Docket Entries for K-V Pharmaceutical v. Cook Et. Al filed in the Northern District of Georgia Federal District Court

Here are the documents that have been filed in K-V v. v. Cook et al
Assigned to: Judge Charles A. Pannell, Jr, cause of action: 42:1396(a) State Plans for Medical Assistance.  Note you cannot click on any of the links and view the documents without setting up a Pacer account and paying for the documents.  As I have time, I will post some of the main documents on the blog.  Note I  will not be able to post the transcript of the hearing dated 8/7/2012 at this time.

Date Filed	#	Docket Text
07/17/2012	1	COMPLAINT filed by K-V Pharmaceutical Company, Ther-Rx Corporation. Consent form to proceed before U.S. Magistrate and pretrial instructions provided. ( Filing fee $ 350 receipt number 113E-4048681) (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8, # 9 Civil Cover Sheet)(adg) Please visit our website at http://www.gand.uscourts.gov to obtain Pretrial Instructions. (Entered: 07/18/2012)
07/17/2012	2	MOTION for Preliminary Injunction and MOTION for Permanent Injunction with Brief in Support by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1 Text of Proposed Order, # 2 Brief, # 3 Declaration of Jozwiakowski, # 4 Exhibit 1, # 5 Exhibit 2, # 6 Exhibit 3, # 7 Exhibit 4, # 8 Exhibit 5, # 9 Exhibit 6, # 10 Exhibit 7, # 11 Exhibit 8, # 12 Exhibit 9, # 13 Exhibit 10, # 14 Exhibit 11, # 15 Exhibit 12, # 16 Exhibit 13, # 17 Exhibit 14, # 18 Exhibit 15, # 19 Exhibit 16, # 20 Exhibit 17, # 21 Exhibit 18, # 22 Exhibit 19, # 23 Exhibit 20, # 24 Exhibit 21, # 25Exhibit 22, # 26 Exhibit 23, # 27 Exhibit 24, # 28 Exhibit 25, # 29 Exhibit 26, # 30 Exhibit 27, # 31 Declaration of Thomas McHugh, # 32 Exhibit 1, # 33 Exhibit 2, # 34 Exhibit 3, # 35 Exhibit 4, # 36 Exhibit 5, # 37 Exhibit 6, # 38 Exhibit 7, # 39 Exhibit 8, # 40 Exhibit 9, # 41 Exhibit 10, # 42 Exhibit 11, # 43 Exhibit 12, # 44 Exhibit 13, # 45 Exhibit 14, # 46 Declaration of Scott Goedeke, # 47 Exhibit 1, # 48 Exhibit 2, # 49 Exhibit 3, # 50 Exhibit 4, # 51 Exhibit 5, # 52 Exhibit 6, # 53 Exhibit 7, # 54 Exhibit 8, # 55 Exhibit 9, # 56 Exhibit 10, # 57 Exhibit 11, # 58 Exhibit 12, # 59 Exhibit 13, # 60 Exhibit 14, # 61 Exhibit 15, # 62 Declaration of Dr. Lawrence Robillard)(adg) (Entered: 07/18/2012)
07/17/2012	3	Certificate of Interested Persons and Corporate Disclosure Statement by K-V Pharmaceutical Company, Ther-Rx Corporation. (adg) (Entered: 07/18/2012)
07/17/2012	4	APPLICATION for Admission of Margaret D. Hall Pro Hac Vice by K-V Pharmaceutical Company, Ther-Rx Corporation. (adg) (Entered: 07/18/2012)
07/17/2012	5	APPLICATION for Admission of Drew W. Marrocco Pro Hac Vice by K-V Pharmaceutical Company, Ther-Rx Corporation. (adg) (Entered: 07/18/2012)
07/18/2012		Submission of 2 MOTION for Preliminary Injunction and MOTION for Permanent Injunction, submitted to District Judge Charles A. Pannell. (adg) (Entered: 07/18/2012)
07/18/2012	6	Amended Certificate of Interested Persons and Corporate Disclosure Statement by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) Modified on 7/19/2012 (adg). (Entered: 07/18/2012)
07/18/2012	7	Summons Issued as to David A. Cook, Jerry Dubberly. (adg) (Entered: 07/19/2012)
07/19/2012		RETURN of 5 APPLICATION for Admission of Drew W. Marrocco Pro Hac Vice, 4 APPLICATION for Admission of Margaret D. Hall Pro Hac Vice to attorneys for correction re: signature and payment. (pb) (Entered: 07/19/2012)
07/19/2012	8	APPLICATION for Admission of Drew W. Marrocco Pro Hac Vice (Application fee $ 150, receipt number 113E-4053115)by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 07/19/2012)
07/19/2012	9	APPLICATION for Admission of Margaret "Peg" Donahue Hall Pro Hac Vice (Application fee $ 150, receipt number 113E-4053153)by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 07/19/2012)
07/20/2012		NOTICE Expedited Briefing Schedule for MOTION for Preliminary Injunction [Doc. No. 2]. The defendants' response brief shall be filed no later than Monday July 30, 2012 at 4 p.m. The plaintiffs may file a reply brief no later than Thursday August 2, 2012 at 4 p.m. The court will schedule a hearing, if necessary, upon receipt of all briefs. (mam) (Entered: 07/20/2012)
07/24/2012	10	NOTICE of Appearance by Michelle Townes on behalf of David A. Cook (Townes, Michelle) (Entered: 07/24/2012)
07/24/2012	11	NOTICE of Appearance by Jason S. Naunas on behalf of David A. Cook (Naunas, Jason) (Entered: 07/24/2012)
07/25/2012		APPROVAL by Clerks Office re: 9 APPLICATION for Admission of Margaret "Peg" Donahue Hall Pro Hac Vice (Application fee $ 150, receipt number 113E-4053153), 8 APPLICATION for Admission of Drew W. Marrocco Pro Hac Vice (Application fee $ 150, receipt number 113E-4053115). Attorney Margaret (Peg) Donahue Hall, Drew W. Marrocco added appearing on behalf of K-V Pharmaceutical Company, Ther-Rx Corporation (pb) (Entered: 07/25/2012)
07/26/2012	12	ORDER GRANTING 8 Application for Admission Pro Hac Vice of Drew W. Marrocco. Signed by Judge Charles A. Pannell, Jr. on 7/26/2012. (adg) (Entered: 07/26/2012)
