Kentucky Board of Veterinary Examiners Rules and Regulations Relating to Prescribing and dispensing Drugs

KENTUCKY ADMINISTRATIVE REGULATIONS
201 KAR 16:010. Code of ethical conduct.

Section 7. (1) A veterinarian shall not sell, or offer for sale, prescription medicine or drugs at any place other than:
(a) His office, clinic, or hospital; or
(b) Other place where he is treating patients.
(2) The prescription drugs or medicines sold, or offered for sale, shall be used in the treatment of the patient the veterinarian is treating.
(3) A veterinarian may fill the prescription of another licensed veterinarian who has established a bona fide veterinarian-client-patient relationship in a case.


201 KAR 16:110. Prescription and dispensation of drugs for animal use.
RELATES TO: KRS 321.181(5)(b)
STATUTORY AUTHORITY: KRS 321.235(3), 321.240(5)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 321.181(5)(b) provides that the practice of veterinary medicine includes the prescribing, administering, or dispensing of drugs and medications for veterinary purposes. KRS 321.235(3) and 321.240(5) authorize the board to promulgate administrative regulations to carry out and enforce the provisions of KRS Chapter 321. This administrative regulation establishes a procedure for the prescription and dispensation of drugs by licensed veterinarians for use in animals and livestock.
Section 1. Definitions. (1) "Legend drug" means veterinary prescription drug.(2) "Prescription" means an order from a veterinarian to a pharmacist or another veterinarian authorizing the dispensing of a veterinary prescription drug to a client for use on or in a patient;
(3) "Veterinary drug" means:
(a) A drug for animal use recognized in the official United States Pharmacopoeia or National Formulary of the United States;
(b) A drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals;
(c) A drug, other than feed, medicated feed, or a growth promoting implant intended to affect the structure or function of the body of an animal; or
(d) A drug intended for use as a component of a drug in paragraph (a), (b), or (c).
(4) "Veterinary prescription drug" means:
(a) A drug that is not safe for animal use without a veterinarian using or ordering the use of the product, and that is required by federal law to bear the following statement: "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian";
(b) A drug that is required by state law to be dispensed only on order or prescription of a licensed veterinarian;
(c) The extra-label use of an over-the-counter animal drug or human drugs; and
(d) A medicament compounded by mixing two (2) or more legally-obtained over-the-counter or prescription drugs.
Section 2. Prescribing and Dispensing. (1) A veterinary prescription shall include all of the following:
(a) The name and address of the veterinarian and, if the prescription is a written order, the signature of the veterinarian;
(b) The name and address of the client;
(c) The species and identity of the patient for which the prescription is issued;
(d) The name, strength, and quantity of the drug prescribed;
(e) The date on which the prescription is issued;
(f) The directions for administering the drug;
(g) If the patient is a food producing animal, the withdrawal time for the veterinary drug;
(h) If the prescription authorizes extra-label use, the manner in which the client may use the drug;
(i) Any cautionary statements required by law; and
(j) Number of refills allowed.
(2) A veterinarian shall not:
(a) Prescribe for or dispense to a client a veterinary prescription drug or a drug for extra-label use without personally examining the patient unless a veterinary-client-patient relationship exists between the prescribing veterinarian, client and patient, and the veterinarian determines that the client has sufficient knowledge to administer the drug properly;
(b) Prescribe or dispense a veterinary prescription drug to a client unless the veterinarian indicates in the appropriate records described in Section 4 of this administrative regulation, within seventy-two (72) hours after the prescription is issued or the drug is dispensed, that the prescription has been issued or that the drug has been dispensed;
(c) Prescribe a drug to a client for extra-label use on a patient unless all of the following apply:
1. A veterinary-client-patient relationship exists between the veterinarian, client and patient and the veterinarian has made a careful medical diagnosis of the condition of the patient within the context of that veterinarian-client-patient relationship;2. The veterinarian determines that there is no drug that is marketed specifically to treat the patient’s diagnosed condition, or determines that all of the drugs that are marketed for that purpose are clinically ineffective;
3. The veterinarian recommends procedures for the client to follow to ensure that the identity of the patient shall be maintained; and
4. If the patient is a food producing animal, the veterinarian prescribes a sufficient time period for drug withdrawal before the food from the patient may be marketed; or
(d) Transmit a prescription electronically unless the client approves the transmission and the prescription is transmitted to a pharmacist or veterinarian designated by the client.
Section 3. Labeling. (1) A veterinarian shall not dispense a drug that has been prepared, mixed, formulated or packaged by the veterinarian unless the veterinarian affixes to the container in which the drug is dispensed a label containing all of the information specified in Section 2(1) of this administrative regulation, except the address of the client.
(2) A veterinarian shall not dispense a veterinary prescription drug that has been prepackaged by its manufacturer for dispensing unless the veterinarian affixes to the container in which the drug is dispensed a label containing all of the information specified in Section 2(1) of this administrative regulation, except the address of the client.
(3) A veterinarian may dispense a veterinary over the counter drug without affixing any information to the container in which the drug is dispensed if a label that has been affixed to the container by its manufacturer provides adequate information for its use.
Section 4. Prescription Records. (1) A veterinarian shall maintain complete records of each veterinary prescription drug that the veterinarian receives, prescribes, dispenses or administers, and of each prescription issued by the veterinarian that authorizes extra-label use.
(2) Records of each veterinary prescription drug shall include the name of each veterinary prescription drug that is received, the name and address of the person from whom the drug is received and the date and quantity received, the name and address of the person to whom the drug is dispensed and the date and quantity dispensed and, if the veterinarian prescribes or administers the drug, the information specified in Section 2(1) of this administrative regulation.
(3) Records of each prescription authorizing extra-label use shall include the information specified in Section 2(1) of this administrative regulation.
(4) A veterinarian shall maintain records of each veterinary prescription drug for not less than five (5) years after the date on which the veterinarian prescribes, dispenses or administers the drug or extra-label use.
Section 5. (1) A veterinarian shall not be required to write a prescription for controlled substances or a prescription for any medication that, in the veterinarian’s medical judgment, is not appropriate for the patient’s medical care.
(2) A veterinarian may refuse to write a prescription if it is not directly requested by a client with whom there is, in the veterinarian’s opinion, a current and existing veterinarian-patient-client relationship.
(3) A prescription shall be construed to include any manner of authorization for filling a prescription, including verbal or electronic communication.(4) The veterinarian may delegate to an office employee the authority to communicate a refill of a legend drug to the pharmacy on behalf of the veterinarian pursuant to written protocol established prior to the delegation of that authority.
Section 6. (1) A veterinarian shall ensure that all federal legend drugs and veterinary prescription drugs are maintained, administered, prescribed, dispensed, and destroyed in compliance with all state and federal laws.
(2) A veterinarian shall not prescribe or dispense a quantity of drug that is greater than that the amount required for six (6) months of treatment for an animal, herd, or flock.
(3) To prescribe, sell, distribute, or dispense any drug requiring a prescription for use in the context of an animal, herd, or flock, a veterinarian shall first do all of the following:
(a) Perform an appropriate history and physical examination;
(b) Make a diagnosis based upon the history, physical examination, and pertinent diagnostic and laboratory tests;
(c) Formulate a therapeutic plan, and discussed it with the animal’s owner, agent, or guardian, along with the basis for it and the risks and benefits of various treatments options, a part of which might be a prescription drug; and
(d) Ensure availability of the veterinarian or the veterinarian’s staff for appropriate follow-up care.
Section 7. (1) A veterinarian may dispense a prescription drug only if the prescribing veterinarian has established a veterinarian-client-patient relationship.
(2) If the dispensing veterinarian does not have a veterinarian-client-patient relationship, a veterinary assistant may assist in the delivery of a veterinary drug, legend drug, or veterinary prescription drug only under the direct supervision of the licensed veterinarian by who the assistant is employed.
(3) If the dispensing veterinarian does have a veterinarian-client-patient relationship, a veterinary assistant may assist in the delivery of a veterinary drug, legend drug, or veterinary prescription drug under the indirect supervision of the veterinarian by whom the assistant is employed.
(4) If a veterinary assistant acts under the provisions of this section, it shall be the responsibility of the licensed veterinarian to ensure that the requirements of this administrative regulation are met.

