Sunday, December 23, 2012

FDA and States Meet On Regulation of Drug Compounders

F.D.A. and States Meet About Regulation of Drug Compounders - NYTimes.com:

"Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how the states see the federal role. Some states said they would prefer to see the F.D.A. handle large-scale compounders like the New England Compounding Center, or N.E.C.C., the Massachusetts pharmacy that was the source of the outbreak.

“The consensus in our group was that there is a role for the F.D.A. to be involved in facilities like N.E.C.C.,” said Cody Wiberg, the executive director of the Minnesota Board of Pharmacy. “If you’re talking about compounding, most states have the authority and resources to handle that. If you’re talking about nontraditional compounding,” he said, referring to large-scale enterprises like N.E.C.C., “fewer states may have the resources to do that.”"

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Tuesday, December 18, 2012

CA Board of Pharmacy - Use Of GS1 EPCIS - Pedigree

Follow the link below, to Dirk Rodgers post on the December 4th Board meeting, that touches on some important points surrounding CA pedigree law. . .

California Board of Pharmacy Clarifies Use Of GS1 EPCIS:

". . . transcribed the exchange below as it happened because I think it provides a number of important clarifications about the technologies that can successfully be used to meet the California pedigree law and I think it should be read by everyone who has an interest in that."

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Thursday, December 13, 2012

FDA on Making Medical Devices Safer at Home

Follow the link below for additional free consumer information and resources:

Consumer Updates > Making Medical Devices Safer at Home:

""(Home use) devices once were designed only to keep you alive. Now they're designed to keep you as independent as possible," according to Mary Brady, MSN, RN, a senior policy analyst at FDA's Center for Devices and Radiological Health (CDRH).

However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.

There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn't hear an alarm on his ventilator signaling that the tubing had become disconnected."

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Monday, December 10, 2012

How To Get CA CDPH HMDR Exemptee Training

You need to take the best and highly recommended California Department of Public Health (Food & Drug Branch) - Exemptee Training Certification course:
The reasons are simple:
  1. This training course is incredibly popular
  2. This is a highly regarded program, taught by a well-respected instructor
  3. This internet-based online training course can be taken at your leisure 365 x 24 x 7, anytime & anywhere you want, until you fully complete the course 
Don't overlook this high quality training offering, because it will fit your training certification needs!

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Friday, December 7, 2012

Safe Doses Act - Penalties for Pharma Cargo Thefts - Statement by HDMA Pres. John Gray

Follow this link to read John Gray's statement on the passing of the Safe Doses Act . . .

HDMA - Press Releases - 10/09/12:

"President Obama signed into law the Strengthening and Focusing Enforcement to Deter Organization Stealing and Enhance Safety Act of 2011 (SAFE DOSES Act, H.R. 4223/S. 1002). The legislation is sponsored by Congressman Sensenbrenner (R-Wis.) in the House, as well as Senators Schumer (D-N.Y.) and Kyl (R-Ariz.)"

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Monday, December 3, 2012

Public Citizen to FDA - RE: Compounding Pharmacies

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."

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

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Thursday, November 29, 2012

DEA probes Walgreens pharmacies over drug diversion in Florida

The Miami Field Division of the DEA issued 3 Walgreens pharmacies in FL with orders to show cause - notifications that are given to facilities requiring them to prove why they should be allowed to keep their licenses.

DEA probes Walgreens pharmacies over drug diversion in Florida - South Florida Sun-Sentinel.com:

"In April the DEA said it would inspect six Walgreens pharmacies and its Florida distribution center after the agency noticed a jump in purchases of the painkiller oxycodone. On September 14, the distribution center's registration was suspended. An administrative hearing is scheduled to begin on that matter on January 7, 2013.

The DEA has been ratcheting up its focus on drug wholesalers and pharmacies over the past year as attempts to battle what the Centers for Disease Control and Prevention calls a prescription drug abuse epidemic. Deaths from narcotic pain-killers now exceed those of heroin and cocaine combined.

Florida has long been considered the epicenter of prescription drug abuse and the DEA has dismantled dozens of "pill mills" - sham pain clinics whose doctors write prescriptions for thousands of pain pills to drug dealers and addicts."