07/26/2012	13	ORDER GRANTING 9 Application for Admission Pro Hac Vice of Margaret Donahue Hall. Signed by Judge Charles A. Pannell, Jr on 7/26/2012. (adg) (Entered: 07/26/2012)
07/30/2012	14	MOTION to Stay with Brief In Support by David A. Cook, Jerry Dubberly. (Attachments: # 1 Brief Memorandum of Law in Support of Motion to Stay, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Text of Proposed Order)(Naunas, Jason) (Entered: 07/30/2012)
07/30/2012	15	RESPONSE in Opposition re 2 MOTION for Preliminary Injunction MOTION for Permanent Injunction filed by David A. Cook, Jerry Dubberly. (Attachments: # 1 Brief Memorandum of Law in Support of Defendants' Opposition to Motion for Preliminary and Permanent Injunction, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Exhibit 4, # 6 Exhibit 5, # 7 Exhibit 6)(Townes, Michelle) (Entered: 07/30/2012)
07/30/2012	17	Minute Entry for proceedings held before Judge Charles A. Pannell, Jr: Telephone Conference held on 7/30/2012. Hearing set on Motion for Preliminary Inj and Motion to Stay on 8/6/2012 at 11:00 a.m. Hearing Concluded. (Court Reporter Martha Frutchey)(adg) (Entered: 08/01/2012)
07/31/2012	16	ORDER Setting Hearing on Motion 2 MOTION for Preliminary Injunction and 14 MOTION to Stay : Motion Hearing set for 8/6/2012 at 11:00 AM in ATLA Courtroom 2307 before Judge Charles A. Pannell Jr. The plaintiffs' responsetime to the motion to stay is shortened to 8/3/2012 at 4:00 PM. The defendants may file a reply brief, if desired, at any time prior to the August 6 hearing. Signed by Judge Charles A. Pannell, Jr on 7/31/2012. (adg) (Entered: 07/31/2012)
08/02/2012	18	REPLY to Response to Motion re 2 MOTION for Preliminary Injunction MOTION for Permanent Injunction filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4)(Varghese, Manoj) (Entered: 08/02/2012)
08/02/2012	19	Exhibit 4 re 18 REPLY to Response to Motion re 2 MOTION for Preliminary Injunction MOTION for Permanent Injunction filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) Modified on 8/3/2012 to correct docket text (adg). (Entered: 08/02/2012)
08/03/2012	20	RESPONSE in Opposition re 14 MOTION to Stay filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 08/03/2012)
08/05/2012	21	NOTICE Of Filing by K-V Pharmaceutical Company, Ther-Rx Corporation Second Declaration of Thomas McHugh (Varghese, Manoj) (Entered: 08/05/2012)
08/05/2012	22	APPLICATION for Admission of Erin M. Shoudt Pro Hac Vice (Application fee $ 150, receipt number 113E-4081988)by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 08/05/2012)
08/07/2012		NOTICE In the event the preliminary injunction is granted, the court is considering requiring the payment of bond. The parties are directed to submit (via electronic filing) their proposals for bond amount no later than August 8, 2012 at noon. The court is aware of Eleventh Circuit case law giving discretion to waive the bond requirement. The parties need not discuss these decisions or their applicability to this case. The purpose of soliciting the proposals is to allow the parties to address the appropriate bond amount not whether bond will be required.(mam) (Entered: 08/07/2012)
08/07/2012	23	TRANSCRIPT of Proceedings held on 8/6/12 (Mot for Prelim Inj Hrg) before Judge Charles A. Pannell, Jr. Court Reporter/Transcriber Martha J. Frutchey, Telephone number 404-215-1573. Transcript may be viewed at the court public terminal or purchased through the Court Reporter/Transcriber before the deadline for Release of Transcript Restriction. After that date it may be obtained through PACER. Redaction Request due 8/28/2012. Redacted Transcript Deadline set for 9/7/2012. Release of Transcript Restriction set for 11/5/2012. (Attachments: # 1 Notice of Filing Transcript) (pjm) (Entered: 08/07/2012)
08/07/2012	24	Minute Entry for proceedings held before Judge Charles A. Pannell, Jr: Motion Hearing held on 8/7/2012; 2 Motion for Preliminary Injunction TAKEN UNDER ADVISEMENT; 2 Motion for Permanent Injunction TAKEN UNDER ADVISEMENT; 14 Motion to Stay TAKEN UNDER ADVISEMENT; Opening statements by counsel. Paul C. Brown, sworn & testified for defendants. Court heard from counsel. Written order to follow. Hearing Concluded. (Court Reporter Martha Frutchey)(adg) (Entered: 08/07/2012)
08/07/2012		APPROVAL by Clerks Office re: 22 APPLICATION for Admission of Erin M. Shoudt Pro Hac Vice (Application fee $ 150, receipt number 113E-4081988). Attorney Erin M. Shoudt added appearing on behalf of K-V Pharmaceutical Company, Ther-Rx Corporation (pb) (Entered: 08/07/2012)
08/07/2012	25	MOTION to Dismiss Complaint For Injunctive And Declaratory Relief by David A. Cook, Jerry Dubberly. (Attachments: # 1 Brief Memorandum of Law in Support of Motion to Dismiss)(Naunas, Jason) (Entered: 08/07/2012)
08/07/2012	26	PROPOSED ORDER Proposed Order on Motion for Preliminary Injunction re: 18 Reply to Response to Motion, 2 MOTION for Preliminary Injunction MOTION for Permanent Injunction. (Varghese, Manoj) (Entered: 08/07/2012)

