| Drugs | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831*** | Lot number: 12052013:03 Expiration date: 06/03/2014 | Class II | Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping | RX South LLC DBA RX3 Pharmacy |
Wednesday, March 26, 2014
RX south LLC dba RX# Pharmacy--
Hospira, Inc. Particles in vial
| Drugs | Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30. | Lot 25-220-DD, Exp 1JAN2015 | Class I | Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. | Hospira Inc. |
Oklahoma Told It Can’t Shield Suppliers of Execution Drugs
An Oklahoma judge ruled on Wednesday that the state could not keep secret the identities of the suppliers of lethal-injection drugs, raising doubts about the executions of two prisoners next month and fueling a growing legal battle in several states over secrecy in methods of execution.
The state argued that a supplier-secrecy law, passed in 2011, was necessary because of a shortage of execution drugs and threats against companies that supply them. But lawyers for the two prisoners, Clayton Lockett and Charles Warner, countered that without knowing the source of the drugs, courts could not determine whether the execution protocol satisfied the constitutional ban on cruel and unusual punishment, and prisoners were denied the right to know, and potentially question, how they would be put to death.
Judge Patricia Parrish, of the Oklahoma County District Court, declared the secrecy statute to be an unconstitutional violation of due process in an oral decision from the bench.
continue to read here
Condemned inmates seek info on lethal drug By Mike Ward, Austin Bureau : March 26, 2014
AUSTIN — Two condemned killers, including a one-time drifter who claimed he killed 70 people in a cross-country crime spree spanning 19 years, have sued state officials to force them to disclose details about the execution drugs that will be used to end their lives.
In a lawsuit filed in Travis County state court, Tommy Lynn Sells, 49, and Ramiro Hernandez Llanes, 44, alleged the Texas Department of Criminal Justice is illegally refusing to provide their attorneys with information about the powerful barbiturate pentobarbital that will be used to execute them, despite earlier court orders and attorney general opinions making that information available to them and the public.
continue to read here
In a lawsuit filed in Travis County state court, Tommy Lynn Sells, 49, and Ramiro Hernandez Llanes, 44, alleged the Texas Department of Criminal Justice is illegally refusing to provide their attorneys with information about the powerful barbiturate pentobarbital that will be used to execute them, despite earlier court orders and attorney general opinions making that information available to them and the public.
continue to read here
Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--31 Comments Now Available for Public Viewing
-
See Attached
-
Public Submission
-
Posted:03/10/2014
-
ID:FDA-2013-N-1523-0008
-
Agency:FDA
-
RIN:Not Assigned
-
Docket ID:
-
Organization:
-
Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
-
NOMINATION: Human Chorionic Gonadotropin (hCG) in any dosage form not injectable (i.e. it is "difficult to compound" hCG in oral, sublingual, intranasal, and topical delivery...
-
Public Submission
-
Posted:02/06/2014
-
ID:FDA-2013-N-1523-0002
-
Agency:FDA
-
RIN:Not Assigned
-
Docket ID:
-
Organization:
-
Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
-
See Attached
-
Public Submission
-
Posted:03/07/2014
-
ID:FDA-2013-N-1523-0007
-
Agency:FDA
-
RIN:Not Assigned
-
Docket ID:
-
Organization:
-
Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
-
See attached file(s)
-
Public Submission
-
Posted:03/21/2014
-
ID:FDA-2013-N-1523-0030
-
Agency:FDA
-
RIN:Not Assigned
-
Docket ID:
-
Organization:
-
Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
-
See attached file(s)
-
Public Submission
-
Posted:03/21/2014
-
ID:FDA-2013-N-1523-0029
-
Agency:FDA
-
RIN:Not Assigned
-
Docket ID:
-
Organization:
-
Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
-
See attached file(s)
-
Public Submission
-
Posted:03/21/2014
-
ID:FDA-2013-N-1523-0021
-
Agency:FDA
-
RIN:Not Assigned
-
Docket ID:
-
Organization:
-
Submitter Name:
Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations--Letters Posted so Far for Public Viewing
-
See Attached
-
Public Submission
-
Posted:03/07/2014
-
ID:FDA-2013-N-1525-0002
-
Agency:FDA
-
RIN:Not Assigned
-
Docket ID:
-
Organization:
-
Submitter Name:
Comment Period Closed
Mar 04, 2014 11:59 PM ET
FDA Issues Second 483 to Leiter's Cambrian Park Drugs, Inc. dba Leiter's Compounding Pharmacy, San Jose, CA
Leiter's Cambrian Park Drugs, Inc. (dba Leiter's Compounding Pharmacy), San Jose,
CA
- 483 Issued 03/06/201466 (PDF - 1.3MB)
Recall on Bella Vi Dietary Supplement
| 03/26/2014 | Bella Vi | Dietary Supplement | Products contain undeclared Sibutramine and/or combination of Sibutramine and Phenolphthalein | Pure Edge Nutrition, LLC |
FDA to drugmakers: Tell doctors, patients not all drug approvals are permanent
 |
Posted: March 25, 2014 - 3:00 pm ET
The Food and Drug Administration wants drugmakers to change labeling on drugs approved through the accelerated approval pathway so doctors and patients know such approvals could subsequently be revoked.
