Tuesday, February 4, 2014

Dallas pharmacist and four others convicted in illegal prescription drug scheme

By


A Dallas pharmacist and four others were convicted Monday by a jury in federal court of running an illegal prescription drug scheme, the U.S. attorney’s office said.
Lisa L. Hollier, 44, of Sunnyvale, filled the bogus prescriptions written by a co-conspirator — a doctor who testified during the trial, federal authorities said.
The defendants were convicted of conspiracy to unlawfully distribute controlled substances. Officials described the “pill mill” scheme in a news release.
The doctor, Nicolas Padron, wrote the prescriptions for fake patients who were found in homeless shelters and elsewhere by three people acting as drug dealers.
After Hollier filled the prescriptions, the phony patients gave the pills to the dealers, who sold them on the street for a profit. The dealers came up with the money to buy the drugs and sometimes paid Hollier directly for the prescriptions.
Padron, 54, of Garland, pleaded guilty in September to his role in conspiracy and faces up to 10 years in federal prison and a $500,000 fine.
Padron and his office manager, Jose L. Martinez, 54, of Flower Mound, operated the scheme out of Padron Wellness Clinic on Emerald Isle Drive in Dallas. They opened the clinic in the fall of 2010.
The dealers drove the patients in groups to the clinic. They and Martinez also were convicted on Monday. The dealers are Joesephis Austin, 60, of Dallas, Patricia A. Bryant, 59, of Dallas, and Walter R. Hudspeth, 62, of Dallas.
Padron did little or no physical examinations at his clinic and prescribed a “cocktail” of drugs, including hydrocodone and alprazolam. He would sometimes see two or more patients at a time and falsely diagnose them with lower back pain and anxiety.
Hollier filled the prescriptions from her pharmacy, Urban Independent Pharmacy, on Samuell Boulevard.
Padron has also pleaded guilty in an unrelated case to one count of conspiracy to commit health care fraud.
quoted herehttp://crimeblog.dallasnews.com/2014/02/dallas-pharmacist-and-four-others-convicted-in-illegal-prescription-drug-scheme.html/

CDER's 2014 Guidance Agenda Shows Heavy Focus on Social Media, Biosimilars Guidance

CDER's 2014 Guidance Agenda Shows Heavy Focus on Social Media, Biosimilars Guidance

Compounding Lobby Calls FDA’s Marketing Blitz ‘Misleading’

Drug Industry Daily

Feb. 03, 2014

The compounding pharmacy lobby is pushing back against the FDA’s campaign to encourage hospitals to buy compounded drugs only from agency-registered sites as disingenuous and misleading, saying the products aren’t necessarily safer for patients.
Read More

Jessie Hoffman and Christopher Sepulvado v. State of Louisiana, NO. 3:12-cv-00796 , PLAINTIFF’S SECOND AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF


read here

MADP Launches Vigil at Oklahoma Pharmacy Accused of Providing Lethal Injection Drugs

 

Kansas City, February 3—Today, Missourians for Alternatives to the Death Penalty (MADP) is beginning a vigil at the Tulsa pharmacy, The Apothecary Shoppe—which several news sources have alleged provided lethal injection drugs to the state of Missouri—in hopes of urging them to not supply future execution doses.
“A pharmacy should be a place of healing, not death. We implore the Apothecary Shoppe to join us in upholding the sanctity of life for all people” said MADP vice-chair Cathleen Burnett.
The secrecy and lack of transparency surrounding Missouri’s execution protocols and procedures continues to deeply trouble MADP. It is unacceptable for departments of corrections to hide information from the courts, prisoners and the public about the drugs they will use in executions or to use drugs that do not come with assurances that they will work reliably and predictably.
Our understanding is that the pharmacy contracted by the Department of Corrections is a compounding pharmacy that will manufacture the pentobarbital for the purpose of carrying out executions.  This is deeply troubling because the FDA does not regulate compounding pharmacies or review compounded drugs for safety or efficacy.
Because compounded drugs are made-to-order, each batch is unique, and you cannot generalize from one batch to another. If one batch of compounded drugs is potent and works well, that does not mean a different batch will meet the same standards. Compounded drugs have caused many severe safety problems in the last decade, including a recent contaminated batch of steroid injections that killed more than 50 people and sickened more than 700 others.
continue to read here

Settlement reached in Roanoke meningitis death lawsuit - Roanoke Times: Roanoke News

