Friday, January 3, 2014
FDA needs pharmacies' buy-in Agency has more authority, but how it will proceed is not yet clear
By FRED HIERS Halifax Media Group
Published: Friday, January 3, 2014 at 1:00 a.m.
Last Modified: Thursday, January 2, 2014 at 10:40 p.m.
It was too much for federal regulators to ignore and the public to tolerate: 64 people dead after a Massachusetts pharmacy shipped contaminated drugs to 23 states.
The New England Compounding Center in Massachusetts had already been in hot water with both federal and state regulators for a decade. The Massachusetts violations had left many angry national lawmakers asking why federal regulators had not closed the business, much less allowed it to pump thousands of doses of fungal-contaminated drugs into the patient stream.
To add to federal regulators' embarrassment, another state had warned the U.S. Food and Drug Administration and Massachusetts regulators about new NECC violations. The warnings were ignored.
continue to read here
Florida: Fix for Compounding Law Proposed By Carol Gentry
After a long delay, the Florida Department of Health wants to fix a gap in the law that made it powerless over out-of-state compounding pharmacies.
Hear Health News Florida’s audio story on the outbreak and its aftermath.
When tainted injections from New England Compounding Pharmacy caused a fungal meningitis epidemic in 2012, the state discovered it had licensed hundreds of such facilities to send drugs into Florida. It also found that Florida law gave DOH no authority over those located in other states.
DOH could have asked the legislature to fix the gap in the law during the 2013 session in the spring, but did not, as Health News Florida reported last June (see Who Forgot to Fix Compounding Law?). It was never made clear who dropped the ball.
In any event, DOH now has a proposed bill – approved by the Board of Pharmacy in October – that would plug the gap. It would allow Florida to send or hire inspectors to an out-of-state licensee and bill that pharmacy for the cost.
It would also require the pharmacy to provide a toll-free number that patients in Florida could call and maintain clear records of who got which drugs so that if there were a problem, those at risk could be contacted.
The outbreak caused by contamination of the steroid injectable liquids shipped from New England Compounding Pharmacy killed 64 people, including seven in Florida, according to the Centers for Disease Control and Prevention.
The pharmacy that made the tainted drugs was shut down soon after the outbreak was discovered in September 2012, and was later declared bankrupt. Other Florida-licensed compounding pharmacies based in and out-of-state have also triggered outbreaks or been found to have dangerous conditions by DOH or the Food and Drug Administration.
(more to come)
quoted from here
Thursday, January 2, 2014
1099 compounding sales jobs in Colorado, Georgia, Iowa, Indiana, Kansas, New Mexico, New Jersey, Minnesota, Missouri, Nevada, New York, Oklahoma, Texas, Washington
1099 Pharmaceutical Representative
NVYDiA Medical - Pharmaceutical Compound SalesIf you are currently in Pharmaceutical or Medical Sales and have established relationships with physicians (Primary Care, Internal Medicine, Neuro's, Ortho's, Plastic's, Podiatrists, Chronic Pain, Spine, Radiation Oncology, Hospice, Urology, Hand Surgeons, Lower/upper Extremity, Sports Medicine, Rheumatology, Rehabilitation, etc.) this is a great opportunity for you.This is not a position you have to leave your current job for. This is an opportunity for you to supplement your income with an additional revenue stream added to your existing salary. This opportunity can increase your yearly income without you going outside of your call pattern, if you have existing relationships. If you have solid contacts in medical, pharmaceutical or other healthcare industries, send your resume and we will contact you.Below is a general description of what you will be offering your physicians:First, we offer everyday used injectable drugs that are administered with in the clinic, for example, B-12, steroid injections, Testosterone injections, antibiotic injections, etc. Our business model has cut out the middle man to offer these products at a discounted price. What makes this sale so easy, is that we are offering products that the doctors or clinics are purchasing, we are just helping them save money.Second, pharmaceutical compounding, (done in compounding pharmacies) is the creation of a particular pharmaceutical product to fit the unique needs of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose needed. More recently it has been suggested that some doctors and clinics have turned away from major drug manufacturers and turned to compounding pharmacies because they often provide a much higher quality of product and charge much lower prices than the major manufacturers.Positions available in: Colorado, Georgia, Iowa, Indiana, Kansas, New Mexico, New Jersey, Minnesota, Missouri, Nevada, New York, Oklahoma, Texas, WashingtonFor those who meet the qualifications and are interested, send your resume to: resumes@nvydiamedical.com
Diamondback Drugs Inside Sales Job Opening
Inside Sales/Customer Service Representative Diamondback Drugs 2 reviews - Scottsdale, AZ
2 to 3 years of direct work experience in a sales or telesales capacity (Veterinary Industry Preferred). Currently Licensed or can obtain Pharmacy Technician
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Veterinary Pharmaceutical Sales Representative
Veterinary Pharmaceutical Sales Representative
Dec 8, 2013
PRIMARY FUNCTION: Responsible for the maintenance and expansion of your assigned customer base within an assigned territory for veterinary supplies, products, & programs....
