Excellent Articles Available at Hyman, Phelps & McNamara, P.C.,

	The Long and Winding Road to FDA Regulation of LDTs  October 2013
	What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions September 2, 2013
	Draft Guidance on Medical Device Recalls: Improvements Are Needed  July / August 2013
	How, and When, Will FDA Regulate LDTs?  July 15, 2013
	New Paper Argues 510(k) Program Has Strengths That Critics Have Overlooked  April 22, 2013
	The US FDA and its Draft Guidance on Medical Device Appeals  April 2013
	Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations February 2013
	Summary of CMS Final Rule on Transparency Reporting  February 12, 2013
	Real-World Implications of United States v. Caronia  January 31, 2013
	Should DEA Provide Guidance & Conduct Rulemaking on Suspicious Orders to Ensure Balanced Approach to Reduce Abuse & Ensure Avail. of Needed Medicine?  January, 2013
	FDASIA's Impact on Novel IVDs  October 1, 2012
	Ten Short Tips For The Medical Device Industry  September / October 2012
	USP Recognizes Work of Food Ingredients Expert Committee  September 2012
	US FDA should be required to provide 510(k) decision summaries for devices - a missed opportunity by lawmakers  July 2012
	Garbage Runs, Fake Identities, and Surprise Home Visits - Strategies to Deal With FDA's Nontraditional Investigative Tools  June 20, 2012
	A Year in Review: CDRH Draft Guidance Documents of 2011  May / June 2012
	CMS proposed ACA rule - 2-4-2012  April 2012
	Foreign Territory: Dietary Supplement Clinical Trials Conducted Abroad  April 2012
	FDA Appeals - Improving Your Odds of Success: Trends, Expectations, Strategies  March 21, 2012
	Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs  March 2012
	Proper Reform Is Needed of the Appeals Process at the US Food and Drug Administration's Device Center  January 2012
	Recent Developments in Food and Drug Law  January 2012
	CMS Proposed Rule on Reporting of Payments or Transfers of Value and Physician Ownership or Investment Interests  December 22, 2011
	Court Ruling Casts Doubt On FDA's Use Of Guidance Documents  December 16, 2011
	HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA Intent  December 2011
	Death, Taxes and DEA Inspections: Dealing with the Inevitable  November/December 2011
	Knocking On Your Front Door: Government Visits To Employees' Homes  August 19, 2011
	FDA's Pursuit of Punishing People  July / August 2011
	New Guidance from US FDA May Mean Just One Thing for Medical Device Manufacturers - More 510(k)s  August 2011
	Draft Guidance for RUO Products Issued  August 1, 2011
	Regulating Molecular Diagnostic Assays: Developing a New Regulatory Structure for a New Technology  May 2011
	Just What the Doctor Ordered? Legal Implications of Scheduling and Prescription-Only Approach to Methamphetamine Precursor Regulation  May 2011
	Guidance for Industry Helps FDA (Mostly) Win First Amendment Case on Health Claims May 2011
	Personalized Medicine: Improving the Regulatory Pathway  May 2011
	Uncertainty Persists with RUO Products - FDA May Be Considering More Restrictive Approach with Research Use Only Assays  April 1, 2011
	D.I.Y. Enforcement: Relators, the False Claims Act and the FDCA  January/February 2011
	What Happens to Medical Device Reports Once They Reach FDA?  January 2011
	Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products  January 2011
	Must FDA Treat Similarly-Situated Competitors the Same Way?  December 2010
	On FDA And Food Ingredient Safety: Is The "Gras" Henhouse At Risk?  December 3, 2010
	The Cost of Inadequate Substantiation  November 5, 2010
	The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine  October 8, 2010
	Publish and Perish: A Disturbing Trend in the European Union's Regulation of Nutrition Health Claims Made on Foods  September / October 2010
	New Use of Old Tools: Career-Ending OIG Exclusion and FDA Debarment  September / October 2010
	Regulating Laboratory-Developed Tests  September 15, 2010
	Using Social Media in FDA-Regulated Industries: The Essential Guide  September 2010
	The FTC's New Take on Health-Related Advertising: What Companies Facing FTC Enforcement Need to Know  September / October 2010
	15th Anniversary Essay: Regulation Then and Now  August 2010
	Advertising and Promotion: FDA Is Not the Only Cop on the Beat  August 2010
	The Problem of Regulatory Uncertainty  July 2010
	Whistleblowers: Treat Them With Kid Gloves  July 2010
	Regulatory Pathways for Clearance or Approval of IVDs  May 2010
	The Lanham Act: Another Vehicle to Enforce the Food, Drug, and Cosmetic Act?  April 2010