Complete act can be viewed here.

Vets face difficult drug shortages in Canada

Shared from Trends Magazine found here:

Vets face difficult drug shortages in Canada 

The situation is worsening for Canadian veterinarians in desperate need of key drugs to treat their patients.

Veterinarians continue to remain in short supply of important drugs including morphine, fentanyl and Phenobarbital after production issues with generic drug manufacturer Sandoz, a subsidiary of Novartis.

A fire at a Sandoz production plant halted production of its 235 products, according to the Montreal Gazette. The fire, which broke out March 4, stopped production for about a week before limited production resumed March 12.

Making matters worse, in 2011 Sandoz began a major production upgrade at its Boucherville plant following warnings from the U.S. Food and Drug Administration (FDA) that it had discovered serious deficiencies in its production methods. The FDA warned the company that it would block its exports to the U.S. unless the deficiencies were corrected.

The upgrade caused a slowdown in production, which affected distribution of drugs to both human and animal doctors.

Suzanne Misisaszek, DVM, of Whitemud Creek Veterinary Clinic in Edmonton, Alberta, said she has had trouble finding the drugs she needs for her practice.

According to Misiaszek, the list of drugs in short supply includes glycopyrrolate, diazepam, midazolam, phenobarbital, meperidine, morphine, fentanyl and hydromorphone.

Misiaszek says that Sandoz has told her that no human drugs will be delivered to veterinary wholesalers before the end of 2012, as the priority is to supply human hospitals first.

For Misiaszek, the Canadian VMA and the American Veterinary Medical Association (AVMA) have been giving her practice the most guidance in how to approach the situation.

"This shortfall came without warning and our provincial and national VMAs have really stepped up to help with recommendations," Misiaszek said.

Misiaszek says her clinic has had to turn to alternatives for anesthesia in order to keep a reserve of anesthetics that are presently in short supply. Sometimes, compounded drugs are the only alternative, forcing veterinarians to spend more and pass on cost increases to clients.

"We are using alternative products for anesthesia in regular patients to ensure we have some of the shorted drugs for special cases," Misiaszek said. "An example of a shortfall concern is epileptic patients that use rectal valium as part of their rescue protocol. This is now unavailable without being compounded. This greatly increases the expense and decreases the shelf life of the product."

Sandoz announced that in mid-February, it introduced an allocation system based on 2011 demand which ensures that each customer receives a fair share of available medicines. Further improvements in output are expected which should increase allocation levels for all products in production to at least 100 percent of forecasted market needs by November 2012, the company announced. However, Sandoz has said it will maintain its allocation system through the first quarter of 2013, in order to avoid unnecessary stockpiling and potential backorders.

Sandoz said it had optimized production output at the plant while correcting its production practices, allowing the company to meet the vast majority of Canadian market needs for its entire injectable portfolio. In May, Sandoz Canada reported that it is now supplying more than 80 percent of market needs for its entire injectable portfolio, and more than 90 percent for the products currently in production.

"Sandoz Canada continues to make strong progress in its efforts to maintain a reliable supply of essential medicines following the temporary slow-down in production announced at its Boucherville plant earlier this year," Sandoz announced May 16, 2012.

Still, the situation is forcing veterinarians into a corner, Misiaszek says.

"We are now using more expensive drugs that we have less experience with," Misiaszek said.

Misiaszek said she is starting to use more alfaxalone, and relying more heavily on dexdomitor and using a butorphanol/buprenorphine combo instead of hydromorphone. Being in short supply of hydromorphone has led her clinic to revamp its anesthetic protocols entirely.

Misiaszek says she has also had a hard time treating seizuring patients without injectable phenobarb or valium. In such instances, she often ends up having to compound.

She recommends that veterinarians keep the shortfall drugs in stock for emergencies, using alternatives whenever possible.

