Thursday, September 26, 2013

The Law of Compounding Medications And Drugs: More Sway for F.D.A. Is Object of New Bill By SABR...

The Law of Compounding Medications And Drugs: More Sway for F.D.A. Is Object of New Bill By SABR...: A bipartisan committee of lawmakers from the Senate and the House reached a compromise on Wednesday on legislation that would give the Fo...

The Law of Compounding Medications And Drugs: NOTE: Until the draft of the federal compounding ...

The Law of Compounding Medications And Drugs: NOTE: Until the draft of the federal compounding ...

The Law of Compounding Medications And Drugs: Veterinary Feed Directive Proposed Rule Lands At O...

The Law of Compounding Medications And Drugs: Veterinary Feed Directive Proposed Rule Lands At O...

The Law of Compounding Medications And Drugs: BREAKING NEWS!! Lawmakers strike agreement on comp...

The Law of Compounding Medications And Drugs: BREAKING NEWS!! Lawmakers strike agreement on comp...: Health policy leaders in the House and Senate announced an agreement on legislation to strengthen regulation of non-traditional compoundi...

Thursday, September 19, 2013

NABP Model Act Amended to Address Shared Service Concept, Medication Reuse Programs, and Internet Pharmacy Safety



 
The National Association of Boards of Pharmacy® (NABP®) recently amended the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) in its effort to assist the boards of pharmacy as they work to protect the public health. The Model Act was revised to replace technology-specific language with shared services conceptual language, to reflect revised language in the National Association of Boards of Pharmacy Position Statement on the Return and Reuse of Prescription Medications in the Pharmacy Setting (PDF), and to include language aimed to enhance public protection against rogue Internet drug outlets. Additional revisions were made to address appropriate regulation for prescriber dispensing or prescriber drug outlets, and to clarify language pertaining to telemedicine practices. The Model Act is available for download in the Members section of the NABP Web site. A full summary of the changes can be found in the September issue of the NABP Newsletter (PDF, pg 169).
quoted from NABP

FLORIDA The Board of Pharmacy’s Compounding Rules Committee will meet 9/20/2013 to discuss amendments to rules concerning the definition of compounding and the standards of practice for compounding sterile preparations. Becky Lukaesko at bml@stateside.com



Law Review articles Regarding the Practice of Veterinary Medicine


Hanekamp, Kwakman, Beyond Zero Tolerance: A New Approach to Food Safety and Residues of Pharmacologically Active Substances in Foodstuffs of Animal Origin, 12 ENVIRONMENTAL LIABILITY 33-39 (2004).
Centner, Legal Rights of Veterinarians Under Veterinary Good Samaritan Statutes and Equine Liability Statutes, 210 J. AMERICAN VETERINARY MED. ASSOC. 190-194 (1997).
Comment, Legislation Without Representation: How Veterinary Medicine Has Slipped Through the Cracks of Tort Reform, 1990 UNIV. ILLINOIS L. REV. 953-987 (1990).
Comment, Regulating through Rules: Suggested Changes in the Federal Regulation of Veterinary Compounding, 13 HOUSTON J. HEALTH L. & POLICY 129-161 (2012).
Geyer, Extralabel Drug Use and Compounding in Veterinary Medicine, 52 FOOD AND DRUG L. J. 291-295 (1997).
Grossman & Scoggins, The Legal Implications of Covenants Not to Compete in Veterinary Contracts, 71 NEBRASKA L. REV. 826-878 (1992).
Hankin, What Is the Scope of the Duty to Provide Veterinary Care?, 43 MARYLAND BAR J. 18, 20-23 (4-2010).
Hannah, Veterinarians and the Law, 3 AGRICULTURAL LAW UPDATE 4-6 (8-1986).
Download: download Open | Download
Huss, Valuation in Veterinary Malpractice, 35 LOYOLA UNIV. CHICAGO L.J. 479-553 (2004).
King, The Standard of Care for Veterinarians in Medical Malpractice Claims, 58 TENNESSEE L. REV. 1-71 (1990).
Lacroix, Current Trends in Animal Law and Their Implications for the Veterinary Profession, 36 VETERINARY CLINICS SMALL ANIMAL 341-353 (2006).
McKEAN (ed.), Legal Issues Affecting Veterinary Practice, 23 VETERINARY CLINICS OF NORTH AMERICA: SMALL ANIMAL PRACTICE pp. 921-1140 + index (W. B. Saunders Co., Philadelphia) (1993).
Summary: - Beran, Zoonoses in Practice, 1085-1108 . - Brody, Safety in the Veterinary Medical Workplace Environment: Common Issues and Concerns, 1071-1084 . - Garbe, Wildlife Jurisprudence, 1060-1070 . - Heamon, APHIS and the Accredited Veterinarian: A Partnership in Regulatory Medicine, 1053-1060 . - Richardson & Geyer, Estate Planning for Veterinarians, 1121-1140 . - Geyer, Malpractice Liability, 1027-1052 - Dinsmore, Veterinary Lawsuits: Trends and Defense Strategies, 1019-1026 . - Hannah, The Impact of Animal Welfare and Animal Anti-Cruelty Laws on Veterinarians, 1109-1120 . - Copeland, How to Be an Effective Expert Witness, 1007-1018 . - Stribling & Picut, Food and Drug Regulatory Issues, 991-1006 - Hamilton & Andrews, Property Issues in Practice, 975-990 . - Copeland, Employer-Employee Relations, 957-974 . - Grossman & Scoggins, Contractual Considerations in Veterinary Practice, 945-956 - Carney, Choosing a Lawyer, 937-944 - Tannenbaum, Ethics: The Why and Wherefore of Veterinary Law, 921-936 .
McKean, Veterinary Pharmaceuticals Distribution--A Case for State Model Veterinary Code Enactment, 10 J. AGRICULTURAL TAXATION & LAW 137-161 (1988).
Note, Bailment and Veterinary Malpractice: Doctrinal Exclusivity, or Not? 55 HASTINGS L. J. 1009-1029 (2004).
Note, Toward a More Equitable Approach to Causation in Veterinary Malpractice actions, 16 HASTINGS WOMEN’S L. J. 201-220 (2005).
Note, What's Up Doc?: A Critique of Veterinarian Experts Addressing Toxic Torts in the Environment under the Daubert Threshold Inquiry, 22 J. NATURAL RESOURCES & ENVIRONMENTAL L. 55-68 (2007).
Nunalee & Weedon, Modern Trends in Veterinary Malpractice: How Our Evolving Attitudes Toward Non-Human Animals Will Change Veterinary Medicine, 10 ANIMAL L. 125-161 (2004).
Download: download Open | Download
Symposium, The Animal Drug Amendments of 1968: A Twenty Year Retrospective, 43 FOOD DRUG COSMETIC L. J. 779-877 (1988).
Toby, State Regulation of Complementary and Alternative Veterinary Therapies: Defining the Practice of Veterinary Medicine in the 21st Century, 1 KENTUCKY J. EQUINE, AGRICULTURAL, NATURAL RESOURCE L. 29-48 (2009).
von Oehsen, The FDA's Regulation of Veterinary Biotechnology: Business as Usual or a New Era of Environmental Protection, 43 FOOD DRUG COSMETIC L. J. 847-877 (1988).
WILSON, LAW AND ETHICS OF THE VETERINARY PROFESSION (Priority Press) (1989).

