Wednesday, March 5, 2014
Colorado State Board of Pharmacy Meeting Scheduled for 3/20/2014 --check the list of compounding pharmacies with complaints board will deal with in March- OK Pharmacy LLC, Precision, Pencol Compounding Pharmacy, and Village Ferility Pharmacy
| Colorado State Board of Pharmacy Meeting | |
| Date: | 03/20/2014 |
| Time: | 08:30 AM |
| Title: | Colorado State Board of Pharmacy Meeting |
| Location: | 1560 Broadway Ste 110D, Denver, CO 80202 |
| Regular Meeting. Agenda submission deadline is 2/24/14. | |
California Board of Pharmacy Meeting Scheduled for March 17-18, 2014 ( No Agenda Posted Yet)
| March 17-18, 2014 | Department of Consumer Affairs 1625 N. Market Blvd. 1st Floor Hearing Room Sacramento, CA 95834 |
Arkansas Board of Pharmacy Meeting Scheduled for March 18 and 19, 2014
| Title | March 2014 Board Meeting |
| Date | 03/18/2014 - 03/19/2014 |
| Time | 8:30 AM - 04:30 PM |
| Address | 322 South Main Street Suite 600 Little Rock, AR 72201 |
| Location | ASBP Board Room |
| Event Contact | John Kirtley |
| Event Phone | 5016829010 |
| Event Email | asbp@arkansas.gov |
| Description | The Arkansas State Board of Pharmacy has rescheduled the
February 11th and 12th Board meeting. The new dates for the meeting will be
March 18th and 19th. RECIPROCITY: The law exam for Reciprocity applicants will
be given on March 17th. Reciprocity applicants will then appear before the Board
beginning at 8:30 AM on March 18th. MEETING: Date and Time: Tuesday, March 18th
– 8:30 AM Duration: 1 ½- 2 hours – IT IS NOT ADVISABLE TO SCHEDULE AN OUTGOING
FLIGHT PRIOR TO 12:00 NOON. Once all applicants have met with the Board, you
will receive your license and may leave the meeting. You are not required to
attend the meeting on Wednesday. quoted from here |
New Bill Aims to Curb Prescription Drug Diversion and Abuse
Legislation aimed to improve enforcement efforts related to prescription drug diversion and abuse has been introduced to the US House of Representatives. If approved, the “Ensuring Patient Access and Effective Drug Enforcement Act of 2013” would amend the Controlled Substances Act by requiring companies registered with Drug Enforcement Administration (DEA) to ensure employees with access to controlled substances meet criminal background checks and drug testing requirements. The new bill would also require the formation of a Combating Prescription Drug Abuse Working Group consisting of 20 members, including representatives from DEA, FDA, National Drug Control Policy, patients, pharmacies, and manufacturers. The bill has been referred to the Energy and Commerce Committee and to the Judiciary Committee.quoted from here
Job Opening in Houston for Pharmacist with Sterile Compounding Experience
Houston Compounding Pharmacist Needed
- Job Location:
Houston, TX
- Category:
Pharmacy - Staff Pharmacist
0 0 0 New
HOUSTON PHARMACIST NEEDED - ONE WEEK COVERAGE - LOCAL COMPOUNDING PHARMACY
Soliant Health is seeking a Pharmacist with sterile compounding experience. We need Pharmacist who are available for one week up to three months of coverage. Start Date: ASAP The pharmacy operating hours are Monday - Friday 9a-6p (schedule subject to change). Pharmacist must have current experience working in a sterile IV compounding pharmacy setting. Qualifications: TX license active and clear, current inpatient or home infusion pharmacy experience, minimum one year experience working in a compounding setting, and strong professional references. Soliant Health is a nationwide leader in pharmacy staffing. We work with Directors and Pharmacy Managers to fill interim, per diem, and direct hire needs. Our employees enjoy weekly paychecks, direct deposit, and a strong network of contacts for future opportunities in the hospital and compounding pharmacy settings. To apply, send your resume to Larry.Thomas@soliant.com.
Soliant Health is seeking a Pharmacist with sterile compounding experience. We need Pharmacist who are available for one week up to three months of coverage. Start Date: ASAP The pharmacy operating hours are Monday - Friday 9a-6p (schedule subject to change). Pharmacist must have current experience working in a sterile IV compounding pharmacy setting. Qualifications: TX license active and clear, current inpatient or home infusion pharmacy experience, minimum one year experience working in a compounding setting, and strong professional references. Soliant Health is a nationwide leader in pharmacy staffing. We work with Directors and Pharmacy Managers to fill interim, per diem, and direct hire needs. Our employees enjoy weekly paychecks, direct deposit, and a strong network of contacts for future opportunities in the hospital and compounding pharmacy settings. To apply, send your resume to Larry.Thomas@soliant.com.
Tuesday, March 4, 2014
Track-and-Trace Not Enough to Halt Drug Counterfeiters
Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. Criminals are expanding from “lifestyle” drugs to widely used anti-cholesterol and cancer medicines, attracted by huge profits and low risks from drug counterfeiting activities, noted Marcia Crosse, director for healthcare at the Government Accountability Office, testifying at a Feb. 27, 2014 hearing before the House Energy and Commerce, Oversight and Investigations subcommittee.
A main problem is that penalties for distributing counterfeit drugs are too low to spur prosecution and to deter illegal operators, explained Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy. FDA is working with other federal agencies to identify and take action against illegal operators, with a focus on fraudulent Internet pharmacy sites that sell low-cost “Canadian” medicines. But most counterfeiters end up facing charges of “misbranding” or importing “unapproved foreign-made drugs,” which carry minor fines and minimal jail terms.
Read more »
A main problem is that penalties for distributing counterfeit drugs are too low to spur prosecution and to deter illegal operators, explained Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy. FDA is working with other federal agencies to identify and take action against illegal operators, with a focus on fraudulent Internet pharmacy sites that sell low-cost “Canadian” medicines. But most counterfeiters end up facing charges of “misbranding” or importing “unapproved foreign-made drugs,” which carry minor fines and minimal jail terms.
