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Friday, August 31, 2012

More Great Training on Compounding for Veterinarians

Gigi Davidson will be presenting Compounding:  Pearls and Perils: 2012 Update, What Your Pharmacist Doesn't Know About Filling Prescriptions for Animals, and Right Bug, Right Drug: Maximizing Safety and Efficacy of Antibiotic Administration at the 2012 17th Annual North Carolina Veterinary Conference November 2-4, 2012.

For more information on this conference click here.

Upcoming CE Regarding best Practices for Prescribing and Obtaining Compounds

Upcoming CE at KIAWAH ISLAND RESORT in SC on September 7-9,2012.  Part of the CE includes Gigi Davidson, RPH, DIVCP presenting topics on Compounding:


New Drugs and New Ideas for Old or Unavailable Drugs: Finding Alternatives During Drug Shortages, New Uses for Old Drugs, New FDA Approvals
Best Practices for Prescribing and Obtaining Compounds: Protect Yourself and Your Patients-Checklist for Vetting Compounding Pharmacies, Compound Marketplace--What's Legal and What's Not, Simple Tools for Assessing the Quality of Compounds
Drug Interactions: Which Ones Really Matter? Basic Primer on Drug Interactions in Animals vs. Humans, Significant Drug Interactions for Top 50 Veterinary Drugs, Recognizing the "Rare" Drug Interaction When it Happens in Your Patient
 
For more information click here.
 
 
 
 
 
 
 
 
 
 

 

Animal Drug Compounding: American Health Institute's Position

 
What is Animal Drug Compounding?
Compounding is the mixing of drugs to fit the unique needs of a patient. AHI and AVMA define it as “customized manipulation of an approved drug or drugs by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient.” Examples can include:
  • Mixing two injectable drugs;
  • Preparing a paste or suspension from crushed tablets; and
  • Adding flavoring to a drug.
Is Animal Drug Compounding Legal?
Animal drug compounding is legal only in very specific circumstances described in FDA regulation. According to the FDA, legal compounding is not the making a drug from bulk or raw active ingredients. Compounding should not be used to circumvent the drug approval process or to sell a specific drug at a cost below what is approved by the FDA. Consumers and animal health practitioners should be aware that products are being promoted to veterinarians under the guise of compounding that do not fit within the narrow legal definition, and present a threat to the health of the animal.
FDA Regulation of Animal Drug Compounding
The FDA Regulations and Compliance Policy Guide 608.400, “Compounding of Drugs for Use in Animals,” describe specific circumstances under which compounding is permitted.
For pets and food-producing animals, compounding is permitted when:
  • A valid veterinarian-client-patient relationship exists.
  • The health of an animal is threatened, or suffering or death may result from failure to treat.
  • Compounding is performed by a licensed veterinarian or a licensed pharmacist upon the order of a veterinarian within the scope of professional practice.
  • There is no approved animal or human drug that, when used as labeled or in conformity with the extra-label drug use regulations, will, in the available dosage form and concentration, appropriately treat the diagnosed condition.
  • Preparations are compounded from FDA-approved animal or human drugs. The regulations do not permit compounding from bulk (raw pharmaceutical ingredient) drugs.
Specifically for food-producing animals, compounding is not permitted when:
  • An approved animal drug can be used in place of the compounding.
  • The results in violative food residue or any residue may present a risk to public health.
  • The drug in question is listed on the food animals prohibited list.
Veterinarians must comply with all aspects of the federal extra-label drug use regulations, including record-keeping and labeling requirements. In addition to federal laws, all relevant state laws relating to the compounding of drugs for use in animals must be followed. Adequate procedures and processes must be created to ensure that the compounded product is safe and effective.

Compounding from Unapproved Substances
Federal regulations describe specific circumstances under which veterinarians – or pharmacists acting upon veterinarians’ prescriptions – are legally permitted to compound drugs for extra-label use in animals. Under these regulations, compounding of drugs for non-food animals may only be performed using FDA-approved animal or human drug products, and only when there is no approved animal or human drug product available in the relevant dosage, form and concentration to appropriately treat the diagnosed condition. Compounding from human drugs for use in food animals is not allowed if an approved animal drug can be utilized.
Veterinarians may occasionally face situations where they diagnose conditions for which no FDA-approved product is available for use to relieve the animal’s suffering or prevent the animal’s death. Because there are so many different diseases and so many different species of animals, it is not possible to have an approved drug for every condition a veterinarian may be asked to treat. Although the FDA considers compounding a violation of the Federal Food, Drug and Cosmetic Act, it acknowledges the need for compounding from bulk active or raw ingredients within certain areas of veterinary practice.
How to Identify an FDA-Approved Animal Drug Product
FDA-approved animal drug products can be identified by the six-digit New Animal Drug Application (NADA) number for brand-name drug products, or the six-digit Abbreviated New Animal Drug
Application (ANADA) number for generic drug products. The NADA or ANADA number and the statement “Approved by FDA” can also be found on the drug product’s label or package insert. Additionally, the FDA’s online databases, Animal Drugs @ FDA and the FDA Orange Book contain lists of approved animal and human drug products. The presence of a National Drug Code (NDC) number on a product label does not confer FDA approval.
What is Considered Inappropriate Drug Compounding?
Examples of inappropriate compounding pharmacy practices can include:
  • Compounded preparations that mimic those of FDA-approved drug products:
Beware of pharmacies that purport to sell compounded preparations that are the same as, or functionally similar to, commercially available FDA-approved products. Often these products are marketed as cheaper alternatives to the approved drug. The FDA has not identified price as a legitimate reason for prescribing a compounded preparation. Legitimate compounding is prescription-driven and predicated upon the need to customize a preparation to meet the individual needs of the animal.
  • Manufacturing under the guise of compounding:
The use of commercial-scale equipment and the preparation of large quantities of compounded products in anticipation of receiving orders.
  • Promotion and advertising of unapproved new animal drugs:
The FDA considers products compounded from bulk active ingredients to be unapproved new animal drugs.
  • Wholesale distribution of compounded preparations:
It is not legal for compounded preparations to be developed in large quantities and sold to third-party vendors (including veterinarians and distribution companies) or wholesalers.

