Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, August 4, 2014
Lyme disease antibiotic cost soars — for pets and people
Lyme disease antibiotic cost soars — for pets and people
Mary Beth Pfeiffer, Poughkeepsie Journal 9:40 a.m. EDT August 4, 2014
Bayer Ponders Its Health Care Drug Future, Still Keen on Diabetes Care
Bayer Ponders Animal Health Future, Still Keen On Diabetes Care / The diversified big pharma is continuing to discuss the need for critical mass in the animal health sector, and whether the business should stay within the company, but for now diabetes care is to remain because of the way it generates cash without needing extra investment. / “The Pink Sheet” DAILY July 31 2014 2:10 PM
Humana Weighing Options for its Internal PBM
Humana Weighing Drug Purchasing Change With PBM “Strategic Review” / The insurer is considering strategic options for its internal PBM, which manages more than 300 million drug claims for more than 9 million individuals, mainly in the Medicare space. / “The Pink Sheet” DAILY August 1 2014 4:30 PM
Tenth Question of the Day August 4, 2014 Is the following hypo involving a durable medical equipment supplier and a compounding pharmacy a prime example of kickback violations? Why or why not?
A durable medical equipment supplier and a compounding pharmacy are separate
corporations, but both are owned by the same people. The DME
supplier refers its nebulizer patients to the pharmacy for the respiratory
medications. The pharmacy refers its customers who buy respiratory medications to the durable medical equipment supplier. The money from both is used to pay advertising, employees and expenses. When you look at the customers of both companies they are basically all the same. What if the corporations are not separate. What if there is one corporation but each business has a different name under the corporation.
Review United States. v. Davis, 132 F.3d 1092 (5th Cir. 1998), holding that even if primary reason for payment is not referrals, it still violates kickback statute as long as it is one of the reasons for the referral. This is know as the "one purpose test" which was established in the landmark case of United States. v. Greber, 760 F.2d 68, 69 (3rd Cir. 1985), cert. denied, 474 U.S. 988 (1985). This test has also been adopted by the Fifth, Ninth, and Tenth Circuits. See U.S. v. Davis, 132 F.3d 1092 (5th Cir. 1998); U.S. v. Kats, 871 F.2d 105 (9th Cir. 1989); and U.S. v. McClatchey, 217 F.3d 823 (10th Cir. 2000) (reaff'd., U.S. v. LaHue, 261 F.3d 993 (10th Cir. 2001)).
corporations, but both are owned by the same people. The DME
supplier refers its nebulizer patients to the pharmacy for the respiratory
medications. The pharmacy refers its customers who buy respiratory medications to the durable medical equipment supplier. The money from both is used to pay advertising, employees and expenses. When you look at the customers of both companies they are basically all the same. What if the corporations are not separate. What if there is one corporation but each business has a different name under the corporation.
Review United States. v. Davis, 132 F.3d 1092 (5th Cir. 1998), holding that even if primary reason for payment is not referrals, it still violates kickback statute as long as it is one of the reasons for the referral. This is know as the "one purpose test" which was established in the landmark case of United States. v. Greber, 760 F.2d 68, 69 (3rd Cir. 1985), cert. denied, 474 U.S. 988 (1985). This test has also been adopted by the Fifth, Ninth, and Tenth Circuits. See U.S. v. Davis, 132 F.3d 1092 (5th Cir. 1998); U.S. v. Kats, 871 F.2d 105 (9th Cir. 1989); and U.S. v. McClatchey, 217 F.3d 823 (10th Cir. 2000) (reaff'd., U.S. v. LaHue, 261 F.3d 993 (10th Cir. 2001)).
Pharmacy monographs and an illusory duty of care
We are sometime not sure what to make of pharmacy monographs. You know what we mean. Those sheets that pharmacists print out and give us with our prescriptions. They are not drug labeling, and they are not medication guides. They are summaries intended for patient perusal, with information taken from the labeling, but digested in a fashion intended for the lay reader. Notably, the FDA has not asserted any prerogative to review and approve pharmacy monographs, leaving publishers essentially self-regulated under an FDA action plan.