Compounding Sales Representative Arkansas--Compensation of $200,000 to $500,000
Independent Sales Representative - Compound Pharmacy & Drug Sensitivity Testing General Location Fayetteville, Arkansas 72704 Apply Save Job code --- Function Sales Call point -Multiple Call Points- Segment Physician Category Pharmaceutical Date Expires 01/16/2014 Compensation Compensation $200,000 - $500,000 Comp Type Commission Only Salary --- Bonus --- Commission $200,000 - $500,000 Auto package None Travel 0 - 10% - See more at: http://www.medreps.com/jobdetail.aspx?jobid=729258#sthash.diPWTzqF.dpuf
Independent Sales Representatives US Health Group Inc in TX and OK
- ExperienceMid-Senior level
- Job functionSales, Business Development
- Employment typeOther
- IndustryMedical Devices, Hospital & Health Care
- Job ID10239861
About this job
Job description
US Health Group is currently seeking experienced Independent Sales Representatives in Texas and Oklahoma to help promote our portfolio of industry-leading ancillary services, with an emphasis on our compound pharmacy and toxicology divisions. Why rep a single product or service when you can bring a suite of solutions to your physicians?
US Health Group provides the support of a $1BB company to entrepreneurial sales reps who are focused on taking their income to the next level. Rock stars, future rock stars and road warriors please apply.
US Health Group provides the support of a $1BB company to entrepreneurial sales reps who are focused on taking their income to the next level. Rock stars, future rock stars and road warriors please apply.
Good Day Pharmacy- Sales/Marketing Represntative (compounding)
Good Day Pharmacy
Sales / Marketing Representative (Compounding)
Job Description
Job Description
Good Day Pharmacy in Loveland, CO is currently looking for a Sales / Marketing Representative (Compounding) to join our team! This position will be responsible for marketing Good Day Pharmacy?s services to area health care professionals. A complete and competent level of knowledge on Good Day?s product and service lines is required.
Responsibilities:
* Under the supervision of the Marketing Director, execute an effective marketing plan
* Build business relationships with assigned customers and area health care professionals
* Attend and participate in meetings as required
* Distributing samples to only licensed practitioners, and following all samples regulations
* Ability to schedule & host regular educational/marketing/sales meetings with area practitioners & meet monthly goals as established
* Research information to assist with planning and providing content for creation of marketing materials
Relationships and Roles:
* Demonstrate and maintain effective internal and external communication
* Demonstrate ability to interact and cooperate with all company employees
* Build trust, value others, communicate effectively, drive execution, foster innovation, focus on the customer, collaborate with others, solve problems creatively and demonstrate high integrity
* Proactively establish and maintain effective working team relationships with all departments and stores
Good Day Pharmacy in Loveland, CO is currently looking for a Sales / Marketing Representative (Compounding) to join our team! This position will be responsible for marketing Good Day Pharmacy?s services to area health care professionals. A complete and competent level of knowledge on Good Day?s product and service lines is required.
Responsibilities:
* Under the supervision of the Marketing Director, execute an effective marketing plan
* Build business relationships with assigned customers and area health care professionals
* Attend and participate in meetings as required
* Distributing samples to only licensed practitioners, and following all samples regulations
* Ability to schedule & host regular educational/marketing/sales meetings with area practitioners & meet monthly goals as established
* Research information to assist with planning and providing content for creation of marketing materials
Relationships and Roles:
* Demonstrate and maintain effective internal and external communication
* Demonstrate ability to interact and cooperate with all company employees
* Build trust, value others, communicate effectively, drive execution, foster innovation, focus on the customer, collaborate with others, solve problems creatively and demonstrate high integrity
* Proactively establish and maintain effective working team relationships with all departments and stores
Contact Information
| Business Name: | Good Day Pharmacy |
| Street: | 3780 E. 15th St. |
| City/State/Zip: | Loveland, CO 80538 |
| Local Phone: | (970) 461-1975 |
| Fax: | (970) 461-4042 |
| Email: | goodday@gooddaypharmacy.com |
| Website Address: | http://www.gooddaypharmacy.com |
Hospira, Inc, Initiates Recall of One Lot of 2% Lidocaine HCl Injection
Hospira, Inc, of Lake Forest, IL, has initiated a voluntary recall for one lot of Lidocaine HCl Injection, USP 2%, 5 mL Single-Dose Vial, National Drug Code 0409-4276-01, Lot 32-135-DD due to the presence of particulate matter. Hospira initiated the recall after a reddish orange particulate was observed on the inner surface and floating in the solution. This recall is in addition to a similar recall of 1% Lidocaine HCI Injection that Hospira initiated on October 4, 2013.
