Sunday, March 31, 2013

Mass. weighs new regs for compounding pharmacies

BOSTON (AP) — Lawmakers are considering changes in how sterile compounding pharmacies are regulated after a deadly nationwide fungal meningitis outbreak that was linked to a steroid distributed by a Massachusetts firm.
The Legislature's public health committee has scheduled a hearing for Tuesday on several proposals that call for strengthening oversight and licensing of the pharmacies.
Among them is a bill filed by Gov. Deval Patrick that would require compounding pharmacies to obtain a special state license. The bill would also create whistleblower protections for pharmacy workers and enforce new fines and penalties for compounding pharmacies that break the rules.
More than 50 deaths and hundreds of illnesses have been tied to the meningitis outbreak. New England Compounding Center of Framingham shut down operations last fall.

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United States: FDA Emphasizes Patient-Specific Prescriptions

The FDA's reliance on the compliance policy guide as a basis for the need for a patient-specific prescription is also noteworthy.
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date against compounding pharmacies on the issue of patient-specific prescriptions. The FDA stated that the receipt of a valid prescription for an individually identified patient prior to the distribution of compounded drugs is "relevant" to Section 503A (21 U.S.C. 353a) of the Food and Drug Administration Modernization Act (FDAMA) and the compliance policy guide FDA issued on compounding issued in 2002 (CPG). Based on Medi-Fare Drug's alleged lack of patient specific prescriptions, the FDA also stated the compounds were unapproved new drugs that had not been through the drug approval process.
The FDA's use of FDAMA is noteworthy in light of a circuit split that created conflicting decisions regarding FDAMA. An amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), FDAMA regulates compounds. FDAMA exempts compounds from certain FDCA requirements if the compounds, among other things, are prepared "on prescription order for [an] individual patient."1 FDAMA also contained an advertising ban, which the United States Supreme Court struck down as unconstitutional inWestern States.2 The Ninth Circuit in Western States found the advertising provision could not be severed from the remainder of FDAMA, and therefore found the entire statute unconstitutional.3 In 2008, the Fifth Circuit disagreed with the Ninth Circuit, finding FDAMA's advertising provision could be severed, thereby resurrecting the remainder of FDAMA and declaring it good law.4 Since that time, the FDA has applied FDAMA in the Fifth Circuit and to the pharmacies who were plaintiffs in the suit. The FDA has not applied FDAMA to the remainder of the country.
Medi-Fare Drug is located in South Carolina, which is not in the Fifth Circuit, and Medi-Fare Drug was not a plaintiff in the Fifth Circuit suit. By basing its claim that individually identified patients prescriptions are required partly on FDAMA, the FDA is applying FDAMA requirements to a pharmacy that is not located in the district where it is the law.

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As officials investigate, patients fear the future

Lawsuits in meningitis outbreak aim to ease toll from mounting bills, failing health.

DETROIT -- In September, Milda Mattila became unsteady on her legs. Soon, she was unable to walk.
The 87-year-old South Lyon, Mich., woman had been infected with fungal meningitis through a tainted steroid shot meant to relieve back pain.
"Why did I have to get this?" she asked her family.
That question fills households and hospital rooms as hundreds of people struggle with the physical, emotional and financial scars left in the wake of the national fungal meningitis outbreak that has killed at least 51 people. Nationwide, 730 people have fallen ill.
Investigations of the compounding pharmacy that produced the tainted shots are ongoing. Lawmakers and officials at federal and state agencies are trying to make sure that a similar crisis never happens again. Patients face an uncertain future with no ready answers on whether they will ever fully recover or who will pay their mounting hospital bills. Lawsuits are pending, but the company behind the outbreak has filed for bankruptcy protection.
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In 2006 ASHP Urged More Control Over Sterile Compounding and Recognized The Piece Meal State Action