From time to time, we are surprised when a plaintiff produces a pharmacy monograph in discovery, one that he or she received from the pharmacy and has saved. (We have not seen the data, but we expect that people who save pharmacy monographs are the same people who have their utility bills from the mid 1990s and who know where the instructions and warranties are for all their household appliances.) But even when this happens, we are unsure how the monographs help us. The parties we represent – drug manufacturers – do not publish these things, and they generally don’t have any duty to warn patients anyway
continue to read here
From time to time, we are surprised when a plaintiff produces a pharmacy monograph in discovery, one that he or she received from the pharmacy and has saved. (We have not seen the data, but we expect that people who save pharmacy monographs are the same people who have their utility bills from the mid 1990s and who know where the instructions and warranties are for all their household appliances.) But even when this happens, we are unsure how the monographs help us. The parties we represent – drug manufacturers – do not publish these things, and they generally don’t have any duty to warn patients anyway
continue to read here
Who Remembers this Case with the Human Growth Hormone! Drug Manufacturer Settles Allegations Of Kickbacks Paid To Pharmacy Benefit Manager By Kimberly J. Kannensohn and Krist Werling, McGuireWoods LLP*
The U.S. Attorney for the District of Massachusetts has come out strong against undisclosed relationships and payments between drug manufacturers and pharmacy benefit managers (PBMs). On April 2, Pfizer announced that its subsidiary, Pharmacia & Upjohn Company, Inc., has agreed to pay a total of $34.7 million to resolve criminal allegations which stem from the marketing and promotion of Genotropin. Genotropin (somatropin [rDNA origin] for injection) is a human growth hormone product that was developed and marketed by Pharmacia before its merger with Pfizer. In addition to the kickback allegations, prosecutors also alleged that Pharmacia promoted Genotropin for a variety of off-label purposes including anti-aging, cosmetic use, and athletic enhancement despite the fact that the Genotropin label approved the drug solely for the treatment of growth-related diseases. Several PBMs have settled similar allegations but Pfizer is the first drug manufacturer to settle charges related to these relationships. - See more at: http://www.healthlawyers.org/News/Health%20Lawyers%20Weekly/Pages/2007/April%202007/April%2020%202007/Drug_Manufacturer_Settles_Allegations_Of_Kickbacks_Paid_To_Pharmacy_Benefit_Manager.aspx#sthash.gyOKPIaU.dpuf
Anti kick back Law in Arizonia--its a crime and unethical conduct to offer a commission to a person who refers a person to a pharmacy or a laboratory etc. Also a crime when paying for those compounding clinical trials
Criminal Code—Miscellaneous Offenses—A.R.S. § 13-3713(A)—Consideration for referral of patient, client or customer; fraud; violation; classification.
It is unlawful for a person to knowingly offer, deliver, receive, or accept any rebate, refund, commission, preference, or other consideration in exchange for a patient, client, or customer referral to any individual, pharmacy, laboratory, clinic, or health care institution providing medical or health-related services or items under A.R.S. § 11-291 et seq. (providing for indigent care), or A.R.S. § 36-2901 et seq., or providing for the Arizona Health Care Cost Containment System, other than specifically provided under those sections. Certain payments in connection with clinical trials regulated by the U.S. Food and Drug Administration from a medical researcher to a physician licensed by the Arizona Medical Board or the Board of Osteopathic Examiners in Medicine and Surgery are not violations of this section. A violator is guilty of: a class 3 felony for payment of $1,000 or more; a class 4 felony for payment of more than $100 but less than $1,000; or a class 6 felony for payment of $100 or less
Professionals and Occupations—Pharmacy—A.R.S. § 32-1901.01(A)(18), (25), (B)(19), (24), (C)(15)—Definition of unethical and unprofessional conduct; permittees; licensees.
Unprofessional conduct by a pharmacist, pharmacy intern, or graduate intern, under the Pharmacy chapter, whether occurring in Arizona or another state, includes: paying rebates or entering into an agreement for the payment of rebates to a medical practitioner or any other person in the healthcare field; and violating or attempting to violate, directly or indirectly, or assisting in or abetting in the violation of, or conspiring to violate, this chapter. Unprofessional conduct, under the Pharmacy chapter, for the purpose of disciplining a pharmacy technician or pharmacy technician trainee includes: violating or attempting to violate, directly or indirectly, or assisting in or abetting in the violation of, or conspiring to violate, this chapter. Unethical conduct, under the Pharmacy chapter, whether occurring in Arizona or another state, for the purpose of disciplining a permittee includes distributing premiums or rebates of any kind in connection with the sale of prescription medication. However, distributing rebates or premiums to the prescription medication recipient is permitted. Unethical conduct, similar to unprofessional conduct also includes violating and attempting to violate, directly or indirectly, or assisting in or abetting the violation of or conspiring to violate, this chapter.