According to FDA, the recalled product was distributed to distributors/wholesalers, hospitals, and pharmacies located in Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin between September 2013 and through October 2013. FDA advises that health care providers stop use and quarantine the product. To arrange return of the product, providers may call Stericycle at 866/364-8812 between the hours of 8 AM and 5 PM ET, Monday through Friday. Adverse reactions may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Programquoted from here
Second FDA 483 Issued to Pine Pharmacy and Home Care Products Center, Inc. Williamville, NY
Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY
- 483 Issued 12/16/201391 (PDF – 5.3MB)
- 483 Issued 7/19/201392 (PDF – 1.4MB)
FDA 483 Clinical Apothecaries, Medina OH
Clinical Apothecaries, Medina, OH
- 483 Issued 11/20/201323 (PDF - 660KB)
FDA 483 for Brookfield Prescription Center, Inc. (dba MD Custom RX), Brookfield WI
Brookfield Prescription Center, Inc. (dba MD Custom Rx), Brookfield, WI
- 483 Issued 12/13/201315 (PDF – 5MB)
FDA 483 for Abrams Royal Pharmacy Dallas, TX
Abrams Royal Pharmacy, Dallas, TX
- 483 Issued 12/20/20131 (PDF – 5.3MB)
- Firm Press Release2: Abrams Royal Pharmacy Issues Voluntary Nationwide Recall of All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance (12/18/2013)
New Drug Approvals From FDA Declined in 2013
By MATTHEW PERRONE AP Health Writer
The Food and Drug Administration approved 27 first-of-a-kind drugs in 2013, down from 39 new medications in 2012, which was a 15-year high.
Despite the decline, FDA officials say the tally of innovative medications approved last year is in line with the historical trend. On average, the FDA has approved 28 first-of-a-kind drugs annually over the past five years.
FDA drug approvals are watched closely by analysts as both a barometer of industry innovation and the federal government's efficiency in reviewing new therapies.
Experts say the number of drug approvals declined in 2013 mainly because there were fewer drugs submitted for review.
continue to read here
Setting Your Compounding Pharmacy Apart --ce webinar
| Setting Your Compounding Pharmacy Apart | |||||||||||||||||||||||||||||||||
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Sr. Director of Pharmacy Operations (NJ-based position)--Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, a publicly-traded pharmaceutical development and manufacturing company, is growing and looking for Senior Management to lead the operations of our mail-order compounding pharmacy. The ideal candidate will have extensive experience in starting up and managing operations for a high-volume, multi-location mail-order pharmacy (preferably a compounding pharmacy) with documented accomplishments. Experience in an FDA-registered facility (pharmacy or pharmaceutical manufacturer) is preferred.
Desired Skills and Experience
ESSENTIAL DUTIES AND RESPONSIBLITIES:
The primary focus of this position would be to take an existing mail-order compounding pharmacy with a focus on sterile preparations and streamline the product portfolio in order to scale-up production of specific proprietary products. This needs to be executed by:
EDUCATION/EXPERIENCE:
R.Ph. or Pharm.D. and technical certifications (preferred).
Incumbent will have at least 10-12 years of experience successfully managing a high-volume pharmacy production environment which a Bachelor’s Degree; 8-10 years with a Master’s Degree and relevant experience.
The primary focus of this position would be to take an existing mail-order compounding pharmacy with a focus on sterile preparations and streamline the product portfolio in order to scale-up production of specific proprietary products. This needs to be executed by:
- Lean process improvements
- Implementation of the latest software and process protocols to meet USP and cGMP standards
- Set and maintain department goals, objectives and service levels
- Staffing, hiring, performance management, mentoring, training, motivating and coaching team members to develop existing skills and continually improve performance
- Adapt to new ideas and constant changes; ability to self-motivate, self-manage and work independently with minimal direction
- Make sure all department personnel constantly upgrade skills to keep pace with production and implement training when necessary
- Implement production strategies to meet best-in-class quality, 100% perfect shipments, at the best possible cost
- Allocate one's time effectively and work under pressure; handle multiple demands and competing priorities
- Promote a safe workplace and act in a safe manner at all times while proactively eliminating unsafe work conditions
- Compliance with and support of company standards and practices
EDUCATION/EXPERIENCE:
R.Ph. or Pharm.D. and technical certifications (preferred).
Incumbent will have at least 10-12 years of experience successfully managing a high-volume pharmacy production environment which a Bachelor’s Degree; 8-10 years with a Master’s Degree and relevant experience.
Inmates' Lawyers Ask Mo. Board Of Pharmacy To Act Before Execution--Missouri has been obtaining its execution drug from an out-of-state compounding pharmacy that isn't licensed to do business in Missouri
By Chris McDaniel
Originally published on Thu January 2, 2014 3:36 pm
Lawyers representing death row inmates have filed a complaint with the Missouri Board of Pharmacy, citing St. Louis Public Radio and the Beacon’s investigation from earlier this week.
