Saturday, November 29, 2014

NM Mexico Board of Pharmacy Regulation Changes - New Mexico Veterinary Medical Association--office use for non-sterile compounds allowed

NM Mexico Board of Pharmacy Regulation Changes - New Mexico Veterinary Medical Association

Louisiana Board of Pharmacy Application for Renewal of Non-Resident Pharmacy Permit Contains a Survey Regarding Compounding and ask Pertient Disciplinary History Questions

Application for Renewal of Non-Resident Pharmacy Permit ...

www.pharmacy.la.gov/assets/docs/.../057_AppRenPHY-NR_2015-F.pdf

Nov 1, 2014 - (Complete this application for pharmacies located OUTSIDE the state.) ... date and sign this application; send with fee, payable to “Louisiana Board of Pharmacy”,.

Friday, November 28, 2014

DEA and Medical Boards Target Weight Loss Clinics

DEA and Medical Boards Target Weight Loss Clinics and ...

greenandassociates.blogspot.com/.../dea-and-medical-boards-target-weig...

Nov 2, 2014 - We have seen more investigations of physicians or advanced practitioners (physician assistants and nurse practitioners) prescribing phentermine to patients.

Essendon supplements saga: Hearing to discuss evidence

Essendon supplements saga: Hearing to discuss evidence ...

www.northweststar.com.au/.../essendon-supplements-saga-hearing-to-discus...

21 hours ago - A dispute over crucial anti-doping evidence which the 34 past and present Essendon players facing bans say has been denied to them by ASADA is expected to ..

Essential Read: FDA Panel Warns Against Certain Back Pain Injections

FDA Panel Warns Against Certain Back Pain Injections

Medscape-6 hours ago

Originally, the question put to the panel was, "Do you recommend FDA add a contraindication to the labeling of injectable corticosteroids for the use of these ...

Review Shows that Licensing Boards Voted Improperly: For instance, after initially voting at a legal board meeting to shut down a Webster compounding pharmacy that gave a teenager medicine that was 1,000 times too potent, triggering a heart attack, a handful of board members voted to reverse the action at a meeting a week later without a legal quorum. The pharmacy has since closed on its own, and DPH is continuing to investigate the matter

read entire article here

Reminder: There are more than just the state and federal pharmacies rules to comply with; Here is an example of what veterinarians in Texas must also comply with relating to labels, use, controlled substances, extra and off-label use and compounded drugs--Make sure your legal counsel is advising you on the full umbrella of laws that may impact your specific practice

Texas Administrative Code

TITLE 22	EXAMINING BOARDS
PART 24	TEXAS BOARD OF VETERINARY MEDICAL EXAMINERS
CHAPTER 573	RULES OF PROFESSIONAL CONDUCT
SUBCHAPTER E	PRESCRIBING AND/OR DISPENSING MEDICATION

Rules

§573.40	Labeling of Medications Dispensed
§573.41	Use of Prescription Drugs
§573.42	Use of Scheduled Drugs in Training and/or Racing
§573.43	Controlled Substances Registration
§573.44	Compounding Drugs
§573.45	Extra-Label or Off-Label Use of Drugs

Veterinarians in Texas: Are you ready for an inspection? Texas Board Notes there are still issues with controlled substances and prescription labels; Great Compliance Inspection List to help you get ready for no-notice inspections in Texas

ARE YOU READY FOR A COMPLIANCE INSPECTION?

We continue to document chronic problems that exist in the areas of Continuing Education (CE), controlled substances, and Prescription Labels. Licensees are subject to no-notice inspections at anytime. Veterinarians are strongly encouraged to keep their CE records in the facility where they are practicing. Under rule 573.64, CE records must be maintained for the last 3 renewal cycles and be provided to the Board investigators for inspection upon request. When practicing veterinary medicine, relief and mobile veterinarians are requested to keep with them copies of their CE records, current renewal certificate and DEA/DPS Controlled Substances Registrations Certificates Controlled substances logs must maintain balance on hand at all times. The log book must also contain the proper information concerning the purchase, identification and use of controlled substances. For more information on controlled substances and record keeping, please review rule 573.50. Prescription labels must contain the species being treated. For further information on labeling, please review rule 573.40.

Click here to view a Compliance Inspection List.

Clinic Postings

Compliance visits have revealed that some licensees are not posting the required Complaint Information Notice " . . . in an effective way to inform his/her consumers . . . about how to file complaints . . ." as required by rule 573.29.

Also, many practitioners are under the impression that DEA and DPS Drug registration Certificates must be posted. These notices do not need to be posted and in fact we discourage posting them. The registrant's drug license number is shown on these certificates and if the wrong client got these numbers, drugs could be ordered under the practitioner's registration number.

