has a nice constellation of items and articles related to counterfeit medicine.

Counterfeit Medicine - US FDA Website:

"Counterfeit Medicine - Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health. 
FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation's drug supply from the threat of counterfeits."
'via Blog this'

Free information and resources about counterfeit medicine:
US FDA Website - Counterfeit Medicine

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Saturday, January 21, 2012

New FDA Guidance - Physical-Chemical Identifiers for Anticounterfeiting


This just recently published by the FDA:

FDA Guidances (Drugs); Newly Added Guidance Documents:
Chemistry, Manufacturing, and Controls (CMC): Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB - Final Guidance 10/11/11)
'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 


Thursday, January 19, 2012

US counterfeit drug seizures up 200 per cent in 2011

Updated May 11, 2022

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

SecuringPharma - US counterfeit drug seizures up 200 per cent in 2011:
"China remained the primary source of counterfeit goods across all categories, representing 62 per cent of all seizures by value, with the value of pharmaceutical seizures from China increasing by more than $4.3m and the value of perfume seizures up $7m on the prior year.

Meanwhile, India and Pakistan both featured in the top 10 source countries in 2011, mainly due to seizures of counterfeit pharmaceuticals. Pharmaceutical seizures accounted for 86 per cent of the value of seizures from India and 85 per cent from Pakistan, said the CBP.

The top 10 source countries - in descending order - were: China; Hong Kong; India; Pakistan; Taiwan; Switzerland; Malaysia; South Korea; UK; and Mexico."
'via Blog this

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Friday, July 15, 2011

Serious Gaps in US Drug Safety

Updated February 2, 2021:

Links in the original post broke.

- - -  the original post follows below  - - -

This caught my eye in the National Journal, Pew Study Finds Gaps in FDA Oversight of Imported Drugs.

In a nutshell, Pew Finds Serious Gaps in Oversight of U.S. Drug Safety points to the Pew white paper that finds that increased outsourcing of manufacturing, a complex and globalized supply chain and criminal actors create the potential for counterfeit or substandard medicines to enter the supply chain and reach patients.

Thursday, December 23, 2010

Homeland Security Cracks Down On Counterfeit Drugs

I'm glad to see that the Department of Homeland Security is stepping up efforts to combat counterfeit drugs, according to this news release, PhRMA Statement on Department of Homeland Security Efforts to Crack Down on Counterfeiting Crimes.

PhRMA states:  "The most common mechanism for counterfeit drugs to enter the U.S. drug supply is through purchases made on illegal online pharmacy sites that are operated by criminals in other countries with known counterfeiting problems. Cracking down on these illegal sites can help protect patient safety and help ensure that the closed U.S. drug supply system is not compromised."

Return Home: http://drughealth.blogspot.com/

Monday, November 15, 2010

Drugs and Supplements From China Still Largely Unregulated

Updated February 9, 2021

Links in the original post broke.

People also ask about:

- - -  original post follows below  - - -

Probably not surprising, and certainly disappointing, as reported by this KansasCity.com news article, Drugs, supplements come to U.S. from China largely unregulated.

I'm most concerned about, "One consequence of the lack of regulation has been a rising number of counterfeit drugs."

Related links:
GAO Report Blasts FDA for Failure to Implement 2008 Recommendations

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store

Wednesday, May 26, 2010

Global Drug Supply - Counterfeit Drug Debate Heats Up


One would think that it should be fairly straightforward to drive fake and counterfeit drugs out of the global drug supply chain. It turns out there are polarized viewpoints and specific interests by many involved, as reported by SecuringPharma, Counterfeit drug debate heats up at World Health Assembly.

The situation boils down to, some:
". . . countries disagree with the WHO's working definition of the term 'counterfeit', which they maintain is being confused with intellectual property rights (IPR) issues, preferring instead terms such as 'falsely labelled', 'spurious' and 'substandard'."
Return Home: http://drughealth.blogspot.com/

Saturday, May 15, 2010

IFPMA Launches 10 Principles On Counterfeit Medicines

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) hopes the The IFPMA Ten Principles on Counterfeit Medicines will highlight the full scope of the problem and demonstrate that the fight against counterfeit medicines is simply about protecting patients’ health.