Settlement reached in Roanoke meningitis death lawsuit - Roanoke Times: Roanoke News

Must Read JAMA Risk of Compounded Drugs

Monday, February 3, 2014

More get-tough measures to stop horse racing cheats in NM By Rob Nikolewski on February 3, 2014

SANTA FE  – In another effort to clean up New Mexico‘s reputation in horse racing, four bills have been introduced in the current 30-day legislative session.
“If you’re a bad guy and you’re doping your horses, the tracks should be allowed to keep you off the grounds,” said state Sen. Mary Kay Papen, D-Las Cruces, who has introduced two bills in the Senate that mirror two bills in the House of Representatives introduced by Rep. Candy Spence Ezzell, R-Roswell
-continue to read here

Seven comments provided so far for Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability

source found here

31 comments provided so far to Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the FDA

source found here

Motion Filed by Gregory Lott's Attorneys Includes FDA 483s of Compounding Pharmacies

Read the motion Gregory Lott's attorneys filed in court (PDF)

www.dispatch.com/content/.../lottmotion.pdf
The Columbus Dispatch
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4 hours ago - after the administration of lethal injection drugs is. “lingering” and ... compounded drugs to carry out his execution as set forth in the Ninth Cause of. Action in his ...

Must READ!! Pew Files Comments to FDA Draft Guidance on 503A

Pew Comments to FDA Draft Guidance on 503A

www.pewhealth.org › Reports & AnalysisIssue Briefs
8 hours ago - Anticipatory compounding is the creation of a drug product prior to receipt of a prescription. Office stock compounding is the creation of a standardized drug ...

LIFE SCIENCES Legal Summit February 27, 2014

Seminar includes:  The FDA and Preemption
The blockbuster Supreme Court decisions in Mensing and Bartlett continue to be interpreted and applied by state and federal courts. These attorneys will address the current state of the preemption defense in light of these landmark cases.

more topics and information found here

Responding to FDA Form 483 and Warning Letters: Dos and Don’ts


Posted in Regulatory and Compliance by Jamie Hartford on February 3, 2014
Follow these six rules for responding to FDA’s inspectional observations and warning letters
read here

The Ashp Discussion Guide For Compounding Sterile Preparations PDF And Ebook Files - DocsFiles

The Ashp Discussion Guide For Compounding Sterile Preparations PDF And Ebook Files - DocsFiles

Kentwood Pharmacy CEO, others face additional charges for repackaging returned pills

By John Agar | jagar@mlive.com The Grand Rapids Press  
GRAND RAPIDS, MI – A federal grand jury has brought additional charges against Kim Mulder, the owner and CEO of Kentwood Pharmacy, who is accused of repackaging drugs that had been returned by nursing homes and adult foster homes, U.S. Attorney Patrick Miles announced Friday, Jan. 31.
Thirteen workers have also been charged in the long-running investigation.
A second superseding indictment says Mulder conspired with Richard Clarke, the director of sales, and Lawrence Harden, the chief pharmacist, to return, restock and re-dispense drugs that had been returned.
“By allegedly submitting claims for drugs that were misbranded, adulterated and dispensed in violation of federal and state laws, the indictment charges that the defendants defrauded Medicare, Medicaid and Blue Cross Blue Shield of Michigan,” Miles’ office said in a statement.
Related: Indictment: CEO, 8 former Kentwood Pharmacy workers charged in scheme to resell returned drugs
Related: Feds: Kentwood Pharmacy a 'pharmacy cesspool,' workers face sentencing
The indictment says the pharmacy received more than $70 million from the healthcare benefit programs. The government is seeking forfeiture of $60 million because of the alleged fraud.
Conspiracy to commit healthcare fraud is a 10-year felony.
The government contends that the defendants misbranded drugs by placing them into stock bottles, with incorrect lot numbers and expiration dates, and into vials with no lot numbers or expiration dates. They allegedly tried to conceal their actions by sorting returned drugs at a strip-mall office and a pharmacist’s basement.
Along with the additional charges, five other workers have been indicted.
Three semi-retired pharmacists have already been fined. James Orr and Thomas Verhage were ordered to pay $30,000 and Eugene Biegert $15,000 for causing drugs to be misbranded after shipment in interstate commerce.
The men did not benefit financially, but kept their jobs by taking part.
The government said patients may have received misbranded or adulterated drugs from Kentwood Pharmacy as early as 2004, through November 2010.Those who believe they received such drugs from Kentwood Pharmacy can contact the U.S. Attorneys’ Office here or call 616-808-2034.
Agencies involved in the investigation, which is ongoing, include U.S. Food and Drug Administration, FBI, Drug Enforcement Administration, Homeland Security, Internal Revenue Service and state police.
John Agar covers crime for MLive/Grand Rapids Press E-mail John Agar: jagar@mlive.com and follow him on Twitter at twitter.com/ReporterJAgar
quoted form here

