The Law of Compounding Medications And Drugs

Saturday, August 25, 2012

The Center For Drug Evaluation And Research (CDER) is responsible for warning letters used for pharmacy compounding issues. See the July 2012 Regulatory Procedures manual found here. The manual provides the following information guidance:

The Compliance Management System (CMS) is now being used for electronic submission of Warning Letter recommendations from district offices. All recommendations by the district offices must use CMS for submitting the proposed Warning Letter, the FDA 483 supporting alleged violations, the EIR, and any written response by the firm. For any questions, or if you need to submit a document as a hardcopy, the CDER contact is: Director, Division of Domestic Drug Quality, 301-796-3255, fax 301-847-8743. Also, see Exhibit 4-1, the agency’s “Procedures for Clearing FDA Warning Letters and Untitled Letters.” All agency components responsible for issuing Warning Letters and Untitled Letters must follow these procedures.

FDA Division of New Drugs and Labeling Compliance

The FDA Regulatory Procedures Manual Dated July 12 (found here) defines the responsibilities of the Division of New Drugs and Labeling Compliance. Note that number 7 and 8 appear to be identical.

1-4-2 Division of New Drugs and Labeling Compliance
The division’s primary responsibility is to protect the public health by ensuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act as it relates to over-the-counter (OTC) drugs, prescription (Rx) drugs, and drugs falling within the health fraud program area.
The division consists of five teams, the Over-The-Counter Drugs Team, the Internet and Health Fraud Team, the Pharmacy Compounding Team, the New Drugs and Labeling Team, and the Import-Export Team. The functional statements for the Division of New Drugs and Labeling Compliance are:
1. Protects the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug, and Cosmetic Act as it relates to over-the-counter (OTC) drugs, prescription (Rx) drugs, and drugs falling within the health fraud program area;
2. Develops compliance strategies, programs and policy guides to ensure that all OTC and Rx drugs marketed in the United States are properly labeled and meet applicable new drug requirements and to remove from the market fraudulent drug products that pose direct or indirect public health risks;
3. Maintains the integrity of imported drug products by assuring their compliance with applicable legal requirements;
4. Provides guidance and consults on export policies and procedures;
5. Directs field inspections and investigations and recommends, directs and/or coordinates case development and compliance actions regarding OTC, Rx, and health fraud drug products;
6. Provides enforcement and litigation support and guidance for OTC, Rx, and health fraud drugs, including support for State Attorney General and Office of Criminal Investigation cases;
7. Develops legislative proposals, implementing regulations, policy, and guidance documents; enforcement strategies; and outreach activities relating to pharmacy compounding;
8. Develops legislative proposals, implementing regulations, policy and guidance documents, enforcement strategies, and outreach activities relating to pharmacy compounding;
9. Monitors the Internet in support of division enforcement initiatives, actions and outreach programs; and,
10. Prioritizes unapproved drugs identified for regulatory action using risk based assessment and develops compliance strategies to address the most significant legal violations.

Medical Products Promoted Through Social Media: FDA to Issue Guidance

This article is found here.

A customer loads Pfizer's Facebook page and leaves a comment on a wall post asking about an off-label use of one the company's products. How should the pharmaceutical company respond, if at all? That issue is one of the many topics to be addressed in guidance the Food and Drug Administration is required to issue within two years. Section 1121 of the Food and Drug Administration Safety and Innovation Act (S. 3187), signed into law by President Obama on July 9, tasks the agency with issuing guidance on its policy "regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration." The forthcoming guidance is essential for the current generation. The developing social media and internet media are different from broadcast and print. They reach a global audience, can exist indefinitely,and are an active dialogue between people.The most contentious issue will be how companies should respond to off-label questions posed on social media platforms. Almost everyone objected to the FDA's stance in a December 2011 draft guidance that companies respond privately to any question on social media that addressed off-label uses.