In a nutshell, here are the 10 principles:
  1. Medicine counterfeiting is first and foremost a crime against patients
  2. Counterfeit medicines threaten the full spectrum of legitimate medicines.
  3. Patents have nothing to do with counterfeiting and counterfeiting has nothing to do with patents.
  4. All substandards are not counterfeits.
  5. A medicine that is authorized for marketing by one regulatory authority but not by another should not be regarded as counterfeit.
  6. Government regulatory and enforcement authorities must be fully vested with the proper power and adequately resourced to fight counterfeits.
  7. Stopping the international trade in counterfeit medicines is vital.
  8. All stakeholders across the pharmaceutical supply chain must be made aware of the health threats posed by counterfeit medicines and collaborate.
  9. Global cooperation is needed
  10. The leadership of the World Health Organization (WHO) is crucial.
More Information:
IFPMA launches Ten Principles on Counterfeit Medicines - News Release

Return Home: http://drughealth.blogspot.com/

Saturday, May 1, 2010

FDA Wants Companies To Prevent Cargo Theft

The FDA is committed to protecting consumers from the threat of stolen, counterfeit, and diverted FDA-regulated products such as prescription or over-the-counter medicines, medical devices, or infant formula.

The U.S. Food and Drug Administration sent a letter (FDA urges industry to prevent cargo thefts - UPI.com),  to companies and a wide range of other key stakeholders detailing the agency’s concern over cargo and warehouse thefts of FDA-regulated products.  In its letter, the FDA seeks to:
  1. raise awareness among industry about each firm’s responsibility to review and strengthen their security practices
  2. inform industry of the actions the FDA will take when the agency becomes aware of a large-scale theft, and outlines steps that firms should take
  3. emphasize the importance of notifying and informing members of the supply chain and the public after thefts occur.
The FDA believes every company should have a clear plan developed on how to respond to these incidents, since swift action is essential. The agency believes prevention of cargo theft is critical. To help achieve that goal, the FDA will continue to work closely with manufacturers and wholesalers to find ways to better secure the nation’s supply chain, which protects the public health.

Additional FDA Resources:
The FDA Cargo Thefts Webpage - FDA created this webpage to provide timely notice to the public about cargo thefts involving FDA-regulated products that have been stolen either from warehouses or tractor-trailers.

Return Home: http://drughealth.blogspot.com/


Saturday, January 23, 2010

FDA Says Watch Out For Fake Alli Capsules

The U.S. Food and Drug Administration (FDA) is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).  The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:
  • Outer cardboard packaging missing a “Lot” code;
  • Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
  • Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
  • Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
  • Contains larger capsules with a white powder, instead of small white pellets.
Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Related Posts:
Counterfeits In The Global Drug Supply

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Wednesday, January 20, 2010

Counterfeits In The Global Drug Supply

More bad news about fake drugs getting into the global drug supply.  This Chemical and Engineering News article is very well written, Fake Pharmaceuticals - Those fighting against counterfeit medicines face increasingly sophisticated adversaries.

Here are my takeaways:
  • "The best “guesstimate” is that 1% of drugs in the developed world are counterfeit. In developing nations, between 10 and 50% of drugs are thought to be fake."
  • "Is it possible to stop medicines counterfeiting altogether? I doubt very much whether it is. All we can do is to try our best to secure the supply chain."
Related Reading:
Making a Killing: The Deadly Implications of the Counterfeit Drug Trade

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog


- - -

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

Wednesday, November 18, 2009

More Good News - Fighting Drug Counterfeiting - PQM

Learn about the latest worldwide effort to fight substandard and counterfeit drugs, in this PharmTech Talk article, USP and USAID Launch New Program to Improve Drug Quality. In a nutshell, Alexis Pellek writes:

"The $35-million program, called Promoting the Quality of Medicines (PQM) will work to improve the safety of medicines in approximately 30 countries worldwide by working to strengthen regulatory bodies, increasing the supply of legitimate products, detecting and reducing availability of counterfeits through testing and other methods, and raising public awareness of the dangers of substandard drugs."
Previous Posts: FDA Draft Guidance on Anti-Counterfeiting FDA On Drug Counterfeiting FDA - Global Drug Supply Chain Needs Better Oversight 

Return Home: http://drughealth.blogspot.com/ 

Trackback url: http://blog.pharmtech.com/2009/11/06/usp-and-usaid-launch-new-program-to-improve-drug-quality/trackback/

Wednesday, November 11, 2009

Global Supply Chain - Counterfeiting - Sobering

This Q & A article from PharmTech is an interesting read, Preventing counterfeits from entering the supply chain. I find it sobering that a small percentage of drugs are counterfeit, yet counterfeited drugs represent a growing and substantive volume of tampered, contaminated, diluted, substituted, adulterated, and misrepresented ingredients. 



Wednesday, July 15, 2009

FDA Draft Guidance on Anti-Counterfeiting

“Drug counterfeiting is a serious public health concern,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients,” reports this FDA news release, FDA Issues Draft Guidance for Industry on Drug Anticounterfeiting - Focus on physical chemical identifiers. The U.S. Food and Drug Administration (FDA) today issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug. This draft guidance is an important step in working with manufacturers to make drug products more difficult to duplicate by counterfeiters: Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (pdf). 



From SkillsPlus International Inc.