On Tuesday, we reported that the Department of Corrections has been obtaining its execution drug from an out-of-state compounding pharmacy that isn't licensed to do business in Missouri. Under normal circumstances, the pharmacist could be guilty of a felony.
"The St. Louis Public Radio story makes clear that the Department of Corrections and its chosen pharmacy are violating (Missouri law)," Joseph Luby, an attorney for the inmates wrote in a letter to the board. "We ask that you take immediate steps to prevent this illegal importation of compounded pentobarbital, which not only violates binding law, but which places Mr. Smulls at risk of suffering an excruciatingly painful execution."
continue to read here
On Tuesday, we reported that the Department of Corrections has been obtaining its execution drug from an out-of-state compounding pharmacy that isn't licensed to do business in Missouri. Under normal circumstances, the pharmacist could be guilty of a felony.
"The St. Louis Public Radio story makes clear that the Department of Corrections and its chosen pharmacy are violating (Missouri law)," Joseph Luby, an attorney for the inmates wrote in a letter to the board. "We ask that you take immediate steps to prevent this illegal importation of compounded pentobarbital, which not only violates binding law, but which places Mr. Smulls at risk of suffering an excruciatingly painful execution."
continue to read here
Caremark Insurance Policy Regarding Compounded Medications
Compound Medication – a medication mixed for a specific patient and
not available commercially. To be eligible for reimbursement claims for
compounds must list the 11 digit National Drug Code (NDC) for each
ingredient used in the compound. National drug code (NDC) number,
requiring a Physician’s Order to dispense, and eligible for coverage under this
Plan.
quoted from here
Budget Deal Portends Well For FDA In FY 2014, Funding Advocates Say
FDA funding advocates said they expect the agency will be in a good position to obtain funding for a myriad of new responsibilities now that a bipartisan budget deal has been hashed out and funding priorities are expected to be set in the next two weeks by congressional appropriators -- who have prioritized FDA funding in recent years.
quoted from InsideHealthPolicy.com
Practical Equine Medications
Jan 02, 2014
Important!! Court Grants Temporary Injunction Against OK Compounding
On August 29, 2013, the District Court of Tulsa County in the state of Oklahoma granted a temporary injunction to enjoin the defendants, including Christopher Parks and OK Compounding, LLC (collectively, OK Compounding), from engaging in certain conduct in connection with plaintiff Rush University Medical Center (Rush). Among other things, the temporary injunction prohibits OK Compounding from representing that Rush approves its products or services, is affiliated with OK Compounding, or is associated with a topical pain cream research study purportedly being conducted by OK Compounding. OK Compounding, located in Skiatook, OK, allegedly partnered with Rush, located in Chicago, IL, in a pain cream research study. Further, OK Compounding had purportedly enrolled patients in the study. Rush denied any association with OK Compounding or its alleged study about topical pain medication. Rush and OK Compounding agreed to the temporary injunction. More information, including court documents related to the case, is provided on the Oklahoma State Courts Network Web site.
quoted from the NABP found here
Audet and Partners, LLP Comments On Report That Health Care Fraud Lawsuits Brought By Justice Department Yielded $2.6 Billion In Recoveries To Federal Government In 2013
Whistleblower lawsuits and False Claims Act cases alleging various types of health care fraud produced recoveries to the federal government of $2.6 billion is 2013.
Also prominent among whistleblower lawsuits favorably resolved for the federal government in 2013 were cases involving claims of “off-label marketing” by pharmaceutical manufacturers. In these cases, drug companies were alleged to have promoted their products for uses not approved by the U.S. Food and Drug Administration (FDA).
continue to read here
San Francisco, CA (PRWEB) January 02, 2014
In its continuing effort to safeguard expenditures of taxpayer dollars, the United States Justice Department has reported a 2013 recovery of $3.8 billion in settlements and judgments resolving a myriad of whistleblower lawsuits and False Claims Act cases.* Cases involving health care fraud comprised more than one-half of the total reported recovery, or $2.6 million.
The bulk of health care whistleblower and False Claims Act lawsuits involved Medicare and Medicaid fraud. Especially evident within this group of cases were fraud and false claims for pharmaceuticals and medical devices that also included TRICARE, the governmental arm that provides medical benefits for military personnel and their families.Also prominent among whistleblower lawsuits favorably resolved for the federal government in 2013 were cases involving claims of “off-label marketing” by pharmaceutical manufacturers. In these cases, drug companies were alleged to have promoted their products for uses not approved by the U.S. Food and Drug Administration (FDA).
continue to read here
MD Buyline's Healthcare Recall Management Solution Automatically Matches Affected Products in Hospitals
MD Buyline announced today the availability of SmartMatchTM as a value-added enhancement to its Buyline Recall TrackerTM recall management solution. SmartMatch helps healthcare providers ensure patient safety and mitigate risks by focusing staff on recalled products in their facilities. Using the latest in cognitive computing and machine learning technologies, SmartMatch searches hospitals’ inventory (based on purchase history) for items that have been recalled and notifies the hospital staff when matches are identified, which drastically reduces the time and effort hospital staff must spend finding, assigning and resolving recalls.