Patient Record Keeping

Rule 573.52 of the Rules of Professional Conduct, addresses patient records and what should be included in each record. Section (a)(12) of this rule states ". . . Each entry in the patient record shall identify the veterinarian who performed or supervised the procedure recorded." When reviewing the patient records involved in consumer complaints, we continue to have difficulty identifying the DVM that performed a given procedure. Please remember each entry on the record should include at least the initials of the licensee that performed the procedure.

quoted from Texas State Board of Veterinary Medical Examiners

Look at this DEA fact sheet on Ketamine

Ketamine

Significant Guidance Documents of DEA office of Diversion Control that Pharmacist and their Legal Counsel Should be Aware of

List of Significant Guidance Documents of the Drug Enforcement Administration Office of Diversion Control

Practitioner’s Manual: A Guideline to the Practitioner’s Responsibilities under the Controlled Substances Act of 1970 (August, 2006)
Mid-Level Practitioner’s Manual: An Informational Outline of the Controlled Substances Act of 1970 (January, 1993) (Under Revision - Refer to the Pharmacist's Manual for general guidance. If you have a specific question, contact your local DEA Office for assistance).
Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act of 1970 (2010)
Narcotic Treatment Programs: Best Practice Guideline (April, 2000)
Chemical Handler’s Manual: A Guide to Chemical Control Regulations (April 2013)
ARCOS Registrant Handbook (1997)
A Security Outline of the Controlled Substances Act of 1970 (May, 1991)
Policy Statement: Dispensing Controlled Substances for the Treatment of Pain [71 FR 52716; September 6, 2006] (Docket No. DEA-286)

Second Question of the Day November 28, 2014 How many are aware that it is a federal criminal offense to make a threat toward a federal employee? You may want to read 18 U.S.C. 115(a)(2) before you speak words with intent to impeded, intimidate or interfere with a federal employees job whether it be FDA, DEA, FBI, etc.

Section 115(a)(2) of Title 18 covers threats against all Federal employees, including those covered by § 351, when such threat is done "with intent to impede, intimidate, or interfere with" such Federal employee "while engaged in the performance of official duties, or with intent to retaliate against" such Federal employee.

Overview of Texas Employees Group Benefits Program for Fiscal Year 2015: HealthSelect of Texas Benefits for Compounded Medication Coverage

Pharmacy Benefit Management Update
Compound Prescription Drugs
 Compound drugs products refers to a prescription medication product that requires
compounding by a pharmacist.
 Compound Drugs consist of two or more solid, semi-solid or liquid ingredients, at least one
of which is a Prescription Drug.
 Effective July 1, 2014, the coverage of compound drugs under the HealthSelect plan
administered by Caremark and the HealthSelect Medicare Rx plan administered by
SilverScript will entail a 2-step process.
 All Compound Medications with a cost greater than $300 will require a pre-authorization to
insure that it is being prescribed for a “medically accepted indication”; and
 Compounded prescription drug product may be covered if it contains at least one FDA
approved drug component, although reimbursement is limited to the compounding fees and
FDA approved component(s) only. Bulk chemicals are not FDA approved drug products.
Agenda item 5g - Meeting book dated May 20,2014

Defense Health Agency Webcast/Powerpoint on Pharmacy

DHA Webcast September, 2014 - The Defense Health ...

pec.ha.osd.mil/.../DHA%20Pharmacy%20September%20DCO_9-17-201...

Sep 17, 2014 - Documentation  Training (PowerPoint slides &User Guide), Implementation ..... (i.e. FDA approved) and current patient care needs (i.e. paying forcompound .

Pharmacy Purchasing and Product November 2014 Magazine has Articles on DQSA and 503B Outsourcing Facilities

Home - Pharmacy Purchasing & Products Magazine

www.pppmag.com/

Nov 20, 2014 - November 2014 ... FDA Expectations for 503B Outsourcing Facilities. Although the 2012 compounding tragedy at the New England Compounding Center ...

Powerpoint: FDA Progress, Trends and Compliance at the AFDO in Denver

FDA – Progress, Trends, and Compliance - Denver - AFDO

denver.afdo.org/uploads/1/5/9/4/15948626/830-fda-morrison.ppt

June 24, 2014 ... FDA continues to increase the number of foreign inspections; FDA has global offices. 3 ... Designed to improve the safety of drug compounding and further protect the drug supply by building an electronic, interoperable system ...