Compounding issues are always on the docket at pharmacy meetings, but the subject almost never draws the attention of mainstream media—at least in the absence of tragedy.
That’s precisely what caught the eye of USA Today, which recently rehashed a relatively recent episode involving contaminated heart-surgery solution from an outsourcing firm implicated in nearly a dozen illnesses and three deaths at a Virginia hospital.
The article prompted a response by the American Society of Health System Pharmacists (ASHP), and representatives of the group met recently with members of Congress to call for more active regulation of compounding by the Food and Drug Administration (FDA). Whether the latest revival of attention is sufficient to stir legislative action at the federal level remains to be seen.
Central to the matter, too, is the effect stricter industry standards are having on small hospitals, many of which cannot afford to meet the physical and financial burdens of complying with the rules. As these hospitals look to outside firms to prepare their sterile solutions, they may be putting themselves at risk, since not all outsourcing companies take adequate steps to ensure the safety of their products.
Deaths Prompt Lawsuits
In early August, USA Today reported on the trouble with bacteria-tainted cardioplegia surgery solution blamed for at least 11 illnesses and four deaths among patients at Mary Washington Hospital in Virginia from December 2004 to September 2005. The cases sparked lawsuits against the compounder, Central Admixture Pharmacy Services (CAPS), a Lanham, Md.–based division of B. Braun Medical, Inc., as well as the Fredericksburg facility.
CAPS is not a stranger to FDA action. A search of the agency’s Web site revealed several incidents in which the compounder’s products have been recalled because of safety issues. In 1998, for example, the company had to take back eight cases of heparin syringes that had been mismarked as saline flush syringes. Also that year, CAPS recalled nearly 137,000 syringes after some were found to be contaminated with Enterobacter cloacae, a leading cause of hospital-acquired infections. B. Braun declined to comment on its subsidiary.
In a letter to USA Today on August 9, ASHP CEO Henri R. Manasse Jr, PhD, ScD, called patient injury associated with compounding “entirely preventable.” He chose to target his comments not just on outsourcing firms but also hospitals themselves.
“It is imperative that pharmacists and pharmacy technicians be adequately trained and have sufficient facilities and equipment that meet technical and professional standards,” Dr. Manasse wrote. “When hospitals and other care settings outsource some aspects of pharmacy services such as sterile compounding, those organizations and their pharmacy departments must share the accountability for patient outcomes stemming from all medication-related activities performed by contractors on- or off-site.”
However, Dr. Manasse added, regulators also bear responsibility for ensuring the safety of compounded products. “The fact that Central Admixture Pharmacy Services is a Food and Drug Administration–registered facility suggests that a re-examination of the regulatory framework (including rigor and frequency of inspections) of commercial large-scale operations that compound sterile products for hospitals is in order,” he stated.
The extent of compounding is not fully known. Congressional testimony from the Government Accountability Office (GAO, formerly the Government Accounting Office) in 2003 cited a 2001 FDA estimate that 6% of all prescriptions were compounded. The GAO, however, stressed that there was “considerable uncertainty” about that figure.
Although the FDA regulates compounders—which also fall under rules set by state boards of pharmacy—ASHP fears that oversight is insufficient. “We do believe the regulatory framework through the FDA needs to be examined,” said Kasey Thompson, PharmD, the group’s Director of Patient Safety. “Apparently, it’s not the same as that covering a pharmaceutical manufacturer and may not have the same regulatory strength in terms of good compounding practices.”
Dr. Thompson and his ASHP colleagues recently went to Capitol Hill to brief senators about the issues surrounding compounding.
The pharmacy association is particularly concerned for its members from smaller hospitals that cannot shoulder the cost of complying with standards for sterile preparation—and as a result must outsource sterile product preparation.
“Implicit in this case is that a group like CAPS that’s registered with FDA and has national operations has advertised to meet professional standards, such as USP <797>, and can fill that void,” Dr. Thompson said, referring to the U.S. Pharmacopoeia’s 2004 rules governing sterile preparation of pharmaceuticals. “Outsourced compounding does fill a void, but you have to have faith in the outsourcer and the processes they use.”
Bill Zeruld, a spokesman for the U.S. Pharmacopoeia, said his group does not enforce the <797> standard, nor does it track how many hospitals or compounders comply with its requirements. Although the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) looks for <797> compliance in its inspections, the group said it does not collect data on the number of facilities nationwide that meet the standard.
Charlene Hill, a JCAHO spokeswoman, called <797> “a valuable set of guidelines that describe a best practice for establishing safe processes in compounding sterile medications.” However, Ms. Hill added, when surveying, “we’re not [assessing compliance with] those guidelines,” which are more specific than JCAHO’s own standards.