AHI’s Role
Veterinarians occasionally use compounded preparations to meet a specific animal’s medical need. AHI, the American Veterinary Distributors Association (AVDA), and the American Veterinary Medical Association (AVMA) are working together to help veterinarians understand FDA requirements for compounding preparations for veterinary use, and the distinction between drug products approved by the FDA and compounded preparations.
For more information on animal drug compounding, view the veterinary compounding guidelines developed by AHI, AVDA, and AVMA.
 
Article is found here. AHI also has a wonderful brochure that can be found here.

Pennsylvania's Brochure on Compounding With Questions To Ask


To view click here.  This brochure contains a good set of questions that pharmacists, doctors, veterinarians and consumer should ask:


Questions you should ask about suppliers…
Is the supplier FDA registered/inspected?
Is the supplier reputable?
Is the supplier licensed with applicable state
and/or federal authorities?
Do the supplier's substances meet USP–NF standards?
If USP–NF grade substances are not available, is there a Certificate of Analysis?

Indian drug companies like Glenmark, Dr Reddy's, Sun Pharma break into worlds fastest growing list

Indian drug companies like Glenmark, Dr Reddy's, Sun Pharma break into worlds fastest growing list

Makena maker offers price cut for preterm birth drug

Makena maker offers price cut for preterm birth drug

Thursday, August 30, 2012

Article About Georgia to Cover Cost of Makena From Courthouse New Service

Georgia Ordered to Cover Costly Pregnancy Drug
ATLANTA (CN) - Georgia is violating Medicaid laws by failing to cover Makena, the only drug approved to treat preterm births, a federal judge ruled.
Makena is a progesterone-based drug designed to reduce the risk of premature birth in women pregnant with a single baby who have had a prior preterm birth. After the Food and Drug Administration approved the treatment in early 2011, KV Pharmaceutical charged $1,500 for Makena, while a compounded version was available for $20 a week. KV Pharma lowered the price to $690 in April 2011, but it continued to face protests from patient and doctor groups.
Though the Medicaid Act requires states to cover Makena for its FDA-approved indications, KV Pharma claimed that some states favored a compounded version of the drug over Makena and imposed unlawful restrictions on its product.
It filed federal complaints over the restrictions in Georgia and South Carolina.
In the Georgia case, the drugmaker insisted that Makena is theoretically a "covered outpatient drug." And yet, the Georgia Department of Community Health (DCH) restricted access to Makena by asking physicians to document the "medical necessity" of prescribing it over CHC, short for compounded hydroxyprogesterone caproate.
KV Pharma also sued the FDA in July for allowing compounding pharmacies to offer the lower-cost version of the drug, which contains the same active ingredients, but does not undergo the approval process.
The Northern District of Georgia refused to stay KV Pharma's lawsuit against the state pending the outcome of its action against the FDA, noting that the resolution of that lawsuit is irrelevant to the Georgia case.
U.S. District Judge Charles Pannell ruled that KV Pharma is likely to prove that Georgia Medicaid is breaking the law by failing to cover Makena.
"Because the court finds that the FDA drug approval process means something, the defendants' current policy favoring CHC over Makena is the opposite of what it should be," Pannell wrote. "As a result of the upside-down policy, the FDA-approved drug is not covered."
KV Pharma proved that the loss of revenue from Makena sales had contributed to its financial difficulties, including its filing for bankruptcy earlier this month, the court found.
Though Georgia may pay more for Makena, it will not suffer irreparable damages, and patients will benefit from an FDA-approved drug, the ruling states.
Pannell granted a preliminary injunction to KV Pharma, finding that Makena's Medicaid coverage would not disserve public interest.
"The parties agree that it is in the public interest to prevent preterm births," the ruling states. "Requiring the defendants to take steps to do so by utilizing the only FDA-approved drug as opposed to non-approved CHC, even at a higher cost, advances this public interest."
 
Article is found here.