Op. Atty. Gen. No. I79-291
Discount for prompt payment offered by a pharmacist to a nursing home would be a rebate and a violation of A.R.S. § 32-1927 and § 32-1932, which authorizes the suspension, revocation, or placing on probation a pharmacy permit for rebates of any kind in connection with the sale of prescription medication, other than to the prescription medication recipient.
Professions and Occupations—Board of Pharmacy—A.A.C. R4-23-404(A), (B), (D)—Unethical practices.
Rebates are prohibited. A pharmacist or pharmacy permittee shall not offer, deliver, receive, or accept any unearned rebate, refund, commission, preference, patronage dividend, discount, or other unearned consideration, whether in the form of money or otherwise, as compensation or inducement to refer a patient, client, or customer to any person. However, the regulation does allow a rebate or premium paid completely and directly to the patient. A pharmacist or pharmacy permittee shall not make payment for a prescription order prescribed by the medical practitioner and shall not make payment to a long term care or assisted living facility or other health care institution in money, discount, rental, or other consideration in an amount above the prevailing rate for prescription medication or devices dispensed or sold for a patient or resident of the facility institution or drug selection or drug utilization review services, drug therapy management services, or other pharmacy consultation services provided for a patient or resident of the facility or institution. Additionally, prescription order-blank advertising is prohibited. A pharmacist or pharmacist permittee shall not directly or indirectly furnish a medical practitioner with, nor actively or passively participate in an arrangement for, order-blanks that display the name of a pharmacy or pharmacist in any manner. A pharmacist shall not claim a fee for service that is not performed or earned or divide a prescription order to obtain an additional fee.
Professions and Occupations—Pharmacy—A.R.S. § 32-1901.01(A)(1, 14-16, 25, 27-29), (B)(8, 17, 18, 24, 26, 27)—Definition of unethical and unprofessional conduct; permittees; licensees.
For the purpose of disciplining a permittee, unprofessional conduct under the Pharmacy chapter, whether occurring in Arizona or another state, includes: committing a felony, whether or not involving moral turpitude, or a misdemeanor involving moral turpitude or any drug-related offense; obtaining or attempting to obtain a permit or a permit renewal by fraud, misrepresentation, or knowingly taking advantage of the mistake of another person or an agency; willfully making a false report or record required by this chapter, required by federal or state law pertaining to drugs, devices, poisons, hazardous substances, or precursor chemicals or required for the payment for drugs, devices, poisons, or hazardous substances or precursor chemicals or for services pertaining to such drugs or substances; knowingly filing with the board any application, renewal, or other document that contains false or misleading information; distributing premiums or rebates of any kind in connection with the sale of prescription medication, other than to the prescription medication recipient; fraudulently claiming to have performed a service; fraudulently charging a fee for service; and advertising drugs or devices, or services pertaining to drugs or devices, that is untrue or misleading in any particular, and that is known, or that by the exercise of reasonable care should be known to be untrue or misleading.
It is unlawful for a person to knowingly offer, deliver, receive, or accept any rebate, refund, commission, preference, or other consideration in exchange for a patient, client, or customer referral to any individual, pharmacy, laboratory, clinic, or health care institution providing medical or health-related services or items under A.R.S. § 11-291 et seq. (providing for indigent care), or A.R.S. § 36-2901 et seq., or providing for the Arizona Health Care Cost Containment System, other than specifically provided under those sections. Certain payments in connection with clinical trials regulated by the U.S. Food and Drug Administration from a medical researcher to a physician licensed by the Arizona Medical Board or the Board of Osteopathic Examiners in Medicine and Surgery are not violations of this section. A violator is guilty of: a class 3 felony for payment of $1,000 or more; a class 4 felony for payment of more than $100 but less than $1,000; or a class 6 felony for payment of $100 or less
Professionals and Occupations—Pharmacy—A.R.S. § 32-1901.01(A)(18), (25), (B)(19), (24), (C)(15)—Definition of unethical and unprofessional conduct; permittees; licensees.
