The Law of Compounding Medications And Drugs

Wednesday, December 3, 2014

Emerging Issues in FDA Law: Implementation of DQSA University of Maryland Francis King Carey School of Law

Emerging Issues in FDA Law: Implementation of DQSA
University of Maryland Francis King Carey School of Law
Law & Criminal Justice, Healthcare & Wellness, Innovation & Technology, Medicine
Date / Time
Wednesday, Dec 3, 2014
8:00 am - 5:00 pm
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Location
Arnold & Porter LLP
555 12th St NW, Washington, DC 20004 (map)
Speaker(s)Daniel Kracov, Elizabeth Stevulak, Diane Hoffmann, Lee Rosebush, David Miller, and more
Websitehttp://www.fdli.org/conferences/conference-pages/dqsa2014/agenda
Event CoordinatorLuke Gibson, lgibson2@law.umaryland.edu, 410.706.3789
Presented by: FDLI and the University of Maryland Schools of Law and Pharmacy
Details: This one-day conference focuses on the Drug Quality and Security Act and its two major issue areas: implementation of track and trace procedures and regulation of pharmacy compounding. The program brings together government workers, consultants and industry representatives to discuss implementation, FDA guidance and future considerations. With guidance from expert speakers, participants will review the key parts of the act, recently released guidance from the FDA, implementation deadlines, and look ahead to future deadlines. The Drug Quality and Security Act will continue to have a significant impact on drug manufacturers, wholesalers and pharmacies. Join us to learn about specific requirements for all stakeholders throughout the drug distribution supply chain.
Who Will Attend:
Attorneys, regulatory staff and compliance personnel who work for drug manufacturers, pharmacies, third party distributors, warehouses and distribution facilities.
Regulatory and other scientists who work in pharmacy compounding
Academics, consultants and other research organizations and the press who study and report on issues related to drug safety and pharmacy compounding.
Attendees
Jai Egekeze

Imprimis to Aquire Park Compounding For $4.137 Million

Imprimis to Aquire Park Compounding For $4.137 Million ...

www.sdbj.com/.../imprimis-aquire-park-com...

San Diego Business Journal

11 hours ago - Imprimis to Aquire Park Compounding For $4.137 Million. By Brittany Meiling Tuesday, December 2, 2014. Imprimis Pharmaceuticals Inc., a San Diego-based

Animal Drug Approvals December 2014 Update (Green Book)

– http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/UCM425462.pdf

Tuesday, December 2, 2014

breaking news!! Quarter horse trainer suspended 38 months for using clenbuterol BY JEREMY BALAN

http://m.ocregister.com/articles/use-643917-clenbuterol-horse.html

Free Seminar on Compliance Issues in Billing and Coding

Compliance Issues in Billing & Coding

Donna Morris, MJ, CHC, CPC
Assistant Compliance Officer, Director of Regulatory Compliance
Rush University Medical Center

Wednesday, December 3, 2014
7:00 - 8:00 pm Central Time

This online session is free of charge. Login information will be sent upon registration.

Wyoming Board of Pharmacy Gives Compliance Types including Finding a lot of progress in compliance with 797!!

Compliance Corner
By Richard Burton, RPh, Inspector/Compliance Officer
Schedule II Perpetual Inventory
The Board inspectors are finding multiple issues and are being asked
multiple questions as to how the pharmacy should maintain the perpetual inventory.
The Wyoming Controlled Substances Act, Rules and Regulations
Chapter 4, Section 1 (c)(iv) states, in part: “All retail and institutional
pharmacies shall maintain a perpetual inventory for all schedule II controlled
substances. This inventory shall be reconciled no less than once a
quarter.” The rule does not state how the inventory is to be maintained,
which leaves much discretion on the part of each individual pharmacy.
This has led to numerous ways that the perpetual inventory is maintained
within each pharmacy. Some pharmacies keep the inventory electronically
and some keep information by hard copy. Either way is permissible by the
Board. Some pharmacies reconcile quarterly, some reconcile monthly, and
some reconcile with each dispensing of a Schedule II drug. An important
note to remember is that the reconciliation (at least quarterly) should be
documented in whatever format the pharmacy is using (hard copy or
electronically). If a particular Schedule II drug has no activity during the
previous three months, it should be counted and the reconciliation documented
(the rule states “all” Schedule II CS). Discrepancies discovered

December

West Virginia Board of Pharmacy Makes Good Points with Inspector’s Corner: Is Your Dispensing Software Up to Speed?