American Medical Association Resolution on Compounded Medications H-120.945


H-120.945 AMMA Action on Non FDA-Approved Compounded Medications

Our American Medication Association:
  1. recognizes that compounding pharmacies must comply with current United States Pharmacopeia and National Formulary (USP-NF) compounding monographs, when available, and recommends that they be required to conform with USP-NF General Chapters on pharmaceutical compounding to ensure the uniformity, quality, and safety of compounded medications;
  2. recognizes the accreditation program of the Pharmacy Compounding Accreditation Board (PCAB™) and the PCAB™ Seal of Accreditation as a means to identify compounding pharmacies that adhere to quality and practice standards, including those set forth in the USP-NF, for the preparation of individualized medications for specific patients;
  3. encourages all state boards of pharmacy to require compounding pharmacies in their states to obtain the PCAB™ Seal of Accreditation or, alternatively, to satisfy comparable standards that have been promulgated by the state in its laws and regulations governing pharmacy practice; and
  4. encourages state boards of pharmacy and the National Association of Boards of Pharmacy (NABP), the umbrella organization for state boards of pharmacy, to work with the United States Food and Drug Administration (FDA) to identify and take appropriate enforcement action against entities that are illegally manufacturing medications under the guise of pharmacy compounding. (BOT Action in response to referred for decision Res. 521, A-06)
Source is here.

Continued NABP Actions Vital to Protecting Public from Rogue Internet Drug Outlet Dangers, Task Force Advises - National Association of Boards of Pharmacy® (NABP®)

Continued NABP Actions Vital to Protecting Public from Rogue Internet Drug Outlet Dangers, Task Force Advises - National Association of Boards of Pharmacy® (NABP®)

Counterfeit Drug Distributor Convicted, Used Internet to Distribute Products - National Association of Boards of Pharmacy® (NABP®)

Counterfeit Drug Distributor Convicted, Used Internet to Distribute Products - National Association of Boards of Pharmacy® (NABP®)

Wednesday, August 29, 2012

K-V v. Keck: Court Takes Motion for Injunction Under Advisement

08/28/2012 30 Minute Entry. Proceedings held before Chief Judge Margaret B Seymour: Motion Hearing held on 8/28/2012 re 6 MOTION for Preliminary Injunction filed by Ther-Rx Corporation, K-V Pharmaceutical Company. Court takes motion under advisement, written order forthcoming. Parties to notify court if they are able to work out prior to entry of order. Court Reporter Kathleen Richardson. (mdea ) (Entered: 08/28/2012)

Complaint and Motion for Injunction in K-V v. Hamos et al (state of Illinois)

The case of K-V Pharmaceutical Company et al v. Hamos et al (which is the state of Illinois) has been assigned to the Honorable Joan H. Lefkow.  To view the complaint click here.  If anyone wants to see the exhibits to the complaint please let me know which exhibit number and I will download and post it.
To view the memorandum in support of K-V's request for injunctive relief against Illinois click here.

Emerging Markets to Play a Key Role in the Pharmaceutical Industry's Growth


Full story: PR-inside.com

IMARC Group, one of the world's leading research and advisory firms, expects the emerging markets to play a key role in driving the growth of the pharmaceutical industry.

Unit Caraco Received US Ok to Resume Operations


Full story: Fox News

Indian generic drug maker Sun Pharmaceutical Industries Ltd. said Tuesday the U.S. drug regulator has allowed resumption of operations at unit Caraco Pharmaceutical Laboratories Ltd.'s manufacturing facility and packaging sites in Detriot and Wixom, Michigan.

Use of Compound Drugs in California's Workers' Compensation Program


The Working Papers, Use of Compound Drugs, Medical Foods, and Co-Packs in California’s
Workers’ Compensation Program, An Overview of the Issues, by BARBARA O. WYNN (January 2011) can be found here.

FDA Warning Letters in August

The following warning letters are found here:
August 16, 2012 Farmers Coop Co33 Kansas City District Office CGMP/Medicated Feed/Adulterated Not Issued *
August 15, 2012 Dragon Herbs34 Los Angeles District Office New Drug/Labeling/False & Misleading Claims Not Issued *
August 15, 2012 Healing Ways35 Los Angeles District Office New Drug/Labeling/False & Misleading Claims Not Issued *
August 02, 2012 HSAC Enterprises, Inc. dba Kare-N-Herbs36 New England District Office Drug/Labeling/False & Misleading Claims Not Issued *

Alarming Report About API from China

Melanie Lee and Ben Hirschler at Reuters have written a Special Report: China's "wild east" drug store dated August 28, 2012.  This report contains alarming information about API from China.  It should be read by everyone and serves as a reminder to ask questions about the source of API used by compounders. To read the report click here.

Tuesday, August 28, 2012

KV has Now Sued Illinois Over Payment for Makena


KV Pharmaceutical sues Illinois over payment for drug Makena

Date: Tuesday, August 28, 2012, 12:08pm CDT - Last Modified: Tuesday, August 28, 2012, 8:23pm CDT
KV Pharmaceutical Co. sued the Illinois Department of Healthcare and Family Services to compel the state’s Medicaid program to pay the company more than $500 per injection of KV's Makena drug, instead of just $20 for non-branded versions.
To read the remainder of the article click here.