Read more »
President Proposes 8 Percent Increase to FDA Fiscal 2015 Budget
The White House on Tuesday proposed increasing funding for the FDA in fiscal 2015 by 8 percent above fiscal 2014, and requested that $25 million be directed towards the agency’s expanded authority to inspect compounding pharmacies.
To View This Article:
FDA Watchdog Speaks Out on Dangerous Drugs and Docs
For four decades, physician Sidney Wolfe has been holding federal regulators and the drug industry accountable for unsafe drugs and medical devices. Forbes Magazine dubbed him “The FDA’s Big Bad Wolfe.” He has battled the introduction of new medications by the pharmaceutical industry so aggressively that a Boston doctor once snapped, “Is there any drug Sid Wolfe likes?”
continue to read here
continue to read here
FDA Warns 3 Drug Compounders Over Sloppy Practices
Law360, Washington (March 04, 2014, 7:44 PM ET) -- The U.S. Food and Drug Administration on Tuesday released three warning letters it sent to drug compounding pharmacies, slamming all three for unsanitary conditions at their facilities and two for producing drugs without individual prescriptions.
Nora Apothecary and Alternative Therapies Inc., Pallimed Solutions Inc. and Wedgewood Village Pharmacy Inc. all received FDA warnings detailing the shortfalls in their sterile facility procedures, which ranged from visible sterile drug contamination to inadequate clean room facilities and monitoring programs.
In particular, Pallimed received the most the scathing FDA review,...
Nora Apothecary and Alternative Therapies Inc., Pallimed Solutions Inc. and Wedgewood Village Pharmacy Inc. all received FDA warnings detailing the shortfalls in their sterile facility procedures, which ranged from visible sterile drug contamination to inadequate clean room facilities and monitoring programs.
In particular, Pallimed received the most the scathing FDA review,...
more here
FDA budget increase not enough, advocates say
Posted: March 4, 2014 - 5:00 pm ET
The Food and Drug Administration will get a 1% funding increase from President Barack Obama's proposed fiscal 2015 budget, a level some say is not enough to cover the agency's new responsibilities and the increasingly global nature of the products it regulates. The budget requests roughly $2.6 billion for the FDA in fiscal 2015, which begins in October. Included is $25 million more to oversee controversial high-risk compounding pharmacies.
“Given that the FDA regulates about 25 cents of every dollar of the gross domestic product, it does not have enough money to fulfill its public health mission,” said Kasey Thompson, vice president of policy, planning and communications for the American Society of Health-System Pharmacists. He is also president and chairman of the Alliance for a Stronger FDA.
“Given that the FDA regulates about 25 cents of every dollar of the gross domestic product, it does not have enough money to fulfill its public health mission,” said Kasey Thompson, vice president of policy, planning and communications for the American Society of Health-System Pharmacists. He is also president and chairman of the Alliance for a Stronger FDA.
continue to read here
FDA Animal Drug Approvals March 2014 (Green Book)
Animal Drug Approvals March 2014 Update (Green Book) – http://www.fda.gov/downloads/
FDA Warning Letter Dated February 14, 2014 to Nora Apothecary Pharmacy
| February 14, 2014 | Nora Apothecary Pharmacy39 | Detroit District Office | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
FDA Warning Letter dated February 19, 2014 to Pallimed Solutions, Inc.
| February 19, 2014 | Pallimed Solutions, Inc.36 | New England District Office | CGMP/Drugs/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Not Issued |
FDA Warning Letter dated Feb. 21, 2014 to Wedgewood Village Pharmacy Inc
| February 21, 2014 | Wedgewood Village Pharmacy, Inc.34 | New Jersey District Office | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
Systech Named Sponsor at KC Event “Exploring Drug Quality and Security Act: (HR 3204) and Its Impact to Drug Manufacturers, Pharmacies, and Healthcare,” on 03/28/2014
New York, NY, March 04, 2014 --(PR.com)-- Systech teams up with The Knowledge Group for KC’s upcoming webcast entitled “Exploring Drug Quality and Security Act: (HR 3204) and its Impact to Drug Manufacturers, Pharmacies, and Healthcare.” This two-hour event will be held on Friday, March 28, 2014 at 12:00 PM - 2:00 PM ET.
For further details about this event, please visit:
http://theknowledgegroup.org/event_name/the-drug-quality-and-security-act-hr-3204-implications-for-drug-manufacturerspharmacies-and-healthcare-live-webcast/
Systech International is the global leader in brand protection technologies, with solutions that address the needs of Enterprise Serialization, Authentication, and Track and Trace, serving a wide variety of industries ranging from pharmaceutical, biotechnology and medical devices to food and beverage and healthcare.
As global supply chains become more complicated and counterfeiting threats continue to grow, Systech will continue to be at the forefront of brand protection innovation.
KC Event Synopsis
On November 2013, President Obama signed into law The Drug Quality and Security Act (HR 3204) that authorizes the Food and Drug Administration (FDA) to develop a track-and-trace system to protect the public from counterfeit, stolen, and harmful drugs. The law replaces State level ePedigree regulations.
The bill clarifies Food and Drug Administration (FDA) over-sight of drug compounding under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and creates a new section, 503B, that provides over-sight of a new class of manufacturers - large compounding entities called ‘outsourcing facilities.’ These entities will be subject to FDA registration, regulation, and reporting requirements (list of products compounded, active ingredients, and adverse effects).
This law comes in response to a meningitis outbreak attributed to tainted steroid injections that caused 64 deaths and sickened hundreds in 2012.
The electronic tracking system is designed to prevent counterfeited or stolen compounded prescription drugs from entering the U.S. Within four years, drug manufacturers will have to include serial numbers on all drug packages and, within 10 years, to add electronic codes to track medicines from factories to pharmacies. Pharmaceutical serialization, transaction verification, lot and unit-level tracing, and other requirements come into effect as early as Jan 1, 2015.