The FDA had noted that it may be true "that the original, unsolicited off-label question may have been available to a very broad audience." Nonetheless, "the firm should not make its detailed response with off-label information publicly available within the same forum." The issue is important because federal law only permits companies from promoting a drug or medical device for uses that have received FDA clearance. The FDA also has not been hesitant to issue warning letters to companies it believes have engaged in improper off-label communications through social media.

Draft guidance.

FDA Looking to Overhaul Compliance Approach

Visit www.drugregulations.org for the latest in Pharmaceuticals.

An article published in Regulatory Focus gives FDA's latest thinking on the relationship between Compliance and Quality.

In a presentation to the Regulatory Affairs Professionals Society's (RAPS) San Francisco membership chapter on 27 July 2012, Roh, regional food and drug director for FDA's Pacific Region, said the US Food and Drug Administration (FDA) is heading towards a significant change in compliance policy in the coming years. This is a result of rapidly surging imports of pharmaceutical, medical device and biologics products. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies.

The rate at which products were being imported from overseas manufacturing facilities was fast outstripping FDA's ability to effectively exercise oversight. Some of the largest US trading partners are projected to experience enormous growth trends in imports, Roh said in his presentation. China in particular is expected to experience a 426% growth in exports by 2020, while India (+465%) and Mexico (+159%) are projected to exhibit similar percentage increases, though on a smaller overall scale. This could have huge ramifications for the US, which already imports approximately 10% of all products regulated by FDA. The US is expected to see growth rates between 5% and 8% during most years, with estimations going as high as 15% during some years.

To read rest of this article, click here.

GSK to close Indian API plant and turn to third-party contractors

FDA readies for GDUFA-driven surge in supply chain data

August 24, 2012

By Nick Taylor

The FDA has posted draft guidance to prepare for a GDUFA-driven surge in data on the generic drug supply chain. And it is a familiar scenario, with the FDA drawing heavily on the 2009 electronic drug registration and listing guidance.

Friday, August 24, 2012

Compounders Sent Letters Regarding Prascend (Pergolide)

IACP is reporting that it has become:

aware of letters being sent to compounders by Boehringer Ingelheim about their product Prascend (pergolide). The manufacturer cautions all pharmacists that any compounding of pergolide for veterinary use must only be done using their finished drug product and not the active pharmaceutical ingredient (API). If you’ve received that letter and want to know the specifics, contact us at iacpinfo@iacprx.org

To read more information on the IACP website, click here

Denver Pharmacy To Pay $87,500 In Settlement - Topix

U.S. appeals court strikes down FDA tobacco warning label requirement

August 24, 2012 12:19 PM(CBS/AP)

Today, the U.S. Court of Appeals in Washington upheld a decision barring the federal government from requiring tobacco companies to put large graphic health warnings on cigarette packages to show that smoking can disfigure and even kill people. Although not a compounding decision, this case is a significant decision relating to the FDA and warning labels. To read more about this case, click here.

Thursday, August 23, 2012

Cutting the red tape: Is the FDA a threat to patient health? - Pharmaceutical Technology

Cutting the red tape: the FDA responds with exclusive interview - Pharmaceutical Technology

FDA investigators, state inspectors, compliance officers attend training on animal compounding

Reminder (as previously posted on blog) that training was taking place this week (ends today at noon) by FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in inspections of animal drug compounding pharmacies and veterinarians’ extra label drug use in food producing animals or review or take compliance action on these inspection reports.

COURSE DESCRIPTION / OBJECTIVES:
This course is intended to instruct field investigators on the laws, regulations and policies pertaining to compounding of animal drugs and the Animal Drug Use Clarification Act related to the extra-label drug use in animals. Compounding of animal drugs has increased exponentially in the last few years. Certain compounding practices undermine the animal drug approval process, and present unknown and potentially hazardous risk to animal and human health. Animal drug compounding is addressed in various laws, regulations, and policies. In order to adequately assess violations of concern, investigators need to understand the laws, regulations and policy that distinguish animal from human drug compounding. Extralabel drug use practices may especially result in violative food animal tissue residues. Investigators need to understand under what circumstances extra-label drug use can or cannot be utilized in veterinary medicine.