Collaborative Practice: Do We Need to Adopt Legislation?

Collaborative Practice: Do We Need to Adopt Legislation? 
posted: 08/15/2012

by Greg J. Baran, R.Ph., MPA director of governmental affairs, and Denise M. Pratt, Pharm.D., MSHP immediate past president

There has been considerable discussion amongst the national pharmacy associations suggesting that states should enact collaborative practice legislation. At this time, 11 states are considering 27 bills related to collaborative practice. Several pharmacists have inquired as to whether MPA is pursuing legislation to allow pharmacists to participate in medication therapy management (MTM) programs by amending the Michigan Public Health Code to allow for collaborative practice agreements.
To read remainder of article click here.

 

Mass. Gov. signs prescription drug bill - Boston.com

Mass. Gov. signs prescription drug bill - Boston.com

Copy of Reply in K-V v. Keck (state of South Carolina)

To view the state's Reply Memorandum in Support of Motion to Dismiss filed on August 27, 2012, click here.

Reply Filed by Keck in K-V Lawsuit Against State of South Carolina: Copy of Reply to Be Posted Later Today

08/27/201229 REPLY to Response to Motion re 22 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM Response filed by Anthony Keck. (Strom, Joseph) (Entered: 08/27/2012)

Louisiana Rules Regarding Advertising: How Many Are Complying With These in The Compounding World?

§1115.  Advertising
A. False, fraudulent, deceptive, or misleading advertising as prohibited by R.S. 37:1241 of the Pharmacy
Practice Act and this section shall include, but is not limited to, any public misrepresentation done or
made with the knowledge, whether actual or constructive, that is untrue or illegal, or is said to be done falsely when the meaning is that the party is in fault for its error.  Actual or constructive knowledge as used in this context shall include intentionally, negligently, mistakenly, or accidentally representing an untrue fact.
B. No person shall carry on, conduct, or transact business under a name which contains a part thereof the words “pharmacist”, “pharmacy”, “apothecary”, “apothecary shop”, “chemist’s shop”, “drug store”, “druggist”, “drugs”, or any word or words of similar or like import, or in any manner by
advertisement, circular, poster, sign, or otherwise describe or refer to a place of business by the terms
of “pharmacy”, “apothecary”, “apothecary shop”, “chemist’s shop”, “drug store”, “drugs”, or any word or words of similar or like import, unless the place of business is a pharmacy validly permitted by the board.
C. Pharmacies and pharmacists are prohibited from advertising professional ability, experience, integrity, or professional qualifications, or soliciting professional practice by means of providing prescribers of prescriptions with prescription forms imprinted with any material referring to a pharmacy or pharmacist.
D. No advertising shall include any reference, direct or indirect, to any controlled dangerous substance as provided for in Schedules II, III, IV, or V of RS. 40:964. The provision of coupons or vouchers for controlled substances through authorized prescribers, which accompany legitimate prescriptions for such controlled substances issued to patients, shall not be prohibited by this section.
AUTHORITY NOTE:  Promulgated in accordance with R.S. 37:1182.
HISTORICAL NOTE:  Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1311
(October 1997), amended LR 29:2089 (October 2003), effective January 1, 2004, amended LR 33:1131 (June 2007).

Rules found here.

General Rules in Lousiana Regarding Compounding Practices

§2535.  General Standards 
A. Compounding Practices.  Compounded medications may be prepared using prescription medications,
over-the-counter medications, chemicals, compounds, or other components.
1. A pharmacy shall have written procedures as necessary for the compounding of drug products
to assure that the finished products have the identity, strength, quality, and purity they are
represented to possess.
2. All compounding shall be accomplished utilizing accepted pharmacy techniques, practices,
and equipment.
3. Products or duplicates of products removed from the market for the purposes of safety shall
not be used to compound prescriptions for human use.
B.   Beyond Use Date.  Compounded medications shall be labeled with a beyond use date of no more than one hundred eighty (180) days, unless documentation on file supports a longer beyond use date.
January 2012 Page 188C. Records and Reports.  Any procedures or other records required to comply with this section shall be maintained for a minimum of two years.
D. Compounding for Prescriber’s Use.  Pharmacists may prepare practitioner administered compounds for a prescriber’s use with the following requirements:
1. an order by the prescriber indicating the formula and quantity ordered to be compounded by
the pharmacist;
2. the product is to be administered by the prescriber and not dispensed to the patient; and
3. the pharmacist shall generate a label and sequential identification number for the compounded
drug.
E. Anticipated Use Products.  The pharmacist shall label any excess compounded product so as to
reference it to the formula used and the assigned lot number and estimated beyond use date based on
the pharmacist’s professional judgment and/or other appropriate testing or published data.
F. Labeling of Compounded Products.
1. For patient-specific compounded products, the labeling requirements of R.S. 37:1225, or its
successor, as well as this Chapter, shall apply.
2. All practitioner administered compounds shall be packaged in a suitable container with a label
containing, at a minimum, the following information:
a. pharmacy’s name, address, and telephone number;
b. practitioner’s name;
c. name of preparation;
d. strength and concentration;
e. lot number;
f. beyond use date;
g. special storage requirements, if applicable;
h. assigned identification number; and
i. pharmacist’s name or initials.
AUTHORITY NOTE:  Promulgated in accordance with R.S. 37:1182.
HISTORICAL NOTE:  Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708
(October 1988), effective January 1, 1989, amended LR 23:1316 (October 1997), amended LR 29:2105 (October 2003), effective January 1, 2004.
 