New and existing companies face some regulatory confusion and legal risks. Hence, enforcing the new act may be delayed. This gives companies the opportunity to prepare early for the impending regulations by attending this webinar.
This webinar will address some important issues regarding the new law:
• H.R. 3204 Regulatory Overview
• The Manufacturer and H.R 3204
• Wholesale Distributor and H.R 3204
• Dispenser Focus and H.R 3204
• Re-packager / 3PL and H.R 3204
Specific Issues:
• Regulatory and business implementation issues
• Key definitions for product and transaction requirements
• Serialization requirements for packages
• Product tracing (lot and unit level) of transaction history, statements, and information
• Requests for information on transaction histories
• Verification of product identity and transaction requirements
• Data retention, returns, drop shipments, grandfathering
• Network compliance timelines for supply chain participants
About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series
The Knowledge Congress is a series of live webcasts produced by The Knowledge Group, LLC, which examine trends, regulatory, and technology changes across a variety of industries. For further details, please visit: www.knowledgecongress.org.
For further details about this event, please visit:
http://theknowledgegroup.org/event_name/the-drug-quality-and-security-act-hr-3204-implications-for-drug-manufacturerspharmacies-and-healthcare-live-webcast/
Systech International is the global leader in brand protection technologies, with solutions that address the needs of Enterprise Serialization, Authentication, and Track and Trace, serving a wide variety of industries ranging from pharmaceutical, biotechnology and medical devices to food and beverage and healthcare.
As global supply chains become more complicated and counterfeiting threats continue to grow, Systech will continue to be at the forefront of brand protection innovation.
KC Event Synopsis
On November 2013, President Obama signed into law The Drug Quality and Security Act (HR 3204) that authorizes the Food and Drug Administration (FDA) to develop a track-and-trace system to protect the public from counterfeit, stolen, and harmful drugs. The law replaces State level ePedigree regulations.
The bill clarifies Food and Drug Administration (FDA) over-sight of drug compounding under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and creates a new section, 503B, that provides over-sight of a new class of manufacturers - large compounding entities called ‘outsourcing facilities.’ These entities will be subject to FDA registration, regulation, and reporting requirements (list of products compounded, active ingredients, and adverse effects).
This law comes in response to a meningitis outbreak attributed to tainted steroid injections that caused 64 deaths and sickened hundreds in 2012.
The electronic tracking system is designed to prevent counterfeited or stolen compounded prescription drugs from entering the U.S. Within four years, drug manufacturers will have to include serial numbers on all drug packages and, within 10 years, to add electronic codes to track medicines from factories to pharmacies. Pharmaceutical serialization, transaction verification, lot and unit-level tracing, and other requirements come into effect as early as Jan 1, 2015.
New and existing companies face some regulatory confusion and legal risks. Hence, enforcing the new act may be delayed. This gives companies the opportunity to prepare early for the impending regulations by attending this webinar.
This webinar will address some important issues regarding the new law:
• H.R. 3204 Regulatory Overview
• The Manufacturer and H.R 3204
• Wholesale Distributor and H.R 3204
• Dispenser Focus and H.R 3204
• Re-packager / 3PL and H.R 3204
Specific Issues:
• Regulatory and business implementation issues
• Key definitions for product and transaction requirements
• Serialization requirements for packages
• Product tracing (lot and unit level) of transaction history, statements, and information
• Requests for information on transaction histories
• Verification of product identity and transaction requirements
• Data retention, returns, drop shipments, grandfathering
• Network compliance timelines for supply chain participants
About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series
The Knowledge Congress is a series of live webcasts produced by The Knowledge Group, LLC, which examine trends, regulatory, and technology changes across a variety of industries. For further details, please visit: www.knowledgecongress.org.
| Contact Information |
| The Knowledge Congress Thomas LaPointe, Jr., Executive Director 1.800.578.4370 Contact www.knowledgecongress.org Therese Lumbao, Director Account Management & Member Services tlumbao@knowledgecongress.org |
Health Tips For Every one: Benefits Of Compounding Pharmacy Ocala
Health Tips For Every one: Benefits Of Compounding Pharmacy Ocala: By Leticia Jensen Sicknesses come upon each individual at one focus or an alternate in all their years in the universe. Frequently they vi...
Monday, March 3, 2014
Recent editorials published in Iowa newspapers
The Des Moines Register. Feb. 26, 2014.
Pharmacy Board forgets it's to serve the public
Iowa has dozens of state boards responsible for licensing everyone from cosmetologists and doctors to hearing aid technicians and athletic trainers. The primary mission of these boards is supposed to be protecting the public health and safety.
That means they are supposed to ensure licensed workers meet the state's educational requirements and abide by the regulations the state establishes for these occupations. The boards are supposed to issue cease-and-desist orders to those not abiding by the rules and respond to complaints from consumers.
Though these complaints are not public when they are initially filed, if the board investigates and decides to file a "statement of charges" against the license holder, those charges become a public document. The board's subsequent decision in the case — whether that is dismissal of charges, the imposition of sanctions or the revocation of the person's state license — are also public documents.
Most of the time, this information is posted on board websites and sometimes sent out by boards in news releases. Iowans who want to know whether their barbers or doctors have been sanctioned can easily check online. Just scroll through recent board actions or type in a name and see what the search yields.
But every once in a while, an Iowa licensing board forgets that it exists to protect the public and focuses, instead, on protecting the reputations of people and entities it is supposed to regulate.
That is exactly what the Iowa Board of Pharmacy did last November.
This board, which oversees thousands of pharmacists, pharmacies, drug wholesalers and controlled-substance handlers, removed a link on its website that connected the public with the board's past statements of charges and disciplinary action.
One day all the information was available online. The next day, it wasn't there.
Instead of being able to easily access information on discipline against pharmacists or pharmacies, Iowans were met with this message: "Please contact Lloyd Jessen for a list of licensees and registrants who have been disciplined by the Board."