"Try to be as familiar as possible with all products available to veterinarians - you never know when you will have to rely on them," Misiaszek said. "We tend to get stuck in our comfort zone."

However, cost to clients can often rise as a result of using alternative drugs.

Misiaszek also recommends webinars led by a boarded anesthesiologist that address alternative drug options.

Using an adverse event book for any new protocol instituted can also track how patients are doing on certain medication combinations, allowing practitioners to make adjustments in a timely manner, Misiaszek said.

Misiaszek says she has had to take staff time to revamp protocols, restructure ordering and pricing, and train staff on the new procedures.

Unfortunately, Misiaszek says she doesn’t see the shortage problem going away any time soon.

"This is a long term problem for us that will probably get worse as our ‘stock’ supply diminishes," she said. "I think that we will be able to cope with alternatives and compounded medications to ensure we have the proper drugs to treat our patients."

Looking long-term, however, Misiaszek says she hopes the drugs will be back in stock and that Health Canada will not source all of the drugs to only one supplier in the future.

Pennsylvania State Board of Pharmacy Meeting Today to Discuss Compounding Issue

Pennsylvania's Board of Pharmacy Agenda for today, September 18, 2012, indicates that the following will be discussed:

Ther-Rx Corporation – Compounding of hydroxyprogesterone caproate
injection ..

To view the entire agenda click here

The Use of Drugs in Food Animals: Benefits and Risks

The Use of Drugs in Food Animals: Benefits and Risks

Auburn University College of Veterinary Medicine Hosting Veterinary Pharmacy Law Seminar

Pharmacy Law Review

• Veterinary Pharmacy Law
• Continuing Education
• For Veterinarians and Veterinary Technicians
• Sunday, September 23, 2012
• 1 p.m. to 3 p.m.
• Overton Educational Wing
• Auburn University College of Veterinary Medicine

Approved by the Florida and Alabama board for the law/pharmacology continuing education credit.

THIS 2-HOUR COURSE:

• Explains current U.S. Drug Enforcement Administration laws for purchasing, documentation, dispensing, and storage and disposal of outdated controlled substances used in veterinary medical practices.
  
• Describes in detail the current compounding regulations and extra-label use of medications that are laws through the U.S. Food and Drug Administration.
  
• Explains devices, policies, and procedures for documentation of training and guidelines for occupational employee safety are included.

COURSE EXPERTISE

The course is taught by Sue Duran and Starr Miller who have a combined instruction training experience of 60 years in the area of veterinary pharmacy. Dr. Duran and Ms. Miller are diplomates of the International College of Veterinary Pharmacy (ICVP), an international college of experts who teach and dispense at veterinary teaching hospitals.

STATE-OF-THE-ART SETTING

Veterinarians and technicians can receive credit while experiencing the most up-to-date in learning. Veterinary Pharmacy Law takes place in the Overton Educational Wing, the college’s newest addition which features theatre-style lecture rooms and the latest in technology.

REGISTRATION

• Register Online
• The course is limited to 75 participants.

FEES

Veterinarians: $250

• Early Bird Discounted Price:
• $175 (by August 5)
• $200 (by September 7)

TRAVEL INFORMATION

Auburn is serviced by Hartsfield-Jackson Atlanta International Airport. Travel to Auburn is available by rental car (approximately 90 minutes via I-85 South) or by shuttle (Express 85: 888-238-7738. Reservations are required.).
Auburn is in the CENTRAL time zone.
Atlanta is in the EASTERN time zone.
Visit our Web site at vetmed.auburn.edu/ce for directions, maps, and links to area accommodations.

QUESTIONS?

• Contact Kris Robertson Street
• 334-844-2497 or kris.street@auburn.edu 

Task force targets Chinese shipments of meth chemicals

Task force targets Chinese shipments of meth chemicals

Stars and Stripes
September 15, 2012

About 80 percent of the meth in the United States is now made in Mexico mainly using Chinese ingredients shipped across the Pacific, according to the U.S. Drug Enforcement Administration. The DoD task force, which includes ... China has become the top ... 

The CPG applies to all Compounders; Physicians, Veterinarians, and Pharmacists and There is a Great Need to Educated Those Individuals as David Miller Points Out

David G. Miller, RPh, IACP Executive Vice President & CEO recently discussed his presentation about U.S. v. Franck's Lab, Inc. at the annual convention of the American Veterinary Medical Association (AVMA). To read his comments, especially about the need for education, click here.

Recalls, Market Withdrawals, & Safety Alerts Qualitest Issues Voluntary, Nationwide Recall for One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the Potential for Oversized Tablets

Recalls, Market Withdrawals, & Safety Alerts Qualitest Issues Voluntary, Nationwide Recall for One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the Potential for Oversized Tablets

Indiana Board of Veterinary Examiners Statute and Administrative Rules Regarding Prescrptions

Indiana Board of Veterinary Examiners Statute and Administrative Rules, IC 25-38.1-4-5  Prescriptions,  provides:

     Sec. 5. (a) A licensed veterinarian may write prescriptions. Pharmacists shall give the prescriptions written by a licensed veterinarian the same recognition given the prescriptions of persons holding an unlimited license to practice medicine or osteopathic medicine.
    (b) A valid veterinarian-client-patient relationship must exist before a licensed veterinarian dispenses or prescribes a prescription product.
    (c) Veterinary prescription products, including drugs and immunizing products restricted by state and federal law for use by licensed veterinarians, may not be diverted or transferred to an individual for use on an animal if there is not a current veterinarian-client-patient relationship with the original prescribing veterinarian.
    (d) If a veterinarian prescribes a drug for the client's animal, upon request, the veterinarian shall provide the prescription to the client, unless prohibited by state or federal law or to prevent inappropriate use.
As added by P.L.2-2008, SEC.12. Amended by P.L.58-2008, SEC.40.

To view the entire statute click here.