There are also additonal rules regarding compounding in Lousiana. Rules are found here.
 
 

Kentucky Law Regarding Compounding for a Practitioner's Office or Institutional Administration

201 KAR 2:310. Compounding for a practitioner’s office or institutional administration.
RELATES TO KRS 315.191(1)(a).
STATUTORY AUTHORITY: KRS 315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) requires the board to
promulgate administrative regulations to regulate and control all matters relating to
pharmacists, pharmacist interns, pharmacy technicians, and pharmacies. This administrative
regulation addresses compounding for use by a practitioner’s office administration or
institutional administration.
Section 1. A pharmacist, pharmacist intern, or pharmacy technician may prepare a
compounded drug for a practitioner’s office administration or institutional administration.
Section 2. A compounded drug that contains a controlled substance shall not be
compounded for office or institutional administration.
Section 3. The pharmacist shall receive a written, verbal, facsimile, or electronic request for
a compounded drug from a practitioner, indicating the formulation, strength, and quantity
ordered.
Section 4. Label Requirements. A label shall be generated for the compounded drug and
shall include:
(1) The name of the practioner;
(2) The designated name and strength of the compounded drug;
(3) The quantity dispensed;
(4) A lot or batch number of the compounded drug;
(5) The beyond use date for the compounded drug;95
(6) The date the compounded is dispensed;
(7) The pharmacy's name, address, and telephone number;
(8) Any special storage requirements;
(9) A notation stating "For Office or Institutional Administration Only-Do Not
Dispense to Patient;
(10) Any auxiliary label required for the compounded drug.
Section 5. The compounded drug shall be administered in the practitioner’s office or
institution and shall not be dispensed to the patient.
Section 6. The prescription for the compounded drug shall be kept pursuant to 201 KAR
2:170.
(35 Ky.R. 1954; 2006; eff. 3-11-09.)

Found here.

2012 Compounders Day CE in California on September 8, 2012

2012 Compounders Day

Saturday, September 08, 2012

Attendees can earn up to 6 hours of ACPE-accredited continuing pharmacy education.

Why You Should Attend
Compounders Day is a unique venue that offers pharmacists practicing in a compounding environment to meet and network with other compounding pharmacists.  Additionally, the educational programming has been selected by compounding pharmacists for compounding pharmacists and, therefore, is tailored to meet the special needs of this practice setting. 

Meeting Location 
Town & Country Resort & Conference Center
500 Hotel Circle North
San Diego, CA 92108
Reservation number:  (800) 772-8527

Take advantage of discounted hotel room rates of $119 per night (plus tax), single or double occupancy! 
To receive the discounted room rate, call the Town and Country directly at (800) 772-8527 by August 31, 2012, and ask for the CPhA Academies Weekend rate.    

Refund Policy
All requests for refunds must be made in writing to the California Pharmacists Association and postmarked at least five business days prior to the start of the program.  NO REFUNDS WILL BE PROVIDED AFTER SEPTEMBER 3, 2012.  Refunds will be provided in the amount of the registration fee less a $50 administrative fee.

Accreditation
The Pharmacy Foundation of California (#0113) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.  A Statement of Continuing Pharmacy Education Credit will be sent within 4 weeks of the conclusion of the event to all registered participants that complete the appropriate program evaluations for the CE programs attended and submit the completed evaluations to on-site staff on September 8, 2012. 

Arkansas Pharmacy Association Meeting Tonight, August 28, 2012

Tue Aug 28, 2012 7:00 PM

2012 APA District Meeting
 
Meeting begins at 7pm with a business meeting.  Attendees will receive reports from the Arkansas Pharmacists Association, the Arkansas State Board of Pharmacy, the UAMS College of Pharmacy, and the Harding College of Pharmacy.
 
The CE for the evening will be a "Pharmacy Open Door Forum" where audience members are able to interact with the leaders of pharmacy in Arkansas to get answers to the issues currently facing the profession.
 
The APA District Meetings are approved for 2.5 hours of continuing education by the Arkansas State Board of Pharmacy.




Location: Arkansas Tech University - East Banquet Room

For more information:

Contact: Arkansas Pharmacists Association
Phone: 501-372-5250
Email:  celeste@arrx.org 

Off-Label Drug Use Extremely Common

Daniel Weiss, Senior Editor
Published Online: Tuesday, August 21, 2012
 

Numerous studies have quantified the widespread practice of prescribing drugs off-label, but many patients are unaware that it is allowed, according to a new analysis.

Off-label drug use (OLDU) is extremely common, yet many patients appear to be unaware that they are engaging in the practice, according to an analysis that will appear in the October 2012 issue of Mayo Clinic Proceedings.