For Source see here.

SC company guilty of wholesaling $55 million in stolen drugs

August 21, 2012 | By Eric Palmer

Federal authorities have caught up with a drug wholesaler who bought more than $55 million worth of stolen drugs, put them back into the legitimate supply chain, then falsified "drug pedigrees," to try and hide the scheme. The case is another in a series of arrests or convictions as it continues to press on cargo theft and warehouse crimes.

Altec Medical has been sentenced to pay a $2 million fine and forfeit $1 million after it was found buying the illegally obtained drugs, the FDA reports. Federal authorities say when the Easley, SC-based company bought the prescription medications from William D. Rodriguez, it knew he was fencing them from parties that obtained them illegally. Altec has also been placed on a year's probation.

Read more: SC company guilty of wholesaling $55 million in stolen drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/sc-firm-guilty-wholesaling-55-million-stolen-drugs/2012-08-21#ixzz24NXn4hmu
Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

US FDA pulls 27 ANDAs for drugs made at banned Ranbaxy plants

Indian court puts off Novartis patent hearing to Sept. 11 Read more: Indian court puts off Novartis patent hearing to Sept. 11 - FiercePharma http://www.fiercepharma.com/story/indian-court-puts-novartis-patent-hearing-sept-11/2012-08-22?utm_source=rss&utm_medium=rss#ixzz24NU62Afy Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma

August 22, 2012 | By Tracy Staton

India's top court won't start the big Novartis ($NVS) patent argument today as scheduled. In just the latest delay in the closely watched case, the hearing was postponed to Sept. 11.

Read more: Indian court puts off Novartis patent hearing to Sept. 11 - FiercePharma http://www.fiercepharma.com/story/indian-court-puts-novartis-patent-hearing-sept-11/2012-08-22?utm_source=rss&utm_medium=rss#ixzz24NULbaV8

Expert: Manufacturers in Two Indian States More Likely to Produce Substandard Drugs

Drug manufacturers in the Indian states of Haryana and Uttar Pradesh are more likely to produce substandard or falsified drugs than those in more regulated Indian states, an expert says. . . .

To read the remainder of this article, click here (note you must be a member PharmaSupplyChain.com)

SecuringPharma - AmerisourceBergen subpoenaed in diversion probe

Profiting From Pills: Should Doctors Dispense? // Pharmalot

Teva Gets Subpoena Over Foreign Bribes Probe // Pharmalot

Wednesday, August 22, 2012

FDA Enforcement Report - Week of August 22, 2012

This report contains an overwhelming number of drug recalls from Franck's Pharmacy, which has closed its door (see previous post). All recall drugs contain the following reason for the recall:

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

To view the report with the list of drugs, click here.

Center for Drug Evaluation and Research CDER Goals

FDA Goals for the Center for Drug Evaluation and Research CDER for FDASIA

One of the significant provisions in the recently enacted Food and Drug Administration Safety and Innovation Act (FDASIA) was the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V). John Jenkins, MD, Director of the Office of New Drugs (OND), in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) recently gave a presentation discussing PDUFA goals, trends in drug approval, and looking ahead....
To read the remainder of the Policy and medicine blog, click here.

Federal Legislation Needed to Stop Gray Market Wholesaler Activity Related to Drug Shortages - National Association of Boards of Pharmacy® (NABP®)

K-V v. Keck (State of South Carolina): K-V's Reply Memorandum in Support of Motion for Preliminary Injunction

To view the Reply Memorandum in Support of Motion for Preliminary Injunction, click here.
To view exhibit A (order of district court), click here.
To view exhibit B (supplemental declaration of Scott Goedeke), click here.
To view exhibit C (declaration of John H. Moore, M.D., CPI), click here.
To view exhibit D (declaration of Paula Rary), click here.
To view exhibit E (declaration of Alexander R. Smythe, II, M.D.), click here.
To view exhibit F (declaration of Paula E. Orr, M.D.), click here.
To view exhibit G (declaration of Myles D. Davis, M.D.), click here.
To view exhibit H (declaration of Deborah J. Davis, M.D.), click here.
To view exhibit I (second declaration of Thomas McHugh), click here.