continue to read here
continue to read here
Hospira's India plant disappoints the FDA again
The FDA has come down hard in recent months on some of India's key generic drug makers, having taken actions against Indian plants operated by Wockhardt, Ranbaxy Laboratories and Agila Specialties. But Indian facilities operated by Western drugmakers have also been targets of citations, including one owned by Hospira ($HSP). The Irungattukottai plant, which was tagged with a warning letter in May, came up short of expectations during a recent follow-up inspection.
The Lake Forest, IL-based drugmaker did not say what problems were outlined in the Form 483 this time around but acknowledged them in a Dec. 20 filing with the Securities and Exchange Commission. It said most of the 23 observations had to do with processes and procedures and that it expected to get the majority of the observations addressed over the next several weeks. It said it didn't anticipate any interruption to its production. The inspection was completed Dec. 10.
While companies do not always publicize receiving Form 483s, Hospira said it acknowledged this one because the plant had received the earlier warning. That letter laid out a variety of shortcomings with sterility, including unsanitary surfaces, airflow questions and problems with the sterility of gloves worn by workers. In the letter, the agency ordered Hospira to create a corrective action plan for both its foreign and U.S. plants, including how it intends to train employees involved in aseptic processes. Hospira has already spent the last several years, and more than $300 million, addressing issues at three plants in the U.S. and has recently said it is close to resolving concerns with them.
The Lake Forest, IL-based drugmaker did not say what problems were outlined in the Form 483 this time around but acknowledged them in a Dec. 20 filing with the Securities and Exchange Commission. It said most of the 23 observations had to do with processes and procedures and that it expected to get the majority of the observations addressed over the next several weeks. It said it didn't anticipate any interruption to its production. The inspection was completed Dec. 10.
While companies do not always publicize receiving Form 483s, Hospira said it acknowledged this one because the plant had received the earlier warning. That letter laid out a variety of shortcomings with sterility, including unsanitary surfaces, airflow questions and problems with the sterility of gloves worn by workers. In the letter, the agency ordered Hospira to create a corrective action plan for both its foreign and U.S. plants, including how it intends to train employees involved in aseptic processes. Hospira has already spent the last several years, and more than $300 million, addressing issues at three plants in the U.S. and has recently said it is close to resolving concerns with them.
Read more: Hospira's India plant disappoints the FDA again - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/hospiras-india-plant-disappoints-fda-again/2013-12-30#ixzz2pIQuleDF
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China takes aim at poor-quality drug production
Companies caught engaging in bribery will also be blacklisted
Read more: China takes aim at poor-quality drug production - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/china-takes-aim-poor-quality-drug-production/2014-01-02#ixzz2pIP6cu1U
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$100M fund outlined for victims of NECC manufacturing problems
Backlash led to new authority for FDA to regulate large compounding pharmacies
Read more: $100M fund outlined for victims of NECC manufacturing problems - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/100m-fund-outlined-victims-necc-manufacturing-problems/2014-01-02#ixzz2pIOr4jOh
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Pharmacy fills health care niche with customized medications
Patients who get customized prescription medications from Cascade Specialty Pharmacy don’t necessarily get new drugs, but they may get the drugs they need in a different form. Instead of a standard capsule, the medication might be mixed into a salve or cream to be rubbed directly on an affected area and absorbed through the skin.
continue to read here
continue to read here
Eye on FDA blog: A Look Back at 2013 and FDA January 2, 2014 by Mark Senak
Happy New Year! It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come. Here is a little overview of events that shaped the FDA landscape this year:
- Legislation and FDA Authority - Occasionally FDA gets new regulatory authorities as a result of legislation passed by Congress. Despite the fact that this Congress has not produced as much legislation as others have, the Congress did pass and the President did sign legislation – the Drug Quality and Security Act – that gives the agency new authorities in regulating compounding pharmacies. The action came after several high-profile recalls during the course of the year that resulted in Congressional hearings, FDA testimony and consequential legislation. An overview of the compounding issue events can be found at the blog web site tab on Compounding.
- continue to read here
Third Question of the Day January 4, 2014 Recent FDA information states: It’s important to note that Part 530.13 specifically states, “Nothing in this part shall be construed as permitting compounding from bulk drugs.” What is the FDA's position for those in the 5th Circuit regarding compounding from bulk for animals?