Inspector’s Corner: Is Your Dispensing
Software Up to Speed?
If you are planning to open a new pharmacy, or thinking
of buying a new computer system for your prescription department,
be certain that it meets all legal requirements and
is adaptable to changes in those requirements (for example,
Drug Enforcement Administration (DEA) requirements for
electronic prescribing of CS). As inspectors look at new pharmacies
and perform regular inspections, the software system
in place touches on many areas they are looking at, including
proper dispensing records. Of course, the dispensing software
plays a vital part in today’s practice to ensure that prescriptions
are lawful, and to prevent errors, create proper labels
and inserts, and other such things. Many pharmacies, from
the single independent to the major pharmacy corporations,
purchase or create systems that may not always be current
on changes in law or adaptable to new laws, rules, or other
legal requirements.
Software is generally not written by pharmacists, and even
if it is, it may not keep required data in legally acceptable
or adaptable form. If there is an error, it is doubtful that a
claims auditor or investigator will be very sympathetic to an
excuse that the computer did not work right when deciding to
refuse a reimbursement or looking at possible administrative
or criminal behavior. In the end, it is the pharmacy and its
pharmacists who are responsible for compliance.
A recent example is the change of scheduling of hydrocodone
combination products (HCPs) to Schedule II CS.
Nearly everyone could handle that. However, once changed
to Schedule II, how did you handle refills as allowed for
previously written prescriptions? What about the fact that
the federal guidance says that up to five refills of the pre-
October 6, 2014 HCP prescriptions could be honored, but
West Virginia law limits HCPs to no more than two refills?
What about the West Virginia limit of these dispensings
to no more than a 30-day supply at one time, versus the
federal law that does not have any limit on the amount a
single prescription can call for? These types of issues merit
a conversation with your programmers or vendors to ensure
that your pharmacy is compliant.

quoted from West Virginia Board of Pharmacy December 2014 Newsletter

Pharmacy Compounding of OTCs:an Oxymoron

Pharmacy Compounding of OTCs:an Oxymoron
Pharmacy compounding continues to be a hot topic. This
is, of course, due to the still new federal Compounding
Quality Act, which amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act). As is widely known, pharmacy
drug compounding is the combination of active and inactive
ingredients only when done for a specific prescription order
for a specific individual patient, or in limited quantities in
anticipation of the receipt of valid prescription orders based
on past history of receiving such orders. Over-the-counter
drugs (OTCs) are those that can be sold without a prescription.
So, can a pharmacy compound OTCs and sell them on
the front end? Simply put, no.
According to Webster’s Ninth New Collegiate Dictionary,
copyright 1983, the definition of “oxymoron” is “a combination
of contradictory or incongruous words. . .” Since pharmacies
can only compound for specific prescriptions, the idea
of compounding OTCs that are sold without a prescription
is directly contradictory to and incongruent with the FD&C
Act compounding laws. This would be manufacturing of
OTCs, which requires full compliance with federal laws for
current Good Manufacturing Practices. So, although you
might have the best recipe for diaper paste or the best remedy
for a skin irritation, unless you have gotten it approved
through the Food and Drug Administration (FDA) process for
manufacture as an OTC, and unless you do it in a properly
licensed manufacturing facility under FDA requirements, if
you decide to whip up a batch and sell it as an OTC, you are
engaged in illegal manufacturing.