K-V's Opposition to State of Georgia's Motion to Dismiss

To view K-V's Opposition to the State of Georgia's Motion to Dismiss, click here.

Reminder: Administrative Record is Due in K-V v. FDA on 8/29/2012

08/09/2012		MINUTE ORDER granting 20 Motion for Extension of Time to File Administrative Record. Defendants are ORDERED to submit the administrative record on or before August 29, 2012. Signed by Judge Amy Berman Jackson on 8/9/12. (DMK) (Entered: 08/09/2012)
08/09/2012		Set/Reset Deadline: The Administrative Record is now due by 8/29/2012. (jth) (Entered: 08/09/2012)

Franck's Answer to Complaint in Josephine Bienick Case

To view Franck's answer to Josephine Bienick complaint, click here.

Texas Lawmakers Struggle in the Fight Against 'Designer Drugs'

One drug — Makena — offers window into madness of health-care politics

FDA Clarifies Regulation on Carcinogenic Compounds Used in Food-Producing Animals

August 22, 2012

The Food and Drug Administration (FDA) today is announcing the publication of a final rule that implements certain technical amendments to the regulations on carcinogenic compounds used in food-producing animals (subpart E of part 500, title 21 of the Code of Federal Regulations). These amendments are intended to clarify certain provisions of the regulation, but do not alter the existing process for approving carcinogenic compounds.

In particular, this final rule revises the definitions of the terms “S_o” and “S_m”, terms used to express the concentrations of residues of carcinogenic concern in the total human diet and in specific edible animal tissues, respectively. The revisions are intended to emphasize that these terms primarily refer to the concentration of a residue of carcinogenic concern that represents no significant increase in the risk of cancer to the human consumer, rather than on the specific 1 in 1 million risk of cancer to the test animals approach.

FDA sought comment on these changes through a proposed rule published on December 20, 2010 (75 FR 79320). The Agency received few comments and the proposed revisions were finalized without change.

Under Section 512(d)(1)(I) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), known as the Delaney Clause, FDA cannot approve any compound for use in food-producing animals where the drug or its metabolites has been found to induce cancer in man or animals.

There is an exception, however, commonly referred to as the DES (Diethylstilbestrol) Proviso. The DES proviso carves out an exception to the Delaney Clause allowing cancer-causing compounds (or compounds with cancer-causing metabolites) to be used in food-producing animals if: 1) the drug does not harm the animal, and 2) tests approved by FDA do not detect residues of the drug in any food from the animal. The regulations under part 500 implement the DES Proviso.

To view source and to read more information, click here.

PowerPoint from FDA on API

PowerPoint Presentation on Importation of Active Pharmaceutical Ingredient (API)
Requirements, presented by Bill Nychis, Acting Team Leader, US FDA, Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Division of New Drug Labeling & Compliance (DNDLC),Import-Export Team and presented 7/16/08 New York API Seminar can be found here.

Import Alert 66-41

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-41

Published Date: 08/21/2012

Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.

Reason for Alert:

NOTE:
Revision to this Import Alert dated 10/19/2010 updates the language to the "Reason for Alert" and "Guidance" sections. Changes are noted and bracketed by three asterisks (***).

*** Unapproved drugs present serious safety and effectiveness concerns.

When evidence exists for the marketing or promotion of unapproved drugs to individuals residing in the United States, the products should be considered for detention without physical examination.