Jessen is the pharmacy board's executive director, and his email was provided with the message on the website.
Pharmacy Board forgets it's to serve the public
Iowa has dozens of state boards responsible for licensing everyone from cosmetologists and doctors to hearing aid technicians and athletic trainers. The primary mission of these boards is supposed to be protecting the public health and safety.
That means they are supposed to ensure licensed workers meet the state's educational requirements and abide by the regulations the state establishes for these occupations. The boards are supposed to issue cease-and-desist orders to those not abiding by the rules and respond to complaints from consumers.
Though these complaints are not public when they are initially filed, if the board investigates and decides to file a "statement of charges" against the license holder, those charges become a public document. The board's subsequent decision in the case — whether that is dismissal of charges, the imposition of sanctions or the revocation of the person's state license — are also public documents.
Most of the time, this information is posted on board websites and sometimes sent out by boards in news releases. Iowans who want to know whether their barbers or doctors have been sanctioned can easily check online. Just scroll through recent board actions or type in a name and see what the search yields.
But every once in a while, an Iowa licensing board forgets that it exists to protect the public and focuses, instead, on protecting the reputations of people and entities it is supposed to regulate.
That is exactly what the Iowa Board of Pharmacy did last November.
This board, which oversees thousands of pharmacists, pharmacies, drug wholesalers and controlled-substance handlers, removed a link on its website that connected the public with the board's past statements of charges and disciplinary action.
One day all the information was available online. The next day, it wasn't there.
Instead of being able to easily access information on discipline against pharmacists or pharmacies, Iowans were met with this message: "Please contact Lloyd Jessen for a list of licensees and registrants who have been disciplined by the Board."
Jessen is the pharmacy board's executive director, and his email was provided with the message on the website.
BREAKING NEWS! Jury acquits Iowa pharmacist of fraud charges
DES MOINES, Iowa — Jurors acquitted an Iowa pharmacist of health care fraud Monday, rejecting allegations that he fraudulently billed Iowa's largest health insurance company for life-saving drugs sent to hemophilia patients.
The federal jury in Des Moines returned the verdict after a weeklong trial in the case of Michael Stein, the owner of Pharmacy Matters in Iowa City. It was a defeat for the U.S. Attorney's office and Des Moines-based Wellmark Blue Cross and Blue Shield.
"We have looked forward for months to the opportunity to tell our side of this case to a jury," Stein said in a statement. "My family and I are very happy that once we did that, justice prevailed."
Prosecutors had argued Stein billed Wellmark for expensive drugs to treat hemophilia, an inherited disorder that causes internal bleeding, when his pharmacy actually did little or no work in dispensing those drugs. They argued his pharmacy acted as a "pass-through entity" for Florida drug companies who were seeking access to customers covered through the nationwide Blue Cross and Blue Shield network. Stein was a provider for Wellmark, and therefore part of the nationwide network.
Drugs from the Florida companies briefly passed through Stein's pharmacy before going to Blue Cross and Blue Shield customers across the nation, prosecutors said, and then Stein would file claims for reimbursement with Wellmark. In a few cases, he billed for drugs that never passed through his pharmacy because they were sent directly to patients who needed them urgently to save their lives.
Stein's attorneys argued that all of the patients who received hemophilia medication through Stein's pharmacy were entitled to have it covered through a Blue Cross Blue Shield-affiliated insurer. They also said prosecutors failed to prove Stein made any false statements or intended to defraud Wellmark.
Attorney Mark Weinhardt, who represented Stein, told the jury Friday that the case was a tragic and unjust prosecution that was driven by Wellmark.
"This is a contract dispute between a pharmacy and an insurance company that never should have gotten personal and never should have seen the inside of a criminal courtroom," he said in a statement Monday.
A spokesman for U.S. Attorney Nick Klinefeldt declined comment on the acquittal.
The case has been unusual from the beginning. Stein's pharmacy sued Wellmark in 2009 after the insurer refused to pay millions of dollars in reimbursements for so-called factor drugs that had been dispensed to hemophilia patients. Wellmark said those claims were not allowed under its contract.
There was also a lengthy civil trial in 2012. But just as an Iowa judge was preparing to rule last year, Stein was indicted criminally over the same claims that were at issue in the civil case. Experts disagreed on whether Stein was providing services for which he could bill Wellmark on behalf of covered patients. quoted from here
The federal jury in Des Moines returned the verdict after a weeklong trial in the case of Michael Stein, the owner of Pharmacy Matters in Iowa City. It was a defeat for the U.S. Attorney's office and Des Moines-based Wellmark Blue Cross and Blue Shield.
"We have looked forward for months to the opportunity to tell our side of this case to a jury," Stein said in a statement. "My family and I are very happy that once we did that, justice prevailed."
Prosecutors had argued Stein billed Wellmark for expensive drugs to treat hemophilia, an inherited disorder that causes internal bleeding, when his pharmacy actually did little or no work in dispensing those drugs. They argued his pharmacy acted as a "pass-through entity" for Florida drug companies who were seeking access to customers covered through the nationwide Blue Cross and Blue Shield network. Stein was a provider for Wellmark, and therefore part of the nationwide network.
Drugs from the Florida companies briefly passed through Stein's pharmacy before going to Blue Cross and Blue Shield customers across the nation, prosecutors said, and then Stein would file claims for reimbursement with Wellmark. In a few cases, he billed for drugs that never passed through his pharmacy because they were sent directly to patients who needed them urgently to save their lives.
Stein's attorneys argued that all of the patients who received hemophilia medication through Stein's pharmacy were entitled to have it covered through a Blue Cross Blue Shield-affiliated insurer. They also said prosecutors failed to prove Stein made any false statements or intended to defraud Wellmark.
Attorney Mark Weinhardt, who represented Stein, told the jury Friday that the case was a tragic and unjust prosecution that was driven by Wellmark.