FDA Information on Compounding for Animals:
Compounding
Under the FD&C Act, an animal drug that is
compounded using an unapproved drug or bulk drugs as the starting material is
adulterated. An animal drug that is compounded using an approved human or animal
drug as the starting material is not adulterated, and using such a drug is
considered a legal extra-label use as long as all other conditions required by
law are met. You can find these requirements in Sections 512(a)(4) and (5) of the FD&C Act8 and Title 21 of the CFR, Part 530.139. It’s important to note that Part
530.13 specifically states, “Nothing in this part shall be construed as
permitting compounding from bulk drugs.”
Drugs Prohibited from Extra-Label Uses in Animals
Under the AMDUCA provisions, FDA has the right to prohibit extra-label uses of certain drugs in animals. The following drugs (both human and animal), families of drugs, and substances are prohibited from extra-label uses in all food-producing animals, including horses intended for human food:
- Chloramphenicol
- Clenbuterol
- Diethylstilbestrol (DES)
- Dimetridazole
- Ipronidazole and other nitroimidazoles
- Furazolidone and nitrofurazone
- Sulfonamide drugs in lactating dairy cattle, except for the approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine
- Fluoroquinolones
- Glycopeptides
- Phenylbutazone in female dairy cattle 20 months of age or older
- Cephalosporins (not including cephapirin) in cattle, swine, chickens, or
turkeys:
- For disease prevention purposes;
- At unapproved doses, frequencies, durations, or routes of administration; or
- If the drug is not approved for that species and production class.
The following drugs, or classes of drugs, that are approved for treating or preventing influenza A are prohibited from extra-label uses in chickens, turkeys, and ducks:
- Adamantane
- Neuraminidase inhibitors
The above list can be found at Title 21 of the CFR, Part 530.4110. Currently, no approved drugs are
prohibited from extra-label uses in companion animals.
quoted from here
Question of the Day January 2, 2014 Why do most state boards of pharmacy insist that a complaint be filed against a compounding pharmacy or pharmacists before they will investigate and enforce their own rules? Why are more state boards of pharmacy not willing to enforce their own rules against compounding pharmacies and pharmacists when they learn about violations from the FDA, the news media, etc.? Shouldn't this be changed as suggested by the comment below?
The "complaints driven" component of how enforcement actions work is why it is so easy for pharmacies and physicians can get away with these illegal kickback relationships.
Kenneth Woliner, MD
www.holisticfamilymed.com
Kenneth Woliner, MD
www.holisticfamilymed.com
Wednesday, January 1, 2014
American Pharmacy Association: How new compounding, track-and-trace law may affect pharmacists; FDA issues pharmacy compounding draft guidance January 1, 2014
President Barack Obama signed the Drug Quality and Security Act (H.R. 3204) into law on November 27. What are the practical implications for most pharmacists of the new compounding and track-and-trace legislation?
The short answer is that the compounding part of the legislation, which became effective upon enactment, may affect more pharmacists than initially anticipated (see page 56 for more information). The track-and-trace part of the legislation will affect all pharmacists to some extent, according to Michael Ghobrial, PharmD, JD, APhA Associate Director of Health Policy.
Of course, the language in the legislation is not the last word. FDA has to decide how to implement it through the regulatory process. Traditional community pharmacies are “probably” not going to be affected by the compounding part of the law “unless we get more stringent regulation from the FDA,” said Lee Rosebush, PharmD, JD, MBA, MS, Counsel at the BakerHostetler law firm in Washington, DC. “While we got by with 3204, we may not necessarily get by with the regulations proposed by FDA.”
“Here’s the big question everybody’s going to be asking: If [registration with FDA] is voluntary, why would you want to have the FDA breathing down your neck? And the answer to that is brilliant,” Ghobrial said. “People will sign up because their product is less likely to be sold if they’re not an FDA-overseen outsourcing facility.”
Traditional pharmacies that do sterile compounding based on specific, individualized prescriptions have no reason to register with FDA, emphasized Rosebush. Pharmacies that are going to supply office use medication, however, have to do the registration. “You’re going to see a business model determination,” Rosebush said. “You’re going to see entities say, ‘Well, is the $15,000 user fee and the cGMP [current Good Manufacturing Practices] compliance worth moving into this new business model?”
Rosebush has “several clients who are large compounding pharmacies,” he said. “I do have some that are willing to register with the FDA and are currently pursuing compliance policies that use cGMPs and USP [U.S. Pharmacopeia] <797> standards. We eagerly await the publication of regulations in this area.” He added, “Some of my clients do not feel that they will have to register with the FDA and are not planning on registering with the FDA.”
continue to read at http://www.pharmacist.com/how-new-compounding-track-and-trace-law-may-affect-pharmacists-fda-issues-pharmacy-compounding-draft
The short answer is that the compounding part of the legislation, which became effective upon enactment, may affect more pharmacists than initially anticipated (see page 56 for more information). The track-and-trace part of the legislation will affect all pharmacists to some extent, according to Michael Ghobrial, PharmD, JD, APhA Associate Director of Health Policy.