Louisiana Board of Pharmacy Regulation Revision Committee Agenda for Meeting on February 6, 2014

Regulation Revision Committee

Time: 8:30 am - 2:30 pm
Location: Board Office
For more information, contact: Ms. Judy Dinecola, Secretary
Download Agenda

Kansas Board of Pharmacy Special Board Meeting on February 28, 2014

Board of Pharmacy Special Board Meeting
  • Dates: 28 – 28 Feb, 2014
  • Location: Lawrence , Kansas
  • Address: 2010 Becker Drive
  • How to find us: University of Kansas School of Pharmacy

West Coast Pharmacy Exchange Meeting April 24-27, 2014 with compounding and pharmacy law sessions

Join us for the premier pharmacy meeting, West Coast Pharmacy Exchange, being held in beautiful Palm Springs, CA on April 24-27, 2014. Connect with your peers, enjoy educational programming, and learn what you need to advance your career - including the future of pharmacy with Provider Status (SB 493)! Come experience the engaging keynote general sessions, continuing education courses, an extensive exhibit hall with an array of pharmacy-related products and services available, and of course - plenty of fun for you and your family!

Bio-identical Hormone Replacement Treatment for Compounding Pharmacists

UAN: 0113-0000-14-575-L01-P
At the completion of this activity, the participant will be able to: 1. Define bio-identical hormones
2. Discuss benefits and effects of said hormone. 3. Review how to counsel pharmacy patients on proper use of said hormones
Stephen Pomerance, BS, Super Care Drugs
 
 

12:15PM - 1:45PM

2014 New Pharmacy Laws Update

UAN: 0113-0000-14-566-L03-P
This program will review and summarize all new laws pertaining to the practice of pharmacy in California, emphasizing those with potentially far-reaching impact, and examining their real world effects.
At the completion of this activity, the participant will be able to:   1.  Recognize all new pharmacy laws in California.  2.  Distinguish between old and new rules of pharmacy practice.  3.  Identify potential pitfalls caused by the new pharmacy laws.  4.  Construct a pharmacy action plan to ensure conformity with all new laws.
Tony Park, PharmD, J.D., California Pharmacy Lawyers
 
for more information and courses see here

After Supplying For Three Missouri Executions, Pharmacy Plans To Register In State


An Oklahoma compounding pharmacy has supplied Missouri with the drug it's used three times to execute inmates, despite the fact that the pharmacy isn't licensed here.
Now the Apothecary Shoppe is attempting to become licensed in Missouri.
According to records obtained by St. Louis Public Radio, the Oklahoma Board of Pharmacy received a letter from the Apothecary Shoppe on Jan. 13, when the pharmacy said it was planning on registering in both Missouri and Texas.

continue to read here

Sterile Compounding: New Laws and Regulations: A Review

I recently attended a symposium conducted by Western University of Health Sciences, College of Pharmacy entitled, Sterile Compounding New Laws And Regulations. This took place at the Newport Beach Hyatt on January 18 of this year, and it was truly rewarding. There were great speakers who had up-to-date information on the new laws – both state and federal – affecting sterile compounding.  David Miller, RPh, Executive Vice President of International Academy of Compounding Pharmacists, gave a great review of the Federal legislation (HR 3204) affecting sterile compounding pharmacies. He was able to define the various sections of 503A and 503B and how they impact current compounding pharmacy business models. Another great speaker was Amy Gutierrez, Chief Pharmacy Officer, for the Los Angeles County Department of Health Services.  She reviewed NECC accident as well as other issues affecting patient health relating to compounding pharmacies. This event took place on a Saturday, but was well worth the time and the information gained through an update of how pharmacy laws are affecting our practice to ensure that the needs of the patients of our clients are met. To view the class overview, objectives, and speakers’ bios, please click here.