Evidence of marketing or promotion may consist of information contained in: solicitations for mail orders; press releases; internet websites; advertising materials; label indications of US patents or patent applications; or other public announcements directed to persons residing in the U.S. ***

REFERENCE:
Compliance Policy Guide (CPG) 120.500 (formerly 7150.10): "Health Fraud" Factors in Considering Regulatory Action" http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073838.htm

Regulatory Procedures Manual Chapter 9, Subchapter: "Coverage of Personal Importations" http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179266.htm

CHARGE:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]"
*** OASIS charge code: UNAPPROVED ***

When unaccompanied by labeling which makes drug claims, but other evidence attributable to the manufacturer, owner or consignee,*** importer of record, or end-user *** exists which establishes the product's intended use as a drug, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranded, Section 502(f)(1)]"
*** OASIS charge code: DIRECTIONS ***

RECOMMENDING
OFFICE:
Division of Import Operations and Policy (HFC-170)
Center for Drug Evaluation and Research, Office of Compliance (HFD-300)

Guidance:

*** Districts may detain without physical examination shipments of the unapproved and/or misbranded drugs listed in the attachments to this Import Alert.

Districts may detain shipments of unapproved and/or misbranded drugs which upon examination do not appear to comply with and/or which fail to meet the criteria for discretionary release found in the Regulatory Procedures Manual Chapter 9, Subchapter: "Coverage of Personal Importations".

Districts should contact CDER Import-Export Team before detaining any OTC product that appears to only meet the misbranding criteria and would therefore be detained on misbranding charges exclusively ***; or gives the appearance of not meeting a final OTC monograph; or may not, otherwise, be covered by FDA�s OTC Drug Review ***. When detaining products which appear to meet these Criteria are not listed in the attachment, districts should forward documentation to DIOP for consideration for inclusion in this alert.

Products subject to DWPE are generally not amenable to the use of enforcement discretion as indicated in RPM Chapter 9, Subchapter: "Coverage of Personal Importations" ***

SPECIAL NOTE:
Districts should continue to enforce, as appropriate, related import alerts restricting fraudulent, dangerous and commercial unapproved and/or misbranded drug importations.
.

Product Description:

Unapproved new drugs, *** Misbranded drugs ***

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]".

OASIS Charge Code - UNAPPROVED

*** When unaccompanied by labeling which makes drug claims, but other evidence attributable to the manufacturer, owner, or consignee exists which establishes the product's intended use as a a drug, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranded, Section 502(f)(1)]". ***

OASIS Charge Code - DIRSEXMPT

Source found here.

Tuesday, August 21, 2012

Pharmacy compounding or drug manufacturing?

Debarment of Responsible Corporate Officials is Affirmed by Court of Appeals

Debarment of Responsible Corporate Officials is Affirmed by Court of Appeals

Posted by David Restainoon August 01, 2012

A recent decision by a federal court of appeals emphasizes the responsibility of managers to ensure that persons within their control do not market prescription drugs for off-label uses. Anyone involved in compliance should take note.
The case relates to three corporate officers of Purdue Frederick Company, which was alleged to have “misbranded” OxyContin by marketing it as less addictive, less subject to abuse & diversion, and less likely to cause tolerance and withdrawal. Such misbranding violates the federal Food, Drug and Cosmetic Act. Among other extreme financial punishments, the officers received a 12-year exclusion from participating in federal health care programs by the Department of Health and Human Services (HHS). They appealed and – although not successful in overturning the debarment – the officers were successful in having its length remanded back to the lower court for further proceedings.

To read rest of blog click here.

CVM Updates FDA Solicits Comments Related to the Collection of Sales and Distribution Data of Antimicrobial Animal Drugs

Press Announcements FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium

FDA NEWS RELEASE

For Immediate Release: Aug. 21, 2012

Media Inquiries: Sarah Clark-Lynn 301-796-9110, sarah.clark-lynn@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

En Español

FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium

The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.

The FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the agency issued its first warning about the product on June 1, 2012. Other reports include liver injury, severe bleeding, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression.

