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Friday, January 31, 2014

As Previously Reported: Food and Drug Administration (FDA) Sends Warning Letters to Two Compounding Pharmacies for Issuing Drugs Without Patient-Specific Prescriptions

Earlier this month, FDA sent warning letters to two compounding pharmacies for issuing drugs without patient-specific prescriptions. The letters cite the Drug Quality and Security Act (DQSA), but are based on facility inspections that took place before the law was enacted. FDA’s actions seem to indicate that it will be taking a strong stance on interpreting existing law regarding anticipatory compounding that may be in conflict with individual states’ laws. These actions echo concerns raised by ASCRS and the ophthalmic community during the DQSA’s development that it did not adequately address office use and repackaging to ensure those drugs’ continued availability. The DQSA’s sponsors and others in Congress made statements for the record when it was considered that the intent of the legislation was not to disrupt access to these drugs. ASCRS and others in the ophthalmic community will continue to work with the FDA and Congress to ensure that compounded drugs for office use remain available.
We will keep you updated.

quoted from here

Idaho Board of Pharmacy Draft Rule Dockets--compounding rules 27-0101-1301

Draft Rule Dockets:
Compounding Rules 27-0101-1301

Idaho Board of Pharmacy Hiring a Pharmacy Drug Compliance Officer--Job Opening

The Board of Pharmacy has a job opening in Northern Idaho for a:
click the link above for more information and to apply. This posting will be open January 21, 2013 thru February 4, 2013

Flordia Board of Pharmacy Compounding Rules Committee Agenda for February 10, 2014; Rules Committee Agenda on February 11, 2014 and Board Meeting February 11-12, 2014

February 10, 2014
Compounding Rules Committee
The Florida Hotel & Conference Center
1500 Sand Lake Road
Orlando, FL 32809
Get Directions → (407)859-1500
Materials:
FAW Notice (PDF)
Agenda (PDF)

February 11, 2014
Rules Committee
The Florida Hotel & Conference Center
1500 Sand Lake Road
Orlando, FL 32809
Get Directions → (407)859-1500
Materials:
FAW Notice (PDF)
Agenda (PDF)

Feb 11 - Feb 12, 2014
Board Meeting
The Florida Hotel & Conference Center
1500 Sand Lake Road
Orlando, FL 32809
Get Directions → (407) 859 - 1500
Materials:
FAW Notice (PDF)
Agenda (PDF)

Materials Deadline: December 20, 2013

District of Columbia Board of Pharmacy Meeting for February 6, 2014

Thursday, February 6, 2014 - 9:30am to 2:30pm
Location: 
899 North Capitol Street, NE, Washington, DC 20002

Building: 
Health Professional Licensing Administration

Details: 
To view the Open Session Agenda - click the agenda link at the bottom of this page. The Board of Pharmacy meetings will cover the following issues:
  • Regulate the practice of pharmacists, pharmaceutical detailers, and pharmacy interns in the District of Columbia
  • Evaluate applicants' qualifications
  • Administer exams
  • Recommend standards and procedures
  • Issue licenses
  • Receive and review complaints
  • Request investigations
  • Conduct hearings
  • Examine witnesses and administer oaths

Oregon Board of Pharmacy Agenda for February 4-5, 2014 Board Meeting

February 4-5, 2014 Board Meeting Agenda ​

Colorado Board of Pharmacy Compounding Task Force Meeting Agenda for February 11, 2014 Meeting--includes a discussion of interstate commerce

Colorado Compounding Task Force Meeting
Date: 02/11/2014 - 02/11/2014
Time: 01:00 PM - 03:30 PM
Title: Colorado Compounding Task Force Meeting
Location: 1560 Broadway, Ste110D, Denver, CO 80202
Special Meeting:  The third and final meeting of the Colorado Compounding Task Force
Attachment(s):
File
February Agenda.pdf

Colorado State Board of Pharmacy Practice of Pharmacy Webinar Scheduled for March 5, 2014

Colorado State Board of Pharmacy Practice of Pharmacy Webinar

This is an opportunity for pharmacists, pharmacy interns, pharmacy technicians, and other interested parties to review the Colorado State Board of Pharmacy Laws and Rules concerning the practice of pharmacy in Colorado. Please remember: This is your chance to ask us lots of questions! The pharmaceutical inspectors will present the webinar. No C.E.U. will be available for this class. Space is limited.
  • Date: Wednesday, March 5, 2014
  • Time: 9:00 - 11:00 a.m.
The following link can be used to register for this webinar. You will receive a confirmation email with further information.