Of course, the language in the legislation is not the last word. FDA has to decide how to implement it through the regulatory process. Traditional community pharmacies are “probably” not going to be affected by the compounding part of the law “unless we get more stringent regulation from the FDA,” said Lee Rosebush, PharmD, JD, MBA, MS, Counsel at the BakerHostetler law firm in Washington, DC. “While we got by with 3204, we may not necessarily get by with the regulations proposed by FDA.”
Compounding: Practical impact
Under the new law, traditional pharmacies are still regulated by state boards of pharmacy. Compounding pharmacies are still regulated by state boards of pharmacy, Ghobrial said. But now compounding pharmacies that voluntarily elect to be “outsourcing facilities” are regulated by both state boards of pharmacy and FDA.“Here’s the big question everybody’s going to be asking: If [registration with FDA] is voluntary, why would you want to have the FDA breathing down your neck? And the answer to that is brilliant,” Ghobrial said. “People will sign up because their product is less likely to be sold if they’re not an FDA-overseen outsourcing facility.”
Traditional pharmacies that do sterile compounding based on specific, individualized prescriptions have no reason to register with FDA, emphasized Rosebush. Pharmacies that are going to supply office use medication, however, have to do the registration. “You’re going to see a business model determination,” Rosebush said. “You’re going to see entities say, ‘Well, is the $15,000 user fee and the cGMP [current Good Manufacturing Practices] compliance worth moving into this new business model?”
Rosebush has “several clients who are large compounding pharmacies,” he said. “I do have some that are willing to register with the FDA and are currently pursuing compliance policies that use cGMPs and USP [U.S. Pharmacopeia] <797> standards. We eagerly await the publication of regulations in this area.” He added, “Some of my clients do not feel that they will have to register with the FDA and are not planning on registering with the FDA.”
continue to read at http://www.pharmacist.com/how-new-compounding-track-and-trace-law-may-affect-pharmacists-fda-issues-pharmacy-compounding-draft
Pharmacies that custom-make drugs are soliciting physician investors in Texas and other states for potentially lucrative deals in which the doctors refer patients to the pharmacy and share in any profits; Executive Director of TSBP Indicates they will investigate such deals
Sunday, November 10, 2013
Ethical questions raised as doctors partner with pharmacies
Pharmacies that custom-make drugs are soliciting physician investors in Texas and other states for potentially lucrative deals in which the doctors refer patients to the pharmacy and share in any profits.
In addition, some compounding pharmacies are asking the doctors to refer patients to a clinical trial to test a pain cream or other compound the pharmacy provides, officials familiar with the proposals said.
State regulators, physician groups in Austin and national experts are aware of the trend and concerned the deals could run afoul of federal and state anti-kickback laws, conflict-of-interest rules and patient-care standards.
The arrangements could give doctors a profit motive to overprescribe certain custom medicines, which can be a patient cost and safety issue. But whether the deals are legal depends on how the arrangements are structured, state officials said.
“There are some serious questions whether this is resulting in unfair billings to the taxpayer” through government coverage programs, such as Medicare and Medicaid, said David Miller, senior vice president and CEO of the International Academy of Compounding Pharmacists, which represents more than 3,600 pharmacists and others in the compounding industry. Those billings can go beyond reimbursements for drugs because patients often receive follow-up care to monitor their health after receiving them.
It’s not known how many doctors are signing up for partnerships with compounding pharmacies because no one compiles such data. Officials with three companies soliciting doctors in Austin didn’t return calls; one official who was reached declined to comment.
Compounding pharmacies play an important role in medicine, mixing drugs that patients can’t get otherwise. But the physician-investor arrangements are coming at a time when a few of the pharmacies are getting unwanted national attention. After 64 patients died last year after receiving a compounded drug, Congress has been mulling legislation that would broaden Food and Drug Administration authority over those pharmacies.
Last Monday, the U.S. Justice Department announced that Johnson & Johnson would pay $2.2 billion to settle investigations that it paid kickbacks to doctors and nursing home pharmacies to promote the use of certain, non-compounded drugs, among other things. It was one of the largest health care fraud settlements in U.S. history, department officials said.
Doctors must disclose
Doctors in Texas are allowed to own or invest in pharmacies, surgical centers and medical equipment, but they have an ethical duty to disclose such ownership to patients when referring them to those services, according to guidance from an ethics board of the Texas Medical Association, a group that represents physicians. The doctors also should give patients a list of alternative facilities, if one exists.
A federal measure, known as the Stark law, puts limits on such physician referrals, and states, such as Texas, forbid kickbacks under such laws as the Texas Solicitation of Patients Act.
Whether the arrangements between doctors and compounding pharmacies are legal is one question, said Gay Dodson, executive director of the Texas State Board of Pharmacy. Whether they are ethical is another, she and others said.
“I would tell them to be careful of what they are doing,” Dodson said. “It could be an illegal practice, and it’s something we would investigate if we got notice of it.”