To read article in Pharmacy Times, click here

Iowa to Discuss Rules Regarding Compounding at Board of Pharmacy Meeting on 8/29/2012

To view the proposed agenda for the meeting, click here.

Monday, August 27, 2012

Man seeks dismissal of steroids conviction

Florida businessman who dealt prescriptions cites sentencing delay in case
Updated 9:05 p.m., Monday, August 27, 2012
 
ALBANY — The operator of a South Florida "wellness clinic" that steered millions of dollars worth of steroids' prescriptions to an Orlando pharmacy has asked a judge to overturn his conviction on the grounds his sentencing has been delayed for more than five years.
An attorney for Brian Schafler, 39, of Cooper City, Fla., argued Monday in Albany County Court that his client's sentencing has taken too long due to what he characterized as prosecutorial "negligence."


Read more: http://www.timesunion.com/local/article/Man-seeks-dismissal-of-steroids-conviction-3818543.php#ixzz24o6wZYmJ

Reminder: Alabama State Board of Pharmacy Has New Rules Effective August 27, 2012

To view the new rules, click here.

Second Warning: Press Announcements FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium

Press Announcements FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium

Market Report, "Compounding Pharmacies in the US", Published

Market Report, "Compounding Pharmacies in the US", Published: [object Object]
Boston, MA -- (SBWIRE) -- 08/14/2012 -- Doctor's orders: Drug shortages and demand from the aging population will benefit stores

After experiencing strong revenue growth during the recession, the Compounding Pharmacies industry will benefit from improved conditions in the next five years. The number of individuals aged 65 and over will increase, supporting demand for medications from the industry. Furthermore, doctors and patients will likely turn to compounding pharmacies to prepare medications with alternate doses and strengths as drug shortages loom.

This industry includes stores that make and sell compounded medications. Compounded medications are prescriptions that are written by physicians and prepared by pharmacists for individual patients. These medications are not commercially available; rather, they are prescribed by physicians and prepared by pharmacists to meet unique needs.

View Full Report Details and Table of Contents

This report covers the scope, size, disposition and growth of the industry including the key sensitivities and success factors. Also included are five year industry forecasts, growth rates and an analysis of the industry key players and their market shares.

Sunday, August 26, 2012

Horse deaths on race tracks not uncommon


The deaths of three horses during the production of the television drama "Luck" attracted headlines about the care of animals on TV sets.
But the death of horses on race tracks is not uncommon. Horses often break bones during races and later receive a lethal injection. To read the remainder of this article, click here.

Big Purses, Sore Horses and Death: Article Suggests Drugs Administrated Prior To Race Are Numerous



Large payouts to owners make it profitable for owners to field thoroughbreds that are past their prime, sometimes with fatal results. To read this article click here.

Mangled Horses, Maimed Jockeys: Article Suggest Illegal Doping often occurs on private farms before horses are shipped to the track. Few states can legally test horses there.


The new economics of horse racing are making an always-dangerous game even more so, as lax oversight puts animal and rider at risk. To read the rest of this article, click here.

Video News Report on Franklin and Russellville Pharmacies

Channel 48 news out of Alabama has a video news story regarding the searches at the Franklin  and Russellville Pharmacies,

Click here to watch video.

Proposed U.S. legislation would 'set the standard' for global efforts to combat counterfeit drugs

In this Forbes opinion piece, John Lechleiter, president and chief executive officer of Eli Lilly and Company, examines the business of counterfeit medicines, writing, "With global sales last year estimated as high as $200 billion, counterfeit medicine is big business, and it's growing." "In a recent Forbes column, Henry I. Miller cited an estimate by Roger Bate of the American Enterprise Institute that more than 100,000 people die every year from counterfeit drugs," he continues, adding, "That's why fighting counterfeits is essential to safeguarding health. We need action -- national and international -- to better secure the pharmaceutical supply chain." To read remainder of article click here.

Saturday, August 25, 2012

Top FDA Regulatory Official Stepping Down, Will Assume New Duties RAPS News - Article View

Top FDA Regulatory Official Stepping Down, Will Assume New Duties RAPS News - Article View

Enforcement Trends Reveal Record-High Warning Letter Issuances, Common Violations


Regulatory Focus, which requires a subscription found here, contains the following article.

By Alexander Gaffney

The US Food and Drug Administration (FDA) sent more warning letters during 2011 than at any time during the previous 13 years, and FDA official told a San Francisco chapter meeting of the Regulatory Affairs Professionals Society (RAPS). Speaking at a 27 July meeting, Barbara Cassens, director of FDA's San Francisco District office, highlighted recent FDA enforcement trends, including warning letters, injunctions, arrests, convictions, and the most common deficiencies exhibited by medical device and pharmaceutical manufacturers. Read More...

Indian Drug Representatives Strike for Strengthened Regulations RAPS News - Article View

Indian Drug Representatives Strike for Strengthened Regulations RAPS News - Article View

Outline of Recent Revisions to FDA Regulatory Procedures Manual


From the FDA website found here.