Pharmacy directors at hospitals that rely on outsourcing for their sterile products must know, Dr. Thompson said, that the onus of verifying the safety of those products rests ultimately on their shoulders. “The hospital has to definitively say that the outsourcer has safe processes in place and has documentation to prove its compounding operations are in compliance with state and federal laws, and nationally recognized standards of practice,” he said.
And as for hospitals that do their own compounding, ASHP offers “very comprehensive” training programs, documentation and even Internet-based information, Dr. Thompson added.
Piecemeal State Action
Some states have been trying to address the safety of compounded and outsourced pharmaceutical products, with mixed success. Missouri was the first state to implement random batch testing of compounded drugs, including both sterile and non-sterile products, according to the 2003 GAO testimony.
Louis Ling, JD, General Counsel for the Nevada Board of Pharmacy in Reno, said his agency has been working to create compounding rules for roughly the last four years. “The problem has been that throughout this period, JCAHO and USP have been shifting their standards, which makes it tough when you’re trying to shoot at a moving target,” Mr. Ling said.
Although Nevada’s regulations are not yet finalized, Mr. Ling said they will follow the dictates of USP <797>. Facilities will need to maintain their physical plants to the standards covering the highest risk levels for the products they will be working with, he said, and some form of testing regimen will exist. How rigorous those tests will be, and their frequency—whether random or routine—is unclear for the moment, Mr. Ling said. “That’s a point that we’re all discussing right now.”
What has been determined, he added, is that, in the case of outsourcing firms, the burden of testing will fall on the compounders, not the hospitals that purchase their products. “Somewhere along the way the compounding pharmacies are going to have to be verifying their methods for both potency, which addresses dilution issues, and sterility,” he said.
Like ASHP, the Nevada board is sensitive to the pressures facing the state’s smaller hospitals, many of which, particularly those in rural areas, have fewer than 100 beds. “Fortunately,” Mr. Ling said, “it appears that these regulations are not going to completely keep the rural hospitals from addressing the needs of their patients.”
The logic of outsourcing sterile product preparation is certainly understandable, given the economic and staffing pressures faced by many small hospitals. But as the CAPS episode illustrates, facilities that choose to outsource should have a way to control the quality of the products for which they contract.
“The most important thing is adherence to current standards and best practices, and having adequate facilities where sterility can be assured,” Dr. Thompson said. “Just as important,” he added, “is that staff are adequately trained and qualified,” and faithful to sound infection control practices and aseptic techniques.
“At the end of the day,” he said, “if somebody doesn’t wash his hands, you can have all the equipment in the world and you’re not going to have sterile products.”
Source found here 

Brilliant Blue G Eye Infection Lawsuits Filed Over Recalled Surgical Dye

By: Irvin Jackson | Published: March 29th, 2013

At least four lawsuits have been filed this month against Franck’s Compounding Lab, alleging that individuals suffered severe eye infections that were caused by contaminated doses of Brilliant Blue G, an eye surgery dye.
The product liability lawsuits accuse the compounding pharmacy of distributing contaminated and unsafe drugs, which led to their eye infections.
As a result of problems from Brilliant Blue G surgical dye, plaintiffs allege that they suffered debilitating eye injuries and permanent blindness in some cases.
The complaints were filed by Howard McMaster (PDF) and Brenda Hess (PDF) in the U.S. District Court for the District of Nevada, and by Eldon McKinley (PDF) and Bernice Tharp (PDF) in the U.S. District Court for the Northern District of Indiana.
Each of the lawsuits indicate that the plaintiffs received Brilliant Blue G during an eye procedure in November 2011, including cataract surgery and vitrectomy procedures.