A new FDA guidance (PDF) seeks to clarify how drugs approved through the accelerated approval pathway should be labeled. The pathway in question is used to expedite the approval of medicines intended to treat serious or unmet needs. For instance, if there is a promising drug for a certain type of cancer that shows some early signs of benefit, that product could receive tentative accelerated approval.
continue to read here
|
Another Compounding Pharmacy Sales Rep Opening
Compounding Pharmacy Sales Rep-With Experience ONLY! (Hallandale)
Compounding Pharmacy in South Florida searching for experienced sales person.
Candidate must have:
1. Experience selling sterile and non-sterile compounded medications
2. Background in Anti-Aging, Hormone Replacement, Pain Management, Dermatology, Erectile Dysfunction
3. Able to travel if necessary and manage clients remotely (through technology)
4. Fluent in English (and Spanish a plus but not required)
Serious Candidates only!
Send by email Resume with "position-your name" in email subject line.
compensation: Dependent on Experience
telecommuting okay
Candidate must have:
1. Experience selling sterile and non-sterile compounded medications
2. Background in Anti-Aging, Hormone Replacement, Pain Management, Dermatology, Erectile Dysfunction
3. Able to travel if necessary and manage clients remotely (through technology)
4. Fluent in English (and Spanish a plus but not required)
Serious Candidates only!
Send by email Resume with "position-your name" in email subject line.
- Principals only. Recruiters, please don't contact this job poster.
- do NOT contact us with unsolicited services or offers
post id: 4391746346
posted:
updated:
Tuesday, March 25, 2014
FDA Recall on Super Fat Burner, Maxi Gold and Esmeralda
| 03/25/2014 | Super Fat Burner, Maxi Gold, and Esmeralda | Dietary Supplement | Unapproved new drug | New Life Nutritional Center |  |
The Ugly Truth About Horse Racing
The Ugly Truth About Horse Racing
An exposé by PETA, published in The New York Times, shows a side of the sport that the industry has tried hard to shield from public view.
Tom Noonan--Yet Another Wake Up Call for Horse Racing
Posted in: Horse Racing, Political/Social commentary, Politics. Tagged: Lasix, New York Gaming Commission, New York Times, NYRA, PETA, Scott Blasi, Steve Asmussen, The Atlantic, Thoroughbred Racing Commentary. Leave a comment
Racing at Saratoga brings many of the nation’s best horses, trainers and jockeys to the Spa for a 40-day meet in a resort atmosphere. It also brings industry leaders who participate in the several seminars that take place. Last year the unifying theme may well have been drugs and the public’s perception of widespread abuse.
At one such session last year, trainer John Kimmel lambasted those who thought that mistreatment of horses was a problem, blaming it on - wait for it - the media. He challenged them to go to the backstretch to observe how well the horses are cared for. Little did he know that as he was speaking, someone was doing just that, armed with a video camera. This week, the work of the undercover investigator for PETA (People for the Ethical Treatment of Animals) became public courtesy of Joe Drape of The New York Times and PETA’s web site.