quoted from West Virginia Board of Pharmacy December 2014 Newsletter

West Virginia Board of Pharmacy December 2014 Newsletter

December

North Dakota Board of Pharmacy December 2014 Newsletter

December

Kentucky Board of Pharmacy Provides Suggestions on Compliance

Compliance Corner: Are You in Compliance?
Submitted by Phil Losch, RPh, Pharmacy and Drug Inspector
of the Board
Is your Drug Enforcement Administration (DEA) Combat Methamphetamine
Epidemic Act of 2005 (CMEA) Self-Certification of
Regulated Sellers of Scheduled Listed Chemical Products (SLCPs)
up to date?
As part of the requirements for CMEA, an annual self-certification
is required for all regulated sellers of SLCPs (ie, ephedrine,
pseudoephedrine, and phenylpropanolamine). A regulated seller
must not sell SLCPs unless he or she has self-certified with DEA.
In self-certifying, the regulated seller is confirming:
♦ Employees have been trained,
♦ Records of the training are being maintained,
♦ Sales limits are being enforced,
♦ Products are being stored behind the counter or in a locked
cabinet, and
♦ A written or electronic logbook is being maintained.
The only way to self-certify (recertify) is through the Internet on
the Diversion Control Program website located at www.deadiversion
.usdoj.gov. Once you are on the website, click on “CMEA (Combat
Meth Epidemic Act),” and then click on “Self-Certification” under
the CMEA Required Training & Self-Certification section. Once
certified, you will be able to print your certificate of compliance
that can be posted in your pharmacy. Remember, this is an annual
requirement, not a one-time event.
It has been noticed recently during routine inspections of retail
pharmacies that many certificates that are posted have expired.
It is essential that if you are a retail seller of pseudoephedrine or
ephedrine, you have an active CMEA certificate for your pharmacy
that is up to date.

quoted from Kentucky Board of Pharmacy 2014 Newsletter

Kentucky Board of Pharmacy New Rules Regarding Bualbital Containing Products

Butalbital-Containing Products
Effective September 17, 2014, changes to 902 KAR 55:045 were
finalized, and it was adapted to mirror the exempt prescription product
list published in Title 21 Code of Federal Regulations 1308.32,
with the exception of butalbital-containing products.
What this means:
♦ All butalbital-containing products are Schedule III controlled
substances (CS).
♦ Prescriptions for butalbital-containing products must be reported
to the Kentucky All Schedule Prescription Electronic
Reporting system.
♦ Physician assistants (PAs) cannot prescribe butalbitalcontaining
products.
♦ Refills are no longer valid for any prescription written with
refills for butalibal-containing products by a PA prior to September
17, 2014.
♦ Advanced practice registered nurses (APRNs) must have a valid
DEA registration to prescribe butalbital-containing products.
♦ Refills are no longer valid for any prescription written with
refills for butalbital-containing products by an APRN without
a DEA registration prior to September 17, 2014.
♦ APRNs can only prescribe a 30-day supply and cannot authorize
refills since butalbital-containing products are Schedule
III CS.
♦ Any physician who has his or her license restricted to not allow
the prescribing of CS cannot prescribe butalbital-containing
products, and any refill authorized by the above physician on
or after September 17, 2014, is no longer valid.
quoted from Kentucky Board of Pharmacy December 2014 Newsletter

12/2/14 - FDA: Hard to prove if foreign meds harmed any cancer patients [Albuquerque Journal, N.M.] Dec. 02A U.S. Food and Drug Administration agent testified Monday that there is no way to tell whether cancer patients of a Deming oncologist who were treated with foreign drugs for two years were actually harmed in part because many are now dead.

more here

More on ASADA and Stephen Dank in 2012 and Alavi the pharmacist who allegedly compoundedthe drug.

ASADA seeks subpoenas to compel Shane Charter and ...

www.heraldsun.com.au/.../story-fni5f6kv-1227140988775

Herald Sun

14 hours ago - Pharmacist Nima Alavi is a key ASADA witness in its case against Essendon ... Dank in 2012 and Alavi the pharmacist who allegedly compounded thedrug.

PressReader - Herald Sun - December 02, 2014

www.pressreader.com/australia/herald-sun/textview

15 hours ago - ... the banned peptide Thymosin beta-4 to former Bombers sports scientist Stephen Dank in 2012 and Alavi the pharmacist who allegedly compoundedthe drug.

Wednesday ruling for ASADA witnesses -

Wednesday ruling for ASADA witnesses - Fox Sports

www.foxsports.com.au/.../story-e6frf3e3-1227140988775

Fox Sports

20 hours ago - Pharmacist Nima Alavi is a key ASADA witness in its case against Essendon ... Dank in 2012 and Alavi the pharmacist who allegedly compounded thedrug.