Brilliant Blue G Recall Issued Due to Contamination

Brilliant Blue G is a compounded medication that was sold by Frank’s Compounding Lab to opthalmologists, who were told the product was safe to inject into the patient’s eyeball during surgery to help the doctor achieve desired results during the procedure.
In March 2012, Franck’s Compounding Pharmacy issued a Brilliant Blue G recall, following multiple reports of eye infections.
About two months later, the FDA issued a safety alert announcing the recall for all sterile human and veterinary prescriptions distributed by the pharmacy after investigators discovered microorganisms and fungal growth in areas of the facility that were supposed to be sterile.
According to a report by the U.S. Centers for Disease Control and Prevention (CDC) in May 2012, more than 30 confirmed or probable cases of fungal endophthalmitis were identified among patients who underwent eye surgery that involved products distributed by the pharmacy. Brilliant Blue G was linked to 20 of those cases.
Endophthalmitis is an eye infection that results in inflammation of the eye and can lead to vision loss and the loss of the entire eye in some cases. Antibiotics are usually applied via intravitreal injection (an injection into the eye itself), but in some cases eye removal is required.
The recently filed complaint alleges that the compounding pharmacy knew or should have known that the batches of Brilliant Blue G were unsafe for use, pursuing claims under theories of negligence, strict liability, failure to warn and breach of warranty.
The cases come as compounding pharmacies nationwide are undergoing intense scrutiny following a nationwide fungal meningitis outbreak that killed nearly 50 people and sickened more than 700. That outbreak was linked to epidural steroid injections distributed nationwide by the New England Compounding Center (NECC). Later investigations by the FDA discovered fungal contamination of drugs at that facility as well.
NECC also faces a growing number of fungal meningitis outbreak lawsuits, which drove the company into bankruptcy.
Source found here

N. Ind. woman's diagnosis took 5 painful months ANGELLE BARBAZO, Associated Press

Veterinary compounders and veterinarians are trying to block a push by drugmakers to require patient-specific prescriptions before a medication can be made--Lobbyists weigh in on pharmacy oversight