Reserve your Webinar Seat Now at:
https://www1.gotomeeting.com/register/583408865

Vermont Board of Pharmacy Takes Action Against Royal Palm Compounding Pharmacy After Several Other States Take Action

Vermont Board of Pharmacy Takes Action Against NECC in October 2013--over a year after the outbreak

Here:2012-669

Vermont Board of Pharmacy Draft of Minutes from January 22, 2014 Meeting

Any Compounding Pharmacy Doing Business in Virgnia Will Want to Review these Powerpoint Presentations of the Board of Pharmacy Regarding Compounding Laws in Virginia (including new rules)

Draft Minutes for Virginia Board of Pharmacy January 21 and 27, 2014 Meeting

TuesdayJanuary 21, 2014
9:30 a.m.
Special Conference Committee & Informal Conference Committee
Board Room 2
Draft Minutes
MondayJanuary 27, 2014
9:00 a.m.
Telephone Conference CallDraft Minutes

Update on Washington State Pharmacy Quality Assurance Commission (formerly Washington State Board of Pharmacy)New Rules--including compounding

No. 1161 Update on Pharmacy

Compounding Rule Development
House Bill 1800, which passed during the 2013 legislative

session, addresses resident and nonresident pharmacy compounding.

The new law also requires that compounded medicinal

products meet minimum compendia standards to protect the

health and safety of the public.

In May 2013, the process to develop drug compounding

administrative rules was started. Since then there have been

three public meetings held so that pharmacists, representatives

from pharmacies, and others could provide their thoughts and

recommendations on how the new rules should be shaped. Following

the public meetings, staff has looked at administrative

rules from other states and has begun to draft the compounding

rules. Given the complexity of drug compounding, work on the

draft rules will continue through winter with an opportunity for

public review anticipated during spring or early summer 2014.

When a draft is ready for review, comments and suggestions will

be accepted and encouraged. Interested parties may sign up for

updates at http://listserv.wa.gov/cgi-bin/wa?A0=PQAC-RULES.





No. 1162 Frequently Asked Questions

Question: Can a compounding pharmacy distribute compounded

controlled substance (CS) preparations in Schedules



II through V on an invoice to a prescriber for office use within

the confines of the facility?

Answer: No. Compounding a CS is, by definition, the act of

manufacturing (21 U.S.C. 802(15)). Manufacturing is an activity

that requires a separate Drug Enforcement Administration



(DEA) registration (21 822(a) (1)). A DEA-registered pharmacy

is exempted from having to register as a manufacturer only

when it compounds a CS pursuant to a valid patient specific

prescription, and then dispenses this compounded CS directly



to the ultimate user or a member of his or her household (21

U.S.C. §§ 802(10) and (27)).

Question: Is it within the scope of practice for naturopathic

physicians to prescribe for Vicodin®, Norco®, and other CS?

Answer: While naturopathic physicians can write prescriptions

for all legend drugs except Botox®, their authority to write



prescriptions for CS is limited. Authorized CS include Schedule

III through V codeine and testosterone. Naturopathic physicians

may not prescribe any other CS.

Question: Have Washington State laws changed regarding



the expiration dates of Schedule II prescriptions?

Answer: Yes. The 2013 Washington State Legislature passed



a law, effective July 29, 2013, that states all Schedule II prescriptions

expire six months from the date the prescription

is written. The same law eliminated the ability for patients to



purchase Schedule V codeine-containing cough preparations

without a prescription. Except when dispensed directly by a

practitioner, substances included in Schedule III through V must

be dispensed by prescription only.

Question: What are ancillary utilization plans?

Answer: An ancillary utilization plan is a document that



details the duties and responsibilities of pharmacy assistants and

pharmacy technicians specific to the practice of pharmacy in

the location where they work. Ancillary staff must work within

the scope of their credential. Duties are considered nondiscretionary

and must be under the direct supervision of a licensed

pharmacist.