A Bankrupt KV Now Goes After Some States // Pharmalot

A Bankrupt KV Now Goes After Some States // Pharmalot

Pfizer To Pay $60M For Making Foreign Bribes

An article, Pfizer To Pay $60M For Making Foreign Bribes, written by Ed Silverman and published on August 7, 2012, states that the  "US Securities and Exchange Commission has charged Pfizer with violating the Foreign Corrupt Practices Act after findings various subsidiaries bribed doctors and other health care professionals employed by foreign governments in order to win business."
To read the entire article, click here.

FDA Rejects Allegations it is to Blame for Drug Shortages

In a July 23, 2012, letter, Jeanne Ireland, FDA assistant commissioner for legislation, responds to allegations from a congressional committee report holding it largely responsible for drug shortages.  To read a summary entitled FDA Rejects Blame for Drug Shortages written by Daniel Weiss, Senior Editor and published Tuesday, August 7, 2012, click here.

 

FDA Rules More Pliable Than Laws of Economics

FDA Rules More Pliable Than Laws of Economics

Iowa: Jury Verdict in Favor of Compounding Pharmacy Affirmed on Appeal

In Whitley v C. R. Pharmacy Service, Inc., 2012 Iowa Sup. LEXIS 71 (June 29, 2012), the Iowa Supreme Court affirmed a  trial court decision in favor of a compounding pharmacy in a case were the pharmacy was being sued for malpractice.  To read a summary of this decision written by David B. Brushwood, BSPharm, JD, contributing writer, for Pharmacy Today, click here.  The lower court decision can be read here.  The Iowa Supreme Court court decision can be read here.

DEA Administrative Actions in 2012

The Department of Justice, Drug Enforcement Agency has taken the following administrative actions against doctors and pharmacies during 2012: 

• Physicians Pharmacy, L.L.C.; Decision and Order (August 7, 2012)
• Decision and Order; Perry T. Dobyns, M.D. (August 1, 2012)
• James William Eisenberg, M.D.; Decision and Order (August 1, 2012)
• Margy Temponeras, M.D.; Decision and Order (August 1, 2012)
• Grider Drug 1 & Grider Drug 2; Decision and Order (Thursday, July 26, 2012)
• Muzaffer Aslan, M.D.; Decision and Order (June 20, 2012)
• Patrick K. Chau, M.D.; Decision and Order (June 15, 2012)
• Darryl J. Mohr, M.D.; Affirmance of Immediate Suspension Order (June 12, 2012)
• Kwan Bo Jin, M.D.; Decision and Order (June 12, 2012)
• Serenity Café; Decision and Order (June 12, 2012)
• Bill Alexander, M.D.; Decision and Order (June 12, 2012)
• 4 OTC, Inc.; Decision and Order (June 12, 2012)
• Donald Brooks Reece II, M.D.; Dismissal of Proceeding (June 12, 2012)
• Pharmboy Ventures Unlimited, Inc., Decision and Order (June 7, 2012)
• Matthew J. Kachinas, M.D.; Decision and Order (May 18, 2012)
• Segun M. Rasaki, M.D.; Decision and Order (May 18, 2012)
• Richard H. NG, D.O.; Decision and Order (May 18, 2012)
• James Edgar Lundeen, Sr., M.D.; Dismissal of Proceeding (May 18, 2012)
• Daniel B. Brubaker, D.O.; Decision and Order (March 30, 2012)
• Zhiwei Lin, M.D.; Decision and Order (March 28, 2012)
• Morris W. Cochran, M.D.: Revocation of Registration (March 26, 2012)
• Scott W. Houghton, M.D.; Decision and Order (February 10, 2012)
• Randall L. Wolff, M.D.; Decision and Order (February 1, 2012)
• Emilio Luna, M.D.; Decision and Order (January 31, 2012)
• Southwest K-9; Decision and Order (January 31, 2012)
• Mladen Antolic, M.D.; Decision and Order (January 25, 2012)
• Joseph Deluca, D.O.; Dismissal of Proceeding (January 25, 2012)

The list can be found here.

Judge Amy Berman Jackson Takes FDA's Motion to Dismiss Under Advisement after Hearing

8/07/2012

Minute Entry for Proceedings held before Judge Amy Berman Jackson: Motion Hearing held on 8/7/2012 re: 6 MOTION to Dismiss filed by Defendants' UNITED STATES FOOD AND DRUG ADMINISTRATION, ET AL., The 6 Motion to Dismiss was Heard and Taken Under Advisement. (Court Reporter Kellie Humiston) (jth) (Entered: 08/07/2012)

New Mexico Board of Pharmacy Regular Board Meeting : Retail Distribution of Dangerous Veterinary Drugs

New Mexico Board of Pharmacy Regular Board Meeting Agenda for the August 27-28, 2012 meeting to be held at Ruidoso Convention Center, 111 Sierra Blanca Dr. Ruidoso, New Mexico from 9:00 am to 5:00 pm indicates that new regulations dealing with the retail distribution of Dangerous Veterinary Drugs is to be discussed.  That agenda can be viewed here.  The rule to be discussed is as follows:


TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 15 DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION
16.19.15.1 ISSUING AGENCY: Regulation and Licensing Department, Board of Pharmacy, 1650
University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505) 841-9102.
[02-15-1889...02-15-96; 16.19.15.1 NMAC - Rn, 16 NMAC 19.15.1, 03-30-02]
16.19.15.2 SCOPE: All retail veterinary drug distributors.
[02-15-96; 16.19.15.2 NMAC - Rn, 16 NMAC 19.15.2, 03-30-02]
16.19.15.3 STATUTORY AUTHORITY: Section 61-11-14.B. (13) NMSA 1978 authorizes the Board of Pharmacy to issue drug permits for wholesalers, retailers and distributors of dangerous drugs limited to veterinary use. Section 26-3-3(A) NMSA 1978 (the Drug Product Selection Act or “DPSA”) authorizes pharmacists to dispense lower cost versions of multiple-source drugs that meet a final determination of the federal government that is published in the federal register.  Section 26-3-2 of the DPSA states that the purpose of the DPSA is to assure that all New Mexico citizens continue to receive high quality drugs at a reasonable cost.
[02-15-96; A, 04-30-98; 16.19.15.3 NMAC - Rn, 16 NMAC 19.15.3, 03-30-02]
16.19.15.4 DURATION: Permanent.
[02-15-96; 16.19.15.4 NMAC - Rn, 16 NMAC 19.15.4, 03-30-02]
16.19.15.5 EFFECTIVE DATE: February 15, 1996, unless a different date is cited at the end of a Section or Paragraph. This Part reformatted for inclusion into the New Mexico Administrative Code (NMAC) effective 2-15-96.
[02-15-96; A, 04-30-98; 16.19.15.5 NMAC - Rn, 16 NMAC 19.15.5, 03-30-02]
16.19.15.6 OBJECTIVE: The objective of Part 15 of Chapter 19 is to establish standards to be followed by retailers and distributors for the safe and competent delivery, distribution, and disposal of dangerous drugs limited to veterinary use. and to carry out the purpose of the Drug Product Selection Act by providing a uniform standard for drug product selection of animal drugs.  Section 26-3-3(A) NMSA 1978 permits a pharmacist to select a lower cost multiple source drug that meets a final determination in the federal register when a more costly version of the drug is
prescribed.  Animal drugs approved by FDA are subject to final determinations in the federal register and therefore qualify for drug product selection as described in this regulation.
[02-15-96; 16.19.15.6 NMAC - Rn, 16 NMAC 19.15.6, 03-30-02]
16.19.15.7 DEFINITIONS:
A. "Limited licensure for retailers of veterinary drugs", means a license issued in accordance with the Pharmacy Act 61-11-14.B (13), which authorizes licensees to retail dangerous drugs limited to veterinary use, in accordance with the labeling provisions of the Drug and Cosmetic Act.
B. "Dangerous Drug" means a drug...because of any potentiality for harmful effect or the method of its' use, or the collateral measures necessary to its' use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such drug, and hence for which adequate directions for use cannot be prepared.
C. “Animal drug” means a dangerous (prescription) drug that is the subject of an approved New
Animal Drug Application or an approved Abbreviated New Animal Drug Application under the Federal Food, Drug, and Cosmetic Act.
D. “FDA” means the United States Food and Drug Administration.
CE. "Adequate directions for use" means directions under which the layman can use a drug safely and for the purpose for which it is intended. A dangerous drug shall be sold at retail only on the order or prescription of a practitioner licensed by law to administer or prescribe such drug, if it bears the legend: "CAUTION -- Federal law restricts this drug to use by or on the owner of a licensed veterinarian".
DF. "Licensed Practitioner" means a person engaged in a profession licensed by the state, who within the limits of his license, may lawfully prescribe, dispense or administer drugs for the treatment of a patient's condition, and includes doctors of medicine, osteopathy, dentistry, podiatry and veterinary medicine. EG. "Prescription" means an order given individually for the person for whom prescribed, either directly from the prescriber or indirectly by means of a written order, signed by the prescriber and shall bear the name and address of the prescriber, his license classification, the name and address of the patient, the name and quantity of the drug prescribed, directions for use and the date of issue. No person other than a licensed practitioner
shall prescribe or write a prescription.
H. “Therapeutically equivalent” means animal drug products which have the same amount of the
active drug in the same dosage form which when administered can be expected to provide the same therapeutic effect.
FI. "Expiration Date" means those drugs and particularly those that are biologic in origin, on which
the label is required to bear an expiration date limiting the period during which the drug may be expected to have the labeled potency if it is stored as directed.
GJ. "Proper Storage Temperature" means the temperature at which the label on the drug indicates the product must be kept.
(1) Cold -- any temperature not exceeding 46 degrees F.
(2) Cool -- any temperature between 46 and 50 degrees F.
(3) Room temperature -- the temperature prevailing in a working area.
(4) Controlled room temperature -- temperature maintained thermostatically between 59 and 86 degrees F.
(5) Excessive heat -- any temperature above 104 degrees F.
(6) Protection from freezing -- where, in addition to the risk of breakage of the original container, freezing subjects a product to a loss of strength or potency, or to destructive alteration of the dosage form. The container label bears the appropriate notice to protect from freezing.
[03-07-80...08-27-90, 04-30-98; 16.19.15.7 NMAC - Rn, 16 NMAC 19.15.7, 03-30-02]
16.19.15.8 MANUFACTURER'S LABEL: Retail distribution of veterinary drugs which by federal law require the manufacturer to label the following legend: "CAUTION: Federal law restricted this drug to use or on the order of a licensed veterinarian" shall be as follows:
A. shall be sold at retail by the licensee or an employee or employees designated by the licensee only on the written order or prescription of a veterinarian licensed in this state; or
B. if the order or prescription is other than a written order, the designated individual receiving the
oral order or prescription shall immediately reduce such order to writing and the person receiving the order shall indicate the following information on the written record.
(1) name and address of the licensed veterinarian;
(2) name and strength of drug prescribed;
(3) quantity of drug ordered by the veterinarian;
(4) directions for use and cautionary statements, if given, by the veterinarian prescriber;
(5) date of order;
(6) name of owner and/or consignee of animal or animals;
(7) name of individual taking order from veterinarian prescriber.
[03-07-80...08-27-90; 16.19.15.8 NMAC - Rn, 16 NMAC 19.15.8, 03-30-02]
16.19.15.9 DANGEROUS VETERINARY DRUGS: All dangerous drugs distributed at retail on the order of a licensed veterinarian by the limited retail veterinary drug distributor shall be sold in the original, unbroken manufacturer's containers.
[03-07-80...08-27-90; 16.19.15.9 NMAC - Rn, 16 NMAC 19.15.9, 03-30-02]
16.19.15.10 ANIMAL DRUG PRODUCT SELECTION
A. Upon receipt of a prescription for an animal drug, a pharmacist may dispense any lower cost
animal drug that is:
(1) therapeutically equivalent to the prescribed animal drug;
(2) bioequivalent to the prescribed animal drug; and
(3) listed in FDA’s list of approved animal drug products (the “Green Book”).
B. When performing animal drug product selection pursuant to this regulation, a pharmacist may rely on the bioequivalence information found in the FDA FOIA Summaries published on the FDA internet website.
C. A licensed practitioner may prohibit animal drug product selection by writing with his hand the
words "no substitution" or the diminution "no sub" on the face of a prescription.D. If animal drug product selection occurs as permitted in this regulation, the pharmacist shall indicate on the label of the dispensed container the brand of drug prescribed and the name of the drug dispensed.
E. A pharmacist may not select a therapeutically equivalent animal drug unless he passes on to the
purchaser all savings between the net cost of the product prescribed and the product dispensed.

New Jersey Considering Rules on Sterile and Non-Sterile Compounding

The June 27, 2012, board minutes for the New Jersey Board of Pharmacy dealt with new compounding regulations.  The minutes state:

The Rules and Regulations Committee met last week to review public comments received on the Collaborative Practices proposal  and sterile and non-sterile compounding proposal. Compounding regulations will move forward.  Collaborative Practices public comment responses need to be worked in concert with the Medical Board.

The June 27, 2012 minutes can be found here.

More HIPPA Guidance For Pharmacies

The Montana Board of Pharmacy contains an excellent overview of how HIPPA applies to Pharmacies.  To view this helpful information, click here.

Maine Board of Pharmacy's Position on Office Use

The Maine Board of Pharmacy Minutes of the June 7, 2012 meeting contain the following information regarding office use of compounded preparations in that state:

E-Correspondence of May 18, 2012, David Kosar, regarding dispensing to a practitioner for office use

The Board concluded that compound products are only for a specific patient’s immediate need and anything outside of this would rise to the activity of manufacturing. A pharmacist cannot sell compounded product to a practitioner.

These minutes of the meeting can be found here.