Drug companies are ramping up efforts on Capitol Hill to block specialty pharmacies from mass producing drugs in lightly regulated conditions, urging lawmakers to require that these enterprises return to their traditional roles or face stricter standards.
Commercial drug makers are also pressing a lobbying campaign aimed at stopping these specialty pharmacies, known as compounders, from making “knockoff” drugs for people and their pets that the companies say are costing them millions of dollars in annual profits, records and interviews show.
This rapidly escalating struggle reaches far beyond congressional efforts to rein in reckless compounding pharmacies that began in October after tainted steroids from the Massachusetts-based New England Compounding Center (NECC) were linked to a meningitis outbreak that has killed 48 people.
Amid a public outcry, lawmakers began considering draft legislation to address public safety concerns. With a bill in the works, a range of companies, business associations and health organizations have begun pressing their own interests along a wide front.
Veterinary groups, for instance, have launched their own lobbying campaign opposing the drugmakers. These groups warn that any legislation that required patient-specific prescriptions would deprive them of vital drug stockpiles and that pets would die at their clinics.
Hospitals want to ensure that any new oversight of compounders by the Food and Drug Administration does not cripple the firms’ operations, which could worsen drug shortages.
And the compounders, while agreeing that tighter federal enforcement of safety standards is needed for the large firms, are vigorously resisting the drug companies’ bid to limit competition.
The Senate Health, Education, Labor and Pensions Committee is working on draft legislation directed at compounders and is expected to begin circulating it to interested groups as soon as next month. The House Energy and Commerce Committee, meanwhile, is investigating whether lax oversight of NECC by the FDA contributed to illnesses and deaths.
Since Congress and other federal officials began investigating NECC this fall, the number of groups lobbying on issues related to compounding pharmacies has more than doubled, records show.
“Some are making blatant copies of FDA-approved products,” said Ron Phillips, who is lobbying for the Animal Health Institute, which represents drugmakers. “You can go to any trade show or to their Web sites and they are openly promoting this. A clear line needs to be drawn.”
Over the past two decades, many compounders — who custom-mix medications — have moved from a traditional practice of filling prescriptions for individual patients to mass producing drugs, often without a prescription. Sometimes the drugs are similar to those made by drug manufacturers. Today, compounding is about a $2 billion-a-year industry.
The specialty pharmacists supply about 40 percent of all intravenous medications used in hospitals, up from 16 percent a decade ago, according to industry estimates. Veterinary groups estimate that 20 percent of the medications they prescribe are compounded products.
Compounders also make some of the highest-risk drugs available, sometimes using potent raw ingredients that must go through a critical sterilization process to ensure safety. Many of them are injected directly into patients, such as the steroids linked to the meningitis outbreak, which has sickened 666 people in addition to those who have died.
Yet compounding pharmacies are not required to follow federal safety laws — such as testing their medications for contamination and potency levels — that apply to commercial drugmakers.
As compounders have moved into bulk production, federal regulators have sent conflicting signals about when they will step in.
The drugmaker K-V Pharmaceutical, for instance, won FDA approval in February 2011 for its drug Makena, which is given to pregnant women to prevent premature births, and was given the exclusive right to sell it for seven years. But the following month, the FDA announced it would not take action against pharmacies compounding a similar product.
The day after that announcement, K-V’s stock dropped by more than 60 percent. Since then, the company has cut the per-dose price of Makena from $1,500 to $690.
That episode was widely noted across the drug industry, with compounding experts calling it a watershed moment.
Earlier this winter, officials from K-V Pharmaceuticals were on Capitol Hill for two days, lobbying on the issue and telling congressional staffers that compounded versions of Makena can be “unsafe or ineffective,” said Sarah Sellers, senior director of epidemiology and risk management for K-V’s marketing and distributing arm, Ther-RX.
“If an FDA-approved product is medically appropriate, it should be used preferentially,” Sellers said.
Manufacturers of animal drugs — such as Frontline for flea and tick prevention and Heartgard for heartworm prevention — have also been pushing Congress to stop compounders from making what drug companies consider copycat products.
Compounders say there are times they should be allowed to make products that are essentially copies — when manufactured products are unavailable because of drug shortages and when drugmakers have stopped producing a needed product.
Veterinary compounders and veterinarians are trying to block a push by drugmakers to require patient-specific prescriptions before a medication can be made. Matt Wilson, a partner at Animal Clinic Northview in Ohio, said this creates serious problems in emergency situations. For example, apomorphine is commonly used to induce vomiting in dogs when they have ingested a poison but it must be given within hours to save the pet.
“There are so many drugs that are back-ordered and unavailable. You can’t properly practice medicine if you don’t have these products in hand,” said Wilson, who uses Wedgewood Pharmacy, which is part of the lobbying effort.
Instead of measures that could limit mass production or bar compounds similar to commercial products, compounders are telling Congress they want more-rigorous safety standards for all compounding pharmacies.
The International Academy of Compounding Pharmacists, the industry’s largest trade group, is asking for federal and state legislation that would require compounders to adhere to guidelines that are currently voluntary. The guidelines run more than 400 pages long and were developed by pharmacists, doctors and nurses.
“We believe they need to be mandated by law,” said David G. Miller, IACP’s executive vice president.
Miller said he told congressional staffers that he still wants state inspectors to retain the authority to enforce the standards for most compounding pharmacists. Last month,Miller reversed course on his long-held position that all compounders should be regulated by state boards of pharmacy, saying manufacturing-style firms that market and sell products without patient-specific prescriptions should register with the FDA and be inspected by the agency.
The shift in IACP’s position followed a Washington Post investigation that showed 15 of the nation’s largest compounding pharmacies mass produce medications, often shipping them across state lines without patient prescriptions. The Post also reported that shoddy equipment and unsanitary conditions at some of these firms had caused patient illnesses and deaths long before this fall’s deadly outbreak but that the firms rarely were penalized.
IACP and other groups are squaring off over which pharmacies would fall into the new category and face stepped-up FDA enforcement.
Many compounding experts and drugmakers maintain that size is the key factor for defining this new category.Express Scripts, a company that has a compounding arm that makes fertility drugs, is telling Congress that even though it ships to all 50 states, it does not belong in this new group, since it makes medications for individual patients.
Among those most affected are large hospitals, which often compound medications in-house. They want to be excluded from increased federal scrutiny, arguing that they make drugs only for their individual patients.
Many smaller community hospitals do not have the resources to mix their own medications. If they cannot buy the medications from drug manufacturers, these hospitals often rely on large compounding pharmacies to supply pain medication, anesthetics, and drugs commonly used in labor and delivery. Lobbyists for smaller hospitals say they want more oversight of compounded products.
Source found here