According to Drape’s piece, the investigator worked in Steve Asmussen’s barn at Churchill Downs and Saratoga for four months. It is clear no one was aware they were being recorded. PETA has filed complaints with ten federal and state agencies based on the investigation, but it is a nine-minute video that has the racing world abuzz. Among PETA’s allegations are the mistreatment of horses, the use of batteries to shock horses, administration of Lasix as a performance-enhancing drug, and numerous violations of employment laws
read here
At one such session last year, trainer John Kimmel lambasted those who thought that mistreatment of horses was a problem, blaming it on - wait for it - the media. He challenged them to go to the backstretch to observe how well the horses are cared for. Little did he know that as he was speaking, someone was doing just that, armed with a video camera. This week, the work of the undercover investigator for PETA (People for the Ethical Treatment of Animals) became public courtesy of Joe Drape of The New York Times and PETA’s web site.
According to Drape’s piece, the investigator worked in Steve Asmussen’s barn at Churchill Downs and Saratoga for four months. It is clear no one was aware they were being recorded. PETA has filed complaints with ten federal and state agencies based on the investigation, but it is a nine-minute video that has the racing world abuzz. Among PETA’s allegations are the mistreatment of horses, the use of batteries to shock horses, administration of Lasix as a performance-enhancing drug, and numerous violations of employment laws
read here
Clean up ‘chemical’ horse racing
It’s time for the U.S. Anti-Doping Agency to step in and clean up the thoroughbred racing industry’s addiction to drugs.
As The New York Times has just reported, over a period of four months, a PETA investigator worked for well-known trainer Steve Asmussen, trainer of Curlin and Rachel Alexandra, at two of the most famous racetracks in America: Churchill Downs in Kentucky and the Saratoga Race Course in New York. PETA’s investigation exposed many serious problems but none more harmful than the routine, pervasive and improper use of prescription drugs during training, a regimen that has begun the downward spiral to the slaughterhouse for thousands of horses.
Fragile young horses — raced before their bones have fully matured and unable to handle the pounding and stress — suffer routinely from injuries, lameness, exhaustion and what is euphemistically called "soreness." Owners don’t want to waste time waiting until foals are physically capable. They want to get the cash flow started.
continue to read here
As The New York Times has just reported, over a period of four months, a PETA investigator worked for well-known trainer Steve Asmussen, trainer of Curlin and Rachel Alexandra, at two of the most famous racetracks in America: Churchill Downs in Kentucky and the Saratoga Race Course in New York. PETA’s investigation exposed many serious problems but none more harmful than the routine, pervasive and improper use of prescription drugs during training, a regimen that has begun the downward spiral to the slaughterhouse for thousands of horses.
Fragile young horses — raced before their bones have fully matured and unable to handle the pounding and stress — suffer routinely from injuries, lameness, exhaustion and what is euphemistically called "soreness." Owners don’t want to waste time waiting until foals are physically capable. They want to get the cash flow started.
continue to read here
India cracks down on same Wockhardt plants FDA has banned
Read more: India cracks down on same Wockhardt plants FDA has banned - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/india-cracks-down-same-wockhardt-plants-fda-has-banned/2014-03-24#ixzz2x09iwbnq
Subscribe at FiercePharma Manufacturing
FDA approves J&J to make bulk Doxil at closed Ben Venue plant
Janssen has another manufacturer finish off the drug as part of an 'alternative' process
Read more: FDA approves J&J to make bulk Doxil at closed Ben Venue plant - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-approves-jj-make-bulk-doxil-closed-ben-venue-plant/2014-03-25#ixzz2x09NMNZN
Subscribe at FiercePharma Manufacturing
Hospira CEO gets nearly $10M for steering drugmaker through issues
F. Michael Ball gets $1.1M boost to total compensation in 2013
Read more: Hospira CEO gets nearly $10M for steering drugmaker through issues - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/hospira-ceo-gets-nearly-10-million-steering-drugmaker-through-issues/2014-03-25#ixzz2x091bwIo
Subscribe at FiercePharma Manufacturing
Pharmacists Urged Not to Assist US Executions
Several human rights and anti-death penalty groups have asked the American Pharmacists Association to prohibit members from participating in executions, a request that comes as states increasingly turn to pharmacists for lethal injection drugs.
The groups, which include Amnesty International, the NAACP and the American Civil Liberties Union, are targeting so-called compounded drugs. Such drugs, which are not federally regulated, are individually mixed versions of medications that prison systems are finding increasingly difficult to obtain.
Death penalty opponents say such drugs put inmates at risk of pain and suffering. Two years ago, an outbreak of meningitis that killed 64 and sickened hundreds was traced to a compounding facility in Massachusetts.