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Monday, November 26, 2012

Deaths and Injuries Associated With Bed Rails

Something of interest for HME and DME providers . . .

Agency Investigates Deaths and Injuries Associated With Bed Rails - NYTimes.com:

". . . death certificates and hospital emergency room visits from 2003 through May 2012 shows that 150 mostly older adults died after they became trapped in bed rails. Over nearly the same time period, 36,000 mostly older adults — about 4,000 a year — were treated in emergency rooms with bed rail injuries. Officials at the FDA and the commission said the data probably understated the problem since bed rails are not always listed as a cause of death by nursing homes and coroners, or as a cause of injury by emergency room doctors.

Experts who have studied the deaths say they are avoidable. While the F.D.A. issued safety warnings about the devices in 1995 . . ."

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Tuesday, November 20, 2012

Entrepreneur Shares His Formula in "The Next Step-Retail HME" - Book Release

The book:
  • is a step-by-step guide to starting up and making a retail home medical equipment business successful
  • includes his original business plan for use as a guide
  • provides his most recent profit and loss statement with percentages for comparison
Home healthcare entrepreneur Michael Kuller, RPh shares his formula for retail success in "The Next Step-Retail Home Medical Equipment":
""Using the information provided in this book, anyone can open a retail home healthcare store and make it successful. For those considering a retail home medical equipment business, this book is a must-read ", says Jack Evans, Retail Home Healthcare Expert."
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Follow this link to purchase the book:
The Next Step: Retail Home Medical Equipment: Step by Step Building Your Retail Business

You might also be interested in:
California HMDR Exemptee online training certification - for HME DME retailers wholesalers
   (The CA Department of Public Health administers the Home Medical Device Retailer (HMDR) Licensing Program)

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Monday, November 19, 2012

California HMDR Exemptee Training Requirements

Q.  I'm submitting an application for a Home Medical Device Retailer (HMDR) Exemptee license, as a new applicant.  What are the things that I need to pay attention to, regarding training requirements?

A.  According to the referenced CDPH HMDR license application form:

  • New applicants must meet minimum qualifications, including proof of completing a training program (that addresses 5 topic areas).
  • In order to prove training completion, the applicant must submit a copy of the completed training certificate (or transcript).
  • Specifically, in the Minimum Qualifications - Training Programs section: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.
Be forewarned, the application states, "Unsigned or incomplete applications cannot be processed and will be returned."

Reference:
Application for Home Medical Device Retailer (HMDR) Exemptee license - New and Renewal (Form CDPH 8695 (04/16))

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FDA Law Blog: FDA and CA Board of Pharmacy Talk Pedigree - Annual HDMA Track and Trace Conf

FDA Law Blog: FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace Conference:

"The Healthcare Distribution Management Association (“HDMA”) held its annual Track and Trace Technology Seminar on November 12 – 14, 2012, designed to address drug pedigree and track and trace requirements being developed in the United States and to explore how stakeholders will play a role---and what those roles may be---going forward.  Perhaps most interesting at the conference was the seemingly unanimous support from industry for the implementation of a national pedigree program in some form.  What follows below are some of the highlights of the conference speakers. . . ."

'via Blog this'

In case you're interested:
The CA Board of Pharmacy announced that its Licensing Committee Meeting meeting will be combined with its Board meeting in which regulations for e-Pedigree will be discussed. The meeting is scheduled for December 13, 2012. For a complete list of meetings please go to: http://www.pharmacy.ca.gov/about/meetings.shtml

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TrackBack URL for the referenced article:
http://www.typepad.com/services/trackback/6a00d8341d150c53ef017ee557842d970d

Friday, November 16, 2012

Florida Compounder Tied to Tainted Eye Meds - Sight Lost

Compounder Tied to Tainted Eye Meds, Lost Sight:

"Cultures for 10 patients came up positive for Streptococcus mitis or oralis, matching the strains in seven unused syringes prepared during the same time by the compounder.

An FDA investigation of the company revealed insufficient testing and monitoring of equipment, dirty lab equipment, a failure to maintain sterilization tools, and a leaking boiler near the clean room."