- Quoted from here http://hartleymedical.com/blog/sterile-compounding-new-laws-and-regulations-a-review/#sthash.E2VG0rGL.dpuf

Guidance, Compliance & Enforcement Federal Register Notices

Guidance, Compliance & Enforcement Federal Register Notices

Sunday, February 2, 2014

30 States Have Adopted Uniform Medication and Drug Testing Rules

Recent Horse Health and Welfare News | The Horse | TheHorse.com

www.thehorse.com/news
8 hours ago - Mid-Atlantic States Move Forward With Racehorse Drug Reform. January 31, 2014 ... 30 for an update on adoption of uniform medication and drug testing rules.

Ohio Board of Pharmacy Notice of Hearing Against The Metabolic Weight Loss Clinic did, on or before January 7, 2013 through May 22, 2013, purchase and possess an illegally compounded drug from Civic Center Pharmacy, NW Pharmacy & Compounding, and Complete Pharmacy & Medical Solutions and administered the same to patients, those drugs being: HCG 10,000 iu vials with diluent

read here

Janet Woodcock's Quality Agenda At CDER

Janet Woodcock's Quality Agenda At CDER

Request Information
By Wayne Koberstein, executive editor
New mandates, new user fees, and new uncertainties occupy the FDA’s drug center in 2014.
Speaking in whole sentences may become an everrarer practice in this, the Abbreviated Age of texts and tweets — but Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research (CDER), is someone who speaks in whole paragraphs. She is not reading from a script; she spontaneously composes succinct, lucid, and informative statements based on logic and knowledge, requiring none of the editing we usually expect with extemporaneous speech. Woodcock speaks with the perspective of a builder, not an observer. Over many years, she has helped shape and construct the agency as it is today. Consequently, she has become the most consistent, reliable voice of the FDA for most people in the life sciences industry.

continue to read here

New York Times Has Index Articles About Robert Courtney and his trial regarding diluted cancer drugs

Question of the Day February 2, 2014 Why do all state boards of veterinary medicine not issue clarifying guidance regarding the use of compounding preparations just as the New Mexico Board of Veteinary Medicine has done?

See here

Iowa Board of Pharmacy Agenda for February 5, 2014 Meeting

NABP Verified Pharmacy Program (VPP)

Obtain an Inspection Through the Verified Pharmacy Program

NABP's Verified Pharmacy Program (VPP) streamlines the process for pharmacies obtaining or renewing licensure in multiple states. VPP assists applicants with meeting inspection requirements and allows for the distribution of necessary information to the boards where a new or renewed license is being sought.

more information here

Home infusion and compounding guidelines published

 

Posted by: on Feb 1, 2014
#IVTEAM #Intravenous news: Two policies have been added to the Ivpolicy.com website. The first is the ASHP (2014) guidelines on home infusion pharmacy services preparations “The purposes of these guidelines are to define the role of the pharmacist in providing home infusion care to patients and to outline minimum requirements (indicated by use of the word “shall”) and best practices for the operation and management of services provided by pharmacies in the home or alternate-site setting. In broad terms, home infusion includes the provision of specialized, complex pharmaceutical products; development and execution of plans to manage the medication therapy of patients; and clinical assessment and monitoring of patients in their homes.” The second policy is the ASHP (2014) guidelines on compounding sterile preparations “These guidelines are intended to help compounding personnel prepare CSPs of high quality and reduce the potential for harm to patients and consequences for compound- ing personnel. The recommendations in these guidelines are based on published data, when available; on expert opinion and procedures used in similar industries; and on applicable regulations and standards.”
Reference:
ASHP (2014) Guidelines on home infusion pharmacy services preparations.
ASHP (2014) Guidelines on compounding sterile preparations.

more information here

IACP Essentials of Sterile Compounding Course

Essentials of Sterile Compounding

Kenneth S. Latta, Medisca Network Inc.
Tuesday, March 18, 2014
1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT)
IACP Technician or Student Pharmacist Members – $25
IACP Pharmacist Members – $45
Non-members – $70
Registration opening in February!

Saturday, February 1, 2014

Chinese Authorities Agree to FDA Inspection Expansion

January 31, 2014

Chinese officials have cleared the way for the FDA to station 10 additional drug and device investigators in China. Read More

Massive Novartis OTC Drug Recall Obscures Manufacturing Improvements

January 31, 2014
Novartis is recalling more than 200 lots of OTC cold and flu drugs distributed in seven countries — a massive market correction by the company beset with quality problems at its OTC plants since 2012. Read More

IACP Foundation Research Webinar:
Overcoming IRB Obstacles and Solid-State Stability of Compounded Levothyroxine Fomulations

Melissa J. Durham, PharmD, University of Southern California, School of Pharmacy

Deepa A. Rao, PhD, Pacific University School of Pharmacy
Thursday, April 10, 2014
1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT)
IACP Technician or Student Pharmacist Members – $25
IACP Pharmacist Members – $45
Non-members – $70
Registration will open February!