"This is a contract dispute between a pharmacy and an insurance company that never should have gotten personal and never should have seen the inside of a criminal courtroom," he said in a statement Monday.
A spokesman for U.S. Attorney Nick Klinefeldt declined comment on the acquittal.
The case has been unusual from the beginning. Stein's pharmacy sued Wellmark in 2009 after the insurer refused to pay millions of dollars in reimbursements for so-called factor drugs that had been dispensed to hemophilia patients. Wellmark said those claims were not allowed under its contract.
There was also a lengthy civil trial in 2012. But just as an Iowa judge was preparing to rule last year, Stein was indicted criminally over the same claims that were at issue in the civil case. Experts disagreed on whether Stein was providing services for which he could bill Wellmark on behalf of covered patients. quoted from here
Zynex Non-Sterile Compound Pharmacy Attains Licensing in 19 States
(Marketwired) -- 03/03/14 -- Zynex, Inc. (OTCQB: ZYXI), a medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, neurological diagnostics, and compound pharmacy, announced today that its subsidiary Zynex Medical, recently received its 19th state license for its non-sterile compound pharmacy.
Zynex Medical's compound pharmacy sells non-sterile topical and transdermal pain creams through its existing sales force. The market for pain cream has many similarities to the electrotherapy business, requiring a doctor's prescription and providing a recurring revenue stream. Zynex believes the market for topical and transdermal pain cream represents a $2 billion opportunity in the United States and the Company intends to be licensed in all 50 states by mid to late 2014.
Thomas Sandgaard, Zynex President and CEO, commented, "Compounded, non-sterile topical and transdermal pain creams complement our existing electrotherapy products and further diversify our offerings, allowing us to be a full service, non-invasive pain management company. We introduced topical and transdermal pain creams to our existing Zynex Medical electrotherapy sales force late last year, targeting in particular pain management doctors and physical therapists in the rehabilitation segment, where we already have a strong market presence. We believe this is a great opportunity for revenue growth beyond our traditional electrotherapy products."
About ZynexZynex, founded in 1996, operates under five primary business segments: Zynex Medical, NeuroDiagnostics, Monitoring Solutions, International, and Billing and Consulting. Zynex Medical engineers, manufactures, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation. Zynex Medical's product lines are fully developed, FDA-cleared and commercially sold world-wide. Zynex Medical also operates a non-sterile compound pharmacy providing topical and transdermal pain creams. Zynex NeuroDiagnostics sells the company's proprietary NeuroMove device designed to help recovery of stroke and spinal cord injury patients, and is expanding into markets for EMG, EEG, sleep pattern, auditory and nerve conductivity neurological devices through product development and acquisitions. Zynex Monitoring Solutions, currently in the development stage, was established to develop and market medical devices for non-invasive cardiac monitoring. Zynex International is dedicated to supporting sales and marketing of Zynex products worldwide through a network of medical distributors. Zynex Billing and Consulting division provides medical billing and consulting service for offices and hospitals.
For additional information, please visit: www.ir-site.com/zynex.
Safe Harbor StatementCertain statements in this release are "forward-looking" and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the ability to obtain state pharmacy licenses, the need to obtain additional capital in order to grow our business, our ability to engage additional sales representatives, the success of such additional sales representatives, the need to obtain FDA clearance and CE marking of new products, the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement from insurance companies for products sold or rented to our customers, acceptance of our products by health insurance providers, our dependence on third party manufacturers to produce our goods on time and to our specifications, implementation of our sales strategy including a strong direct sales force, the uncertain outcome of pending material litigation and other risks described in our filings with the Securities and Exchange Commission including the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2012.
Zynex Medical's compound pharmacy sells non-sterile topical and transdermal pain creams through its existing sales force. The market for pain cream has many similarities to the electrotherapy business, requiring a doctor's prescription and providing a recurring revenue stream. Zynex believes the market for topical and transdermal pain cream represents a $2 billion opportunity in the United States and the Company intends to be licensed in all 50 states by mid to late 2014.
Thomas Sandgaard, Zynex President and CEO, commented, "Compounded, non-sterile topical and transdermal pain creams complement our existing electrotherapy products and further diversify our offerings, allowing us to be a full service, non-invasive pain management company. We introduced topical and transdermal pain creams to our existing Zynex Medical electrotherapy sales force late last year, targeting in particular pain management doctors and physical therapists in the rehabilitation segment, where we already have a strong market presence. We believe this is a great opportunity for revenue growth beyond our traditional electrotherapy products."
About ZynexZynex, founded in 1996, operates under five primary business segments: Zynex Medical, NeuroDiagnostics, Monitoring Solutions, International, and Billing and Consulting. Zynex Medical engineers, manufactures, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation. Zynex Medical's product lines are fully developed, FDA-cleared and commercially sold world-wide. Zynex Medical also operates a non-sterile compound pharmacy providing topical and transdermal pain creams. Zynex NeuroDiagnostics sells the company's proprietary NeuroMove device designed to help recovery of stroke and spinal cord injury patients, and is expanding into markets for EMG, EEG, sleep pattern, auditory and nerve conductivity neurological devices through product development and acquisitions. Zynex Monitoring Solutions, currently in the development stage, was established to develop and market medical devices for non-invasive cardiac monitoring. Zynex International is dedicated to supporting sales and marketing of Zynex products worldwide through a network of medical distributors. Zynex Billing and Consulting division provides medical billing and consulting service for offices and hospitals.
For additional information, please visit: www.ir-site.com/zynex.
Safe Harbor StatementCertain statements in this release are "forward-looking" and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the ability to obtain state pharmacy licenses, the need to obtain additional capital in order to grow our business, our ability to engage additional sales representatives, the success of such additional sales representatives, the need to obtain FDA clearance and CE marking of new products, the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement from insurance companies for products sold or rented to our customers, acceptance of our products by health insurance providers, our dependence on third party manufacturers to produce our goods on time and to our specifications, implementation of our sales strategy including a strong direct sales force, the uncertain outcome of pending material litigation and other risks described in our filings with the Securities and Exchange Commission including the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2012.