Is Over-the-Counter Product Compounding Allowed in Kentucky?

The March 2012 Newsletter of the Kentucky Board of Pharmacy contains the following question and answer:

II. Over-the-counter product compounding: is it permissible?
The answer is found in the definition in Statute KRS 315.010:
(5) “Compound” or “compounding” means the preparation or labeling of a drug pursuant to or in anticipation of a valid prescription drug order including, but
not limited to, packaging, intravenous admixture or
manual combination of drug ingredients. “Compounding” as used in this chapter, shall not preclude simple reconstitution, mixing, or modification of drug products prior to administration by non-pharmacists.
The definition states pursuant to or in anticipation of a prescription for the preparation or labeling of a drug. Per KRS 315.010:
(9) “Drug” means any of the following:
(a) Articles recognized as drugs or drug products in any
official compendium or supplement thereto;
(b)Articles, other than food, intended to affect the
structure or function of the body of man or other
animals;
(c) Articles, including radioactive substances, intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man or other
animals; or
(d)Articles, intended for use as a component of any
articles specified in paragraphs (a) to (c) of this
subsection;
Based on the definition provided in the statute, compounded
legend and nonlegend drugs must be pursuant to a valid prescription in Kentucky.

The newsletter can be found here.

Idaho Legislature Repeals All Board Rules and Approves a New Set

2012 was a historic year for pharmacy law in Idaho. The previous rule book was repealed, and a new set of rules was promulgated.  Anyone doing business in Idaho should read the new rules, which are currently available on the Idaho Board of Pharmacy's web site found here.  The administrative code rules went into effect on March 31, 2012.  The one new rule relating to compounding is Rule 240.  According to the Idaho March 2012 newsletter found here Rule 240 "expands the sterile product preparation section. Please note that additional compounding rules, as well as United States Pharmacopeia (USP) Chapter 797 and USP Chapter 795, are not included in these rules."

Hawaii Board of Pharmacy Examines Definition of Office Use for Compounds

During the June 21, 2012, Hawaii Board of Pharmacy Meeting, the Board examined  what the state laws in Hawaii pertaining to "office use" for sterile and non-sterile compounding.  The following discussion is recorded in the meeting minutes:

Questions on Hawaii Compounding Laws

The Chair read the email inquiry from a pharmacy student at the University of New Mexico asking:

1. What are the state laws in Hawaii pertaining to “office use’ for sterile and non-sterile compounding? Can 

pharmacies in Hawaii compound preparations in advance that prescribers can use in their office without a patient-specific prescription for either (or both) sterile and non-sterile compounds?

2. Has Hawaii recently amended their laws so that compounding pharmacies may
help with the drug shortage crisis?

Mr. Inafuku stated that HRS 461-15 under the miscellaneous permit, (a)(6) states, “For any person, as 

principal or agent, to conduct or engage in the business of preparing,manufacturing, compounding, packing, 

or repacking any drug without first obtaining a permit from the board to do so;”.

The Vice Chair stated that pharmacies may not compound a product unless they have a patient specific 

prescription.

Mr. Inafuku stated that a miscellaneous permit holder who compounds will still be subject to FDA 

requirements.

The Vice Chair stated it’s compounding vs. manufacturing. A compounded product is
manufacturing but a pharmacist may compound a product pursuant to a pahent specific prescription and that compounding for office use is considered manufacturing.

That was the consensus of the Board.

These board minutes can be found here.

Missouri Board of Pharmacy Statement on Compounding Hyroxyprogesterone Caproate

In the August 2012 newsletter of the Missouri Board of Pharmacy the Board issued the following Statement on Compounding Hydroxyprogesterone Caproate:

In June 15, 2012, Food and Drug Administration (FDA) issued a statement indicating it will apply its normal enforcement policies for pharmacies compounding hydroxyprogesterone caproate.  In line with the FDA’s statement, licensees are reminded that 20

CSR 2220-2.200(9) provides:

Compounding of drug products that are commercially available in the marketplace or that are essentially copies of commercially available Federal [Food and] Drug Administration (FDA) approved drug products is prohibited.

There shall be sufficient documentation within the prescription record of the pharmacy of the specific medical need for a particular variation of a commericially available compound.  Accordingly, licensees must have sufficient documenation of a specific medical need prior to compounding hydroxypogesterone caproate in the future.

The newsletter can be found here.

India, China plan to jointly oppose EU regulation on API at WTO forum

Joseph Alexander, New Delhi Monday, August 06, 2012, 08:00 Hrs  [IST]

India and China may together move the World Trade Organisation (WTO) against the European Union (EU) regulation on bulk drugs which may affect the current exports of Active Pharmaceutical Ingredients (APIs) from both the countries to Europe. EU has changed the rules for importing active substances into EU for medicinal products for human use and the amended regulation would come into effect fully by July 2013. It would make mandatory the current good manufacturing practices (cGMP) certificate from the local authority for all bulk drugs exports. To read the remainder of the article, click here.

Report from Gynecologic Practice and the Americian Society for Reproductive Medicine Practice Committee

To read the August 2012 report on Compounded Bioidentical Menopausal Hormone Therapy
from the Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee click here. 

U.S. attorney warns against copycat drugs

U.S. attorney warns against copycat drugs

First responders struggle with drug shortages | CapeCodOnline.com

First responders struggle with drug shortages | CapeCodOnline.com

China detains almost 2,000 in fake drug sweep

BEIJING | Sun Aug 5, 2012 9:02am IST

BEIJING (Reuters) - Chinese police have detained almost 2,000 people in a nationwide sweep on fake drugs, seizing more than $180 million worth of counterfeit products and destroying some 1,100 production facilities, the public security ministry said on Sunday. The operation, involving around 18,000 police officers, discovered fake or adulterated drugs purporting to deal with illnesses ranging from diabetes to high blood pressure and rabies, the ministry said in a statement on its website (www.mps.gov.cn).

To read the remainder of the article click here.

Texas launches online database to monitor prescription drugs | Local News | News from Fo...

State launches online database to monitor prescription drugs | Local News | News from Fo...

EU's newly-changed rules on cGMP certificate for bulk drug exports may hit Indian exports

To read this article written by Joseph Alexander, New Delhi on July 31, 2012, click here.