Rule 5. Standards of Practice

888 IAC 1.1-5-1 Standards of practice

Authority: IC 25-38.1-2-14; IC 25-38.1-2-23

Affected: IC 25-1-9

     Sec. 1. A veterinarian may be found guilty of the incompetent practice of veterinary medicine and may be disciplined under IC 25-1-9 if the veterinarian does any of the following:

          (1) Fails to maintain written animal health records as defined by section 2 of this rule.

          (2) Dispenses or prescribes drugs or therapy unless a veterinarian-client-patient

          relationship has been established.

          (3) Knowingly provides prescription drugs or access to prescription drugs for use other than

          in the proper course of veterinary diagnosis or treatment.

          (4) Performs a treatment or procedure that is beyond the skill or knowledge of the

          practitioner.

          (5) Permits, delegates, or requires an employed veterinarian to:

(A) improperly perform the duties of an accredited veterinarian; or

(B) perform services that would constitute a violation of standards provided by this

section.

(Indiana Board of Veterinary Medical Examiners; 888 IAC 1.1-5-1; filed Apr 26, 1988, 2:10 p.m.: 11 IR 3046; filed Aug 11, 1989, 1:35 p.m.: 13 IR 86; filed Dec 27, 1993, 9:00 a.m.: 17 IR 1003; filed May 2, 2001, 10:05 a.m.: 24 IR 2707; readopted filed Jul 19, 2007, 12:53 p.m.: 20070808-IR-888070070RFA; filed Jul 31, 2009, 8:42 a.m.: 20090826-IR-888080679FRA)

Equine Chronicle » Veterinary Compounding

Equine Chronicle » Veterinary Compounding

Veterinary Compounding

September 15, 2012

By Heather Smith Thomas

Compounding is the manipulation of a drug product to produce a dosage or formulation tailored to meet the needs of a specific patient. This can be done by mixing two drugs together, or creating a more palatable oral product by adding flavoring, creating an oral suspension by crushing tablets and mixing them with fluid, etc. Compounding can be done by a licensed pharmacist on the prescription of a licensed veterinarian, or by the veterinarian.

Scarlet Thomas, director of Pharmacy at Hagyard Equine Medical Institute in Kentucky, says compounding can legally be performed only when there’s no approved drug available in correct dosage, form or concentration to appropriately treat the patient. It is not legal to create something that merely duplicates an already existing product.

“There are a number of instances in which compounding could be beneficial or necessary There are a limited number of drugs commercially available for horses. There are more commercial options for small animals, due to the greater number of cat and dog owners,” explains Thomas.

“When there is not an appropriate commercially available product, or when a certain medication is discontinued or unavailable from pharmaceutical companies, compounding becomes necessary. Some medications get dropped by the manufacturer, perhaps due to profitability issues,” she says.

“When products are pulled off the market, for whatever reason (as long as it’s not a safety issue), this might be an appropriate instance to compound that medication. The owner and veterinarian must have some way to obtain these medications, to continue the therapy,” she explains.

In some instances equine patients are allergic to certain preservatives, dyes, fillers, and carriers that exist in commercially available products, and something else must be used. Some patients require tailored dosage strengths to meet a unique need. “If you’re using a human product or small animal product for a horse, and it’s geared toward a 25 pound dog or a 150 pound human and you are treating a 1300 pound horse, this can be challenging,” says Thomas. Compounding the product to appropriately tailor it for that horse is a logical solution.

“In some instances the horse may not be able ingest the medication in its commercially available form. It may be a human product that is not palatable, or it may not be feasible to give the horse 200 tablets of human medication. In those instances it may be necessary to manipulate the drug into a different formulation or dosage, or add flavoring so it could be given orally.”

Legal compounding requires a valid veterinarian-client-patient relationship. “Veterinarians should limit the use of compounded drugs to specific needs in specific patients, when there is no other method or route of drug delivery that is practical for that patient. If there’s a commercial product available that can be given to that horse, that’s the first choice,” says Thomas.

Compounded medications would be the next option, but require a valid prescription from a veterinarian, and must be patient specific. The veterinarian would have to have seen or know the animal and diagnose the condition to be treated. If there’s nothing commercially available to treat that case or there’s something unique about the patient that makes it impossible for the commercial product to be appropriate, then a compounded product would be considered.

“Talk with your veterinarian if a compounded product is necessary for a certain animal. Ask about the source of that compound, making sure it’s a reputable pharmacy that your veterinarian has confidence in and trusts,” she says. Ask which FDA approved drug(s) will be used to compound the prescribed medication. You want to know that the ingredients and potency of the compounded product are reliable

Commercial products that are already on the market should not be compounded. “If medications are compounded in the same dosage formulation as a patented product, it’s usually not for the health and welfare of the horse, but to offer a less expensive product,” she explains. The horse owner may choose a compounded substitute because it’s cheaper, but may be getting something less effective (or even dangerous) if obtained illegally.

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Use Caution When Buying Pet Medications Online

Gigi Davidson, Director of Clinical Pharmacy Services with North Carolina State University’s Veterinary Teaching Hospital, has warned owners about buying pet medications online. She was previously interviewed as part of an extensive report by WBTV in Charlotte, NC. To view the report, click here.  For more information click here.

FBI Investigates Health Care Fraud - TimesDaily.com

FBI Investigates Health Care Fraud - TimesDaily.com
Pictures of search of three pharmacies in Alabama

K-V Supplemental Filing in K-V v. Keck (state of SC)

To view the supplemental filing click here

District Court Denies Gary Osborn and Apothecure's Motion to Preclude Raising the Fine Ceiling As Moot Since Government Agrees $100,000 Is Reasonable Fine

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Frank's Files Answer in Bienick Lawsuit

To view the answer click here.