Pharmacists who provide compounded drugs are violating key provisions of the pharmacists' association code of ethics, including helping patients achieve "optimum benefit" from their medications, according to a letter the death penalty opponents presented to the association on Monday.
continue to read here
The Numbers Are In! 2013 Was An Across-the-Board Record Breaker for Orphan Drugs
See blog post from the FDA Law Blog found here
Make Sure You Check Out the March 2014 Notices Relating to Animal Drugs from the FDA
2014 Notices
Notification of Filing of Food Additive Petition (Animal Use); DSM Nutritional Products 2
March 25, 2014; 79 FR 16252Final Rule; Technical Amendment; Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor 3
March 25, 2014; 79 FR 16180Final Rule; Zoetis, Inc., Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin 4
March 20, 2014; 79 FR 15541Notification of Withdrawal of Approval of New Animal Drug Application; Chlortetracyline; Sulfathiazole; Penicillin 5
March 20, 2014; 79 FR 15540Notice of Agency Information Collection Activities; Designation of New Animal Drugs for Minor Use or Minor Species; Final Rule 6
March 17, 2014; 79 FR 14713Proposed Rule; Confidentiality of Data and Information in a New Animal Drug Application File 7
March 17, 2014; 79 FR 14630Direct Final Rule; Confidentiality of Data and Information in a New Animal Drug Application File 8
March 17, 2014; 79 FR 14609Final Rule; Food Additives Permitted in Feed and Drinking Water of Animals; Benzoic Acid 9
March 13, 2014; 79 FR 14175New Animal Drugs; Change of Sponsor; Final Rule; Technical Amendment 10
March 11, 2014; 79 FR 13542Notice of Filing of Food Additive Petition (Animal Use); Kemin Industries, Inc. 11
March 10, 2014; 79 FR 13263
Monday, March 24, 2014
AQHA Medication Statement AQHA calls for industry action on medication use.
AQHA Medication Statement
AQHA calls for industry action on medication use.
In November 2010, the American Quarter Horse Association gathered together a group of industry experts, including horsemen, officials and medication experts, to discuss the state of medication use in American Quarter Horse racing. Since then, the Association has worked with industry leaders to address matters regarding the use of medications. With recent occurrences of serious medication violations, the Association confirms its stance on the proper use of medications in racing American Quarter Horses, and calls for the industry to further address the issues.
“The American Quarter Horse Association firmly believes racing must be fair and clean for all involved,” said American Quarter Horse Association Executive Vice President Don Treadway Jr. “We also know that recent events are not representative of the actions of tens of thousands of our members, owners and trainers. We continue to work to develop more uniformity within the industry and to further deter the few who seek to cheat.”
AQHA Statement on Medication Use
The American Quarter Horse Association continues its longstanding support of the racing industry and its horsemen. This includes racing that is clean, fair and provides a great experience for the horse, jockey, owner and fan base. AQHA continuously works to ensure not only the integrity and welfare of American Quarter Horses, but also the integrity and welfare of the entire horse industry.
AQHA urges stewards and racing authorities in every racing jurisdiction to levy the maximum penalties allowable against people who are doping our horses, endangering their lives, the lives of jockeys and horsemen and cheating our fans. AQHA also advocates that stronger penalties be developed uniformly that will ban these cheaters from our industry for life. The use of illegal substances will not be tolerated and AQHA is exploring all options to use our resources and funding to assist in identifying and testing new drug variations and prosecuting to the fullest extent possible – including criminal charges -- anyone that uses any illegal drug. The horse racing industry must come together and without question adopt the current model rules, and regardless of breed or role in the industry develop the processes and procedures to address future situations with the strictest penalties we can develop.
An Endorsement of the Horse Racing Integrity and Safety Act of 2013
In case you haven't seen it, here is the letter PETA has sent out in conjunction to the sting on the Steve Asmussen stable at Churchill Downs and Saratoga Racetrack. For PETA, it is a rather tame letter, their main goal is the passage of the Horse Racing Integrity and Safety Act of 2013. Only at the end of the letter does PETA suggest people decide if they wish to patronize horse racing.
Continue to read here
Continue to read here
The Horse: Groups Step Up Call for Model Racehorse Drug Rules
Racing industry organizations have stepped up their call for swift adoption of national model rules on medication and drug testing in the wake of investigations into allegations of mistreatment and over-medication of Thoroughbred racehorses.
continue to read here
continue to read here
House looks to rein in compounding pharmacies--Florida
The News Service of Florida
Published: Monday, March 24, 2014 at 4:39 p.m.