	Oversight of Research Use Only Products  March 1, 2010
	In the Name of Graduate Medical Education: What Mount Sinai Medical Center's FICA Tax Victory Means for Today's Teaching Hospitals  February 2010
	Court Empowers Qui Tam Defendants To Sue Third Parties For Indemnification  February 26, 2010
	But My Lawyer Told Me It Was Okay  January/February 2010
	Ingredient Testing for Food and Supplement Advertising Claims: Keeping Up with an Evolving Standard  October 2010
	In Vitro Diagnostic Tests for Cancer: Regulation of Laboratory Developed Tests  January 2010
	Retailers on the Radar of FDA Under the Family Smoking Prevention and Tobacco Control Act  November/December 2009
	Trends in FDA's Use of Class-Wide REMS  December 2009
	The Family Smoking Prevention and Tobacco Control Act: An Overview  December 2009
	Beating the Heat: What Food & Supplement Marketers Need to Know About the FTC's Summer of Litigation  October 2009
	Contracting with the Dietary Supplement cGMPs in Mind  September 2009
	The Park Criminal Liability Doctrine: Is it Dead or is it Awakening?  September/October 2009
	Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain Medicine  September 2009
	The Custom Device Exemption: What Is It And Does It Ever Apply?  September 2009
	Vindicated on Appeal - It Does Happen  July/August 2009
	Banked-Specimen Retrospective Studies  June 15, 2009
	Search Warrants - What Happens When the FDA Storm Arrives  May/June 2009
	Seeing Red Over "Green" - The Fight Over "Organic", "Natural", and "Sustainable"  May 2009
	Dermatologic Therapy  May 9, 2009
	The Curious Case of the Prosecution of Lawyer Paul Kellogg  March/April 2009
	Hyman, Phelps & McNamara Issues Analysis Discussing the Implications of the Supreme Court's Wyeth v. Levine Decision  March 16, 2009
	Making the Most of Pre-IDE Meetings  March 1, 2009
	Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing  January 2009
	Imported Products - FDA Is Not Fooling Around  January 2009
	FDA'S Implementation of FDAAA'S Food-Related Provisions: A Work in Progress  January 2009
	Taking control of the IVD submission process  January 2009
	Dietary Supplement Labeling and Advertising Claims: Are Clinical Studies on the Full Product Required?  2009
	Adroit Crafting of "Intended Use" Critical - Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words  November 15, 2008
	A Bad Fit: Qui Tam Actions and Off-Label Use Allegations  November 2008
	Surprise!...That Food Is Now a Drug  October 2008
	What is Natural?  September 2008
	Personalized Medicine - Panacea or Pipedream?  September 2008
	Cosmetics Product Enforcement - Not an Oxymoron  September 2008
	Lessons Learned from the AbTox Ruling  September 2008
	Ads Can Do the Body Good  September 8, 2008
	Dietary Supplement GMPs: Legal Perspectives  September 2008
	Food Allergens: Legal Requirements  September 2008
	Regulatory Pathways for Molecular Dx - Detailing the Various Options Available and What Each Requires  August 1, 2008
	Checking the Box Can Get You in the Hot Seat  August 2008
	Cosmetics Labeling and Process for Assigning INCI Names  July 2008
	PhRMA Releases Revised "Code on Interactions with Healthcare Professionals" More Restrictive than July 2002 Version; HPM Issues Summary Memorandum  July 10, 2008
	Primer on Regulation of Diagnostic Assays - Essential Points that Pharmaceutical Companies Need to Know Right Now  July 1, 2008
	Voluntary Labeling Claims  July 2008
	FDA Nutrition Labeling Requirements  July 2008
	Preemption of State Law Tort Suits against Medical Device and Drug Manufacturers June 2008
	FDA's Regulatory Extensions: An Overburdened Agency Assigns Itself New Responsibilities  June 13, 2008
	FDA Moves Against Marketed Unapproved Human Drugs  May/June 2008
	The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDA  May/June 2008
	The Battle Over rbST Labeling Comes to a Draw. Next Up, Animal Clones  May 2008
	FDA's latest ASR guidance document creates more confusion and raises legal issues  April 2008
	FDAAA § 912 - A Fundamental Shift in the Dividing Line Between Foods and Drugs  April 2008
	Playing "Hard Ball" With FDA Might Lead to Criminal Prosecution  April 2008
	As Nanotech Goes to Market, What Lessons Can We Draw From Biotech?  April 2008
	Nutrition Labeling - A Look at FDA's Proposed Requirements  February 2008
	FDAAA Enforcement Summary  February 2008
	FDA Regulation of Nanotechnology: What Are the Rules of the Road?  February 2008
	Court case determines specimen ownership  January 2008
	Clinical Trial Participation Unaffected by Disclosure of Investigator's Financial Stake December 18, 2007