Investor Relations Contact:
303-703-4906
303-703-4906
I have posted this paper several times before but it is really one of the must reads on Drug Compounding for Veterinary Patients--
Submitted: September 23, 2004; Accepted: September 27, 2004; Published: September 22, 2005.
Mark G.Papich
11
Diplomate American College of Veterinary Clinical Pharmacology, North Carolina State University, College of Veterinary Medicine, Raleigh, NC 27606
read here
Sunday, March 2, 2014
Drug Compounding by Dr Colleen Currigan (benefits for animals)
Drug compounding is not new, but there have been some recent high profile events, both in the human and the veterinary world, that have brought the issue back into prominence. These include the 2009 deaths of 21 polo ponies at the U.S. Open Polo Championship in Florida after an error was made when mixing a compounded medication for the ponies, and most recently the 2012 outbreak of human fungal meningitis, when contaminated medication was dispensed to physicians around the country from New England Compounding Center. These events may lead to legislative changes that affect the compounding of medications in veterinary medicine and those changes could impact the prescribing of medications for cats.
What exactly is ‘compounding’? My recent involvement on the American Veterinary Medical Association’s (AVMA) Clinical Practitioners Advisory Committee has taught me a lot about the ins and outs of compounding. The AVMA is working hard to educate veterinarians and pet owners about compounding by posting information on their website, www.avma.org, as well as holding educational webinars for veterinarians. Much of the information that I am including in this blog article came from the AVMA. Below are some compounding facts:
What exactly is ‘compounding’? My recent involvement on the American Veterinary Medical Association’s (AVMA) Clinical Practitioners Advisory Committee has taught me a lot about the ins and outs of compounding. The AVMA is working hard to educate veterinarians and pet owners about compounding by posting information on their website, www.avma.org, as well as holding educational webinars for veterinarians. Much of the information that I am including in this blog article came from the AVMA. Below are some compounding facts:
- Compounding is the manipulation of a drug beyond that stipulated on the label. Examples include mixing, diluting, concentrating, flavoring, or changing a drug’s dosage form, in order to tailor the drug for a specific patient. In the cat world, compounded medications are widely used. Why?
- Many of the drugs that we prescribe are not available in a strength that is appropriate for a cat. Thus manipulation of that drug is the only way we can dose it correctly for a feline patient
- Knowing that cats can challenge the best of us when it comes to being medicated, unless we can somehow manipulate a drug to make it more acceptable to the cat (‘if it’s tuna flavored, I’ll consider it’), we run the risk that some of our patients simply will not get needed medication.
- In other cases, a patient may resist oral medications altogether, no matter how the medication is manipulated. In these cases, there are some medications that can be made up into a gel that can be applied topically on the inside of the cat’s ear (known as a ‘transdermal’ or ‘across the skin’ application of drug). A very limited number of drugs have been studied and shown to work when given by this route, but one that is used commonly to treat overactive thyroid conditions in cats (methimazole) usually works quite well when given by the transdermal route.
- Compounding is regulated by both the federal government (FDA, or Food and Drug Administration) and state governments.
- Compounded drugs are not the same as generic drugs! A generic drug is a non-brand-name version of a drug. Generic drugs are approved by the FDA.
- Compounded drugs are not FDA approved drugs. Even though compounding involves manipulating or tweaking already approved FDA drugs, when a drug is compounded, the new form may or may not perform in the same way as the approved drugs.
- continue to read here
Body-builders, slimmers misusing veterinary horse drug Clenbuterol, health experts warn
Health experts are warning that a veterinary drug misused by some elite athletes is increasingly being abused by the general public.
The latest issue of the Medical Journal of Australia reveals there have been 63 cases of people overdosing on Clenbuterol in the past decade among the general public.The number of cases increased from three in 2008 to 27 in 2012, according to the journal.
The prescription-only drug is legally used to help with breathing problems in horses.
Because of its anabolic properties, it has also been abused by some elite athletes in the past to boost their performance, leading to an official ban by the World Anti-Doping Agency and the International Olympic Committee.
Cyclist Alberto Contador and sprinter Katrin Krabbe were both banned for abusing Clenbuterol.
The medical journal says the drug's use has now spread to body-builders and slimmers.
Dr Jonathon Brett from Sydney's Royal Prince Alfred Hospital says the drug is often taken in high doses, and more than 80 per cent of people who abused the drug ended up in hospital.
He has called for its sale to be restricted.
Patients presenting with an overdoses have symptoms such as nausea, diarrhoea, vomiting, chest pains and other cardiac issues.
The medical journal says there has been one case of cardiac arrest.
quoted from here
Do horse racing officials in the U.S. need to do more to prevent doping?
take or check out results of survey and the comments being posted here
1099 Sales Rep Positions for Compounding Pharmacy--Openings in TX, FL, AL, and SC
Job description
Company Description:
Job Description:
We represent a rapidly growing Compounding Pharmacy.
We are looking for reps to market compounded medications to physicians.
We offer the best/highest commissions in the industry. Full-time and Part-time reps are needed.
This is a 1099 commission only position.
Bring your business to us.
We are presently looking for reps in TX, FL, AL and SC.
We are licensed in many states and are rapidly growing.
We work with every major insurance company. Additionally, we also accept Tricare and Medicare.
We are looking for reps with existing compound business or experience selling in the pharmaceutical/medical field. Specialties include, but are not limited to:
Dermatology
Podiatry
Pain Management
Physiatry
Rheumatology
Obgyn
Primary Care
Internal Medicine
Orthopedic Surgery
Neurosurgery
Wound Care
General Surgery
Neurology
Pulmonology
Please call or email for more information.
561.450.9414
physiciansfirstenterprises@gmail.com
Job Description:
We represent a rapidly growing Compounding Pharmacy.