Garvin Named Professional Compounding Centers of America Advisor - Leesburg Today Online—Daily News Coverage of Loudoun County, Leesburg, Ashburn: Business

Garvin Named Professional Compounding Centers of America Advisor - Leesburg Today Online—Daily News Coverage of Loudoun County, Leesburg, Ashburn: Business

South Carolina Board of Pharmacy February 2014 Newsletter

Orgeon Board of Pharmacy February 2014 Newsletter

CPPA Developing Specialty Pharmacy Accreditation Program


The Center for Pharmacy Practice Accreditation
®
(CPPA) has
announced the development of a new accreditation program for
specialty pharmacy practices. CPPA Executive Director Lynnae
Mahaney, MBA, RPh, FASHP, VHA-CM, indicates that “CPPA
will be able to develop the new specialty pharmacy standards
quickly and efficiently with the existing standards development
methodology, infrastructure, and network of specialty pharmacy
expertise.”
CPPA is a partnership between the American Pharmacists As
-
sociation, the American Society of Health-System Pharmacists,
and NABP. CPPA develops and implements comprehensive
programs of pharmacy practice site accreditation, including the
promotion, development, and maintenance of principles, poli
-
cies, and standards. CPPA offers the general public and users of
pharmacy services a means of identifying those pharmacies that
satisfy the accreditation criteria and are focused on advancing
patient care, safety, and quality.
More information may be found in the press release, available
at
www.pharmacypracticeaccredit.org/news/2013/10/cppa-to-
develop-specialty-pharmacy-accreditation-program
quoted from here

Alabama Board of Pharmacy February 2014 Newsletter

read here

Survey Shows Compliance Trends Unchanged From 2012 : 77.2% for 797

013 USP Chapter <797> Compliance

The 2013 United States Pharmacopoeia (USP) Chapter
<797> Compliance Survey, the third annual report released since
2011, shows that the overall compliance rate of 77.2% remains
nearly unchanged from the 2012 rate. Budgetary restrictions
and physical plant limitations were among the top challenges to
compliance by survey respondents. The report also details the
survey’s findings on what types of facilities are participating in
compounding, and compliance in specific domain areas such as
environmental sampling and gloved fingertip sampling. Of the
survey’s 1,045 participants, 97% of the survey’s respondents
said that USP Chapter <797> “has had a positive influence on
patient safety.” The report notes National Association of Boards
of Pharmacy
®
(NABP
®
) efforts to assist state boards of pharmacy
in evaluating pharmacy compliance with USP Chapter <797>
requirements for sterile compounding in their states. The report
also noted that those who participated in the 2011 survey had a
higher compliance score than those who did not. The survey’s
authors encouraged pharmacy owners with multiple areas of
noncompliance to target one or two areas to improve. They
also encouraged organizations that participated in the survey to
make use of the free Action Plan – generated upon completion
of the survey – and other free resources to “reshape” their sterile
compounding practices. The full report on the survey’s results
is available in the October 2013 issue of
Pharmacy Purchasing
& Products Magazine
and on the magazine’s Web site at
www.pppmag.com/article/1403
quoted from here

Alabama Reminder to follow both state and federal law: Medicaid Rule No. 560-X-16-.20(5)

Alabama Medicaid Rule No. 560-X-16-
.20(5) Quantity Limitations
(5) Maintenance medications are those generally used to
treat chronic conditions or illnesses and are ordered/pre
-
scribed and taken regularly and continuously. Medicaid
recipients can obtain a three month supply of maintenance
medications as designated by the Agency. The patient
must first have demonstrated stability for at least 60
days (same strength and dose) on a given maintenance
medication. Only one co-pay is collected and only one
dispensing fee is paid for the three month supply. A list
of maintenance medications is available on the Medicaid
website.
Medicaid has disseminated and posted guidance to the
Alabama Medicaid Agency website, which is very clear in that
pharmacists should always follow both state and federal phar
-
macy law. The Alabama Medicaid Agency guidance is avail
-
able on its website at
www.medicaid.alabama.gov/documents/
4.0_ Programs/4.5_ Pharmacy_ Services/4.5.4_ Drug _ Info/
4.5.4_Maintenance_Supply_Guidance_Revised_9-5-13.pdf
and states the following: “Alabama State Board of Pharmacy 
 
law prohibits the quantity of a prescription to be changed
without prescriber approval. Approval from the prescriber
must be attained prior to dispensing a maintenance supply."
quoted from here