	The Pursuit of Civil Money Penalties - An Important Weapon in FDA's Enforcement Arsenal  December 2007
	Food, Dietary Supplements, and Cosmetics  December 2007
	FDA's Regulatory Scheme for Human Tissue  November/December 2007
	FDA Amendments Act - HPM Issues Detailed Summary and Analysis  October 2007
	The OxyContin Case - Something for Everyone  September 2007
	FDA Releases Final Guidance on ASRs  September 14, 2007
	CMS Final Rule on the Drug Rebate Program  August 9, 2007
	BioShield II: A Step in the Right Direction?  July 2007
	FDA Issues Second Draft Version of IVDMIA Guidance  July 25, 2007
	Thinking of Marketing a Weight-Loss or Diet Product?  July 2007
	Who Decides A Company's Fate in FDA Enforcement Matters?  May 2007
	Jeff Gibbs Cited as FDA Law Authority by Federal Appeals Court  May 2007
	HPM Announces New Director and Associate  May 2007
	CMS Issues Draft of Revised Clinical Trial Policy, Renamed Clinical Research Policy  April 11, 2007
	Crossing the Line: Kickbacks Come Under Increased Government Scrutiny  April 6, 2007
	CMS Proposes Expanded Use of Part D Data - Will it Stay Confidential?  March/April 2007
	Are Food and Drug Lawyers 'Real' Lawyers?  April 2007
	Questions over FDA's Authority to Regulate Laboratory Developed Tests  March 2007
	ASRs and IVDMIAs: FDA's New Draft Guidances  March 2007
	Abigail Alliance v. von Eschenbach.  March 2, 2007
	Medicare Coverage with Evidence Development and Potential Impact on Your Clinical Trial Policy  January 30, 2007
	Corporate Compliance Officer - Gatekeeper or Jailbird  January 2007
	Winning Legal Strategies for Food & Drug Companies  January 2007
	Justice Department Alters Its Policies for Prosecuting Business Organizations  December 2006
	Falling Short - Final Guidance on Coverage With Evidence Development November/December 2006
	FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients  December 12, 2006
	State of the Union: Drug-Device Combinations  November 2006
	FDA Enforcement of the Food Allergen Labeling Law  October 2006
	Pharmaceutical Law R&D 101: Legal Issues During Research and Development  October 4, 2006
	Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill  September 29, 2006
	Application Of Health Care Fraud And Abuse Laws To Pharmaceutical Marketing September 2006
	Getting CMS Reimbursement for Medical Technology Products  September 7, 2006
	CMS Proposed Changes to ASP Calculation Methodology  August 2006
	Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The Marketplace  August 22-25, 2006
	FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?  August 11, 2006
	Medtronic Reaches Settlement over Allegations of Illegal Physician Payments to Promote Spinal Products  July 18, 2006
	CMS Coverage with Evidence Development Policy Highlights Differences Between FDA and CMS Clinical Evidence Requirements  July 12, 2006
	Medicare to Reconsider Clinical Trial Policy  July 10, 2006
	New Law Reins in "Authorized Generics" Despite Generic Industry Court Losses, But Leaves Several Ambiguities  June 2006
	Sponsor of Clinical Drug Trial Not Required to Continue Providing Drug to Participants After Termination of the Study  May 2006
	Appeals Court Finds Right to Post-Phase I Investigational New Drugs; Makes Controversial Comments about Off-Label Use and Promotion  May 3, 2006
	District Court Rules on Simvastatin 180-Day Exclusivity  May 5, 2006
	Safeguarding the Food Supply - FDA Given Sanitary Food Transport Authority May/June 2006
	Health and Speech Rights at Risk from Attacks on Medical Education  April 12, 2006
	Federal Court Holds FDA to 180-day Statutory Deadline for Approving Drug Marketing Applications  April 10, 2006
	The Drug Enforcement Administration's Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly Now  April 2006
	Product liability drug case not preempted by FDC Act  March 3, 2006
	Medicare CED: Considerations and Implications  March/April 2006
	Bioshield II: One Step Forward, One Step Back?  March/April 2006
	The Deficit Reduction Act of 2005: Amendments To The Medicaid Rebate Program and Drug Payment  February 2006
	It's The Law: Disgorgement and Restitution  February 2006
	FDA Issues Long-Awaited Prescription Drug Labeling Regulations  January 26, 2006
	Responding to FDA Form 483 and FDA Warning Letters  January 18, 2006
	Clinical Trials Disclosure Requirements: Too Much of a Good Thing?  January 2006
	The Drug Enforcement Administration's Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly Now  2006
	Qualified Health Claims: Creatures of Case Law  November/December 2005
	What You Don't Know about AIP Can Hurt You  November 2005