Ohio Considers bill to shield compounding pharmacies who make execution drugs

Senate weighs bill to shield execution drugmaker - Daily ...

www.dailyadvocate.com/.../Senate-weighs-bill-to-shi...

The Daily Advocate

4 hours ago - Opponents say the public has the right to know the drugs source. ...anonymity is aimed at so-called compounding pharmacies that mix doses of specialtydrugs.

Companies acquire rights to low T, IC drugs

December 01, 2014

By Richard R. Kerr

In separate actions, two pharmaceutical makers have acquired the rights to a novel testosterone agent and a patented formulation for interstitial cystitis/painful bladder syndrome (IC/PBS).

Endo International plc announced acquisition rights to testosterone nasal gel (Natesto) from Trimel BioPharma SRL. The drug was approved by the FDA in May 2014.

Endo said it expects the transaction to close in early 2015.

New Guidance for 503B Outsourcing Facilities 12/2/2014byDena KesslerDena Kessler, Lee RosebushLee Rosebush

here

Amoss: Fairness Takes Backseat in Indiana Medication Case | Paulick Report – Thoroughbred Horse Racing News

FDA Spells Out Compounding Pharmacy Reporting

FDA Spells Out Compounding Pharmacy Reporting and ...

www.fdanews.com/.../168806-fda-spells-out-compounding-pharmacy-re...

17 hours ago - The FDA will require large compounding pharmacies to register each year, pay a $15000 annual fee and report a detailed list of all the products they ...

IACP: USP Update on Proposed Chapter 800

USP Update on Proposed Chapter <800> - International ...

www.iacprx.org/news/.../USP-Update-on-Proposed-Chapter-800.htm

1 day ago - Protecting, Promoting & Advancing Pharmacy Compounding. About IACP... 14 hours ago Opinion: Should Health Insurance Pay for Compounded Medications?

An Owner of A Nashville Compounding Pharmacy Says Regulations in place for compounders are "sufficient."

Regulations in place for compounders are sufficient

The Tennessean‎ - 12 hours ago

As the owner of a Nashville compounding pharmacy, I echo Dr. Sullivan's comments (Nov. 11, “Changes for ...

Anyone want to respond to this comment?

Anonymous said...

why wont this die. I have been reading about this incident with NECC everyday all these years. I agree that this is a misfortunate incident that should have never been allowed to happen. But , it dide and for God's sake Lets move on. Compounders are facing a huge issue right now with PBM's. Hey Markey !? lets talk about Express Scripts and big Pharma!

December 2, 2014 at 11:53 AM

Anonymous said...

You do realize this is a flashback that is probably meant to give compounders an idea of why the DEA may be inspecting them.

December 2, 2014 at 1:25 PM

Anonymous said...

The incident with NECC is a sentinel event--immortalized like other public health disasters--it is tip-of-the-iceberg for a practice area that otherwise escapes our surveillance and may buried in background. Exposed patients continue to be at risk, and those that have diagnosed morbidity are in a chronic disease state. We should continue follow-up.

[excerpt]
In a December 2013 “lessons learned” opinion, Pappas noted that while the overall (known) mortality associated with the outbreak remains low, “morbidity relating to persistent symptoms and treatment associated toxicity is high”71 indicating that clinical manifestations of the early outbreak have shifted to a less-well characterized, chronic disease setting. The overall cost to human health caused by the 2012 outbreak is immeasurable, as is the total financial impact to healthcare systems. For a single hospital health system, the identification of particulate in an outsourced compounded product triggered an investigation costing nearly 1 million dollars for 5 lots of compounded medication totaling 1090 units, at an added cost of $802.74 per unit purchased.72 The research letter notes “Fungal contamination of MgSO4 required extensive pharmacy, laboratory, infection control, and hospital administrative support; substantial hospital resources for patient and physician notification; ongoing surveillance; and prophylactic treatment of high-risk patients”.72 Remarkably, as the early publications on the outbreak were being published, pharmacies that would later recall products due to identified contamination or lack of assurance of sterility continued to supply the market with non-FDA approved medicines for sterile use, including methylprednisolone acetate suspension.

See submission at http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1523-0006

December 2, 2014 at 1:49 PM

Wednesday, December 3, 2014

Tuesday, December 2, 2014

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