In addition, some compounding pharmacies are asking the doctors to refer patients to a clinical trial to test a pain cream or other compound the pharmacy provides, officials familiar with the proposals said.
State regulators, physician groups in Austin and national experts are aware of the trend and concerned the deals could run afoul of federal and state anti-kickback laws, conflict-of-interest rules and patient-care standards.
The arrangements could give doctors a profit motive to overprescribe certain custom medicines, which can be a patient cost and safety issue. But whether the deals are legal depends on how the arrangements are structured, state officials said.
“There are some serious questions whether this is resulting in unfair billings to the taxpayer” through government coverage programs, such as Medicare and Medicaid, said David Miller, senior vice president and CEO of the International Academy of Compounding Pharmacists, which represents more than 3,600 pharmacists and others in the compounding industry. Those billings can go beyond reimbursements for drugs because patients often receive follow-up care to monitor their health after receiving them.
It’s not known how many doctors are signing up for partnerships with compounding pharmacies because no one compiles such data. Officials with three companies soliciting doctors in Austin didn’t return calls; one official who was reached declined to comment.
Compounding pharmacies play an important role in medicine, mixing drugs that patients can’t get otherwise. But the physician-investor arrangements are coming at a time when a few of the pharmacies are getting unwanted national attention. After 64 patients died last year after receiving a compounded drug, Congress has been mulling legislation that would broaden Food and Drug Administration authority over those pharmacies.
Last Monday, the U.S. Justice Department announced that Johnson & Johnson would pay $2.2 billion to settle investigations that it paid kickbacks to doctors and nursing home pharmacies to promote the use of certain, non-compounded drugs, among other things. It was one of the largest health care fraud settlements in U.S. history, department officials said.
Doctors must disclose
Doctors in Texas are allowed to own or invest in pharmacies, surgical centers and medical equipment, but they have an ethical duty to disclose such ownership to patients when referring them to those services, according to guidance from an ethics board of the Texas Medical Association, a group that represents physicians. The doctors also should give patients a list of alternative facilities, if one exists.
A federal measure, known as the Stark law, puts limits on such physician referrals, and states, such as Texas, forbid kickbacks under such laws as the Texas Solicitation of Patients Act.
Whether the arrangements between doctors and compounding pharmacies are legal is one question, said Gay Dodson, executive director of the Texas State Board of Pharmacy. Whether they are ethical is another, she and others said.
“I would tell them to be careful of what they are doing,” Dodson said. “It could be an illegal practice, and it’s something we would investigate if we got notice of it.”
HCCA’s 18th annual Compliance Institute
HCCA’s 18th annual Compliance Institute is unparalleled in opportunities to learn the latest techniques and best practices for building and managing effective healthcare compliance programs.
The Compliance Institute offers:
The Compliance Institute offers:
- More than 140 sessions to choose from on a variety of topics from beginner to advanced.
- Nine learning tracks to help make course selection easier. Follow one track all the way through, or hop around. Tracks include: General Compliance/Hot Topics, Long-Term Care, Privacy & Security, Physician Compliance, Compliance Lawyer, Auditing & Monitoring, How to Succeed as a Compliance Professional, Quality of Care, and Advanced Discussion Groups.
- More than 230 speakers who are industry and government leaders in healthcare compliance.
- 20+ networking opportunities throughout the conference to connect with compliance and ethics peers, including: SpeedNetworking, SpeedMentoring, Tweetup, a volunteer event, receptions, lunches, and breaks.
- 24+ CEUs toward a Compliance Certification Board designation, and many others.
- CCB exams at the conclusion of the event. Sit for an exam to become certified in Healthcare Compliance (CHC)®, Healthcare Research Compliance (CHRC) ® or Healthcare Privacy Compliance (CHPC) ®.
New Guidelines Issued on Menopausal Symptom Management CME/CE -Too little evidence supports a benefit of compounded bioidentical hormones, phytoestrogens, herbal remedies, or exercise.
CME/CE Released: 12/31/2013 ; Valid for credit through 12/31/2014
Clinical Context
The most common symptoms associated with menopause are vasomotor symptoms, including hot flushes, and vaginal symptoms. Vasomotor symptoms, which occur in approximately 50% to 82% of US women who go through natural menopause, can be especially troubling.
Vasomotor symptoms increase in prevalence during the transition to menopause, with peak frequency approximately 1 year after the last menstrual period. The American College of Obstetricians and Gynecologists (ACOG) updated its evidence-based guidelines for the treatment of vasomotor and vaginal symptoms associated with natural and surgical menopause.
continue to read here
Vasomotor symptoms increase in prevalence during the transition to menopause, with peak frequency approximately 1 year after the last menstrual period. The American College of Obstetricians and Gynecologists (ACOG) updated its evidence-based guidelines for the treatment of vasomotor and vaginal symptoms associated with natural and surgical menopause.
continue to read here
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