Kentucky racing commission panel to look at whether medication rule places blame in proper place

Kentucky racing commission panel to look at whether medication rule places blame in proper place
Monday, January 27, 2014
Proposed changes to standardbred medication rules and penalties by the Kentucky Horse Racing Commission have prompted a bit of a tempest in thoroughbred circles. The issue will be on the agenda Tuesday for a special meeting of the commission’s rules committee.

HHS OIG Work Plan for FY 2014 - Office of Inspector General

PDF]

HHS OIG Work Plan for FY 2014 - Office of Inspector General - U.S. ...

oig.hhs.gov/.../Work-Plan-2014.pdf
United States Department...
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18 hours ago - management processes, including key issues such as food and drug safety, child support ...... Payment for compounded drugs under Medicare Part B (new) .

Military Officals Briefing on Tricare and Compounding Prescription Coverage

Compounded Prescriptions
TRICARE does not cover drugs that are not approved by the FDA and cannot reimburse for non-FDA approved bulk chemical ingredients in compound prescriptions.
A planned review of this policy has been suspended due to the recently enacted "Drug Quality and Security Act."
TRICARE will re-examine its policy after an FDA review, but no date has been set for completion.
- See more at: http://www.moaa.org/
Main_Menu/Take_Action/Top_Issues/Enjoying_Retirement/
Health_Care/TRICARE_Officials_Brief_MOAA.html#sthash.NRpeybze.dpuf

PCCA Job Opening for Inside Sales Manager


Inside Sales Manager

Houston, Texas Area - Jan 14, 2014
Job Detail:
PCCA (Professional Compounding Centers of America), an independent compounding pharmacy's complete resource for fine chemicals, devices, equipment, training & support, is looking for an Inside Sales Manager join their inside sales team in Houston, TX. Relocation assistance is available for the r...
more here

The Drug Shortage Report: Trial Delayed for South Lyon Pharmacy & Pharmacist...

The Drug Shortage Report: Trial Delayed for South Lyon Pharmacy & Pharmacist...:  A trial to determine whether or not to uphold the license suspension of a South Lyon pharmacy has been delayed. A trial had been set for th...

Third Question of the Day February 1, 2014 Is it fair of the federal government (Congress and FDA) to force compounding pharmacists and pharmacies to make decisions about whether to stay traditional compouders or convert to outsourcers when all the guidance and drug lists have no been put in place?

While the argument is that no one has to decide anything right now as far as the DQSA, in reality that is not true--compounding pharmacists who own compounding pharmacies are having to make tough decisions right now about which direction to go.  It is not a matter of just snapping their fingers and filling out paper work. For those good, honest compounders, many factors have to be weighed and balanced.  The factors relate to facilities, drugs to compound, and staff to employee or in some cases lay off, funding and resources, etc.  These are very difficult decisions requiring a lot of careful weighing of these factors.  Guidance needs to be given to those compounders who do both human and animals since a distinction was made by Congress.  They face what appears to be much tougher decisions than those who do solely human compounds or solely veterinary compounds (who aren't affected by DQSA).  The more information the FDA and the states can provide and the sooner they can provide it the better for the good and much needed compounding pharmacists and pharmacies. 

Second Question of the Day February 1, 2014 What will it take to convince groups that represents compounding pharmacies and pharmacists to police their own bad actors so that the entire class of good compounders are not also punished along with the bad compounders?


Question of the Day February 1, 2014 What will it take to get states to enforce their own rules and regulations against compounding pharmacie and pharmacists?


Great Cheat Sheet from IACP on When FDA Comments and Nominations are Due from Compounders

IACP Reference Documents: FDA Comments and Nominations Due Dates - What is Due When?

IACP has created some documents to help you navigate the myriad of FDA Comments and Nominations due dates for the coming months.

Click here for a Due Dates Reference Sheet.
Click here for a comprehensive IACP "Cheat Sheet" outlining exactly what is due and when, as well as FDA links providing instructions on how to submit your information.

For more information, please contact IACP at iacpinfo@iacprx.org.