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ASHP's Sterile Compounding Checklist

Updated June 2, 2016:

The link in the original post below is broken.  You might also be interested in:

ASHP - Sterile Compounding Resource Center

= = = original post below = = =

The American Society of Health-System Pharmacists (ASHP) just published this document:
     Eight Critical Steps Related to Sterile Compounding Services - Member Action Check List

In the checklist, ASHP says:
"ASHP strongly encourages you to review this list, even if your pharmacy department does not have a contract with an external compounding facility. This is important because off-site clinics or affiliated entities within your health system may have developed independent contracts that the pharmacy department was not involved in securing."

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Thursday, November 15, 2012

Pt & Disability Groups Support Bill to Begin Market Pricing System for HME in Medicare

Patient and Disability Groups Support Bill to Begin Market Pricing System for Home Medical Equipment in Medicare - PR Newswire - The Sacramento Bee:

"More than 30 patient advocacy and consumer groups endorsed a bill in Congress that would replace Medicare's current "competitive bidding" program for durable medical equipment with a better market pricing system that preserves access to homecare. Millions of Americans use medically required durable medical equipment and services at home, including oxygen therapy, wheelchairs, and hospital beds.

The bill, H.R. 6490, was introduced in the House of Representatives by a bipartisan group of lawmakers in September and has gained strong bipartisan support from several dozen members of Congress. The bill would replace the current, controversial bidding program with a more sustainable system, says the American Association for Homecare."

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Wednesday, November 14, 2012

California HMDR Law (Home Medical Device Retailer)

By the way, the FAQs are no longer available from the CDPH.

HMDR Law and FAQ:
"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety and Youth Tobacco Enforcement Section and is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program.  This section of the Sherman Law can be found by following the link below.  It is in the Adobe PDF format so you will need an Adobe reader program to open and print the document."
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California HMDR Sherman Law Abstract (PDF)
(NB: on the date of this blog post, the PDF carried an effective date of January 1, 2016)

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Tuesday, November 13, 2012

The ASHP Compounding Resource Center

ASHP (The American Society of Health-System Pharmacists) has created a webpage full of compounding information. It includes current news, reference books, publications, and resources.

Compounding Resource Center:

"Welcome to the ASHP Compounding Resource Center, the first stop for ASHP information and resources on compounding standards and practices."

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Monday, November 12, 2012

CA Board of Pharmacy - Track your license expiration date & renew on time

Track your license expiration date, so that you can renew on time. This is important, just in case you don't get the automatically generated renewal notice.

Don't get caught scrambling!  Make sure you start the renewal process no later than 4 weeks before your license expires.

CA Board of Pharmacy:
"I did not receive my renewal notice and my license is coming up for renewal. What do I do? 
Approximately six weeks before the expiration date of your license, a renewal application will be mailed to your last known address of record. Licensees are responsible for renewing their licenses even if they do not receive a renewal notice. The board does not send duplicate renewal applications.   
If you have not received the renewal notice within 4 weeks of expiration of the license, you may renew your license by submitting a Request for Renewal form. Do not submit a renewal request more than 60 days before the expiration date of the license. 
A renewal request form may be viewed and printed by clicking on the appropriate license type below: . . . "
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Thursday, November 8, 2012

Fungal Meningitis Outbreak - State Pharmacy Chief Fired

More die in fungal meningitis outbreak; state pharmacy chief fired - Vitals:

"Massachusetts officials have fired the director of the state’s pharmacy board and suspended its attorney for failing to alert them that the company at the center of an outbreak of fungal meningitis was making and distributing drugs in mass quantities even though it wasn’t licensed to do so, the Boston Globe reported Wednesday.

Federal health officials say the outbreak of fungal meningitis traced to contaminated pain injections from the pharmacy has killed 31 people. They said 424 people have been confirmed sick in 19 states, including 10 who don’t have meningitis but who have infections in the ankle, shoulder or other joints."

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Sunday, October 28, 2012

What is HMDR Exemptee Training?

What is HMDR Exemptee Training?

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) wholesalers.

Since 2002 SkillsPlus has provided up-to-date training for their clients. This website page, California Exemptee HMDR and DME Providers Certification Course,  provides information specific to the California Exemptee certification course. For those seeking two certifications, this course also meets the requirements for the Board of Pharmacy California Designated Representative.