Unprofessional conduct by a pharmacist, pharmacy intern, or graduate intern, under the Pharmacy chapter, whether occurring in Arizona or another state, includes: paying rebates or entering into an agreement for the payment of rebates to a medical practitioner or any other person in the healthcare field; and violating or attempting to violate, directly or indirectly, or assisting in or abetting in the violation of, or conspiring to violate, this chapter. Unprofessional conduct, under the Pharmacy chapter, for the purpose of disciplining a pharmacy technician or pharmacy technician trainee includes: violating or attempting to violate, directly or indirectly, or assisting in or abetting in the violation of, or conspiring to violate, this chapter. Unethical conduct, under the Pharmacy chapter, whether occurring in Arizona or another state, for the purpose of disciplining a permittee includes distributing premiums or rebates of any kind in connection with the sale of prescription medication. However, distributing rebates or premiums to the prescription medication recipient is permitted. Unethical conduct, similar to unprofessional conduct also includes violating and attempting to violate, directly or indirectly, or assisting in or abetting the violation of or conspiring to violate, this chapter.
Op. Atty. Gen. No. I79-291
Discount for prompt payment offered by a pharmacist to a nursing home would be a rebate and a violation of A.R.S. § 32-1927 and § 32-1932, which authorizes the suspension, revocation, or placing on probation a pharmacy permit for rebates of any kind in connection with the sale of prescription medication, other than to the prescription medication recipient.
Professions and Occupations—Board of Pharmacy—A.A.C. R4-23-404(A), (B), (D)—Unethical practices.
Rebates are prohibited. A pharmacist or pharmacy permittee shall not offer, deliver, receive, or accept any unearned rebate, refund, commission, preference, patronage dividend, discount, or other unearned consideration, whether in the form of money or otherwise, as compensation or inducement to refer a patient, client, or customer to any person. However, the regulation does allow a rebate or premium paid completely and directly to the patient. A pharmacist or pharmacy permittee shall not make payment for a prescription order prescribed by the medical practitioner and shall not make payment to a long term care or assisted living facility or other health care institution in money, discount, rental, or other consideration in an amount above the prevailing rate for prescription medication or devices dispensed or sold for a patient or resident of the facility institution or drug selection or drug utilization review services, drug therapy management services, or other pharmacy consultation services provided for a patient or resident of the facility or institution. Additionally, prescription order-blank advertising is prohibited. A pharmacist or pharmacist permittee shall not directly or indirectly furnish a medical practitioner with, nor actively or passively participate in an arrangement for, order-blanks that display the name of a pharmacy or pharmacist in any manner. A pharmacist shall not claim a fee for service that is not performed or earned or divide a prescription order to obtain an additional fee.
Professions and Occupations—Pharmacy—A.R.S. § 32-1901.01(A)(1, 14-16, 25, 27-29), (B)(8, 17, 18, 24, 26, 27)—Definition of unethical and unprofessional conduct; permittees; licensees.
For the purpose of disciplining a permittee, unprofessional conduct under the Pharmacy chapter, whether occurring in Arizona or another state, includes: committing a felony, whether or not involving moral turpitude, or a misdemeanor involving moral turpitude or any drug-related offense; obtaining or attempting to obtain a permit or a permit renewal by fraud, misrepresentation, or knowingly taking advantage of the mistake of another person or an agency; willfully making a false report or record required by this chapter, required by federal or state law pertaining to drugs, devices, poisons, hazardous substances, or precursor chemicals or required for the payment for drugs, devices, poisons, or hazardous substances or precursor chemicals or for services pertaining to such drugs or substances; knowingly filing with the board any application, renewal, or other document that contains false or misleading information; distributing premiums or rebates of any kind in connection with the sale of prescription medication, other than to the prescription medication recipient; fraudulently claiming to have performed a service; fraudulently charging a fee for service; and advertising drugs or devices, or services pertaining to drugs or devices, that is untrue or misleading in any particular, and that is known, or that by the exercise of reasonable care should be known to be untrue or misleading.
Ninth Question of the Day August 4, 2014 If a state law provides that no registered pharmacist or owner of any pharmacy licensed in that state can pay a commission for referring customers or clients then if company x is Texas resident pharmacy but doing business and licensed in Flordia or Nevada but pays their reps a commission doesn't this violate Nevada and Florida law and shouldn't those states revoke the pharmacist and/or pharmacy license to do business in that state? Should these pharmacies and pharamcists be prosecuted in states where they violate kickback laws? Should they be prosecuted federally for kickback laws? If the commissions were taken out of all compounding drug sales, how quick would the industry clean itself up?