Reforms slow in wake of meningitis outbreak

March 31, 2013
Legal action is proceeding in the nation's fungal meningitis outbreak, but regulatory reform has been slow.
Last week, Michigan At-torney General Bill Schuette requested a grand-jury in-vestigation into whether the New England Compounding Center violated state law in distributing tainted steroid solutions in Michigan.
Yet while Congress and state regulatory agencies are debating changes in the way compounding pharmacies are regulated, little action has been forthcoming six months into the outbreak. Nor is any expected soon.
That's a concern for men-ingitis patients such as Jona Angst.
"I would have thought they would have jumped on it," the Brighton resident said. "It seems they're trying to do something — but it has been six months."
The contaminated steroids had been used by health-care facilities, including Michi-gan Pain Specialists in Genoa Township, to treat back pain.
Angst developed an epi-dural abscess — an infection but not full-blown meningitis — after receiving shots last year and is in treatment.
"The medicine's been horrible, I've been losing my hair," she said. "But it's been horrible for all of us."
The outbreak was first reported in September and Congress first took up the issue in November.
U.S. Rep. Mike Rogers, R-Brighton said Congress needs to be thorough it its investigation into the outbreak and in drafting solutions to prevent it from happening again.
"We must first fully understand what went wrong and caused the tragic deaths of dozens of Americans to ensure that any legislative solution put forth actually solves the problem," said Rogers in a statement to the Press & Argus.
Rogers sits on the House Energy and Commerce Committee, which oversees the Food and Drug Administration. He said the committee is also investigating the "oversight of the NECC to understand its knowledge of the operations."
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Saturday, March 30, 2013

In 2011 the Risks Associated With Veterinary Compounding Pharmacy Choices Was Pointed Out--Confirming One Must Know the Compounding Pharmacy They Are Doing Business With

Risks Associated with Veterinary Compounding Pharmacy Choices (AAEP 2010)

Updated: Wednesday, February 9, 2011 9:00 AM
Posted: Wednesday, February 9, 2011 12:00 AM


Virginia Board of Veterinary Medicine Use of Compounded Drugs in Vetererinary Practice Adopted Februrary 7, 2013-includes office use

Virginia Board of Veterinary Medicine
Use of Compounded Drugs in Veterinary Practice
Applicable Laws

§ 54.1-3401. Definitions.

As used in this chapter, unless the context requires a different meaning:
"Compounding" means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling of a drug or device (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed prescribing patterns; (ii) by or for a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. The mixing, diluting, or reconstituting of a manufacturer's product drugs for the purpose of administration to a patient, when performed by a practitioner of medicine or osteopathy licensed under Chapter 29 (§ 54.1-2900 et seq.), a person supervised by such practitioner pursuant to subdivision A 6 or A 19 of § 54.1-2901, or a person supervised by such practitioner or a licensed nurse practitioner or physician assistant pursuant to subdivision A 4 of § 54.1-2901 shall not be considered compounding.


§ 54.1-3410.2. Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements.

A. A pharmacist may engage in compounding of drug products when the dispensing of such compounded products is (i) pursuant to valid prescriptions for specific patients and (ii) consistent with the provisions of § 54.1-3303 relating to the issuance of prescriptions and the dispensing of drugs.
Pharmacists shall label all compounded drug products that are dispensed pursuant to a prescription in accordance with this chapter and the Board's [Pharmacy] regulations, and shall include on the labeling an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding.
B. A pharmacist may also engage in compounding of drug products in anticipation of receipt of prescriptions based on a routine, regularly observed prescribing pattern.
Pharmacists shall label all products compounded prior to dispensing with (i) the name and strength of the compounded medication or a list of the active ingredients and strengths; (ii) the pharmacy's assigned control number that corresponds with the compounding record; (iii) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; and (iv) the quantity.
C. In accordance with the conditions set forth in subsections A and B, pharmacists shall not distribute compounded drug products for subsequent distribution or sale to other persons or to commercial entities, including distribution to pharmacies or other entities under common ownership or control with the facility in which such compounding takes place.
A pharmacist may, however, deliver compounded products dispensed pursuant to valid prescriptions to alternate delivery locations pursuant to § 54.1-3420.2.
A pharmacist may also provide compounded products to practitioners of medicine, osteopathy, podiatry, dentistry, or veterinary medicine to administer to their patients in the course of their professional practice, either personally or under their direct and immediate supervision.
Pharmacists shall label all compounded products distributed to practitioners for administration to their patients with (i) the statement "For Administering in Prescriber Practice Location Only"; (ii) the name and strength of the compounded medication or list of the active ingredients and strengths; (iii) the facility's control number; (iv) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; and (v) quantity.
E. Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding.
J. Practitioners who may lawfully compound drugs for administering or dispensing to their own patients pursuant to §§ 54.1-3301, 54.1-3304, and 54.1-3304.1 shall comply with all provisions of this section and the relevant Board regulations.