Consumers who are taking these products or who have recently stopped taking Reumofan Plus or Reumofan Plus Premium should immediately consult a health care professional. Consumers should not buy or start using these products.

Ongoing FDA laboratory analyses of Reumofan Plus found that it contains the prescription drug ingredients:

dexamethasone – a corticosteroid, commonly used to treat inflammatory conditions, that can impair the body’s ability to fight infections and cause high blood sugar levels, bone and muscle injuries, and psychiatric problems. Dexamethasone can also cause adrenal suppression when taken for a prolonged period of time or at high doses. Sudden discontinuation of corticosteroids after long-term use or use at high doses can result in a withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood sugar levels, fever, dizziness, and muscle and joint pain.

diclofenac sodium – a non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines.

methocarbamol – a muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks, such as driving a motor vehicle or operating machinery.

A separate FDA lab analysis of Reumofan Plus Premium found that it contains two of the ingredients listed above, diclofenac sodium and methocarbamol.

Reumofan Plus and Reumofan Plus Premium are labeled in Spanish. However, versions of these products may also exist with English labeling.

The products are manufactured in Mexico by Riger Naturals and sold in the U.S. in some retail outlets, at flea markets, and on various popular Internet sites.

The hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium may interact with other medications and result in serious adverse events. Health care professionals are urged to ask their patients about use of Reumofan Plus, Reumofan Plus Premium, and other similar products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, psychiatric changes, or the use or abrupt discontinuation of corticosteroids.

Additionally, health care professionals should evaluate patients who have used Reumofan Plus and/or Reumofan Plus Premium for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate.

Health care professionals and consumers are encouraged to report any adverse events related to Reumofan Plus and Reumofan Plus Premium to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

online at www.fda.gov/Medwatch/report.htm;
by phone at 800-FDA-1088 (800-332-1088); or,
by returning FDA form 3500, available on the MedWatch “Download Forms” page by mail to the address on the pre-addressed form or by fax at 800-FDA-0178.

Texas AG Opinion Says Texas May Not Import Prescription Drugs from Canada

By Ronald L. Scott, J.D., LL.M.
rscott@central.uh.edu

To read Ronald Scott's article click here.

FAME-backed loan for $150,000to help compounding pharmacy in Maine expand

FAME-backed loan to help pharmacy expand

A Portland-based pharmacy is set to receive a $150,000 loan backed by the Finance Authority of Maine to expand its operations in the city.

Apothecary by Design LLC, a locally owned pharmacy with headquarters on Marginal Way, will use the funds to relocate its speciality department to nearby Preble Street while expanding its headquarters, according to theBangor Daily News.

The loan is facilitated by FAME, which approved 90% loan insurance on the $150,000 loan being offered by Bangor Savings Bank at an Aug. 16 meeting. This is not the first financing collaboration between the three entities; since 2008, FAME has offered loan insurance to FAME on Bangor Savings Bank loans a number of times, according to the Bangor Daily News.

The expansion will see a doubling in the size of the pharmacy's compounding lab. The company currently employs 38 people.

FAME also approved the re-advancement of funds on an existing loan to the pharmacy, as well as the renewal of an existing line of credit.

Founded in 1983, FAME is charged with supporting the growth of the state's business community. FAME offers an array of business assistance programs, including loan insurance, tax credits and financing programs.

UPDATE: Mass Pill Mill Indictments and Shutdowns Cut Local Crime

Monday, August 20, 2012

Alabama State Board of Pharmacy Amended Rules Effective August 27, 2012

The following rules have been amended:

1. 680-X-2-.08 PHARMACIST CONSULTANTS OF

PHARMACEUTICAL SERVICES

2. 680-X-2-.09 TRAINING FOR PRECEPTORS

3. 680-X-2-.16 PRACTICAL TRAINING PROGRAM

STANDARDS

4. 680-X-2-.19 PARENTERAL THERAPY

5. 680-X-2-.20 NUCLEAR PHARMACY

Rule Amendments found here.