K-V v. Hamos (state of Illinois): Status Hearing Set

09/13/2012

24

MINUTE entry before Honorable Susan E. Cox: A status hearing is set for 9/19/12 at 9:45 a.m. for the purpose of scheduling a settlement conference. Counsel that appear for this pre-settlement conference discussion must be counsel who will represent their respective clients at the conference, or are able to discuss the issues of the case and to schedule the conference on behalf of their clients. The Court expects counsel to discuss issues in the case which may affect the settlement process. Mailed notice (vkd, ) (Entered: 09/13/2012)

Illinois Veterinary Medicine and Surgery Practice Act of 1994 Relating to Dispensing Drugs and the Illinois Rules

(225 ILCS 115/25) (from Ch. 111, par. 7025)
(Section scheduled to be repealed on January 1, 2014)
Sec. 25. Disciplinary actions.
1. The Department may refuse to issue or renew, or may revoke, suspend, place on probation, reprimand, or take other disciplinary action as the Department may deem appropriate, including fines not to exceed $1,000 for each violation, with regard to any license or certificate for any one or combination of the following: 

***

(13.5) Any pharmacist licensed in the State,

merchant, or manufacturer selling at his or her regular place of business medicines, feed, appliances, or other products used in the prevention or treatment of animal diseases as permitted by law and provided that the services he or she provides do not include diagnosing, prognosing, writing prescriptions, or surgery. *** FF. Using, prescribing, or selling a prescription drug or the extra-label use of a prescription drug by any means in the absence of a valid veterinarian-client-patient relationship. CHAPTER VII: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION SUBCHAPTER b: PROFESSIONS AND OCCUPATIONS PART 1500 VETERINARY MEDICINE AND SURGERY PRACTICE ACT OF 2004 SECTION 1500.50 STANDARDS OF PROFESSIONAL CONDUCT Section 1500.50 Standards of Professional Conduct a) In determining what constitutes dishonorable, unethical or unprofessional conduct of a character likely to deceive, defraud or harm the public, the Board or hearing officer shall consider the following standards as they relate to the person who is the subject of the proposed disciplinary action. The standards shall include, but not be limited to:  ***      2) Wilfully violating or knowingly assisting in the violation of any law relating to the use or dispensing of any medicine or drug as specified in Section 17 of the Act; 3) Wilfully administering or prescribing illegal drugs for animals; 4) Wilfully administering or prescribing prescription drugs illegally. Illegally means: A) In violation of the rules governing a competition or exhibition of animals, including but not limited to the rules of the Illinois Racing Board (11 Ill. Adm. Code 509), the American Kennel Club and the American Show Horse Association;  *** 11) Failing to maintain adequate medical records, including but not limited to the following: *** F) All medical treatment must include identification of each medication given in the practice, together with the date, dosage, and route of administration and frequency and duration of treatment; G) All medicines dispensed or prescribed must be recorded, including directions for use and quantity; H) Any changes in medications or dosages, including telephonically or electronically initiated changes, must be recorded; Statutes and Rules can be found here

Warning Letter to Lancôme signals stepped-up enforcement of cosmetics/cosmeceuticals - Lexology

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The Hindu : Sport News : Many countries crack down on MHA supplements

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FDA says muscle, joint pain creams can cause burns

Read more here: http://www.sacbee.com/2012/09/13/4817100/fda-says-muscle-joint-pain-creams.html#storylink=cpy

A Letter From Janet Woodcock Regarding Changes at FDA

 Fri, 09/07/2012.

Here's the official letter announcing changes at FDA in the CDER division from CDER Director, Dr. Janet Woodcock
CDER Staff:
I want to inform you about some important proposed organizational changes for CDER.
I am having a series of meetings with staff in the Office of Generic Drugs, the Office of Pharmaceutical Science, and the Office of Compliance to discuss these proposed changes in more detail. With the historic passage of the Generic Drug User Fee Amendments of 2012 (GDUFA) and a heightened public focus on generic drugs, I am proposing to elevate the Office of Generic Drugs (OGD) to a “super Office” — an office that houses subordinate offices within its organizational structure. As a super Office, OGD would report directly to me, as do other super Offices such as the Office of New Drugs and the Office of Surveillance and Epidemiology, and a number of other CDER offices.
Generic drugs, which now make up nearly 80 percent of prescriptions filled in the United States, have come to represent affordable access to treatment for many patients. Under the proposed restructuring, OGD Director Greg Geba, M.D., would continue to lead the expanding generic program with the goal of enhancing our ability to give consumers timely access to high-quality, safe, and effective generic drugs. Effective immediately, Dr. Geba will be detailed to me in the Office of the Center Director. Mary Beth Clarke, acting director of the Office of Executive Programs, will continue to be the CDER lead on GDUFA implementation, working closely with OGD and other CDER components to implement this important program.
Also, I will be proposing other structural changes to sharpen our focus and bolster our resources around pharmaceutical quality. Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety. Further, we must be strategic and have systems in place to identify and respond to quality issues before they become problems. This is especially critical due to the global nature of drug manufacturing and the sourcing of raw materials outside of the United States.
Toward these goals and underscoring our commitment to drug quality, we will be exploring the creation of a new Office of Pharmaceutical Quality (OPQ), which would be charged with overseeing quality throughout the life cycle of a drug. OPQ could take on some of the functions currently within the Office of Pharmaceutical Science (OPS), as well as other quality-related functions.I will also propose realigning some functions from the Office of Manufacturing and Product Quality (OMPQ) in the Office of Compliance into the new OPQ. Other OMPQ functions related to enforcement and compliance would continue to reside in the Office of Compliance. All of these changes would be part of our ongoing efforts to ensure that CDER’s organizational structure supports our mission to ensure safe, effective, and high-quality drugs for the public. As a regulatory agency, we want the public to be confident that we are successfully dealing with the global economy that is constantly adding more players, more technologies, and more complexity. I believe these organizational changes would give us the foundation we need to meet these new and ever-changing challenges.
Janet Woodcock  

Maine wants the Canadian drugs FDA is trying to stop

September 12, 2012 | By Eric Palmer

Read more: Maine wants the Canadian drugs FDA is trying to stop - FiercePharma http://www.fiercepharma.com/story/maine-wants-canadian-drugs-fda-trying-stop/2012-09-12?utm_source=rss&utm_medium=rss#ixzz26MQL9EBK
Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma

Forbes Article Poses Questions Is the FDA Approving Drugs Too Quickly?