We are looking for reps to market compounded medications to physicians.
We offer the best/highest commissions in the industry. Full-time and Part-time reps are needed.
This is a 1099 commission only position.
Bring your business to us.
We are presently looking for reps in TX, FL, AL and SC.
We are licensed in many states and are rapidly growing.
We work with every major insurance company. Additionally, we also accept Tricare and Medicare.
We are looking for reps with existing compound business or experience selling in the pharmaceutical/medical field. Specialties include, but are not limited to:
Dermatology
Podiatry
Pain Management
Physiatry
Rheumatology
Obgyn
Primary Care
Internal Medicine
Orthopedic Surgery
Neurosurgery
Wound Care
General Surgery
Neurology
Pulmonology
Please call or email for more information.
561.450.9414
physiciansfirstenterprises@gmail.com
Saturday, March 1, 2014
Press Release From United States Attorney's Office in Puerto Rico Regarding Federal Charges Relating to Compounded Medications
February 27, 2014
SAN JUAN, P.R. – Yesterday, February 26, a Federal grand jury returned a fourteen count-indictment against four individuals for health care fraud and causing the misbranding and adulteration of prescription medications with intent to mislead and defraud, announced Rosa Emilia RodrÃguez-Vélez, United States Attorney for the District of Puerto Rico. The defendants are facing a forfeiture allegation of $225,929.21.
According to the indictment, from on or about January 1, 2010 through on or about September 24, 2011, Family Pharmacy submitted at least 554 false and fraudulent claims to Medicare, through MCS, totaling approximately $309,456.81, seeking reimbursement for adulterated/misbranded Levalbuterol and Budesonide, causing Medicare, through MCS, to disburse approximately $225,929.21.
Defendant Francisco A. Rivera-González was the President and owner of Family Pharmacy, located in the Municipality of Añasco, PR. As part of the business activities of Family Pharmacy he submitted claims to Medicare, through MCS Classicare. Rivera-González caused the adulteration/misbranding of Levalbuterol and Budesonide provided to Medicare beneficiaries and subsequently billed to Medicare. Luis Roberto Jiménez-Feliciano was the owner and president of RJ Medcare, Inc. He facilitated and caused the adulteration/misbranding of Levalbuterol and Budesonide provided to Medicare beneficiaries.
Defendant Francisco J. Cintrón-Acevedo was a licensed pharmacist and owner of Farmacia Cintrón, located in the municipality of Utuado, PR., and the Resident Agent in Charge of Franseb Inc. Cintrón-Acevedo facilitated and caused the adulteration/misbranding of Levalbuterol and Budesonide provided to the Medicare beneficiaries which were subsequently billed to Medicare. Defendant Derilyn Serrano-Bernacet was a pharmacy technician at Farmacia Cintrón. She illegally compounded Levalbuterol and Budesonide provided to Medicare beneficiaries, which were subsequently billed to Medicare.
“As part of the nation’s health care system, Medicare serves vulnerable citizens, specifically our elderly,” said United States Attorney, Rosa Emilia RodrÃguez-Vélez. “Today’s arrests show that we will not tolerate criminals who engage in fraudulent schemes which threaten and harm people’s lives and deplete the Medicare program of funds which are destined for our senior citizens, in order to enrich themselves.”
“The Food and Drug Administration, Office of Criminal Investigations will continue to vigorously protect the health and safety of consumers from misbranded or adulterated drugs,” said Ralph Culkin, Resident Agent in Charge of FDA, Office of Criminal Investigations in Puerto Rico.
“HHS-OIG will continue to support these types of investigations, especially when misbranded and adulterated drugs pose a threat to the public and are billed to the Medicare program”, said Thomas O'Donnell, Special Agent in Charge of the Office of Inspector General's New York Regional Office which also covers Puerto Rico.
The investigation was led by the Food and Drug Administration-Office of Criminal Investigations, with the collaboration of the Department of Health and Human Services, Office of the Inspector General (HHS-OIG).
The case is being prosecuted by Special Assistant U.S. Attorney Wallace A. Bustelo. If found guilty, the defendants could face a possible sentence of (10) years in prison for the Health Care Fraud offense and fines of up to $250,000. A criminal indictment contains only charges and is not evidence of guilt. Defendants are presumed to be innocent unless and until proven guilty.
According to the indictment, from on or about January 1, 2010 through on or about September 24, 2011, Family Pharmacy submitted at least 554 false and fraudulent claims to Medicare, through MCS, totaling approximately $309,456.81, seeking reimbursement for adulterated/misbranded Levalbuterol and Budesonide, causing Medicare, through MCS, to disburse approximately $225,929.21.
Defendant Francisco A. Rivera-González was the President and owner of Family Pharmacy, located in the Municipality of Añasco, PR. As part of the business activities of Family Pharmacy he submitted claims to Medicare, through MCS Classicare. Rivera-González caused the adulteration/misbranding of Levalbuterol and Budesonide provided to Medicare beneficiaries and subsequently billed to Medicare. Luis Roberto Jiménez-Feliciano was the owner and president of RJ Medcare, Inc. He facilitated and caused the adulteration/misbranding of Levalbuterol and Budesonide provided to Medicare beneficiaries.
Defendant Francisco J. Cintrón-Acevedo was a licensed pharmacist and owner of Farmacia Cintrón, located in the municipality of Utuado, PR., and the Resident Agent in Charge of Franseb Inc. Cintrón-Acevedo facilitated and caused the adulteration/misbranding of Levalbuterol and Budesonide provided to the Medicare beneficiaries which were subsequently billed to Medicare. Defendant Derilyn Serrano-Bernacet was a pharmacy technician at Farmacia Cintrón. She illegally compounded Levalbuterol and Budesonide provided to Medicare beneficiaries, which were subsequently billed to Medicare.