All ancillary utilization plans must be approved by the Commission

and a copy of the approved plan must be accessible to

all pharmacy staff and made available for inspection by the

Commission. Ancillary utilization plans are reviewed as part of

an inspection for their relevancy, accuracy, and completeness.

Changes in the operation of a pharmacy that revises the functions

of the ancillary staff must be submitted to the Commission.

All ancillary staff must be duly credentialed and the pharmacy

must comply with the 3:1 pharmacy technician to pharmacist

ratios or seek an exception by the Commission. The standard

ratio includes certified technicians and technicians-in-training.
quoted from here

California Board of Pharmacy Fall 2013 Newsletter, the Script--Includiing a Discussion of State's Rule Changes

Third Question of the Day January 31, 2014 Isn't one way to enforce state laws relating to compounding pharmacies to impose higher or stiffer fines and penalties, which could increase revenue for states and allow for the hiring of more inspectors to enforce the state laws?


Second Question of the Day January 31, 2014 What percentage of compounding pharmacies where complying with state laws relating to compounding pharmacies prior to the DQSA? What percentage are now in compliance with state laws relating to compounding pharmacies? What percentage aren't sure if they are in compliance are not?


California Board of Pharmacy Disciplinary Action Against Jay Scott Drugs and North Highlands Pharmacy

Jay Scott Drugs, PHY 40912, Administrative Case AC 3482
Burbank, CA
Through a disciplinary action of the board, the license is revoked.
Decision effective 1/27/2014.
View the decision
North Highlands Pharmacy, PHY 39917, Administrative Case AC 3428
North Highlands, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 1/13/2014.
View the decision

California Board of Pharmacy Webcast of Meeting January 29-30, 2014

January 29-30, 2014
Webcast
Department of Consumer Affairs
1625 N. Market Blvd.
1st Floor Hearing Room
Sacramento, CA 95834
AgendaMeeting Materials

Arkansas Board of Pharmacy Public Hearing on Proposed Regulation Changes set for February 12, 2014

Public Hearing on Proposed Regulation Changes
Date 02/12/2014
Time 8:30 AM - 04:30 PM
Address 322 South Main Street
Suite 600
Little Rock, AR 72201
Location Suite 600
Event Contact John Kirtley
Event Phone 501-682-9010
Event Email asbp@arkansas.gov
Description PUBLIC NOTICE <br>On February 12, 2014 at 8:30 AM, the Arkansas State Board of Pharmacy will hold a public hearing at the Arkansas State Board of Pharmacy, 322 South Main, Suite 600, Little Rock, AR 72201.&nbsp; The following regulation changes will be considered: <br> <br>Regulation 01 – General Operations: <br> <br>Proposed changes will update the physical address of the Arkansas State Board of Pharmacy to, 322 South Main Street, Suite 600, Little Rock, AR. 72201. <br> <br>Regulation 02 – Pharmacists <br> <br>Proposed changes will clarify that the intern training requirements for pharmacist licensure by examination in Arkansas may be obtained as part of the school curriculum for the colleges of pharmacy under Board approved conditions. <br> <br>Regulation 04 – Pharmacy <br> <br>Proposed changes will update language regarding the electronic recording of legend or schedule III, IV, or V controlled substance prescriptions transferred from a retail pharmacy to a Central Fill pharmacy. Changes will also expand the protocol for methadone clinics to utilize additional drugs in research, clean up language regarding electronic prescribing and make technical corrections within the regulation. <br> <br>Regulation 05 – Long Term Care Facilities <br> <br>Proposed changes will add language to allow licensed in-patient hospice facilities to have emergency kits with a limited supply of prescription medications for use in emergencies. <br> <br>Regulation 07 – Drug Products/Prescriptions <br> <br>Proposed changes will allow pharmacists to electronically receive and document prescriptions in accordance with Arkansas Act 1331 of 2013 and as allowed by federal regulations.&nbsp; Proposed changes will also update language according to Arkansas Act 176 of 2013 to allow a pharmacist to manually enter information into the electronic tracking database when utilizing a Military ID to purchase Schedule V ephedrine, pseudoephedrine or phenylpropranolamine products and update language to clarify the option for a pharmacist to either enter verbal orders directly into the pharmacy’s electronic prescription system or promptly reduce the verbal order to writing.&nbsp; <br> <br> <br>Public comments will be accepted until the conclusion of the public hearing.&nbsp; A copy of the proposed regulation changes can be obtained through our website, <br>by calling (501) 682-0190, writing: <br>Arkansas State Board of Pharmacy <br>322 South Main Street, Suite 600 <br>Little Rock, AR 72201, <br>or by emailing the Board of Pharmacy at <a href="mailto:asbp@arkansas.gov">asbp@arkansas.gov</a>&nbsp;&nbsp; <br>
quoted from here (sorry about the way it is typed but it is straight from website this way)