	Product Jurisdiction - New Developments  October 12, 2005
	Government Investigations: Responding to Requests for Information Including E-Discovery  September 2005
	FDA's Unauthorized User Fee Money Grab  August 12, 2005
	Condition of Approval Studies: FDA Takes A New Look  August 2005
	Just Sign on the Dotted Line?  June 20, 2005
	Exploring other options, Part 2: Facilitating the FDA review process  June 2005
	New Case Raises Doubts on FDA's Authority to Obtain Restitution and Disgorgement May/June 2005
	Exploring other options, Part 1: The trend toward alternative market pathways  May 2005
	Federal and State Requirements for HCT/Ps: An Overview  May 2005
	Further Protecting the Food Supply -- FDA's Final Rule on Recordkeeping Requirements May 1, 2005
	Perspectives on FDA's Ephedra Rule and the Court Order  April 27, 2005
	FDA Issues Good Review Management Principles and Practices Guidance Document  April 22, 2005
	FDA Draft Guidance on Exploratory IND Studies  April 22, 2005
	FDA Must Reform Its Arbitrary Drug Name Review Process  January 28, 2005
	FDA's Right to Get Disgorgement Is Threatened  2005
	Expanding FDA's Authority to Protect the Food Supply: Administrative Detention January/February 2005
	Courts Scrutinize FDA  November 4, 2005
	Comparative Claims: Legally Permissible, But Proceed with Care  September 2004
	Current Good Manufacturing Practices, and FDA Enforcement Actions and Inspections July 2004
	Vermont AWP Disclosure and Drug Marketer Gift Reporting Laws  June 2004
	State Regulation of Pharmaceutical Clinical Trials  2004
	The Food and Drug Administration's Actions on Ephedra and Androstenedione  2004
	FDA's Regulation of Combination Products: The Road Ahead  November 2003
	Close but No Cigar: The WHO Framework Convention on Tobacco Control's Futile Ban on Tobacco Advertising  Fall 2003
	Enforcement and Litigation Conference: Actions Against Competitors  September 23, 2003
	Avoid FDA Problems: Implementing a Corporate Compliance Program  June 5, 2003
	When All Else Fails: Understanding the Medical Devices Dispute Resolution Panel  June 2003
	HIPAA and Drug Company Interactions with Physicians - Beyond Clinical Research May/June 2003
	First Amendment Protection of Commercial Speech: New Opportunities to Educate Healthcare Providers  May 2003
	Promoting Devices for Specific Indications Based Upon a General Clearance  February 2003
	FDA's Regulation of Analyte-Specific Reagents  February 2003
	Western States Medical Center: A Watershed Moment for FDA's Regulation of Commercial Speech  January/February 2003
	Medical Device Reporting: A Risk-Management Approach  January 2003
	Can FDA Seek Restitution or Disgorgement?  2003
	Ripe for Revision: Reassessing the Contitutionality of Food and Drug Administration Restriction on Protected Speech  2003
	Claims for Functional Foods Under the Current Food Regulatory Scheme October/November 2002
	U.S. Food and Drug Law and FDA - A Historical Background  July 2002
	First Amendment Implications of Labeling and Advertising Restrictions  June 22, 2002
	What You Say May Be Used Against You  May/June 2002
	How FDA's New Labeling Rule Could Preempt State Law
	FDA's Regulation of Internet Promotion and Advertising  July 2001
	FDA's Crackdown on Cholesterol Structure - Function Claims - A Portent of Policies to Come?  May/June 2001
	Criminal Prosecutions Initiated for the FDA  April 2001
	The Washington Legal Foundation Litigation and Its Aftermath  February 2001
	Marketing Dietary Supplement/OTC Drug Combination Products
	How to Transfer Ownership of a 510(k) Clearance  April 2000
	Sample Promotion Under the New PDMA Final Rules  January/February, 2000
	Regulation of Labeling and Advertising Claims, in Cosmetic Regulation in a Competitive Environment  2000
	Keep Current with HPM's FDA Law Blog
	Comments, Pediatric Testing of Prescription Drugs: The Food and Drug Administration's Carrot and Stick for the Pharmaceutical Industry
	It's the Law: Compliance with FDA's Financial Disclosure Rule  November 1999
	A Voluntary Disclosure Programs for FDA - The Time has Come  1999
	"It's Time to Make A Good Agency Better": The Food and Drug Administration Modernization Act and the First Amendment
	Displaying Investigational and Unapproved Medical Devices According to FDA Policy October 1997
	The History, Provisions and Implementation of the Generic Drug Enforcement Act of 1992  1994
	The Role of the Department of Justice in Enforcement Matters Relating to the Food and Drug Administration  1991
	Administrative Inspections by the Food and Drug Administration: the Role of the Department of Justice  July 1989E