“As part of the nation’s health care system, Medicare serves vulnerable citizens, specifically our elderly,” said United States Attorney, Rosa Emilia RodrÃguez-Vélez. “Today’s arrests show that we will not tolerate criminals who engage in fraudulent schemes which threaten and harm people’s lives and deplete the Medicare program of funds which are destined for our senior citizens, in order to enrich themselves.”
“The Food and Drug Administration, Office of Criminal Investigations will continue to vigorously protect the health and safety of consumers from misbranded or adulterated drugs,” said Ralph Culkin, Resident Agent in Charge of FDA, Office of Criminal Investigations in Puerto Rico.
“HHS-OIG will continue to support these types of investigations, especially when misbranded and adulterated drugs pose a threat to the public and are billed to the Medicare program”, said Thomas O'Donnell, Special Agent in Charge of the Office of Inspector General's New York Regional Office which also covers Puerto Rico.
The investigation was led by the Food and Drug Administration-Office of Criminal Investigations, with the collaboration of the Department of Health and Human Services, Office of the Inspector General (HHS-OIG).
The case is being prosecuted by Special Assistant U.S. Attorney Wallace A. Bustelo. If found guilty, the defendants could face a possible sentence of (10) years in prison for the Health Care Fraud offense and fines of up to $250,000. A criminal indictment contains only charges and is not evidence of guilt. Defendants are presumed to be innocent unless and until proven guilty.
A tale of two countries: The path to pharmacist prescribing in the United Kingdom and Canada
United Kingdom and Canada point the way
U.S. pharmacy practice may be caught in the middle of a perfect storm. A shortage of primary care physicians, which stands to be exacerbated by droves of newly insured Americans this year, raises the question of whether other health care providers could pick up some of the slack. The Affordable Care Act (ACA) calls for the creation of accountable care organizations, which have the potential to engage pharmacists as full members of the health care team and allow them, and all other members of the team, to perform at the top of their skill sets and licenses. The HITECH Act is driving up use of electronic health records, which better situates pharmacists to collaborate with other members of the health care team.
Pharmacy practice is at a tipping point that could be the culmination of the profession’s efforts to gain provider status, prescribing authority, and overall expanded scope of practice, according to Rita Shane, PharmD, FASHP, FCSHP, Director of Pharmacy Services at Cedars–Sinai Medical Center in Los Angeles and Assistant Dean of Clinical Pharmacy Services at the University of California, San Francisco (UCSF) School of Pharmacy.
Drug Compounding, Drug Safety, and the First Amendment
Drug Compounding, Drug Safety, and the First Amendment
Rebecca Dresser
Washington University in Saint Louis - School of Law
2013
Hastings Center Report, 43:9-10, 2013
Washington University in St. Louis Legal Studies Research Paper No. 14-02-07
Abstract:
In September 2012, news broke of a developing drug disaster in the United States. Health authorities tracking a fungal meningitis outbreak linked the disease to a contaminated steroid injectable drug made by a company called the New England Compounding Center. The contaminated steroid was a compounded drug that had not been approved by the Food and Drug Administration. By the time health officials pinpointed the source of the outbreak, an estimated 14,000 people had been injected with the contaminated drug. By December 2012, thirty-nine had died of meningitis and hundreds more had been diagnosed with the disease and other drug-related conditions. Many factors contributed to this drug disaster. One was a decision by the United States Supreme Court. In a 2002 decision, the Court ruled that a 1997 federal law regulating drug compounding was unconstitutional. Because the law prohibited providers of compounded drugs from promoting their products through advertising and other means, the Court held that it impermissibly restricted commercial speech.
Accepted Paper Series
Date posted: March 1, 2014
Suggested Citation
Contact Information
Rebecca Dresser (Contact Author)
Washington University in Saint Louis - School of Law ( email )
Campus Box 1120
St. Louis, MO 63130 United States |
MUST READ!!! Federal Charges in Purerto Rico Involve Illegally Compounded Asthma Medications
3 February 28-March 2, 2014 - The San Juan Daily Star
www.sanjuanweeklypr.com/pdf/Feb-28-14/local.pdf
15 hours ago - that were illegally compounded and misbranded in various drug stores in three towns on the island. Authorities said the drug stores did not have the facilities to ...Owners of Two Pharmacies in Puerto Rico face federal charges
| 2/28/14 - 4 Puerto Ricans face health care fraud charges [Saudi Press Agency (Saudi Arabia)] |
U.S. Attorney Rosa Emilia Rodriguez says the suspects are accused of submitting at least 554 false claims to Medicare totaling more than $300,000. She said Thursday that they obtained the majority of the money back through reimbursements in a scheme that began in January 2010 and lasted nearly two years. The suspects face a total of 14 charges. ! SAN JUAN, Puerto Rico, Rabi'II 27, 1435, Feb 27, 2014, SPA Four people including the owners of two pharmacies have been arrested on federal health care fraud charges in Puerto Rico, AP reported. U.S. Attorney Rosa Emilia Rodriguez says the suspects are accused of submitting at least 554 false claims to Medicare totaling more than $300,000. She said Thursday that they obtained the majority of the money back through reimbursements in a scheme that began in January 2010 and lasted nearly two years. The suspects face a total of 14 charges. SPA 21:48 LOCAL TIME 18:48 GMT quoted here |
NY Equine Safety Committee concerned about ''stacking'' of legal medications
2/28/2014
The simultaneous use of multiple therapeutic medications to treat the same ailment - a method referred to as stacking - has caused some concern among members of the New York racing community. The issue was brought up Thursday during a phone-in only meeting of the New York Racing Association’s read more
Webinar Replay - Pharmacy Compounding:
An Update from The Joint Commission, the Food and Drug Administration (FDA), and the American Society of Health-System Pharmacists (ASHP)
February 28, 2014
Listen to the replay and view the speaker slide decks from the February 27, 2014 Webinar: Pharmacy Compounding: An Update from The Joint Commission, the Food and Drug Administration (FDA), and the American Society of Health-System Pharmacists (ASHP).
- Audio replay
- Speaker slide decks:
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