Doing Business in China - Considerations for Effectively Leveraging Emerging Markets

The U.S. economic slowdown and the Eurozone debt crisis have created pressure in the pharma industry that shows no signs of relenting. Yet, with the global pharma market forecasted to languish in single digit growth, emerging markets such as Brazil, China, India, Mexico, Russia and Turkey anticipate double digit growth nearing 14 percent through to 2014. 1
It is clear that China and other emerging markets are set to occupy an expanding share of pharma’s geographical portfolio. Of these, China has emerged as central to many U.S. pharma strategies. According to a recent market analysis by IMS, the compound annual growth rate of the Chinese pharmaceutical market over the next five years will be 23.2 percent. Growth has been rapid: China is on course to become the world’s third-largest prescription medicines market, after the U.S. and Japan. 2

To continue reading this article published August 1, 2012, click here.

Business Line : Companies News : Shasun Pharma Q1 net doubles; to pay 20%

Business Line : Companies News : Shasun Pharma Q1 net doubles; to pay 20%

Granules India cites rising China API and intermediates prices as Q1 driver

Granules India cites rising China API and intermediates prices as Q1 driver

Market Research Estimates European Active Pharmaceutical Ingredients (API) Market Growth at 6% CAGR Through 2017

To review this World News Article click here.

Cipla to set up API facilities

To read the article in the Economic Times, date August 5, 2012, click here.

First responders struggle with drug shortages | CapeCodOnline.com

First responders struggle with drug shortages | CapeCodOnline.com

K-V Pharmaceutical Files for Bankruptcy Protection

To read the article in Bloomberg Business week written by David E. Rovella on August 04, 2012, click here.

American Society for Pharmacy Law 2012--Session on Veterinary & Human Compounding

The American Society for Pharmacy Law 2012 Developments in Pharmacy Law Seminar XXIII in conjunction with National Alliance of State Pharmacy Associations, November 15-18, 2012 at Ventana Canyon Resort, Tucscon, Arizona, will include a session on Veterinary and Human Compounding. Click here for registration.  

PPT – "Veterinary Compounding" – PowerPoint presentation

PPT – "Veterinary Compounding" – PowerPoint presentation

Lubbock doctors sound alarm on deadly designer drugs - KCBD NewsChannel 11 Lubbock

Lubbock doctors sound alarm on deadly designer drugs - KCBD NewsChannel 11 Lubbock

Drug Manufacturing or Compounding?

Kyle Sampson, former DOJ lawyer, and Brian J.Wesoloski, of Hunton &Williams LLP have written a summary of the Franck's case that can be found here.   These attorneys represent former FDA officials who filed an amicus curiae brief in U.S. v. Franck's, which can be found here and at previous post.

Another Example of a Federal Prosecution Involving Compounded Drugs

Former Vice-President Of Pharmacutical Company Pleads Guilty To FDA Violations And Health Care Fraud

– Company received more than $2 million in payments from Medicare for misbranded, adulterated and contaminated inhalation medications

February 7, 2012

LOUISVILLE, KY – The former vice-president of National Respiratory Services, LLC (NRS) has pled guilty in United States District Court before Chief Judge Joseph H. McKinley, Jr., to charges of misbranding and altering drugs and to committing health care fraud announced David J. Hale, United States Attorney for the Western District of Kentucky.
Johnny Perry, age 62, of Mt. Washington, Kentucky, was indicted by a federal grand jury in Louisville on August 3, 2011. The five count indictment alleged that between June of 2006 and June of 2008, Perry, as vice-president of NRS, provided compounded medications to patients, but led both Medicare and the patients’ doctors to believe that the pharmaceutical company was providing non-compounded medications (FDA approved-commercially manufactured). Compounded medications are not FDA approved, but FDA regulations permit pharmacists to make compounded drugs, including prescription drugs, in limited amounts and under narrow circumstances, for particular patients, and at the direction of a physician when other available drugs cannot be prescribed.
The defendant, through the NRS Corporation submitted false and fraudulent claims to Medicare for the cost of FDA-approved, commercially manufactured, prescription inhalation drugs, when they were not. As a result of this conduct, NRS received approximately $2,030,343 in payments from Medicare to which they were not legally entitled.

It is further alleged that Ms. Perry, aided and abetted by others, from November 2006 through June 2008, misbranded inhalation drugs in that they contained false and misleading labeling that misrepresented the strength and potency of their active ingredients or the type of drug actually provided. During the same period it is alleged that Perry, aided and abetted by others, adulterated inhalation drugs in that the strength differed from what it was purported or represented to possess and that the drugs were contaminated and non-sterile.
“This case should send a clear message that offenses endangering public health will be vigorously prosecuted,” stated U.S. Attorney David J. Hale. “Misrepresenting the strength and potency of a prescribed medication and delivering contaminated products to patients are unconscionable crimes.”
“The Office of Inspector General is committed to protecting the health of patients covered by Medicare and Medicaid,” said Derrick L. Jackson, Special Agent in Charge of the U.S. Department of Health and Human Services in Atlanta, Georgia, “This company billed for medications that never should have been dispensed in the first place which created serious quality of care concerns.”
The maximum potential penalties are 46 years in prison, a $770,000 fine, and supervised release for a period of 3 years.
The case is being prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb and Assistant United States Attorney James Lesousky, and it was investigated by the Food and Drug Administration, Health and Human Services Office of Inspector General, United States Postal Inspection Service, and the Federal Bureau of Investigation.

Press Release Found here.

USFDA lifts import alert issued on Dr Reddy's Mexico facility

SME News, Saturday, Jul 28, 2012 12:46:31 PM IST

NEW DELHI: The United States Food and Drug Administration (USFDA), has lifted the import alert imposed at Quimicas Falcon de Mexico SA de C.V, Dr Reddy's chemical manufacturing facility at Cuernavaca, Mexico.

To read the remainder of the article, click here.

Proctor and Gamble joins with Israeli gaint to set up two manufacturing facilities in India

P&G Teva to join hands for manufacturing two facilities in Gujarat

SME News, Wednesday, Aug 1, 2012 14:30:28 PM IST

MUMBAI: US-based Proctor & Gamble and Israeli generic giant, Teva Pharmaceutical Industries are planning to join hands and set up two manufacturing facilities in Sanand in Gujarat, India soon. Its one pant will make allopathy drugs and other will be responsible for producing Ayurveda medicines.

 

To read the remainder of the article click here.

Karnataka Pharmacists to start 'India Pharma Revolution'

Karnataka Pharmacists to start 'India Pharma Revolution'

KV Pharma CEO Gets Hefty Raise, Despite All The Problems

Ed Silverman, Contributor, For Forbes Magagzine, has written an article entitled, KV Pharma CEO Gets Hefty Raise, Despite All The Problems. To read this article click here.