Arkansas Board of Pharmacy Meeting Scheduled for February 11-12, 2014

February 2014 Board Meeting
Date 02/11/2014 - 02/12/2014
Time 8:00 AM - 04:30 PM
Address 322 South Main Street
Suite 600
Little Rock, AR 72201

Wisconsin Board of Pharmacy Board Minutes for December 11, 2013--number of compounding issues discussed including Iowa Inspection Reports

Arizona Board of Pharmacy Minutes from January 8-9. 2014 Meeting

read here

Arizona Board of Pharmacy update to Diamondback Inspection where possible misbrading or alteration of drug/ one sample sub-potent and certificate analysis for wrong drug is to issue an advisory letter to Diamondback Drug "encouraging them to purchase high quality compenents from reputable places and to validate the chemcials that they purchase."

Agenda Item 17 – Diamondback Drug Follow-Up Inspection

President Van Hassel asked Mr. Haiber and Mr. Waggoner to address this agenda item.

Mr. Haiber stated at the last Board Meeting the Board asked them to do a follow-up inspection.

Mr. Haiber stated that there was a possible misbranding or alteration of a drug. Mr. Haiber stated that they observed that one sample was sub-potent but was not contaminated.

Mr. Haiber stated that they have fixed issues found on the first inspection.

Mr. Van Hassel asked if there have been significant improvements. Mr. Waggoner stated that they are making the improvements suggested in the first inspection.

Dr. Musil asked about the Sodium Sulfate. Mr. Waggoner stated that the certificate analysis was for the wrong drug.

On motion by Dr. Musil and seconded by Mr. Francis, the Board unanimously agreed to



issue an advisory letter to Diamondback Drug encouraging them to purchase high quality components from reputable places and to validate the chemicals that they purchase.

quoted from here
 

Arizona Board of Pharmacy Approves Weatherford Compounding Pharmacies' Out-of-State License Request Notwithstanding Recent Complaints in Horse Racing World; Arizona Board also approves a numver of other out-of-state compounding pharmacies