Duane Morris LLP - U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies That Would Apply to Human Compounds But Not Animal Compounds

Duane Morris LLP - U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

2013 Sigel Cattle Company, Inc. 9/5/13

2013 Sigel Cattle Company, Inc. 9/5/13

Stricter compounding pharmacy regulations proposed in Lansing September 19, 2013


Written by
Christopher Behnan
Daily Press & Argus

Michigan compounding pharmacies would face stricter state oversight and new licensing and recordkeeping requirements under legislation announced today in Lansing.
The legislation will follow a meningitis outbreak a year ago this month linked to tainted steroids produced at a Massachusetts compoundingpharmacy and distributed across the country, resulting in 19 Michigan deaths to date.
The legislation would require every compounding pharmacy to have a "pharmacist in charge" who would be responsible for all activity at the location.
continue to read here

Vaccinating Cows Could Sharply Cut E. Coli Published: Sep 18, 2013 | Updated: Sep 19, 2013 By Nancy Walsh, Staff Writer, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner


Widespread vaccination of cattle againstEscherichia coli O157 could vastly decrease the human incidence of disease associated with this pathogen, a mathematical simulation suggested.
If the effects of the vaccine simply reflected its efficacy in cattle, a 50% reduction in cases would be expected because the vaccine has been shown to halve the fecal shedding of the pathogen, according toLouise Matthews, PhD, of the University of Glasgow, and colleagues.
However, because the vaccine targets high-density shedding strains of E. coli O157 -- so-called supershedders -- the decrease in human cases could be expected to reach 83% (95% CI 76-93), the researchers reported online in the Proceedings of the National Academy of Sciences.

read more here

Sunday, September 15, 2013

NewStat | Compounding: Stay afloat in the muddy regulatory waters

NewStat | Compounding: Stay afloat in the muddy regulatory waters

The role of compounding in closing therapeutic gaps (Parts 1 and 2)


The role of compounding in closing therapeutic gaps (Parts 1 and 2)

Thursday 5th of September 2013
09:00-17:00
C9, 6 hours

Organised by the FIP Community Pharmacy Section, the FIP Hospital Pharmacy Section (TBC), the FIP Laboratories and Medicines Control Services (TBC) and the FIP Special Interest Groups on Formulation Design and Pharmaceutical Technology, and on Translational Research


Introduction

Compounding is a service that has again been increasingly adopted by pharmacists over the last three decades. Researchers at the University of Sydney have identified some of the motives of these pharmacists as: a strategy for reprofessionalisation; professional satisfaction; demand by patients and doctors for customised medications; and financial returns that are in line with a professional service. Compounding today is not the same as 50 years ago. Pharmacists now have access to a huge range of ingredients, compounding equipment and dosage forms, and are able to help patients and doctors solve medication problems that many have given up trying to fix. The emphasis on solving medication problems has moved compounding from a product focused activity to one in which the compounding pharmacist is a hugely valuable member of the patient’s healthcare team.