California requires home medical device retailers to retain an on-site Exemptee to conduct their business. The Exemptee must be physically present during all hours of operation. This course is recommended by, and meets the training requirements of, the CA Department of Public Health, and covers:
  • California Code of Regulations 
  • Business and Professions Code 
  • Prescription Drug Laws 
  • Controlled Substances 
  • USP Storage Conditions 
  • Health and Safety Code 
Prospective Exemptees can meet the training requirement by taking SkillsPlus Intl Inc.'s web-based, self-study class (that includes a final exam) for training certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

To get a flavor of the web-based training, watch this snippet:


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Wednesday, October 17, 2012

Monday, October 15, 2012

What Is A Pharmacy Designated Representative?

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:
A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.
There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:
Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.
The trick then becomes finding a way to fulfill the training program requirement.

You might also be interested in:

CA Designated Representative online training certification - for drug wholesalers
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Sunday, October 14, 2012

Florida drug database intended to save lives is barely used by doctors

Florida drug database intended to save lives is barely used by doctors - Tampa Bay Times:

"The system can help medical practitioners determine whether a patient has a legitimate medical need for these highly addictive medications — or is a drug abuser seeking the next high.

But the program came with a major loophole: Nobody is required to check it.

Now, a Tampa Bay Times investigation has discovered what experts feared — the vast majority of medical practitioners have never touched the much-touted database:"

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Thursday, October 11, 2012

Price Gouging: A Black Mark On Gray-Market Distributors

Pharmacy Practice News - Price Gouging: A Black Mark On Gray-Market Distributors:

"In response to the report’s critical findings, Patricia Earl, a consultant to the National Coalition of Pharmaceutical Distributors, told hearing attendees, “I cannot emphasize enough the value that small or secondary pharmaceutical distributors bring to the health care system.” She said there were “thousands of small distributors that work with hospitals across the nation. To remain competitive they must comply with laws, follow pedigree and handling regulations to the letter and still offer an economical price point that allows for only a modest profit margin. If they do anything else, they run the risk of permanently losing a customer.”"

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Wednesday, October 10, 2012

Meningitis cases mount as ex-FDA lawyers fault agency for not stepping in

Meningitis cases mount as ex-FDA lawyers fault agency for not stepping in | The Town Talk | thetowntalk.com: "

“The FDA should have put them out of business, and the state should have put them out of business. Neither of them did their job,” said Peter Barton Hutt, who was chief counsel at the agency in the 1970s.

In the wake of the outbreak, lawmakers this week are raising questions about the regulation of the compounding firms and whether the FDA should be given more oversight authority.

However, the FDA already has the power to rein in large-scale drug compounding companies under a 1938 law, Hutt said.

“The statute is clear,” Hutt said. “First, you can’t stockpile under any circumstances, and if there is an approved drug, you can’t compound a competing drug.”"

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Friday, October 5, 2012

Rare Fungal Meningitis Outbreak Spreads To Six States including FL

Rare Fungal Meningitis Outbreak Spreads To Six States : Shots - Health Blog : NPR:

"It's a troubling story authorities think will unfold over the next month or so. An untold number of Americans who got steroid injections in their spine to relieve back pain may end up with a rare fungal meningitis. The drug was contaminated with the spores of a common leaf mold — nobody knows how.


Dr. Lucille K. Georg/CDC - [includes a photo of the] head of an Aspergillus fungal organism, a common leaf mold that most people breathe in every day without getting sick.

So far, the Centers for Disease Control and Prevention has recorded 35 cases of the fungal meningitis in six states: Tennessee, North Carolina, Florida, Virginia, Maryland and Indiana. Five patients have died."

'via Blog this'

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Medical Equipment Technology - New Opportunities for Growth

Medical Equipment Technology - New Opportunities for Growth - Accenture:

"Companies will instead need to adapt and develop new business models to meet healthcare systems changing demands. They will need to align and build up their own capabilities, evaluate models of innovation and new partnerships that can help to unlock future growth opportunities.

The aim of this point of view is to outline three future top growth opportunities for medical equipment manufacturers in the context of the healthcare megatrends driving the industry today and in the future."