Alabama Pharmacists, Techs, and Pharmacy Suspended and Fined in 2012

FEBRUARY ADMINISTRATIVE HEARINGS

Pharmacists:

JOSEPH LEX CORBITT, Pharmacist #7975

License and CS Permit SUSPENDED for 30 years; after 10 years may request a hearing to have SUSPENSION revert to PROBATION.

JAMES B. FOX, Pharmacist #11458

License and CS Permit SUSPENDED for 5 years; immediately reverted to PROBATION with conditions. Assessed administrative fine of $2,500.00 to be paid within 30 days.

ELIZABETH SHAW HARTFIELD, Pharmacist #14500

License and CS Permit SUSPENDED until April 28, 2018; immediately reverted to PROBATION with conditions. Assessed administrative fine of $2,500.00 to be paid within 30 days.

WILLIAM WOOD, JR., Pharmacist #7755

License and CS Permit SUSPENDED 5 years; immediately reverted to PROBATION. Assessed administrative fine of $2,500.00 to be paid within 30 days.

Technicians:

MALLORY ALLENA BEAN, Technician Registration #T28192

Renewal of Technician registration for 2012-2013 granted subject to terms and conditions for 2 years.

TAMMY BENNETT BEEGLE, Technician Registration #T00719

Assessed administrative fine of $250.00.

COURTNEY MCKNIGHT, Technician Registration #T21583

Technician Registration SUSPENDED; may apply to Board for a hearing to consider reversion to PROBATION if conditions met.

CHRISTY S. SANDERS, Technician Registration #T04371

Technician Registration REVOKED.

Extern/Intern:

SAIGE ELIZABETH KAUFMAN, Extern/Intern #10060

Permit shall be SUSPENDED during time she validly holds the same; with SUSPENSION reverting to PROBATION when conditions met.

JANUARY ADMINISTRATIVE HEARINGS

Pharmacists:

MELANIE G. BUTLER, Pharmacist #11513

License SUSPENDED 5 years; shall revert to PROBATION when conditions met. Assessed administrative fine of $6,000.00 to be paid within 90 days.

JOSEPH HAROLD GANDY, Pharmacist #7509

Shall pay $250 per month until total amount of $5,000.00 paid; shall be paid no later than 2 years; SUSPENSION shall continue until compliant with all other provisions of August 13, 1999 Consent Order.

RONALD JACKSON, Pharmacist #9802

License placed on PROBATION for 2 years; assessed administrative fine of $15,000.00 to be paid within 30 days.

GREGORY TODD LAMBERTH, Reciprocity Candidate

Upon satisfying all requirements, application is granted; however, license is SUSPENDED with immediate reversion to PROBATION until 3-2-2016 after conditions met; assessed administrative fine of $2,500.00 to be paid within 30 days.

DAVID RICHARD SCOTT, Pharmacist #10114

License and CS Permit SUSPENDED 20 years; shall immediately revert to PROBATION when conditions met. Assessed administrative fine of $3,000.00 to be paid within 60 days.

KAREN E. WESSON, Pharmacist #14615

License SUSPENDED until documentation is provided showing full compliance with her Board Order of June 14, 2011.

Technicians:

ANGELICA MARTINA BILLUPS, Technician Registration #T22221

Technician Registration REVOKED.

ERICA JONES HUBBARD, Technician Registration #T10585

Technician Registration SUSPENDED for 5 years; shall immediately revert to PROBATION when conditions met. Assessed administrative fine of $600.00 to be paid within 60 days; if fine not paid within 90 days, registration REVOKED.

MELONY KIMBREL MCCARTY, Technician Registration #T08367

Technician Registration REVOKED; Assessed administrative fine of $500.00 to be paid within 60 days.

SHADRECKA MURRAY, Technician Registration #T30652

Technician Registration REVOKED; assessed administrative fine of $6,000.00 to be paid within 60 days.