FiercePharma's Top Ten List

FDA Product Safety Information Adverse Drug Experience (ADE) Reports Animal Drug Reports Available through 2013

Product Safety Information Adverse Drug Experience (ADE) Reports

How many are doing this for unapproved animal compounded medications? Report a Problem Veterinary Adverse Event Voluntary Reporting

Report a Problem Veterinary Adverse Event Voluntary Reporting

FDA’s Has Serious Concerns about Unapproved Animal Drugs

Unapproved Animal Drugs FDA’s Concerns about Unapproved Animal Drugs

FDA Animal Drug Users FDA to Present ADUFA III Process Enhancements Live Webinar and 60-Day NF Qualifying (A)NADA Labeling Supplements ( Q and A/submit your questions prior to the second seminar)

60-Day NF Qualifying (A)NADA Labeling Supplements

The first part of the two-part webinar series entitled “60-Day NF Qualifying (A)NADA Labeling Supplements (QLS)” provides a pre-recorded update on the ADUFA III process enhancement regarding shortened review time of 60 days for a specific subset of labeling supplements requiring pre-approval by CVM. Regulatory citations defining which supplements qualify and which do not are discussed, as are the specific requirements supporting submission of a 60-day QLS. Viewers are encouraged to also attend the second webinar (on January 26, 2015), which provides a live Q and A session to address any questions. Questions should be submitted prior to the second webinar, if available, to Linda.Wilmot@fda.hhs.gov in order to provide CVM time to adequately answer them.

Part One - https://collaboration.fda.gov/p3a1h6p24ft/

Part One Slides

Part Two - Live Q&A Session scheduled for January 26, 2015 from 12:00 pm to 1:00 pm EST.

View webinar at https://collaboration.fda.gov/cvm_qls_live_webinar/

FDA to Present ADUFA III Process Enhancements Live Webinar

November 24, 2014

The Food and Drug Administration's Center for Veterinary Medicine (CVM) announces Part Two of the “60-Day NF Qualifying (A)NADA Labeling Supplements (QLS)” webinar, featuring a live Q and A session, to take place on: Monday, January 26, 2015 from 12:00 noon to 1:00 pm. Questions should be submitted to Linda.Wilmot@fda.hhs.gov prior to the webinar so that CVM has time to adequately prepare the answers to the questions to present at the webinar.

This live Q and A follows the first webinar of the two-part webinar series. Part I, a pre-recorded update on the ADUFA III process enhancement regarding shortened review time of 60 days for a specific subset of labeling supplements requiring pre-approval by CVM, can be viewed at https://collaboration.fda.gov/p3a1h6p24ft/.

Part One is a discussion of the regulatory citations defining which supplements qualify and which do not, and the specific requirements supporting submission of a 60-day QLS.

The live webinar can be viewed at https://collaboration.fda.gov/cvm_qls_live_webinar/.

Additional Information

60-Day NF Qualifying (A)NADA Labeling Supplements

Question of the Day November 28, 2014 Which Compounding Pharmacy's Door will DEA knock on next? Will it continue to pursue them through the administrative process or will we eventually see federal cases brought?

Thursday, November 27, 2014

Question of the Day November 27, 2014 What is the biggest issue in the compounding industry today that is being overlooked by state boards of pharmacies? How would the compounding pharmacy world improve if the state boards of pharmacy would address the issues relating to traditional compounding?

Astana Continental Team suspended by Alexander Vinokourov over doping scandals - Cycling Weekly

Equine Biological Passport to combat gene doping

here

AQHA December 2014 Journal “A Compounded Relationship” takes a look at how to safely compound drugs, plus the dangers of not abiding by these procedures.

here (subscription required)

Wednesday, November 26, 2014

Question of the Day November 26, 2014 Who is the largest and most powerful human compounding pharmacy? Who is the largest and most powerful animal compounding pharmacy? Are they owned by pharmacist or corporations/companies? How long before the biggest and most powerful compounders buy out or force the shut down or bankruptcy of the smaller less powerful compounding pharmacies? Have the buy outs already in process?

Patient Sues Hospital and Pharmacy for Allegedly Giving Contaminated Medications POSTED ON NOVEMBER 25, 2014

Belleville, IL - A Belleville (IL) hospital, along with a local pharmacy, is being sued by a patient for allegedly giving him contaminated medication following a heart surgery, causing her to contract an infection. Melissa Owens has filed a 3-count complaint against defendants Dr. John D. Sadoff, St. Elizabeth’s Hospital, and New England Compounding Pharmacy Incorporated on 27th October in the Saint Clair County Court.

The complaint says Owens underwent an open heart surgery at defendant St. Elizabeth’s Hospital on 27th August, 2012. The coronary bypass surgery was performed by Sadoff. Subsequent to the heart operation, Owens developed a very severe infection, the suit says. On 26th October, 2012, she came to know that her infection was a result of taking contaminated drugs produced by the New England Compounding Pharmacy, according to the complaint. The plaintiff says the medications weren’t sterile.