4. (2) Non-Resident Pharmacy Permits – Schedule B



NON-RESIDENT PHARMACY PERMITS (Out of State) Pharmacy Location Owner
PharmBlue LLC 40 Pennwood Pl. #300, Warrendale, PA 15086 PharmBlue Holdings, LLC
Rx Remedies Suite Q, 500 Highway 51, Ridgeland, MS 39157 Safemeds Solutions, LLC
BioScrip Infusion Services, Inc 199 Technology Dr. Ste. #140 & #150, Irvine, CA 92618 BioScrip Infusion Services, Inc
BioScrip Infusion Services, Inc 102 The American Road, Morris Plains, NJ 07950 BioScrip Infusion Services, Inc
Synergy Pharmacy Services, Inc. 31201 US Highway 19 N, Suite 2, Palm Harbor, FL 34864 Synergy Pharmacy Services, Inc
Diabetes Total Care 2480 Delta Lane, Elk Grove Village, IL 60007 Total Care Rx, Inc.
Anovorx Group, LLC 1710 N. Shelby Oaks Dr.. Memphis, TN 38134 Anovorx Group, LLC
Inverness Apothecary-Trinty LLC 24333 Gordon Terry Parkway, Suite B, Trinity, AL 35673 Inverness Apothecary – Trinity LLC
One Stop Pharmacy Inc 3193 Tech Dr., Suite B, St. Petersburg, FL 33716 One Stop Pharmacy Inc.
Assured Rx 13555 Automobile Blvd, Suite 230, Clearwater, FL 33762 Assured Rx
Transition Pharmacy 4 Neshaminy Interplex Dr., Ste. 111, Trevose, PA 19053 Transition Pharmacy
Maple Pharmacy 61 Spectrum Blvd., Las Vegas, NV 89101 Maple Pharmacy Inc
Boca Town Pharmacy 7400 N. Federal Hwy., Boca Raton, FL 33487 Rx Advisory and Solutions, Inc.
Rx To You Pharmacy, Inc. 3202 SE Federal Hwy., Stuart, FL. 34997 Rx To You Pharmacy, Inc.
Express Plus Pharmacy, LLC 6692 Stirling Rd., Davie, FL 33024 Express Plus Pharmacy, LLC
Weatherford Compounding Pharmacy 2005 Ft. Worth Highway #100, Weatherford, TX 76086 Joe Landers
Magnolia Specialty Pharmacy, Inc 208 S. 27th Ave, Ste, #4, Hattiesburg, MS 39401 Magnolia Specialty Pharmacy, Inc
Physician Preferred Medical, LLC 3300 NW 56th, Suite 101, Oklahoma City, OK 73112 Physician Preferred Medical, LLC
Spence Pharmacy 4821 River Oaks Blvd., Fort Worth, TX 76114 A-1 Drug Mart Inc.
Missoula Pharmacy Inc. 1211 South Reserve St., Suite 102, Missoula, MT 59801 Missoula Pharmacy Inc.
Central Compounding 125 E. Thomas St., Hammond, LA 70401 Central Rexall Drugs, Inc.
Complete Medical Homecare Inc 14309 West 95th St., Lenexa, KS 66215 Concordia Healthcare USA
Canyon Creek Pharmacy, Inc. 2235 Thousand Oaks Dr., San Antonio, TX 78232 Canyon Creek Pharmacy, Inc.
Cornerstone Compounding Pharmacy 1131 N. Pacific Ave. , Glendale, CA 91202 Cornerstone Compounding Pharmacy, Inc.
quoted here here

FDA and Health Canada: Working Together for an Efficient Pathway for Drug Applications

FDA and Health Canada: Working Together for an Efficient Pathway for Drug Applications

Approved Animal Drug Products (Green Book)

Approved Animal Drug Products (Green Book)

Alaska Board of Pharmacy August 2013 Minutes Now Available--includes a number of compounding issues discussed--including compounding inspection training

Alaska Board of Pharmacy Agenda for January 29-31, 2014--tech to pharmacists ratio, inspections of sterile compounding pharmacies to be considered

2014

  • January 29-31, 2014
    9th Floor, Conference Room C
    State Office Building
    333 Willoughby Avenue
    Juneau, AK
    View Meeting Agenda

Excellent Read! NABP: Legal Briefs: Fines Place Board in (Civil) Penalty Box

 

Topics: Pharmacists
By Dale J. Atkinson, JD 
Originally published in the January 2014 NABP Newsletter
It is imperative that boards of pharmacy have administrative jurisdiction over all persons, not just licensees and applicants. This jurisdiction or authority to pursue administrative remedies provides regulatory boards with the right to prosecute and sanction persons or entities for violations of the practice act and regulations. While criminal prosecutions may also be authorized by law, the criminal prosecution teams may have to prioritize which matters to pursue, taking into consideration the harm to the public and access to resources. Boards of pharmacy are keenly aware of the public protection benefits associated with administrative jurisdiction over persons alleged to have violated the act and/or regulations and are more likely to authorize the pursuit of administrative remedies.
Perhaps the issue of unlicensed practice best characterizes the need for regulatory board authority and the public protection benefits derived from such administrative actions. Individuals and entities engaging in the unlicensed practice of pharmacy should be subject to the authority of the board of pharmacy (in addition to the criminal penalties). The same is true of other regulatory boards that wish to administratively prosecute unlicensed persons infringing on the scope of practice. Indeed, such unlicensed persons may be licensed by other boards.
The full article, which reviews a case involving a fine assessed by the Tennessee Medical Board against a Tennessee pharmacist who was found to be practicing medicine and naturopathy without a license, is available in the January 2014 NABP Newsletter (PDF; pages 4-5, 10).