DEMETRICE MONTEZ WILLIAMS, Technician Registration #T26290

Technician Registration REVOKED; assessed administrative fine of $6,000.00 to be paid within 60 days.

Non-Resident Pharmacy:

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NY Times Reports: Horse Given Painkiller Breaks Down at New Mexico Racetrack

By WALT BOGDANICH and REBECCA R. RUIZ

Published: August 17, 2012

A horse that recently tested positive for a supercharged painkiller drawn from a type of South American frog broke down and was euthanized Thursday at a New Mexico racetrack after winning a trial heat for the coming All American Futurity, one of the world’s richest horse races.

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The horse, Jess A Zoomin, was one of eight New Mexico quarter horses that tested positive for the painkiller dermorphin on the same day in late May. All were running in an earlier round of trial heats to earn the right to advance to the Futurity, which has a purse of more than $2 million.

The dead horse’s trainer, Jeffrey Heath Reed, is accused of doping five of those horses. But he has been allowed to continue training — and vying to win the Futurity on Labor Day — after exercising his right to verify the state’s positive tests at a second laboratory.

A second horse that Reed trained, which had not tested positive for dermorphin, also broke down and was euthanized Thursday during another trial heat for the Futurity. Reed declined to comment.

Vince Mares, executive director of the New Mexico Racing Commission, expressed frustration at the length of time the lab is taking to report its dermorphin findings. “We do not have the authority to tell other labs to hurry up,” Mares said.

To date, 35 horses in four states — New Mexico, Oklahoma, Louisiana and Nebraska — have tested positive for dermorphin, the frog secretion that is said to be 40 times more powerful than morphine. Those results have strengthened the hand of racing industry figures who are pushing to lessen the influence of drugs, both legal and illegal, in racing. The dermorphin cases became the focus of a recent congressional hearing on drugs in racing at which all the witnesses called for lifetime bans for anyone found to have knowingly given horses performance-enhancing drugs.

New Mexico recently reformed how it regulates horse racing, including expanded drug testing, in response to an investigation by The New York Times, published in March, that found the state had the country’s most dangerous racetracks. On Labor Day weekend last year, one of the quarter horse industry’s most celebrated jockeys, Jacky Martin, broke his neck at the finish line when his mount collapsed with a broken leg. Martin remains paralyzed.

The Times also reported that the improper use of drugs was rampant at the state’s racetracks, as state racing authorities now acknowledge. Some trainers there were giving horses large overdoses of painkillers, often without fear of penalty.

The quarter horse industry has also been rocked this year by charges that a small group of horsemen had been laundering money through racehorses for two Mexican drug cartels.

Separately, in Kentucky, the state’s racing commission announced Wednesday that it had instituted safety measures aimed at identifying injured or at-risk horses after a rash of fatal breakdowns in May at the country’s most famous racetrack, Churchill Downs.

John Ward, the commission’s executive director, said racing officials have added an extra veterinarian to watch horses for any sign of injury as they walk off the track after racing.

Once horses are entered in a race, officials will examine their past performance charts in search of telltale signs of injury, such as pulling up or being transported off the track. They will also watch video replays of certain races and watch horses in training. Suspect horses would then be observed more closely.

“We are trying to get real-time knowledge of the condition of our equine athletes,” Ward said, adding that the new precautions seemed to be working because the number of fatal breakdowns at Churchill Downs dropped from eight in May to two in June.

As part of its investigation, The Times built its own database using similar telltale signs of injury to identify problem tracks, trainers and breeds. The paper also found that 24 horses die each week at America’s racetracks and that in one recent three-year period more than 3,800 horses had positive drug tests, mostly for illegally high levels of prescription drugs.

Prominent veterinarians say the overuse of pain medicine can mask injury, putting both horse and rider at risk.

Joe Drape contributed reporting.

A version of this article appeared in print on August 18, 2012, on page D1 of the New York edition with the headline: Deadly End for Horse That Tested Positive for Painkiller.