Look at How Far Back (2009) the issue of combating prescription drug abuse has been tied to compounded pain medicine!!

Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain MedicineSeptember 2009

John Gilbert has authored an article titled "Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain Medicine" in the September/October 2009 issue of the International Journal of Pharmaceutical Compounding. 


Click here to view the article 

Click here to view the article abstract 

If you have any questions regarding the above information, please contact:

John A. Gilbert, Jr.

(202) 737-4293

jgilbert@hpm.com1

Advertising and Promotion: FDA Is Not the Only Cop on the Beat

August 2010

Companies involved in advertising and promotion of foods, dietary supplements, cosmetics, over-the-counter (OTC) drugs, and devices understand that the United States Food and Drug Administration (FDA) is active these days in enforcing the Federal Food, Drug, and Cosmetic Act (FDCA). However, companies must also be aware of at least four other enforcement groups which police alleged false or misleading claims in advertising and promotion. 


Click here to view the full FDLI Update Article 

If you have any questions regarding the above information, please contact:

John R. Fleder

(202) 737-4580

jfleder@hpm.com

Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations February 2013 by Douglas B. Farquhar

In a new Contemporary Legal Note published by the Washington Legal Foundation ("WLF"), Douglas Farquhar explores issues surrounding privileged material and so-called "taint teams" when government investigators seize company materials that may be used to build a criminal case. 


Click here to view the full WLF article 

If you have any questions regarding the above information, please contact:

Douglas B. Farquhar

(202) 737-9624

dfarquhar@hpm.com

The shareholders of Rood and Riddle Equine Hospital in Lexington, Kentucky and Dr. Bill and Diana Barnes of Saratoga Springs New York are pleased to announce that Rood and Riddle will purchase Saratoga Equine Veterinary Service in Saratoga Springs, N.Y.

"This is an exciting and unique 

opportunity

 for our practice and we look forward to providing outstanding care to the horses in New York and surrounding areas” says Bill Rood, veterinarian and CEO/President of Rood and Riddle Equine Hospital. Saratoga Equine will operate as a division of Rood and Riddle Equine Hospital.

Saratoga Equine Veterinary Service was founded in 1996 and the surgical and diagnostic center opened in August of 2000. Since that time SEVS has provided emergency and ambulatory care as well as support to a large number of referring veterinarians. "The procurement of SEVS by Rood and Riddle will ensure a continuation and expansion of the level of excellence already established by Saratoga Equine,"says Dr. Bill Barnes.

Though the final details of the operation of Saratoga Equine remain to be determined, Saratoga Equine will build on the strengths of the combined staff of both practices, moving forward with an emphasis on lameness exams and advanced imaging such as nuclear scintigraphy, orthopedic and upper airway surgery of the equine athlete, and therapeutic and corrective podiatry for racehorses and sport horses which form the core of the hospital operation in Lexington. The hospital in Saratoga will expand the presence Rood and Riddle established in New York last year when Dr. Scott Ahlschwede, veterinarian and shareholder in Rood and Riddle, began providing ambulatory veterinary services to our New York clients. The strength of N.Y. racing and the increasing number of our clients opening N.Y. divisions of their operations and the expansion of training in the Saratoga area makes this a logical move for Rood and Riddle to provide the services and leverage their expertise that has been the backbone of the Lexington operation. Dr. Barnes will continue to practice in the Saratoga Springs area as an independent practitioner.

Question of the Day November 2, 2013 Rood and Riddle has a Equine Hospital and Veterinary Compounding Pharmacy. Is this the way of the future for veterinary medicine? Should it be? Pros? Cons? Should it be treated any different that a human hospital with a pharmacy?

Welcome to Rood & Riddle Equine Hospital

Rood & Riddle Equine Hospital is a full-service equine hospital established in 1986 as a referral center for horses requiring specialized medical and surgical care. Today Rood & Riddle is known and respected throughout the world for innovative and highly skilled treatment of horses. The hospital facility offers a full range of services including surgery, internal medicine, advanced diagnostic imaging, a focused Podiatry Center and specialized Reproductive Center. The practice also provides ambulatory services for emergencies, preventative care, general reproduction, radiography, medical care and treatment of your horse at your farm or stable. Our reputation stems from our unwavering commitment to quality, both in the care of horses and in our relationship with clients and community.

Rood and Riddle Veterinary Pharmacy provides unequaled compounded medications to maintainthe health and fitness not only of the world’s top equine athletes but also of beloved pets as well.

Visit the Pharmacy Site »

Rood and Riddle Expanding to New York

Rood & Riddle to offer clinical services as well as expanded ambulatory services in New York.

SARATOGA SPRINGS, NY: Following a real estate closing on Monday September 16^th, Rood & Riddle Equine Hospital has expanded its veterinary services in New York. Beginning Tuesday September 17^th, Saratoga Equine Veterinary Service in Saratoga Springs, New York will be known as Saratoga Equine: A Rood & Riddle Hospital. Located less than a mile from Saratoga Race Course and Saratoga Springs Horse Show, Saratoga Equine will be Rood & Riddle’s first clinical venture outside the state of Kentucky.

 Rood & Riddle CEO Bill Rood announced in June of this year that the hospital would be expanding their hospital services for the first time outside the state of Kentucky, relating that they had agreed to a deal, in principle, with Dr. Bill Barnes, former owner and veterinarian at Saratoga Equine, to purchase his practice in full.

 When asked about the decision to expand after over 30 years in Lexington, KY, Dr. Rood answered, "We believe that this is the time to expand. With the number of farms opening operations in New York, the strong numbers at the Saratoga sales,and the number of our clients training in Saratoga the shareholders of Rood & Riddle feel that this is the time and the location to expand the veterinary services for which we are proud to be known in Kentucky.”