Texas Board of Pharmacy Agenda for February 11, 2014 Meeting--Tech to Pharmacists Ratio, Database Project and complaint against the Pill Box among things to be considered

Texas Board of Pharmacy Continues to Have Job Openings

Wyoming Board of Pharmacy May 2013 Minutes Now Available--Board Discussed A Number of Compounding Issues

Wyoming Board of Pharmacy Meeting Scheduled for February 12-13, 2014

February 12-13, 2014

Cheyenne, Wyoming Begins at 1:00 pm on Wednesday February 12
6920 Yellowtail Road, Cheyenne, WY 82009

quoted from here

ALABAMA STATE BOARD OF PHARMACY Meeting set for February 19, 2014; Agenda to be announced

quoted from here

 

Alabama Board of Pharmacy fines Wetumpka Pharmacy $50,000.00

WETUMPKA PHARMACY, Permit #113792
Permit SUSPENDED for 5 years with immediate reversion to PROBATION subject to terms; assessed administrative fine of $50,000.00.
 
quoted from here

Alabama Board of Pharmacy Fines Advanced Compounding Pharmacy and Entirley Pets Pharmacy, LLC each $1,500.00; both withdraw application

NOVEMBER ADMINISTRATIVE HEARINGS
Non-Resident Pharmacies:
ADVANCED COMPOUNDING PHARMACY, Applicant for Permit
Application withdrawn; assessed administrative fine of $1,500.00.
 
ENTIRLEY PETS PHARMACY, LLC, Applicant for Permit
Application withdrawn; assessed administrative fine of $1,500.00.
 
quoted from here

Alabama Board of Pharmacy Fines Letco Medical $40,000.00

LETCO MEDICAL, Permit #192255
Assessed monetary fine of $40,000.00
 
quoted from here

FDA is extending the comment period for:


This information has recently been updated and is now available.

Update to Food Safety Modernization Act and Animal Feed – http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/ucm347941.htm
 
FDA is extending the comment period for:
 
 
 
Comments on this proposed rule and draft risk assessment as well as comments on the information collection provisions associated with these rules may be submitted until March 31, 2014. Comments were originally due by February 26, 2014.
 

Question of the Day January 31, 2014 What are compounding pharmacies that do both human and veterinary compounding doing to comply with DQSA? How can they comply with both the outsourcing provision for human compounds but still comply on the veterinary side? Is this an unintended consequences of the DQSA forcing compounding pharmacies that do both to either incur more expense or decide whether they will compound human drugs (as outsourcing facilities) or veterinary drugs in compliance with traditional compounding? Doesn't this suggest Congress needs to take immediate action regarding veterinary compounding and resolve the conflict?


Private Equity Firm Clayton, Dubilier & Rice Completes PharMEDium Deal

Clayton, Dubilier & Rice announced the close of an investment in PharMEDium Healthcare Corporation, the leading national provider of hospital pharmacy-outsourced sterile compounding services. Terms of the transaction were not disclosed.PharMEDium’s outsourced sterile compounding services are used by hospitals primarily to facilitate ready-to-use intravenous drug therapy to patients; it is one of the first companies to voluntarily register with the U.S. Food and Drug Administration’s (FDA) as an Outsourcing Facility and to comply with guidelines under the newly created section 503B of the Drug Quality and Security Act. Using only FDA-approved drugs, diluents and containers, the Company creates compounded sterile preparations, which are not otherwise commercially available in the marketplace. PharMEDium provides CSPs in ready-to-use presentation with enhanced safety, labeling, sterility and shelf life, typically exceeding what hospital pharmacies can produce themselves. The Company’s CSPs are primarily used in: (i) intravenous pain management and anesthesia associated with surgical procedures and post-operative care, (ii) the intensive care unit (CSPs including analgesics, antibiotics, anticoagulants and electrolytes), and (iii) labor and delivery (epidurals and oxytocin).Based in Lake Forest, Illinois, PharMEDium serves more than 2,600 acute-care hospitals, including integrated delivery systems, academic medical centers, hospital groups, and standalone urban, suburban and rural hospitals.About Clayton, Dubilier & RiceFounded in 1978, Clayton, Dubilier & Rice is a private equity firm with an investment strategy predicated on producing financial returns through building stronger, more profitable businesses. Since inception, CD&R has managed the investment of $19 billion in 59 businesses representing a broad range of industries with an aggregate transaction value of approximately $90 billion. The Firm has offices in New York and London. For more information, please visit www.cdr-inc.com. - See more at: http://newyork.citybizlist.com/article/clayton-dubilier-rice-completes-pharmedium-deal#sthash.MyEnEZkX.dpuf