There is an interesting article, Is the FDA Approving Drugs Too Quickly? (9/12/12) in Forbes written by John LaMattina, Former president of Pfizer R&D/senior partner at PureTech Venture.  To read the article click here

Idaho Statutes and Administrative Code Relating to Veterinary Medicine/Prescription Rules

The statutes in Idaho relating to discipline of veterinarians provide:

TITLE 54

PROFESSIONS, VOCATIONS, AND BUSINESSES

CHAPTER 21

VETERINARIANS

 54-2115. GROUNDS FOR DISCIPLINE. The board may refuse to issue, renew or reinstate the license of a veterinarian, or may deny, revoke, suspend, sanction, reprimand, restrict, limit, place on probation or require voluntary surrender of, the license of a veterinarian, and may fine and impose other forms of discipline and enter into consent agreements and negotiated settlements with any licensed veterinarian pursuant to the procedures set forth in chapter 52, title 67, Idaho Code, for any or all of the following reasons:

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(15) The use, prescription or sale of any controlled substance, veterinary legend/prescription drug or prescription of an extra-label use for any human or veterinary drug without a valid veterinarian/client/patient relationship.

Idaho Statute found here.

The IDAHO ADMINISTRATIVE CODE IDAPA 46.01.01, Board of Veterinary Medicine Rules of the State Board of Veterinary Medicine that relates to prescriptions and controlled substances provides:

152. CODE OF PROFESSIONAL CONDUCT.

The Board’s code of professional conduct includes, but is not limited to, the following standards of conduct: (7-1-97)

01. Veterinarian/Client/Patient Relationship. A veterinarian shall not dispense or prescribe 

controlled substances, prescription or legend drugs except in the course of his professional practice and after a bona 

fide veterinarian/client/patient relationship as defined by Section 150 of these rules has been established. (3-30-01)

01. Medical Records. Medical records shall include, but not be limited to: (7-1-97)

Successful Year So Far for FDA Prosecutions

From all the press releases since January 2012, it looks like the FDA and the United States Attorneys' Offices have had a very successful year prosecuting crimes under the FDA's jurisdiction.

Recent Press Releases

• August 27, 2012: Nevada Man Indicted for Allegedly Selling Misbranded Drugs Over the Internet and Shipping Them to Customers by Mail¹
• August 23, 2012: California Man Sentenced for Importing Adulterated Cancer Drugs; Forfeits $1.4 Million & Land Rover Automobile²
• August 17, 2012: Local and Out of State Pain Clinic Owners and Doctors Charged in Prescription Drug Conspiracies³
• August 10, 2012: South Carolina Pharmaceutical Distribution Company Pleads Guilty in Multi-Million Dollar Scheme to Purchase and Sell Drugs in the Grey Market⁴
• August 8, 2012: Former PIN Rx Pharmacist Sentenced to Almost 4 Years on Kickback and Tax Charges⁵
• August 1, 2012: Bodybuilding.com, LLC and DeLuca Brothers Sentenced for Violating the FDCA⁶
• July 25, 2012: $100 Million Customs Fraud Uncovered; President of San Diego Customs Brokers Association and Ten Others Charged in Scheme⁷
• July 19, 2012: Bristol Man Pleads Guilty to Misdemeanor Misbranding Charge⁸
• July 19, 2012: Former Employee of Exeter Hospital Arrested in Connection with Hepatitis C Outbreak⁹
• July 12, 2012: Kimberly Smedley Sentenced to 3 Years in Prison for Providing Illegal Silicone Buttocks Injections in Hotel Room¹⁰
• July 2, 2012: GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data¹¹
• June 29, 2012: Chinese National Indicted for Allegedly Smuggling Counterfeit Tobacco Products into the U.S.¹²
• June 21, 2012: Ocala Man Pleads Guilty to Medical Tampering Charges and to Firearm Charge¹³
• June 14, 2012: Federal Jury Convicts Distributor of Counterfeit Pharmaceuticals¹⁴
• June 14, 2012: Two Doctors Guilty of Health Care Fraud¹⁵
• June 14, 2012: Internet Pharmacy Owner Charged in $95 Million Fraud Scheme¹⁶
• May 25, 2012: Palm Beach Man Sentenced for Mislabeling Medical Test Kits¹⁷
• May 23, 2012: Miami Food Supplier Sentenced for Distributing Misbranded Food¹⁸
• May 22, 2012: Bodybuilding.com, LLC and Jeremy DeLuca Plead Guilty in Federal Court to Violating FDCA¹⁹
• May 17, 2012: NY Man Indicted on Charges of Illegal Disposal of a Hazardous Waste²⁰
• May 16, 2012: Rochester Man Sentenced for Importing Counterfeit Pharmaceuticals²¹
• May 15, 2012: Former Hershey Resident Charged Federally with Adulteration of Medical Devices²²
• May 11, 2012: Former Federal Corrections Officer Sentenced to 24 Months' Imprisonment for Trafficking Steroids²³
• May 11, 2012: Mayo Clinic Radiology Tech Pleads Guilty to Spreading Hepatitis C²⁴
• May 9, 2012: Stoughton Nurse Sentenced for International Money Laundering and Illegal Distributing Prescription Drugs²⁵
• May 8, 2012: NJ Woman Sentenced for Counterfeit Cosmetics²⁶
• May 9, 2012: Bodybuilding.com LLC and Jeremy DeLuca Charged with Violating the FDCA²⁷
• May 8, 2012: Nurse Sentenced for Stealing Narcotics From Patients²⁸
• May 8, 2012: Medical Device Distributor Sentenced For Importing, Reselling Counterfeit and Contaminated Surgical Hernia Mesh²⁹
• May 7, 2012: Abbott Labs to Pay $1.5 Billion to Resolve Criminal and Civil Investigations of Off-Label Promotion of Depakote³⁰
• April 25, 2012: NY Man Charged with Illegal Disposal of a Hazardous Waste³¹
• April 25, 2012: Nurse Sentenced for Stealing Vicodin from Patients³²
• April 24, 2012: Dallas Compunding Pharmacy Owner Pleads Guilty in Connection with Misbranded Drug Shipment³³
• April 24, 2012: Eight Central Pennsylvania Men Indicted, $6 Million Seized in Federal Bath Salts Prosecution³⁴
• April 24, 2012: Two Israeli Men Sentenced for Smuggling Counterfeit and Misbranded Cialis into the United States³⁵
• April 19, 2012: U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx³⁶
• April 19, 2012: Four Defendants Indicted in Alleged 2007 Conspiracy to Distribute 110,000 Pounds of Adulterated Mexican Cheese Throughout the U.S.³⁷
• April 10, 2012: Founder of Bodybuilding.com Pleads Guilty to Selling Misbranded Drugs as Dietary Supplements³⁸
• April 2, 2012: Equitable Sharing of $500 Million Google Foreiture Approved³⁹
• March 28, 2012: Kimberly Smedley Admits Illegal Silicone Buttocks Injections in Hotel Room⁴⁰
• March 27, 2012: United States Department of Justice and the State of Washington Announce Successful Health Care Fraud Settlement with Bates Drug Stores in Spokane⁴¹
• March 23, 2012: SK Foods Former Owner and CEO Scott Salyer Pleads Guilty to Racketeering and Price Fixing⁴²
• March 23, 2012: Spearfish Man Indicted on Several Counts of Mail Fraud and Misbranding of a Drug⁴³
• March 20, 2012: Sacramento Man Arrested for Importing Counterfeit Drugs⁴⁴
• March 15, 2012: Sentencings in Human Growth Hormone Distribution Case⁴⁵
• March 14, 2012: Brownsville Woman Arrested for Selling Fake Botox⁴⁶
• March 5, 2012: Illinois Sales Rep Sentenced on Drug Charges⁴⁷
• March 5, 2012: Ferguson Pleads Guilty to Wire, Mail Fraud in Hollywood Body and Laser Center Case⁴⁸
• March 2, 2012: Former Kauai Physician Sentenced to Over 12 Years in Prison⁴⁹
• March 1, 2012: Albuquerque Man Sentenced to 24 Months in Prison for Adulterating Yogurt with Semen⁵⁰
• February 10, 2012: Nationwide Supplier of Medical Equipment Sentenced to 37 Months in Federal Prison for Health Care Fraud, Money Laundering and Selling Adulterated and Misbranded Medical Devices⁵¹
• February 28, 2012: Rhode Island Man Pleads Guilty to Selling Mislabeled Maple Syrup⁵²
• February 21, 2012: Former Monroe County Pharmacy Operator Pleads Guilty to Misbranding of Medication in Federal Court⁵³
• February 21, 2012: Florida Physician Pleads Guilty to Conspiracy to Commit Mail and Wire Fraud⁵⁴
• February 17, 2012: Former PIN Rx Pharmacist Pleads Guilty to Kickback and Tax Charges⁵⁵
• February 17, 2012: Medical Equipment Sales Rep Pleads Guilty to Federal Charge of Health Care Fraud⁵⁶
• February 16, 2012: Local Cancer Doctor Pleads Guilty to Receiving Misbranded Cancer Drugs Two Californians also Named in Indictment⁵⁷
• February 9, 2012: Sioux City Man Sentenced for Selling Erectile Dysunction Mediciation Without a Prescription⁵⁸
• January 30, 2012: Rochester Pharmacist Sentenced for Forging Prescriptions⁵⁹
• January 30, 2012: Registered Nurse Convicted of Illegally Distributing Prescription Drugs and International Money Laundering⁶⁰
• January 24, 2012: R.I. Medical Equipment Sales Representative to Plead Guilty to Health Care Fraud⁶¹
• January 17, 2012: Two Manufacturers Sentenced for Misbranding Products as Dietary Supplements⁶²