South Carolina Board of Pharmacy November 2013 Newsletter

read entire newsletter here

South Carolina Board of Pharmacy Clarification on Identification Requirements for Dispensing CS By SC DHEC Bureau of Drug Control

The Bureau of Drug Control has been asked to clarify the identification requirements for dispensing a CS. §44-53-360(i) states:
Excepting a mail order prescription dispensed in
compliance with Chapter 43 of Title 40 for which the
dispenser requires proper identification of the recipient,
a prescription for a controlled substance in Schedules II
through V may not be filled unless the dispenser knows
the recipient or requires the recipient to produce a
government issued photo identification, and the dispenser
notes the identification source and number on the
prescription, or in a readily retrievable log including:
(1) prescription number;
(2) date prescription filled;
(3) number and type of identification;
(4) initials of person obtaining and recording
      information.
A government-issued photo identification (ID) could include a
state-issued ID or driver’s license, valid passport, military ID, or
concealed weapons permit.

quoted from South Carolina Board of Pharmacy November 2013 Newsletter

South Carolina Board of Pharmacy Clarification on Taking Verbal Orders for Controls By SC DHEC Bureau of Drug Control

According to §40-43-82(C)(1) of the South Carolina Pharmacy
Practice Act, a supervising pharmacist may authorize a statecertified pharmacy technician to receive and initiate verbal telephone
orders. However, §44-53-360(b) of the South Carolina Code of
Laws specifically states, “a pharmacist may dispense a controlled
substance included in Schedule III, IV, or V pursuant to either
a written prescription signed by a practitioner, or a facsimile of
a written, signed prescription, transmitted by the practitioner
or the practitioner’s agent to the pharmacy,  or pursuant to an
oral prescription, reduced promptly to writing and filed by the
pharmacist.” Therefore, state-certified pharmacy technicians are
not allowed to take verbal orders for controlled substances (CS).

quoted from South Carolina Board of Pharmacy November 2013 Newsletter

South Carolina Board of Pharmacy Compliance Tips Consultant Pharmacist Written Monthly Inspections

Upon routine inspections of non-dispensing drug outlets, Board
staff has discovered fraudulent activity regarding the use of photo/
fax copies in place of the original during the written monthly
inspection. According to §40-43-86(C)(1)(f), the consultant
pharmacist must perform written monthly inspections that are
readily available. This is notice that the original must be kept at
the site upon each monthly inspection. Staff recommends that
consultants make a copy of the monthly report to retain for their
records should any discrepancies arise.
Other required duties of the consultant pharmacist include
establishing policies and procedures for the procurement, storage,
and distribution of drugs; establishing and supervising the record
keeping system for the purchase, sale, possession, storage,
safekeeping, and return of drugs; facilitating drug recalls, the
removal of outdated and adulterated drugs, and acting as a drug
information resource for the staff; and being available by phone
for question

quoted from South Carolina Board of Pharmacy November 2013 Newsletter

Veterinarians Not Eligible for NPIs, CMS Clarifies --

Centers for Medicare and Medicaid Services (CMS) has become
aware of cases in which veterinarians are told, incorrectly, that they
must provide a National Provider Identifier (NPI) number for prescriptions they have written to be dispensed. The agency has issued
a clarification, stressing that veterinarians do not meet the regulatory
definition of “health care provider,” and thus may not obtain NPI
numbers. The clarification also states that “Any entity that insists
veterinarians obtain an NPI [is] attempting to require veterinarians
to obtain NPIs fraudulently.” CMS also notes that “if a veterinarian
fulfills the definition of ‘health care provider’ in a profession other
than furnishing veterinary services,” such as if they are also a nurse
practitioner, “the veterinarian would be eligible for an NPI but would
select a Nurse Practitioner code (not a Veterinarian code) from the
Healthcare Provider Taxonomy Code Set when applying for an NPI.”

Quoted from the South Carolina Board of Pharmacy November 2013 Newsletter

This is advertised as a New Pharmacy Compounding Accreditation Program. Thoughts? Anyone used them? PCABTM?

Pharmacy Compounding Accreditation Program

Are you prepared for the upcoming FDA Compounding Regulations?

Do you have a Compounding Policy and Procedure Manual?

Do you have your compounding lab set up correctly?

R.J. Hedges & Associates’ Pharmacy Compounding Program provides your pharmacy with up to date policies and procedures for non-sterile compounding that follows the standards of the USP <795>, USP <797>, Pharmacy Accreditation Compounding Board (PCABTM) and the Food and Drug Administration. R.J. Hedges & Associates Pharmacy Compounding Policy and Procedure Program includes:

• Easy to read and follow policies and procedures
• Regulatory Compliance
• Personnel Management for hiring and specific position responsibilities
• Facility and Equipment Management
• OSHA rules and regulations for chemical and compounding preparation - Bloodborne Pathogen Plan - Hazard Communication Plan
• Compounding Recordkeeping
• Beyond-Use Dating Procedures
• Product Safety, Labeling and Shipping
• Patient Education
• Total Quality Management (TQM)
• Computer Based Training Videos

Order your customized Compounding Policy & Procedure Program today!