Learning objectives

At the conclusion of the session, participants will be able to:
-    Describe how to manage and implement GMP in the pharmacy setting
-    Describe how to guarantee the quality of the product in small scale production
-    Portray and understand the role of compounding in paediatric medicines
-    Portray and understand the role of compounding in oncology
-    Portray and understand the role of compounding in dermatology.


Chair: Eugene Lutz (FIP CPS, USA)
Programme
1) Biopharmaceutical principles of compoundingGiovanni Pauletti (University of Cincinnati, USA)

2) When NOT to compound and consideration before compounding
Maria Carvalho (Portugal)

Break

3) Guidelines and standards in compounding 
Gigi Davidson (USP Compounding Expert Committee 2010-’15, USA)

4) Quality assurance in pharmacy compounding /preparation
Holger Reimann (Germany)
Break

5) Compounding of pediatric medicines
Lisa Ashworth (Children’s Medical Center of Dallas TX, USA) 

6) Sterile compounding 
Vaiyapuri Subramaniam (Veterans Health Administration, USA)
Break 

7) Compounding in dermatology 
Francesc Llambi (APROFARM – COF Barcelona, Spain)

Doxycycline concentration over time after storage in a compounded veterinary preparation Mark G. Papich, DVM, MS, DACVCP; Gigi S. Davidson; Lisa A. Fortier, DVM, PhD, DACVS


Abstract
June 15, 2013, Vol. 242, No. 12, Pages 1674-1678
doi: 10.2460/javma.242.12.1674

Doxycycline concentration over time after storage in a compounded veterinary preparation

Mark G. PapichDVM, MS, DACVCPGigi S. DavidsonLisa A. FortierDVM, PhD, DACVS
Department of Molecular Biomedical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC 27607. (Papich); Department of Clinical Pharmacy Services, College of Veterinary Medicine, North Carolina State University, Raleigh, NC 27607. (Davidson); Department of Clinical Sciences, College of Veterinary Medicine, Cornell University, Ithaca, NY 14853. (Fortier)
Supported by a grant from the Grayson-Jockey Club Research Foundation.
The authors report no conflict of interest relating to this study.
Presented in abstract form at the American College of Veterinary Internal Medicine Forum, Denver, June 2011.
The authors thank Delta Dise and Daria DiGiovanni for technical assistance.
Address correspondence to Dr. Papich ().
Objective—To determine the concentration of doxycycline compounded from doxycycline hyclate tablets into liquid formulations for oral administration in veterinary species and stored for 28 days.
Design—Evaluation study.
Sample—Doxycycline hyclate tablets (100 mg) crushed and mixed with a 50:50 mixture of syrup and suspension vehicles for oral administration to produce 3 batches each of 2 doxycycline formulations: 33.3 and 166.7 mg/mL.
Procedures—Formulations were stored, protected from light, at room temperature (22° to 26°C [71.6° to 78.8°F]) and at a controlled cold temperature (refrigerated 2° to 8°C [35.6° to 46.4°F]). Doxycycline was extracted from the formulations, and concentration was measured by high-pressure liquid chromatography on days 0 (date of preparation), 1, 4, 7, 14, 21, and 28. Concentrations were compared with those of a US Pharmacopeial Convention reference standard. Formulation quality at each point was also assessed through color change, formulation consistency, and suspension uniformity.
Results—On days 0, 1, 4, and 7, the concentration of each formulation was within 90% to 110% of the reference standard (range, 93% to 109%), which was deemed acceptable. However, doxycycline concentrations had decreased dramatically by day 14 and remained low for the duration of the study period. Doxycycline concentrations on days 14, 21, and 28 were all < 20% (range, 14% to 18%) of the reference standard, and the quality of the formulations decreased as well. No effect of storage temperatures on doxycycline concentration was identified.
Conclusions and Clinical Relevance—The concentration of doxycycline, compounded from commercial tablets in the vehicles evaluated to yield doses of 33.3 and 166.7 mg/mL, cannot be assured beyond 7 days.
Full TextPDF (298 KB)PDF Plus (286 KB)

Veterinary Medicine Advisory Committee Roster of the Veterinary Medicine Advisory Committee

Veterinary Medicine Advisory Committee Roster of the Veterinary Medicine Advisory Committee