2012 Revisions and Updates

  • 08/16/2012: Chapter 9 of the Regulatory Procedures Manual1 (RPM) was revised and updated, as detailed below.
    • Chapter 9 - Import Operations and Actions
      • Section 9-1, subsection "Scope and Purpose," was revised to include the following Tobacco Acts - Federal Cigarette Labeling and Advertising Act and Comprehensive Smoking Tobacco Health and Education Act of 1986. Section 9-6, "Recommendation Based on Multiple Samples," was revised to include the amount "at least 25%" in paragraphs 1(b), 2(b), and 3(b), and to also include the following language, "FDA may consider additional information in conjunction with sample analysis when considering whether to recommend products from a manufacturer, shipper, geographic area, or country for detention without physical examination, such as the results of foreign inspections and other types of information discussed in this subchapter." Section 9-15, subsection "Background," was revised to clarify section 801(d)(3)(B) of the Act.
      • Section 9-21, Exhibits - Exhibit 9-1 was deleted so please refer to Exhibit 9-6 instead. Exhibit 9-2 was updated with the current version. Exhibit 9-3 was revised to omit "tobacco products" from the following sentence, "These laws are designed to protect you from, among other things, unsafe or misrepresented foods, drugs, biologics, cosmetics, devices, and other articles." The title of Exhibit 9-11 had the words "for Special Events" added. Exhibit 9-12 was deleted as a duplication of Exhibit 9-6. Exhibit 9-13 was removed.

Warning Letter to Sogeval Laboratories in Coppell, TX


March 13, 2012


2012-DAL-UTL-15
CERTIFIED MAIL:
RETURN RECEIPT REQUESTED

Thomas L. Bell, President and CEO
Sogeval Laboratories, Inc.
635 Fritz Drive, Suite 210
Coppell, TX 75019
Dear Mr. Bell:
During the May 9 through 20, 2011, inspection of your establishment at 635 Fritz Drive, Suite 210, Coppell, Texas, an investigator from the Food and Drug Administration determined that your firm is an own-label distributor of veterinary drug products. These products are drugs within the meaning of section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
The above-stated inspection revealed that your firm's veterinary drugs are adulterated under section 501(a)(2)(B) of the Act, 21 U.S.C. § 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packaging or holding fails to conform to, or is not operated or administered in conformity with Current Good Manufacturing Practice (CGMP) regulations as specified in Title 21, Code of Federal Regulations, Parts 210 and 211 (21 C.F.R Parts 210 and 211). No distinction is made between animal and human drugs, and the failure to comply with CGMP constitutes a failure to comply with the requirements of the Act.
In addition, our October 11 to November 4, 2011 inspection at Sogeval Laboratories, Incorporated, located at 4027 Tampa Road, Suite 3000, Oldsmar, Florida, identified numerous additional CGMP violations.
Please note that we have reviewed Ms. Lemaire's response dated June 2, 2011 in response to FDA's May 2011 inspection at Coppell, Texas and November 22, 2011 in response to FDA's October inspection in Oldsmar, Florida. We have included applicable comments following each item listed below.

The Coppell location

CGMP violations
Your firm distributes under its own label, drug products that are manufactured for you by contract manufacturers. Your firm has responsibility for complaint handling and additional quality control unit (QCU) functions. Your firm's operations must satisfy the requirements of 21 C.F.R. §§ 211.198 and 211.22, but fail to do so. Specifically,
1. Your firm's QCU failed to ensure a thorough investigation in accordance with 21 C.F.R. § 211.192 with conclusions and follow up accomplished as required by 21 C.F.R. § 211.198(a).
For example, the QCU failed to investigate or did not fully investigate complaints in numerous documented instances. Specifically, nineteen (19) consumer complaints were received by your firm from July 2009 to May 2011, for DUOXO Microcellular Cleaning Solution, DUOXO Spot-on, DUOXO Microcellular Solution, DUOXO Seborrhea Shampoo, and DOUXO Calm Emulsion Spray. The complaints included: animal ruptured ear drum, animal skin reactions, respiratory distress in humans, and a related human death. We have concluded your company did not conduct timely, comprehensive investigations. Your firm's management, including the QCU, was not proactive in response to consumer complaints. Quality problems must be thoroughly investigated, root cause determined, and appropriate corrective and preventive actions implemented. Furthermore, your firm does not have a written procedure for conducting investigations when complaints are received. We acknowledge your commitment to develop an SOP for complaint handling; however, your response is inadequate because you do not define a timeframe for completion or define what will be further developed in the SOP.
2. Your firm has failed to follow written responsibilities and procedures applicable to the QCU [21 C.F.R. § 211.22(d)].
Your firm does not have documentation addressing the basic roles, responsibilities, and procedures for your QCU. We acknowledge your commitment to develop an SOP to define the scope of responsibilities of the QCU; however, your response is inadequate because it fails to 1) describe changes that would be implemented in your procedures in the Quality Manual to ensure an effective QC process and, 2) include any analysis of the effectiveness of your procedure. We cannot assess the adequacy of the above corrective actions since the SOPs have not been submitted.
3. The QCU has not fulfilled its responsibility nor exercised its authority to approve or reject drug products manufactured, processed, packed, or held under contract by another company [21 C.F.R. § 211.22(a)].
For example, your firm has been an own-label distributor for contract manufactured veterinary drug products since 2008. However, only two audits have been conducted of these contract manufacturing firms since that time. Our inspection raises concerns about the effectiveness of the audits. Please comment on how future audits will ensure the QCU will identify and correct deficiencies and prevent recurrences. Further, your firm should have agreements in place with your contract manufacturers. We are also concerned about your firm's fundamental understanding of what is required of your QCU and the regulatory expectations to handle specific agreements that delineate responsibilities to each party (e.g., quality control responsibilities). Your firm is ultimately responsible for the quality of your products. Regardless of who manufactures your products, you are required to ensure these products meet predefined specifications prior to distribution and are manufactured in accordance with the Act, and its implementing regulations, including CGMP regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Part 211.