Give us a call at 724-357-8380.

KUDOS to NABP---Key Facts About Rogue Internet Pharmacies

The 10,288 Internet drug outlets currently listed as Not Recommended are characterized as follows:

• 5,017 (49%) offer foreign or non-FDA-approved drugs
• 9,064 (88%) do not require a valid prescription
• 2,394 (23%) have a physical address located outside of the US, and most (62%) rogue sites post no address whatsoever
• 1,638 (16%) do not have secure sites, exposing customers to financial fraud and identity theft

Important: Sellers of Unapproved Drugs Proliferate Online, Posing a Serious Threat to Global Public Health, Reports NABP

The National Association of Boards of Pharmacy^® (NABP^®) today issued a report stressing the continuing global public health threat posed by unapproved drug products distributed via the Internet. As detailed in the Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: October 2013, most rogue online drug sellers reviewed by NABP in the last three months offer foreign drug products or medications not approved by the United States Food and Drug Administration (FDA), as do nearly half of all rogue sites NABP has reviewed since 2008. Global stakeholders – including regulators, public health organizations, and private entities – agree that drug products failing to meet national regulatory safeguards place patient health at risk. NABP and its member state boards of pharmacy continue to encourage and work with federal regulators and other public and private entities to educate the public about the dangers of unapproved drugs and other risks of buying medications from rogue Internet drug sellers. 
continue to read here

This is geared toward doctors but well worth read on new HIPPA Rules: Is Your Compounding Pharmacy Complying With the New Rules?

here

Federal Government Issues Guidance on Refill Reminders Under New HIPAA Omnibus Rule By John E. Morrone, Esq. and Jonathan E. Levitt, Esq.

read here

On Your Side Alert: CVS ExtraCare Rewards and HIPAA concerns - NBC12.com - Richmond, VA News

On Your Side Alert: CVS ExtraCare Rewards and HIPAA concerns - NBC12.com - Richmond, VA News

Compounding Medicine For Animals Posted on November 2, 2013

read here

Reading, understanding and implementing USP 797 is a bit like eating an elephant. You cannot do it all it once, and you may not want to do it at all

that is a quote from Edward Lamb, 

Sterile Compounding Guidelines: Standards, Equipment and Contracting.  In that article, Lamb suggest that 

pharmacy practitioners must commit to consistently compounding medications that are beneficial and safe.  I agree.  The problem I think developed and is continue to develop is a fierce competition of everyone wanting to make more and more money in the compounding business, thus making it harder for even the good compounders to focus on safety.  They are having to worry about just staying in business at this point.  It appears that we are going to see more and more of the mega compounders whether the federal legislation is passed.  But because of this explosion of more people getting in the marketing, companies buying up smaller compounders, etc., this just solidifies fact that the federal legislation should become law and regulate those who voluntarily agree to be outsourcing facilities.

APhA announces support for compounding bill

November 01, 2013 House passage of H.R. 3204, the Senate is expected to take it up soonAPhA has announced it supports the Drug Quality and Security Act (H.R. 3204). While APhA does have some concerns with the proposed legislation, the Association believes it would protect the public from harm while maintaining access for consumers to important and often life-saving compounded preparations.In the last year, APhA has communicated constantly with Members of Congress and their staff to help develop and craft compounding legislation. On September 28, H.R. 3204 passed the House by voice vote. The Senate is expected to take it...
continue to read here

DOUBLE KUDOS!!! Excellent Points: Must Read--Well Written!!!-Tennessee Voices: Proposed law would strengthen oversight of large-scale drug compounders Oct. 31, 2013 8:28 PM

Dr. Patty W. Wright

and Dr. William Schaffner

The fungal meningitis epidemic remains in the news, with patients still coping with long-term complications more than a year after this tragedy came to light.

Late last month, the U.S. House of Representatives passed bipartisan legislation to strengthen federal oversight of a largely unregulated and sometimes unsafe pharmacy practice. We are thankful Tennessee's senior senator, Lamar Alexander, has played a leading role in drafting this important legislation.

During the summer of 2012, more than 700 Americans went into clinics across the country to receive treatment for back pain and other conditions. They walked out with fungal infections. Sixty-three died and hundreds more are still struggling to recover.

continue to read here

Essential Read: Personalized Medicine: The Future is Now

Personalized Medicine: The Future is Now

Texas Board of Pharmacy Disciplinary Records

I have posted this link several times but it is not easy to find on the Texas Board of Pharmacy website unless you know what you are looking for.  So here is the link again.

link to download record

link to search records

Third Question of Day PCCA recently held its International Seminar. Any readers want to report on what the message at that seminar was about federal legislation and future of traditional compounding versus outsourcing facilities?