NV Rev Stat § 639.264 (2013)
1. No registered pharmacist, or owner of any pharmacy licensed under the provisions of this chapter, may offer, deliver or pay any unearned rebate, refund, commission, preference, patronage dividend, discount or other unearned consideration to any person, whether in the form of money or otherwise, as compensation or inducement to such person for referring prescriptions, patients, clients or customers to such pharmacist or pharmacy, irrespective of any membership, proprietary interest or co-ownership in or with any person by whom such prescriptions, patients, clients or customers are referred.
1. No registered pharmacist, or owner of any pharmacy licensed under the provisions of this chapter, may offer, deliver or pay any unearned rebate, refund, commission, preference, patronage dividend, discount or other unearned consideration to any person, whether in the form of money or otherwise, as compensation or inducement to such person for referring prescriptions, patients, clients or customers to such pharmacist or pharmacy, irrespective of any membership, proprietary interest or co-ownership in or with any person by whom such prescriptions, patients, clients or customers are referred.
Fundamentals of Tax-Exempt Healthcare Organizations CLE
Fundamentals of Tax-Exempt Healthcare Organizations
Webinar 1.5 CLE credits requested |
FireceAnimal Top Stories Regarding Animal Medications
Today's Top Stories
- Merck Animal Health posts small revenue increase, even without Zilmax
- Dekkers says Bayer may add to animal health division with M&A, in time
- Merial revenues see sizable jump as NexGard sales are strong in the U.S.
- Zoetis expands product offerings in key China market
- Vétoquinol rides reference products sales in second quarter
Fourth Question of the Day August 4, 2014 If small, independent pharmacies are barely staying afloat as many of them claim then why is their revenue in the millions, they donate lots of money to legislators, they belong to numerous compounding pharmacy associations and they employee many people and claim they have so many patients who use their compounds? Is it just me or does something not add up in on the statements they make? Are they lying to the American public?
Check Out these Code of Ethics for Pharmacists
Pharmacist has a professional commitment to the care of their patients. Pharmacoethics is thus central to the understanding of pharmacy practice as a profession. There are a number of ethical principles that are applicable to healthcare professionals. Following ethical principles are identified in the tradition of pharmacy practice which establish ethical duties, obligations, and rights and provide a standard for rationalization of the ethical decisions.
• Beneficence – The Duty to Do Good
• Nonmaleficence – Preventing harm
• Autonomy – Right of determination
• Veracity – Honesty without deception
• Paternalism – Violating autonomy
• Confidentiality
• Fidelity – Best interest of patient
• Justice – Equality with everyone
The Principle of Beneficence
• The principle of beneficence can be described as “doing good” or working in the best interest of the patient.
• The Code of Ethics for members of the Ontario College of Pharmacist states this principle - Pharmacists are obliged to act in the best interest of, and advocate for the patient.
• Helping patients in achieving the best outcome from their medications; anticipating and helping patients navigate through complicated drug plans; promoting health and wellness in community seminars are all examples of beneficence in action.
continue to read here
• Beneficence – The Duty to Do Good
• Nonmaleficence – Preventing harm
• Autonomy – Right of determination
• Veracity – Honesty without deception
• Paternalism – Violating autonomy
• Confidentiality
• Fidelity – Best interest of patient
• Justice – Equality with everyone
The Principle of Beneficence
• The principle of beneficence can be described as “doing good” or working in the best interest of the patient.
• The Code of Ethics for members of the Ontario College of Pharmacist states this principle - Pharmacists are obliged to act in the best interest of, and advocate for the patient.
• Helping patients in achieving the best outcome from their medications; anticipating and helping patients navigate through complicated drug plans; promoting health and wellness in community seminars are all examples of beneficence in action.
continue to read here
IACP Regional Education Meeting in Dallas--David G. Miller, RPH will present Pharmacy Compounding Law and Regulations; Staying Current in a Changing World
An IACP Regional Education Meeting will be held on Saturday, September 20, 2014, from 3:00-5:30pm at the Omni Hotel in Downtown Dallas. This meeting will follow the conclusion of Freedom Pharmaceutical Inc.'s Third Annual Seminar.