Model Act Amended to Stay at Forefront of Pharmacy Practice Regulations

From the NABP website found here

August 01, 2012 04:42 PM

NABP recently amended the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) in its effort to assist the boards of pharmacy as they work to protect the public health. The Model Act was amended by increasing security provisions for pharmacies, adding Model Rules for medical gases, updating electronic prescribing language, and adding language intended to help improve quality and safety in patient care. These changes were incorporated as a result of the Executive Committee-approved recommendations of the Task Force on the Control and Accountability of Prescription Medications and the Committee on Law Enforcement/Legislation. The Model Act is available for download in the Members section of the NABP Web site.

Why-off-Label Pharmaceutical Speech Will Find Its Voice

The Houston Law Review features a comment written by a student entitled  Central Hudson Plus:  WHY OFF-LABEL PHARMACEUTICAL SPEECH WILL FIND ITS VOICE.  To read the comment click here.

SC to fight lawsuit over pre-term birth drug

By: Robert Kittle | WSPA-TV
Published: August 01, 2012 Updated: August 01, 2012 - 10:12 PM

» Comments | Post a Comment

COLUMBIA, SC -- South Carolina's Department of Health and Human Services is vowing to fight a lawsuit filed against it by a pharmaceutical company. K-V Pharmaceutical has also filed separate lawsuits against Georgia and the U.S. Food and Drug Administration.
Regardless of the outcome it will cost state taxpayers money, either in the cost of defending the lawsuit or in added Medicaid costs. A spokesman for DHHS says the agency doesn't have an estimate for how much the lawsuit may cost.
The lawsuit is about a drug given to pregnant women to prevent pre-term births. Since 2005, South Carolina has been using a generic version of the drug known as 17P. It's actually a hormone, hydroxyprogesterone caproate.
According to DHHS, "The use of compounded 17P is accepted by doctors as a safe and effective therapy to fight prematurity, and since 2005 SCDHHS has worked closely with physicians statewide to make it readily available to women at risk of pre-term births. SCDHHS, the March of Dimes, the SC Chapter of the American College of Obstetrics and Gynecology and the South Carolina Hospital Association are working together through the statewide Birth Outcomes Initiative to actively promote the use of 17P."
But K-V Pharmaceutical is suing, arguing that South Carolina and Georgia should be using only its version of the drug, named Makena. In a release, the company says, "In certain states, Medicaid participants, in particular, have been denied access to the only FDA-approved medication for their condition - despite the clinical judgment made by many healthcare providers that FDA-approved Makena® is the appropriate choice for their patients, and despite FDA’s repeated statements that Makena® offers greater assurance of safety and effectiveness than compounded 17P formulations."

To continue reading article click here.

Oregon Board of Pharmacy FAQ and Answers about Compounding

The Oregon Board of Pharmacy website contains frequently asked questions about compounding.  The Board also supplies the answers, which is a terrific idea to educate pharmacists and the public and to ensure more compliance with the rules and regulations in Oregon.  The questions and answers can be found by clicking here or by reading below:


FAQ for Division 45
1. Do I need to follow the rules set forth in division 45 if I do simple compounding (like magic mouthwash or mixing 2 creams) in my retail pharmacy?
OAR 855-045-0200
No. Simple and infrequent compounding using non-sterile commercial components to fill a single prescription for a non-sterile product is classified as Category 1 compounding. The Board states that Category 1 compounding is not considered compounding for all intensive purposes.
2. When does category 1 compounding become category 2?
When the compounding becomes complex (multiple ingredients, etc…), requires complex calculations, a scale is needed to weigh ingredients, if it requires alterations of the original dosing form (making capsules, etc…), or changes in the route of administration (making suppositories, etc…). Any of these requirements would result in a compound that is no longer classified as category 1.
3. Can you make a compound without a prescription?
OAR 855-045-0200
You may compound a reasonable amount of drug product without a prescription, but you must be anticipating prescriptions for what you are compounding or you must be distributing the product under the Shared Pharmacy Services agreement (as defined in OAR 855-006-0005).
4. Does division 45 apply to nuclear pharmacies?
OAR 855-045-0200
No. Radiopharmaceuticals have their own guidelines and are exempt from division 45. For information on nuclear pharmacies see division 19 and 42.
5. If compounding a non-sterile product, do I need to comply with division 45?
Yes. Division 45 applies to sterile and non-sterile compounding, unless the compound is classified as category 1.
6. Does division 45 incorporate USP chapters 797 and 795 rules?
No. The Board doesn’t require strict application or adherence to all USP 795/797 guide-lines. It is expected that appropriate guidelines be followed based on individual settings.
7. What does CSP stand for?
OAR 855-045-0210
Compounded Sterile Preparation. It incorporates anything compounded in an IV room (prepared sterile products under manufacturers’ guidelines in an environment with possible exposure to contamination) or preparing with non-sterile components and devices that must be sterilized before administration.
8. What are the training requirements for compounding in division 45?
OAR 855-045-0220
The PIC is responsible for training, testing, and assessing all employees involved in sterile and non-sterile compounding. The PIC must also implement policies and procedures for employees to follow that are reviewed at least annually. This includes a verification procedure for pharmacists to determine correct drug, dose, form, calculations, and label. For low to medium risk compounding retesting aseptic skills must occur at least annually and retesting for high risk compounding must occur at least semi-annually. Records must be kept to demonstrate training and testing.
9. Are we allowed to compound anything the doctor prescribes?
OAR 855-045-0230 and 855-045-0240
No. You may not compound products that are commercially available, unless the Board has given prior approval to compound a commercially available product that is temporarily in short supply/unavailable. For parenteral products a commercially available product may be compounded if there are multiple companies that provide the mixture (ex. KCl premixed IV bags) or if the premix IV admixture is commercially available as well as the premixed IV bags (ex. Using a commercially available vial of medication to make an IV bag, even though there is a commercially available premixed IV bag).
10. Are there specific policies and procedures for the compounding pharmacy?
OAR 855-045-0230 and 855-45-0270
If a pharmacy participates in compounding, the PIC must ensure that there are policies and procedures that provide at least the following: an organized index, product formula information, log book, conditions and surveillance of the compounding environment, compounding procedures and requirements, training requirements for all staff, cleaning, QA plan with a BUD (Beyond Use Date/expiration date), product labeling, shipping and delivery procedures, pharmacist final verification, and safety procedures. IV admixtures made for a specific patient does not need to comply with the worksheet or log book requirements if it can still be tracked for recall purposes. The pharmacy must keep records on site and organized for 3 years.
11. What additional policies and procedures are required for sterile compounding?
OAR 855-045-0230
You must follow the requirements described in question 10, but also ensure an appropriate BUD with end product testing and random sampling of the environment and CSPs when it’s appropriate. The PIC needs to have a QA plan in writing with records requiring the cleaning, testing and calibration of all equipment.
12. Do I need to perform random end product testing?
OAR 855-045-0230
It depends, if you are mixing high level CSPs or wish to extend the BUD, you would be required to perform end product testing. The BUD must not exceed USP 797 guidelines unless quality is verified by end product testing.
13. Are there any requirements for purchasing bulk chemicals?
OAR 855-045-0230
Bulk chemicals need to be purchased from an outlet registered by the Board. The bulk chemicals must also have a certificate of analysis and labeling that shows the date obtained and the BUD. The BUD cannot be greater then 5 years from opening, unless tested to extend the BUD by no more then 1 year.
14. What needs to be on the label of sterile parenteral products?
OAR 855-045-0240
The labeling requirements include all of the regular items (patient name, etc…), but also require the following: Rate of infusion, BUD, storage requirements, ingredients information (name, quantity and concentration of all ingredients), and hand written initial of pharmacist who verified it.
15. Can I reassign a parenteral admixture to another patient?
OAR 855-045-0240
Yes, as long as it has been stored properly and the BUD has not lapsed.
16. What defines low risk conditions?
OAR 855-045-0250
An ISO Class 5 environment or better, no more than three commercially manufactured sterile products placed in 1 container, and limited manipulations
17. What is the expiration date of low risk sterile preparations?
OAR 855-045-0250
Without sterile testing; at room temperature the BUD can be up to 48 hrs, under refrigeration the BUD is up to 14 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.
18. What defines medium risk conditions?
OAR 855-045-0250
These conditions meet the same conditions as low risk conditions and include 1 or more of the following; multiple sterile products are combined, will be administered to multiple patients, will give to one patient multiple times, requires complex aseptic manipulations, and a long duration to compound.
19. What is the expiration date of medium risk sterile preparations?
OAR 855-045-0250
Without sterile testing; at room temperature the BUD can be up to 30 hrs, under refrigeration the BUD is up to 9 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.
20. What defines high risk conditions?
OAR 855-045-0250
CSPs are classified as high risk for any of the following reasons: compounded from non-sterile ingredients (manufactured products intended for other routes of administration) or a non-sterile device is used before terminal sterilization. If exposure to an environment that does not meet ISO 5 for greater than 1 hour and the product lacked effective antimicrobial preservatives. If the non-sterile procedures (mixing or weighing) occurred in an environment that does not meet ISO 7 or personnel is improperly gloved or gowned. If water containing preparations are stored for more then 6 hours.
21. What is the expiration date of high risk sterile preparations?
OAR 855-045-0250
Without sterile testing; at room temperature the BUD can be up to 24 hrs, under refrigeration the BUD is up to 3 days and under frozen conditions (-20 degrees C) the BUD is up to 45 days.
22. What are the requirements of an immediate use sterile preparation?
OAR 855-045-0250
It is classified as a low risk compound provided: It doesn’t contain hazardous material, the compound has less then 3 sterile ingredients, involves simple manipulations, is completed in one sitting, and will be administered within the hour. They can be prepared in the following conditions; must use aseptic manipulation, use sterile ingredients and devices, but does not need to meet ISO 5 conditions and does not need to wear gloves or gown.
23. What are the requirements for same day use sterile preparations?
OAR 855-045-0250
The compounded product must be administered within 24 hours of preparation. The compound may be classified as low or medium risk classification if it is prepared using sterile ingredients and devices and has ISO 5 or better environment. Other environmental requirements are a mixing cabinet with restricted air flow, a partitioned area around the cabinet (“buffer zone”) that is clearly identified and the area is cleaned daily with low particle counts and free of cardboard boxes/clutter. Preparations must be completed in 1 sitting, may not exceed 8 CSPs per batch, use gloves, appropriate gown and mask with hair and shoe covers, and single dose ampoules are not reused.

Pharmacist Impersonator, Allen Gregory Schleicher, a/k/a Gregory Klonowski Pleads Guilty to Mail Fraud, Identity Theft, and Money Laundering

PRESS RELEASE: 

Posted by FREDERICA CADE ⋅ July 30, 2012⋅ 

U.S. Attorney’s Office
July 24, 2012
Middle District of Florida
(813) 274-6000
Pharmacist Impersonator Pleads Guilty to Mail Fraud, Identity Theft, and Money Laundering
ORLANDO—Allen Gregory Schleicher, a/k/a Gregory Klonowski, (49, Ruskin) pleaded guilty today to mail fraud, aggravated identity theft, and money laundering. Schleicher faces a maximum penalty of 20 years in federal prison for the mail fraud charge, 10 years in federal prison for the money laundering charge, and a mandatory minimum mandatory of two years’ imprisonment, consecutive to any other sentence, for the aggravated identity theft charge.
According to the plea agreement, in September 2000, Schleicher fraudulently obtained a pharmacist license from the Florida Department of Health by using the name, date of birth, Social Security number, and pharmacy education of another individual (hereinafter referred to as “A.R.S.”) who was a licensed pharmacist. Between September 2000 and July 2009, Schleicher worked as a pharmacist in Central Florida. During that time, he submitted periodic renewals of the pharmacist license belonging to A.R.S. and received paychecks from pharmacies through the mail. Schleicher used the proceeds of his fraudulent conduct to purchase the property located at 1829 Raven Glen Drive in Ruskin, Florida, and, in his plea agreement, agreed to forfeit the property to the United States. Schleicher also admitted that, in 2004, he changed his legal name to Allen Schleicher by fraud.
This case was investigated by the Federal Bureau of Investigation and the Drug Enforcement Administration, with assistance from the Florida Department of Health’s Division of Medical Quality Assurance. It is being prosecuted by Assistant United States Attorney David Haas.

Franck's Pharmacy closes its doors

By Carlos E. Medina
Correspondent

Published: Tuesday, July 31, 2012 at 11:05 a.m.

Last Modified: Tuesday, July 31, 2012 at 11:05 a.m.

The retail location of Franck's Pharmacy closed its doors Tuesday, bringing an end to Paul Franck's connection with his namesake operations.
To continue reading article click here.