Growth Of Injectable Drugs To Benefit West Pharmaceutical Services

read here

Inside Health Reform: In First DQSA Warning Letters, FDA Targets Compounders Without Patient Prescriptions

In First DQSA Warning Letters, FDA Targets Compounders Without Patient Prescriptions (Daily News - 01-30-2014)
FDA issued two warning letters to drug compounders in recent weeks chastising them for lacking patient-specific prescriptions -- the first letters citing the recently passed Drug Quality and Security Act and delving into a point of conflict between state and federal laws.

FDA Law Blog January 30, 2014 An Old Fashioned Park Criminal Prosecution With Some Twists - Part II

By John R. Fleder
On October 2, 2013, HP&M posted the following on this blog:
On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen.  The government alleges that the defendants violated the FDC Act by introducing adulterated cantaloupes into interstate commerce.  The government also alleges that the cantaloupes bore Listeria monocytogenes and 33 people died.  It is quite curious (we are being charitable here) that the government’s press release alleges that 147 people were hospitalized as a result of sales of the cantaloupes, but those allegations appear nowhere in the criminal Information!
continue to read here 

FDA Law Blog January 30, 2014 Speech by High-Level DOJ Official Claims Shared Interests of Prosecutors and Regulated Industry

By JP Ellison
In a speech on January 29th at the CBI Pharmaceutical Compliance Congress that DOJ posted on its own website, U.S. Department of Justice Assistant Attorney General Stuart Delery set forth his views of the three ways that the government’s enforcement interests align with industry’s interests.  While the speech didn’t break any new ground, it serves as a reminder that pharmaceutical enforcement cases remain a DOJ priority and suggests that recent enforcement trends will continue.
AAG Delery Claimed that DOJ and industry shared the following:
  1.  “[A] common interest in promoting ethical corporate culture instead of maintaining a compliance program in name only;”
  2. “Transparency about the conduct [the government] investigate[s];” and
  3. “[A] common interest in ensuring that corporate compliance is not only the right thing to do but also a winning business strategy.”
continue to read here

Thursday, January 30, 2014

New York issues summary suspension against Rockwell Compounding Associates Inc.

. SUMMARY SUSPENSIONS
Pharmacy
Steven J. Cosentino; Pharmacist; Rye, NY 10580; Lic. No. 031570; Cal. No. 27162; Application for summary suspension granted.
Rockwell Compounding Associates, Inc.; Pharmacy; 350 Theodore Fremd Avenue, Rye, NY 10580; Reg. No. 026458; Cal. No. 27163; Application for summary suspension granted.

quoted from here

Regulatory Reconnaissance: Does CDER Need New Leadership? (30 January 2014)

Regulatory Reconnaissance: Does CDER Need New Leadership? (30 January 2014)

New England Compounding Pharmacy, Inc. Bankruptcy New Filing Alert: Motion For Relief From The Automatic Stay

 

On January 29, 2014, a motion for relief from the automatic stay was filed in the bankruptcy case of New England Compounding Pharmacy, Inc.  and its affiliates. The filing was assigned docket number 663 and is described on the court’s official docket as follows:
Motion filed by Plaintiffs Irene and Joseph Phillips, Norma Montague, Ronald and Tammy Driscoll for Relief from Stay Re: Fee Amount $176, Objections due by 02/12/2014. (Attachments: # (1) Exhibit Memorandum in Support of Motion for Limited Relief From Stay on Behalf of Movants) (Gonzalez, Ervin)

quoted here

Look at what one of DOJ and US Attorney's Offices Top Priorities is for 2014!!

Enforcement Priorities looking ahead to 2014
- See more at: http://www.policymed.com/2014/01/pharmaceutical-and-device-healthcare-fraud-enforcement-perspectives-for-2014.html#sthash.qc7itemB.dpuf