David G. Miller, RPh will present “Pharmacy Compounding Law and Regulations: Staying Current in a Changing World.” Participants will learn how regulatory initiatives and court decisions have influenced t...he regulation of compounders, the authority of the Food and Drug Administration (FDA) when inspecting compounding pharmacies, and up-to-date information on the current federal proposed legislation.
Visit www.iacprx.org/RegionalEducationMeetings for more information and to register.
David G. Miller, RPh will present “Pharmacy Compounding Law and Regulations: Staying Current in a Changing World.” Participants will learn how regulatory initiatives and court decisions have influenced t...he regulation of compounders, the authority of the Food and Drug Administration (FDA) when inspecting compounding pharmacies, and up-to-date information on the current federal proposed legislation.
Visit www.iacprx.org/RegionalEducationMeetings for more information and to register.
Sunday, August 3, 2014
More Veterinary Sales Jobs
click job for details
OKOutside Sales Representative Livestock- Stillwater, OKKYGeneral/Marketing Manager (KT)PARegional Operations Manager - Eastern Region KYRegional Sales Rep(Southeast US)TXTerritory Manager - TX Panhandle, NMLATerritory Sales Manager - Louisiana / Mississippi / ArkansasALTerritory Sales Manager - Mississippi / Alabama / FL PanhandleWIPharmacist-Veterinary Pharmacy(WI)CONorth USA/Canada Sales ManagerCAWestern Regional Sales ManagerNHOutside Sales Representative(NH)
more jobs found here
Update to Countries Viewing the Blog
Add Albania and Reunion
Albania
Algeria
Antigua and Barbuda
Albania
Algeria
Antigua and Barbuda
Argentina
Armenia
Armenia
Australia
Austria
Azerbaijan
Bahamas
Bangladen
Bangladen
Bangladesh
Barbados
Belarus
Belarus
Belgium
Benin
Bermuda
Bermuda
Bosina & Herzegovina
Brazil
Bulgaria
Burkina Faso
Canada
Cameroon
Burkina Faso
Canada
Cameroon
Cayman Islands
Chile
China
Columbia
Congo (Republic)
Congo (Republic)
Costa Rica
Cote d'lvoire
Croatia
Cyprus
Czech Republic
Denmark
Dominica
Dominican Republic
Dominica
Dominican Republic
AFDO Presentations Related to to Antibiotics in Agriculture--Antimicrobial resistance is one of the most significant challenges facing modern public health
Antibiotics in Agriculture and the Campaign on Human Health and Industrial Farming - Gail Hansen, Senior Officer, Human Health and Industrial Farming, The Pew Charitable Trusts
Pharmacists Here Are Photos of 483 Violations the FDA Has Observed at Compounding Pharmacies; Consumers You may Want to Review Also
Compounding Pharmacies - Erika Butler, Drug Specialist, U.S. Food and Drug Administration
Even if you Don't Register as an Outsourcing Facility with the FDA, the FDA May Still Be Knocking on Your Door Soon
•FDA has been conducting inspections of
compounding pharmacies for cause (in response to serious adverse event reports,
reports of quality problems, and state requests)
•FDA has also been conducting proactive
inspections to identify pharmacies with deficient sterile practices
•FDA will continue these efforts as
available resources permit
quoted from - Compounding Pharmacies - Erika Butler, Drug Specialist, U.S. Food and Drug AdministrationJustices silent over execution drug secrecy
WASHINGTON (AP) — No U.S. Supreme Court justice has emerged as a principled opponent of the death penalty, even as the number of executions annually in the country has dropped by more than half over the past 15 years and the court has barred states from killing juveniles and the mentally disabled.
No one on the Supreme Court objected publicly when the justices voted to let Arizona proceed with the execution of Joseph Wood, who unsuccessfully sought information about the drugs that would be used to kill him. Inmates in Florida and Missouri went to their deaths by lethal injection in the preceding weeks after the high court refused to block their executions. Again, no justice said the executions should be stopped.
"They're all voting to kill them, every so often. They do it in a very workmanlike, technocratic fashion," Stephen Bright, a veteran death penalty lawyer in Georgia, said of the high court.
Wood's execution on July 23 was the 26th in the United States this year and the third in which prisoners took much longer than usual to die. Wood, convicted of killing his estranged girlfriend and her father, was pronounced dead nearly two hours after his execution began, and an Associated Press reporter was among witnesses who said Wood appeared to gasp repeatedly, hundreds of times in all, before he died.