Q: May a veterinarian prescribe a compounded drug product?
A: A Virginia licensed veterinarian may prescribe a compounded drug product by preparing a valid prescription pursuant to federal and state laws and regulations for an individual patient with which there exists a valid veterinarian-client-patient relationship. The client may obtain the compounded drug product from a pharmacy of their choice that is properly licensed by the Virginia Board of Pharmacy. The payment arrangements for a prescribed compounded drug product are not under the purview of the Board of Veterinary Medicine. However, a pharmacist must be compliant with the Virginia Board of Pharmacy regulation, 18VAC110-20-390(A), which states “A Pharmacist shall not solicit or foster prescription practice with a prescriber of drugs or any other person providing for rebates, ‘kickbacks,’ fee-splitting, or special charges in exchange for prescription orders unless fully disclosed in writing to the patient and any third party payor.”
Q: May a veterinarian obtain compounded drug products from a pharmacy for administration in their office?
A: Yes, a Virginia licensed veterinarian may obtain compounded drug products from a pharmacy that is properly licensed by the Virginia Board of Pharmacy for administration in the course of their professional practice. Pursuant to Virginia Code § 54.1-3410.2(C) the pharmacist is required to label the compounded drug product with the statement “For Administering in Prescriber Practice Location Only.”
Q: May a veterinarian dispense a compounded drug product?
A: A veterinarian may dispense a compounded drug product if compounded by the veterinarian pursuant to Virginia Code § 54.1-3410.2(J).
Q: May a pharmacy provide compounded drug products to a veterinarian for the veterinarian to dispense to his patients?
A: No, Virginia Code § 54.1-3410.2 prohibits pharmacists from distributing compounded drug products for subsequent distribution or sale to other persons.
Q: What is the penalty for a licensee of the Virginia Board of Veterinary Medicine who is found to be dispensing compounded drug product purchased from a pharmacy?
A: The licensee may be subject to disciplinary action.

source found here:  
  1. 54.1-3410.2. Compounding; pharmacists' authority to compound ...
    File Format: Microsoft Word - Quick View
    Feb 7, 2013 – Use of Compounded Drugs in Veterinary Practice ... as incident to, research, teaching, or chemical analysis and not for sale or for dispensing

Question of the Day: Should Compounding Sales Reps or Compounding Marketing Reps Be Paid a Salary or a Commission? Have Salaries Dropped as Low As This Index Shows For These Jobs

Average Salary of Jobs Matching Your Search

In USD as of Mar 30, 2013 15k 30k 45k

Source from Indeed

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Average Compounding Pharmacy Sales Representative salaries for job postings in Katy, TX are 14% lower than average Compounding Pharmacy Sales Representative salaries for job postings nationwide.

After fungal meningitis outbreak, agencies do battle with pharmacies ...

The Food and Drug Administration says it doesn’t have the power it needs to control compounding pharmacies that have expanded out of their traditional one-patient-at-a-time role to making mass drugs.
But consumer advocates say a recent crackdown by the agency shows it most certainly can – and should. A spate of recent FDA inspections have shown that the dirty conditions that led to an outbreak of fungal meningitis that killed 51 people and sickened more than 700 are anything but rare at pharmacies that mix up what are supposed to be “sterile” injectable drugs.
“We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk,” FDA commissioner Dr. Margaret Hamburg writes in her latest blog entry. “Over the past two months, we have inspected over 30 facilities and will continue to work to protect public health.”