The Oldsmar facility

CGMP violations
1. Your firm's QCU failed to ensure a thorough investigation in accordance with 21 C.F.R. § 211.192 with conclusions and follow up accomplished as required by 21 C.F.R. § 211.198(a).
For example,
a) Your firm failed to adequately investigate Adverse Event #2011-054, dated July 12, 2011, regarding human suffering an adverse reaction (asthmatic attacks) allegedly involving use of DOUXO Chlorhexidine PS Shampoo, lot# 003404.
b) Your firm failed to adequately investigate Adverse Event #2011-053, dated July 25, 2011, regarding human suffering adverse reaction (hives, breathing problems) allegedly involving use of PhytoVet P Anti-Itch Shampoo, lot #10911A.
c) Your firm conducted a recall of DOUXO Calm Shampoo 3L, lot # 006901, Exp 09/12, after product complaint of foul odor, dated September 1, 2011. A retain sample of this lot revealed microbial growth. However, no action was taken to determine cause of the microbial growth.
We have concluded that your company did not conduct timely, comprehensive investigations to numerous adverse events received at your distribution facility. Each investigation should include a root cause determination, corrective action plan, and evaluation of product impact.
We acknowledge in your response that you plan to further develop a new SOP for complaint investigation. However, your response is inadequate because you do not define a timeframe for completion or define what will be further developed in the SOP.
2. Your firm's written procedures to control issuance of labels are incomplete [21 C.F.R. § 211.125(f)] and your firm failed to conduct reconciliation between labels issued, used, and returned and product produced [21 C.F.R. § 211.125(c)].
For example,
a) Your firm's Labeling Control Procedure, SOP-OP501.01TR-R01-15-11, lacks information regarding control of issuance of labeling to drug product labeling operations.
b) Your firm does not document: 1) the quantity of labels issued to or returned unused from the production floor, 2) quantity of labels obtained for use or returned unused by each employee or for each production line and, 3) differences in quantity of labels found after (b)(4) inventory.
Your response stated the SOP will be revised to include label issuance details; however, the response failed to include what specific details will be included in the updated SOP. Furthermore, your response did not include the revised SOP.
3. Your firm has failed to follow written responsibilities and procedures applicable to the QCU [21 C.F.R. § 211.22(d)].
Your firm does not have documentation addressing the basic roles, responsibilities, and procedures for your QCU. We acknowledge your commitment to develop an SOP to define the scope of responsibilities of the QCU; however, your response is inadequate because it fails to 1) describe changes that would be implemented in your procedures in the Quality Manual to ensure an effective QC process and, 2) include any analysis of the effectiveness of your procedure. We cannot assess the adequacy of the above corrective actions since the SOPs have not been submitted.
Be advised that we will confirm the implementation and adequacy of all corrective actions upon reinspection of your facilities.
Neither this letter nor the observations noted in this letter are intended to be an all­ inclusive statement of deficiencies that may exist at your facilities. It is your responsibility to ensure that all facilities under your control comply with all of the requirements of the Act and the regulations promulgated under it.
We remind you that under Section 512 of the Act, 21 U.S.C. 360b, to be legally marketed new animal drugs require approved or conditionally approved new animal drug applications, approved abbreviated new animal drug applications, listings on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (Index Listings), or investigational exemptions. We note that your firm markets its topical drug products without approved applications, index listings, or investigational exemptions. You should be aware that unapproved products that lack a required application or index listing are subject to FDA enforcement action to remove them from the market at any time. We also remind you that all drugs, whether marketed with approval or not, must, among other things, be listed with the FDA by a registered firm; manufactured according to CGMP; and have labels and labeling that meet the requirements of the Act and its implementing regulations. You may obtain information on the drug application approval process on our web page www.fda.gov/cvm1.
Please notify this office in writing, within 30 working days of receipt of this letter, of the specific steps that you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions cannot be completed within 30 working days, state the reason for delay and provide timeframes or a schedule detailing when these corrections will be completed.
Your reply should be sent to the Food and Drug Administration, Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, to the attention of Rose Ashley, Compliance Officer. If you have any questions about the content of this letter please contact Rose Ashley at (210) 541-9450, Ext. 1118 or email at Rose.Ashley@fda.hhs.gov.
Sincerely,


/s/
Reynald R. Rodriguez, Jr.
Dallas District Director

RRR/rma