To view all FDA press releases click here.

FDA warns L'Oreal about drug-like claims for anti-aging creams

FDA warns L'Oreal about drug-like claims for anti-aging creams

Nevada State board reprimands doctor Who Used Compound Purchased on Internet from Canadian Pharmacy Not Licensed in State

By Cy Ryan (contact)

Tuesday, Sept. 11, 2012 | 9 p.m.

In another settlement, the board said Dr. Samuel Beck advertised Botox injections, mostly sought by women at his Allure Med Spa in Reno. In reality he was injecting a compound called "Dysport" purchased on the Internet and a Canadian pharmacy not licensed in Nevada.

The board dismissed the counts in the complaint that accused Beck of false advertising by having a large sign on the front window of his business saying Botox injections were available and brochures in his office touting Botox.

But he was penalized for using a drug from unlicensed sources in Canada. In addition to the public reprimand, he was ordered to attend 12 hours of classes on medical ethics and reimburse the board $1,337 for the cost of its investigation.

Entire article is found here.

Georgia Board of Veterinary Medicine Policies Regarding Prescriptions

Internet Pharmacies
At the August 2001 meeting the Georgia State Board of Veterinary Medicine adopted the statement of the American Veterinary Medical Association concerning Internet Pharmacies as follows:
1. Drug therapy, when medically indicated, should be initiated by the attending veterinarian in the context of a valid veterinarian-client-patient relationship.
2. Drugs may be dispensed or prescribed. Veterinarians should honor client requests to prescribe rather than dispense a drug (AVMA Principles of Veterinary Medical Ethics). The client has the option of filling a prescription at any pharmacy.
3. Clients might be advised to select an Internet pharmacy certified by the National Association of Boards of Pharmacy (vipps@nabp.net) whose VIPPSTM program and its accompanying seal of approval identify to the public those online pharmacies that are appropriately licensed and prepared to practice pharmacy via the Internet.
4. Veterinarians asked by pharmacies to approve prescriptions they have not initiated should do so only if the prescription is appropriate and a valid veterinarian-client-patient relationship exists.
5. It is within the veterinarian’s (not the pharmacy’s) purview to determine the medical criteria whereby a drug is indicated.)
6. As with any prescription, a written record should be maintained.
7. Prescribing veterinarians should assure that information regarding the proper use of the prescribed drug and the risks associated with its use are communicated to the client, regardless of the drug source.
8. Use of drugs for foreign origin that lack FDA approval generally is not permitted.