That's a big step up from the previous pace, when FDA might inspect a facility, write a letter, and wait a few years before following up. Hamburg estimates there are more than 7,000 compounding pharmacies in the U.S. "We had a list of facilities we have been keeping our eye on," says FDA spokeswoman Erica Jefferson. The FDA sent Medi-Fare Drug & Home Health Center, Inc. of Blacksburg, S.C., a warning letter earlier this month, pointing out both that it wasn’t preparing products to match prescriptions and that it had “serious deficiencies in your practices for producing sterile drug product, which could lead to contamination of the products, potentially putting patients at risk.”Other FDA reports this year have pointed out patches of rust at one compounding pharmacy in St. Petersburg, Fla. and sloppy sterility practices at one in Swedesboro, N.J. It's about time, say some. “That’s the type of activity we were calling for,” says Dr. Michael Carome of the consumer group Public Citizen, which is agitating for the FDA to do more to regulate compounding pharmacies. Public Citizen has argued that the FDA has all the authority it ever needed to stop rogue compounding pharmacies, but has failed to act.
Luckily, so far, there’s not been another outbreak of illness like the one traced to the New England Compounding Center (NECC), in which 51 people have died of fungal meningitis and more than 700 infected after receiving contaminated injection steroids.
“We haven’t seen any other large-scale scale compounding outbreaks,” Dr. Michael Bell, acting director of the division of health care quality promotion at the Centers for Disease Control and Prevention, told NBC News. He says there’s a steady stream of requests from states to check, however.
The FDA is openly telling the pharmacies and drug manufacturers it regulates that things have changed since the outbreak tied to NECC. Hamburg was questioned by both House and Senate committees about how the incident could even have happened.
“They appear to have the authority to take actions against companies that engage in drug manufacturing,” Carome said. “What we are going to have to wait to see is will they stand behind the citations of violations they are making,” he added. “That is what they have failed to do previously. Hopefully it’s not just for show.”
Currently, the FDA regulates drug manufacturers, while state boards regulate pharmacies, including compounding pharmacies. But the line between what is a manufacturer and what is a compounding pharmacy can be blurry.
Compounding pharmacies are supposed to mix prescriptions one at a time, on a per-patient basis. But there’s so much demand for special formulations that hundreds of these compounders have started large-scale production. Now, they closely resemble drug manufacturers – but without the very strict oversight and long list of sterility requirements that manufacturers must follow.
Jefferson says the crackdown hasn't gone entirely smoothly. "We still run into situations where a facility has not cooperated with us," she said. "We might not be able to take samples. They might say, 'No, you can't see this.'" Then FDA has to seek help from state authorities.
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Lousiana Regulation Revision Committee to Meet April 9, 2013

Tuesday | April 09, 2013 Regulation Revision Committee

Time: 8:00 am - 5:00 pm
Location: Board Office
For more information, contact: Ms. Judy Dinecola, Secretary 

Compounder sold drugs illegally in seven states: Califorina ordered Pallimed Solutions to Stop Shipping into State; Texas, Illinois, Maine, Wisconsin, Vermont, Virginia may do same. By Chelsea Conaboy | Globe Staff March 30, 2013

A Woburn compounding pharmacy that recalled two dozen drugs this week has said it distributed directly to patients and doctors in up to 21 states, but a Globe review found the company lacked the required license to operate as a pharmacy in at least a third of those states.
The California pharmacy board on Wednesday ordered Pallimed Solutions Inc. to stop shipping prescription drugs into that state because it had no license. Texas will consider taking similar action, the pharmacy board director said. State officials in Illinois, Maine, Wisconsin, Vermont, and Virginia — all listed on the distribution list in Pallimed’s recall notice — said the company was not properly licensed to operate within their borders.
The possibility that the pharmacy was operating in states where it is not licensed points to continued gaps in the oversight of compounding pharmacies exposed last year when tainted steroids produced at New England Compounding Center caused a national crisis.

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Friday, March 29, 2013

Question of the Day: After Completing the Inspections of the 30 Pharmacies That Do Sterile Injections Should the FDA Then Inspect 30 High Risk Veterinary Pharmacies?


Actions related to recent sterile drug product inspections
Other Actions
Source found here