Last Modified: Monday, March 24, 2014 at 4:39 p.m.
A House panel Monday unanimously approved a bill aimed at preventing a repeat of a 2012 outbreak of fungal meningitis because of problems at a Massachusetts pharmacy.
HB 7077, sponsored by Rep. Jimmy Patronis, R-Panama City, would set registration requirements and standards for what are known as "compounding pharmacies" that are located in other states but sell medications in Florida. Those pharmacies, in general, create medications that are supposed to be tailored to the needs of individual patients.
Rep. Elaine Schwartz, D-Hollywood, praised the bill, calling it a "public safety issue." But she also raised a question about part of the bill that would allow Florida health officials to travel to out-of-state pharmacies to conduct inspections.
read here
Rep. Elaine Schwartz, D-Hollywood, praised the bill, calling it a "public safety issue." But she also raised a question about part of the bill that would allow Florida health officials to travel to out-of-state pharmacies to conduct inspections.
read here
Another job Opening for a Compounding Sales Rep-- Dallas, Texas
| ||||
| Job Title: | Pharmaceutical Sales Rep | |||
| Job Category: | Pharmaceutical/Biotech / Sales [ View All Pharmaceutical/Biotech Jobs ] | |||
| Job description: | ||||
| Click Meds Rx is currently looking for sales reps in the Dallas area. We are a compounding pharmacy rep group that currently provides prescriptions for pain creams, scar removal creams, nebulized antibiotics, wart removal creams, and wound care creams. That list is constantly growing, and not limited to the compounded medications above though. We have created an online system to increase prescriptions written by physicians, while increasing accountability between doctors, patients, and the pharmacy. Our system also creates better accountability between the pharmacy and the sales rep. If you are currently a compounding pharmacy sales rep, and tired of your boss/pharmacy/whatever, give me a call and we can help you out While experience in compounded medication sales is preffered, it is not required. If you are interested in breaking into the compounding sales rep field we will still consider you!!! | ||||
| Skills: | Experience with compounding pharmacy sales beneficial but not required. | |||
| Employment type: | Contract | |||
| Salary: | commission only USD | |||
Other Information
| ||||
| Degree: | Unspecified | |||
| Experience (year): | Unspecified | |||
| Job Location: | US-Texas-Dallas | |||
| Address: | 18117 hwy 69 N lindale, tx, 75771 | |||
| Zip/Postal Code: | 75771 | |||
| Post Date: | 03/24/2014 / Viewed 15 times | |||
Contact Information
| ||||
| Company: | Click Meds RX | |||
| Contact Name: | Zack Thompson | |||
| Contact Phone: | 903-714-1310 | |||
Horse racing's daily double: drugs and death
Horse racing's daily double: drugs and death
People for the Ethical Treatment of AnimalsMarch 24, 2014
It's time for the U.S. Anti-Doping Agency to step in and clean up the thoroughbred racing industry's addiction to drugs. As The New York Times has just reported, over a period of four months, a PETA investigator worked for well-known trainer Steve Asmussen, trainer of Curlin and Rachel Alexandra, at two of the most famous racetracks in America: Churchill Downs in Kentucky and the Saratoga Race Course in New York. PETA's investigation exposed many serious problems but none more harmful than the routine, pervasive and improper use of prescription drugs during training, a regimen that has begun the downward spiral to the slaughterhouse for thousands of horses.
Fragile young horses - raced before their bones have fully matured and unable to handle the pounding and stress - suffer routinely from injuries, lameness, exhaustion and what is euphemistically called "soreness." Owners don't want to waste time waiting until foals are physically capable. They want to get the cash flow started.continue to read here
Fragile young horses - raced before their bones have fully matured and unable to handle the pounding and stress - suffer routinely from injuries, lameness, exhaustion and what is euphemistically called "soreness." Owners don't want to waste time waiting until foals are physically capable. They want to get the cash flow started.continue to read here
Veterinary Pharmacy Launches Essay Contest for Students in Veterinary Medical and Technician Programs
Diamondback Drugs launches the 2nd Annual Max Memorial Essay Contest for students enrolled in accredited veterinary medical and technician programs throughout the United States.
read here
read here
Subscribe to:
Posts (Atom)