Justice Ruth Bader Ginsburg said she and her colleagues are aware of what happened in Arizona, though she declined to say how the court would rule on a plea to stop the next scheduled execution — of Michael Worthington on Wednesday in Missouri.
continue to read here
"They're all voting to kill them, every so often. They do it in a very workmanlike, technocratic fashion," Stephen Bright, a veteran death penalty lawyer in Georgia, said of the high court.
Wood's execution on July 23 was the 26th in the United States this year and the third in which prisoners took much longer than usual to die. Wood, convicted of killing his estranged girlfriend and her father, was pronounced dead nearly two hours after his execution began, and an Associated Press reporter was among witnesses who said Wood appeared to gasp repeatedly, hundreds of times in all, before he died.
Justice Ruth Bader Ginsburg said she and her colleagues are aware of what happened in Arizona, though she declined to say how the court would rule on a plea to stop the next scheduled execution — of Michael Worthington on Wednesday in Missouri.
continue to read here
Saturday, August 2, 2014
Questions all Veterinarians Should Ask A Compounding Pharmacists; Pet Owners May also want to ask these Questions
Questions to ask your compounder:
• What FDA approved drug will you use to compound the product that I
have prescribed?
• Do you have this prescription available for shipment now or do you
formulate each prescription individually?
• What training have you received on compounding drugs for use in
veterinary medicine?
• How will you determine the expiration date for my compounded
prescription?
• How do you handle any reports of adverse events associated with the
products you compound?
quoted from here
Types of Animal Compounding Activities that May Result in FDA Enforcement Action; If you have already violated any of these, you should consult an attorney for advice
• Compounding a veterinary drug if an approved veterinary or human drug
exists to treat the diagnosed condition,
• Compounding drug products that are copies of commercially available FDA approved
drug products,
• Compounding when there is no valid Veterinarian-Client-Patient relationship,
• Compounding from unapproved drug products or bulk drug substances,
• Compounding veterinary drugs in anticipation of receiving prescriptions,
• Compounding of drug products in bulk using commercial scale manufacturing
equipment,
• Compounding drugs for use when the health of the patient is not threatened or
suffering or death may result from failure to treat,
• Compounding a veterinary drug from a human drug that has been removed
from marketing due to human safety concerns. For example, cisapride, which
is only available under a restricted distribution system.
• Compounding from a human drug for food-producing animals if an approved
food animal drug can be used. Due to food-safety issues, the FDA prohibits
the extralabel use of some drugs in food-producing animals. A list of these
restricted drugs can be found in 21 CFR 530.41.
• Offering compounded drug products at wholesale to other state-licensed
persons or commercial entities for resale,
• Labeling a compounded drug with a withdrawal time established by the
pharmacist and not the prescribing veterinarian,
• Compounding veterinary drugs without regard to state pharmacy laws
quoted from here
Observation: In the last couple of months, It is unbelievable how many statements, advertisements, etc. appear to be flaunting that compounding pharmacists and pharmacies are violating state and federal la almost in a catch me if you can manner.. These may turn out to be the best evidence for the FDA to use for criminal prosecutions and civil enforcement.
Federal Judge Dismisses Dutrow Lawsuit
A federal judge has dismissed a lawsuit filed by trainer Rick Dutrow Jr. against the New York State Gaming Commission, the Association of Racing Commissioners International, and two New York regulators.
Dutrow, who had his license revoked for 10 years by the New York regulatory board, filed the suit against the New York State Racing and Wagering Board (predecessor to the Gaming Commission), John Sabini, who had served as chairman of the NYSRWB and RCI (as well as in other RCI roles); and NYSRWB members Daniel Hogan and Charles Diamond.
Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/86455/federal-judge-dismisses-dutrow-lawsuit#ixzz39Hx39D35
Dutrow, who had his license revoked for 10 years by the New York regulatory board, filed the suit against the New York State Racing and Wagering Board (predecessor to the Gaming Commission), John Sabini, who had served as chairman of the NYSRWB and RCI (as well as in other RCI roles); and NYSRWB members Daniel Hogan and Charles Diamond.
Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/86455/federal-judge-dismisses-dutrow-lawsuit#ixzz39Hx39D35
Third Question of the Day August 2, 2014 Should all organizations and groups involving horses adopt a rule that states: “For the purpose of this rule a forbidden substance should be considered any substance that is not FDA approved for equine use and prescribed by a licensed veterinarian? Why or why not?”
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