'via Blog this'
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Sunday, September 30, 2012

Proposed Legislation - Market-Based Pricing in Medicare for HME

WASHINGTON, Sept. 25, 2012: New Legislation Would Establish Market-Based Pricing in Medicare for Home Medical Equipment and Services | PRNewswire | Rock Hill Herald Online:

"The American Association for Homecare endorses a bill introduced last week in the House of Representatives that would implement market-based pricing for home medical equipment and services such as oxygen therapy, wheelchairs, and other durable medical equipment and services.

A bipartisan group of 14 Representatives in the House introduced a bill, H.R. 6490, that would establish a market pricing programas a budget-neutral replacement for the current, poorly-designed Medicare bidding program for home medical equipment and services. "

'via Blog this'

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Friday, September 28, 2012

ASHP Policy Analysis - Supply Chain Tracking

Review the new ASHP (American Society of Hospital-System Pharmacists) Policy Analysis on electronic tracking of medications to improve the integrity of the supply chain:
ASHP Policy Analysis - Following Pharmaceutical ProductsThrough the Supply Chain

It covers Pedigree, e-Pedigree, and Track-and-Trace. California and Florida laws are presented. Federal legislation is discussed.

Any implementation of a track-and-trace system would likely be driven in large part by manufacturers and wholesalers who would need to develop the technological capability to track drug products, as well as the ability of that technology to interface with various members of the supply chain.

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California e-Pedigree - Proposed Requirements - continued

The California Board of Pharmacy continues to consider presentations from individuals, entities and associations on issues affecting implementation of e-pedigree requirements, readiness to meet the staggered implementation dates, and supply chain security issues.

Here are the posted documents for the recently held meeting:
CA Board of Pharmacy - Enforcement Committee Meeting - September 11, 2012 - Meeting Materials

Comments were submitted by wholesalers, manufacturers, pharmacies, and other entities.  Background reading and materials are included in the meeting materials.

The board will also soon establish a section of the board’s website to contain items related to e-pedigree. One section will be a question and answer section. Questions submitted to the board will be answered in this area.

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Saturday, September 15, 2012

Walgreen Florida Facility Barred From Shipping Oxycodone

Walgreen Florida Facility Barred From Shipping Oxycodone - Bloomberg:

"Walgreen Co. (WAG) was blocked from shipping controlled substances from a distribution center in Jupiter, Florida, after a U.S. Drug Enforcement Administration probe into the sales of painkiller oxycodone found the facility posed a threat to public safety.

The Walgreen center was served today by the DEA with an immediate suspension order that bars it from handling controlled substances including oxycodone and hydrocodone, pending administrative proceedings by the agency, according to an agency statement. The Jupiter facility, one of a dozen owned and operated by Walgreen, has been the single largest distributor of oxycodone products in Florida since 2009, the DEA said."

. . . Earlier this week, DEA Administrator Michele Leonhart ordered that the controlled substance licenses for two CVS Caremark Corp. (CVS) pharmacies in Sanford, Florida be permanently revoked.

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Thursday, September 13, 2012

U.S. revoking 2 Florida CVS stores' controlled substance licenses

U.S. revoking 2 CVS stores' controlled substance licenses - South Florida Sun-Sentinel.com:

"The U.S. Drug Enforcement Administration is revoking the controlled substance licenses of two CVS Caremark Corp drugstores in Florida as part of a government crackdown on potentially addictive painkillers, especially oxycodone, according to a court filing.

The DEA has alleged the two stores, about 30 miles south of Orlando, were inappropriately filling prescriptions for oxycodone, which can be highly addictive, and also had suspicious sales of other controlled substances."

. . .  The DEA has increased its focus on drug wholesalers and pharmacies as it tries to battle what the Centers for Disease Control and Prevention call a prescription drug abuse "epidemic.

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California pharma wholesaler and the supply of black market drugs

The full article provides due diligence information that includes names of the 17 defendants (mostly Californians).

Pharmaceuticals: California pharma wholesaler and the supply of black market drugs / Pharmaceuticals / Health, Care & Pharma / Industries / The Chief Officers' Network - your business advantage - The Chief Offficers' Network:

"In a prosecution begun yesterday, US prosecutors have charged 17 people with offences under the Bank Secrecy Act which deals with money laundering. But underneath that headline is a more troubling story: the purchase and sale into legitimate distribution channels of drugs unauthorised pharmaceuticals."

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