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Request of Records and/or Written Prescription
to be Released
1. Upon receipt of a properly signed and executed release from the
patient, the veterinarian, at his/her discretion, may release the
original x-ray film, patient records, etc. to the patient or his/her
designee.
2. If the Board office receives a complaint against a veterinarian
whereby the veterinarian will not release the records and/or a
written prescription to a patient at the patient’s request, a letter
from the Board will be sent via Certified Mail to the veterinarian to
release the records and/or provide a written prescription to the
patient within 10 days of receipt of the certified letter, and submit
proof that the records have been mailed to the patient (via Certified
Mail) to the Board within 10 days as well. The veterinarian must
either submit to the Board proof of the mailing of the records
and/or written prescription, or respond to the Board as to why the
records and/or written prescription cannot/will not be mailed
within 10 days of the receipt of the certified letter from the Board.
3. If the Board office has not received proof that the records and/or
written prescription have been released to the patient, or has not
received a response from the veterinarian within 15 days of the
date of the request was mailed from the Board’s office, the
veterinarian will:
 Have his/her license sanctioned by the Board with a
PUBLIC REPRIMAND, which will be a permanent part of
the veterinarian’s records; and
 Pay a $500.00 fine.e drug source.
8. Use of drugs for foreign origin that lack FDA approval generally is not permitted.

Policies are found here

Georgia State Board of Veterinary Medicine Board Rules Relating to Prescriptions

Georgia State Board of Veterinary Medicine Board Rules 700-8-.01
(e) Prescription Drugs:
1. After a valid veterinary/client/patient relationship has been established, a veterinarian
must make available, at a reasonable cost, a written prescription.
2. It is unlawful for a veterinarian to release, prescribe, and/or dispense any prescription
drugs without having examined the animal and established a valid
veterinary/client/patient relationship.
Authority O.C.G.A. Secs. 43-1-19, 43-1-25, 43-50-21, 43-50-27, 43-50-41. History. Original Rule entitled "Unprofessional Conduct" adopted. F. Oct. 8, 1974; eff. Oct. 28, 1974. Amended: F. Feb. 15, 1983; eff. Mar. 7, 1983. Amended: F. July 9, 1984; eff. July 29, 1984. Amended: F. Aug. 31, 1984; eff. Sept. 20, 1984. Amended: F. Nov. 8, 1995; eff. Nov. 28, 1995. Amended: F. Sept. 11, 1998; eff. Oct. 1, 1998. Repealed: New Rule of same title adopted. F. Apr. 8, 2002; eff. Apr. 28, 2002. Repealed: New Rule of same title adopted. F. Jan. 29, 2003; eff. Feb. 18, 2003. Repealed: New Rule of same title adopted. F. Apr. 8, 2004; eff. Apr. 28, 2004. Repealed: New Rule of same title adopted. F. Aug. 24, 2007; eff. Sept. 13, 2007.

Georgia Statutes Relating to Prescription Drugs in Veterinary Practice

TITLE 43. PROFESSIONS AND BUSINESSES CHAPTER 50. VETERINARIANS AND VETERINARY TECHNICIANS ARTICLE 1. GENERAL PROVISIONS
43-50-1. Short title.
This chapter shall be known and may be cited as the 'Georgia Veterinary Practice Act.'
HISTORY: Code 1933, § 84-1501, enacted by Ga. L. 1965, p. 92, § 1; Ga. L. 1999, p. 81, § 43; Ga. L. 2003, p. 615, § 1-1.

(1 ) 'Prescription drug' includes any medicine medication or pharmaceutical or biological product whose manufacturers' label must, pursuant to federal or state law, have the following statement printed on its packaging: 'Federal law restricts this drug to use by or on the order of a licensed veterinarian'; or any over-the-counter product that is used in a manner different from the label directions and that by definition requires a valid veterinarian-client-patient relationship for prescription or dispensing.

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(15) 'Veterinarian-client-patient relationship' means that:
(A) The licensed veterinarian or his or her licensed designee has assumed the responsibility for making medical judgments regarding the health of the animal and the need for medical treatment, and the client (owner or caretaker) has agreed to follow the instruction of the licensed veterinarian;
(B) There is sufficient knowledge of the animal by the licensed veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal. This means that the licensed veterinarian has recently seen and is personally acquainted with the keeping and care of the animal by the virtue of examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept; and
(C) A licensed veterinarian is readily available for follow up in the case of adverse reactions or failure of the regimen of therapy.



43-50-41. Disciplinary action; subpoenas; judicial review; reinstatement; investigatory powers; immunity; failure to appear; voluntary surrender of license or registration.
(a) The board is authorized to refuse to grant a license or registration to an applicant, to revoke the license or registration of a person licensed or registered by the board, or to discipline a person licensed or registered under this chapter or any antecedent law, upon a finding by a majority of the entire board that the licensee, registrant, or applicant has:

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(12) Engaged in the excessive prescribing or administering of drugs or treatment or the use of diagnostic procedures which are detrimental to the patient as determined by the customary practice and standards of the local community of licensees; or knowingly prescribed controlled drug substances or any other medication without a legitimate veterinary medical purpose; or knowingly overprescribed controlled drug substances or other medication, in light of the condition of the patient at the time of prescription;

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(14) Used, prescribed, or sold any veterinary prescription drug or prescribed an extralabel use of any drug in the absence of a valid veterinarian-client-patient relationship; or
(15) Has had his or her U.S. Drug Enforcement Administration privileges restricted or revoked.

43-50-44. Exemptions.
This article shall not be construed to prohibit:

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(6) Any merchant or manufacturer selling, at his or her regular place of business, medicines, feed, appliances, or other products used in the prevention or treatment of animal diseases. This shall not be construed to authorize the sale of medicines which must be obtained by a prescription from a pharmacist but shall only include the right to sell those medicines which are classified as proprietary and which are commonly known as over-the-counter medicines;

Complete statute found here