Kudos! Simply to all the pharmacists and pharmacies trying to comply with all the rules, regulations and laws...I am starting to understand and appreciate why a lot of pharmacists go to law school...of course this is true of any industry that is heavily regulated

Texas Board of Pharmacy Meeting 4-6, 2013 Links to all tabs and comments in favor and opposed to tech ration rules--look at the pharmacy by name who support this amendment; then look at opposition

AGENDA

PUBLIC HEARING AGENDA

COMMENTS IN FAVOR OF PROPOSED TECH RATIO RULES

COMMENTS OPPOSED TO PROPOSED TECH RATIO RULES

ADDITION TAB 5

ADDITION TAB 9

ADDITION TAB 10

ADDITION TAB 16

ADDITION TAB 17

ADDITION TAB 27

KUDOS to Texas State Board of Pharmacy for this easy to understand QUICK REFERENCE GUIDE for PRESCRIPTIONS WHICH MAY BE DISPENSED IN TEXAS

here

Texas Board of Pharmacy Report Regarding Extent Prescription Drug Information Is Sold, Traded or Exchanged

here  Important:  It is important to recognize that personal patient identifiable information such as patient name, address, diagnosis, etc. is protected information by the Health Insurance Portability and
Accountability Act and is not to be released unless approved by the patient.  The
protection and confidentiality of patient information is a legal and ethical requirement for all
U.S. health care practitioners and health care institutions including pharmacists and pharmacies.
Patients must give their written approval before such information is released.    

Texas Board of Pharmacy Information Regarding Certified Pain Management Clinics

Certified Pain Management Clinics
Recently, the Texas Medical Board (TMB) and Texas State Board of Pharmacy have received
numerous questions regarding the certification of pain management clinics. Some pharmacists
assume that after September 1, 2010, a physician must be certified before prescribing pain
management drugs. This is NOT the case.
Pharmacists are required to assess each individual prescription and determine if it has been
issued for a legitimate medical purpose. The fact that a physician who issues the prescription
works in a certified pain management clinic does not automatically make the prescription valid
or relieve a pharmacist of the responsibility to determine that the prescription is valid and has
been issued for a legitimate medical purpose. The requirements for the certification of pain
management clinics are as follows:
A pain management clinic is defined in §167.001 of the Texas Medical Practices Act as a
publicly or privately owned facility for which a majority of patients are issued on a monthly basis,
prescriptions for opioids, benzodiazepines, barbiturates, or carisoprodol, but not suboxone.
The physician owner/operator of a pain management clinic must register with the TMB.
Certificates are not transferable or assignable. Only the primary physician owner is required to
register with the board if there is more than one physician owner of the clinic.  Each clinic
requires a separate certificate.
A pain management clinic may not operate in Texas unless the clinic is owned and operated by
a medical director who:
• is a physician who practices in Texas
• has an unrestricted medical license

Texas State Board of Pharmacy Job Openings

TSBP JOB OPENINGS

• Pharmacist I - Houston
• Pharmacist I - Dallas
• Inspector V
• Investigator III
• Administrative Assistant III

A State of Texas Application can be obtained from TSBP (call the TSBP receptionist at 512-305-8001) or:

• State of Texas Application for Employment
• Instructions for Completing the State of Texas Application for Employment
• Employment History Continuation Sheet

Second Question of Day November 1, 2013 Texas Board of Pharmacy is Considering an Amendment to the Pharmacist to Technician Ratio? Is this amendment a good idea? Bad idea?

Amendments Concerning Pharmacist to Technician Ratio
§291.32 Concerning Class A Pharmacies
§291.53 Concerning Class B Pharmacies
§291.153 Concerning Class G Pharmacies

I am trying to figure out an analogy.  In legal world we have paralegals and "legal assistants."  We aren't required to have either but couldn't do job without them.  However, no ratio requirements because the bottom line is as an attorney I am responsible. It is my signature and name on line (although some courts will allow paralegals to sign appellate briefs etc. and this is not without controversy).  So I am going to have enough common sense to know I don't want to supervise and be responsible for more than I can handle which is going to be a very small number.  You might say but this doesn't depend on life or death or health and safety...in some cases you would be wrong....death penalty cases involve whether a person lives or dies...but still probably not the right analogy...Dr. Woliner I am counting on you to point me in the right direction of an apology......

Reminder: Texas Board of Pharmacy Public Hearing and Board Meeting on November 4-5, 2013 Agenda and Materials Available

Public Hearing and Board Business Meeting
Monday, November 4, 2013
1:00 p.m. 
Tuesday, November 5, 2013
9:00 a.m.

The Board will commence in open session to hear public testimony followed by the Board business meeting.  The hearing and  meeting will be held at the William P. Hobby Building, 333 Guadalupe, Tower 2, Room 225, Austin, Texas. Click here to view the public hearing agenda and click here to view the meeting agenda and supporting materials.