FDA Continues To Take Strong Action During Inspections

http://www.pharmalot.com/2012/07/fda-to-meet-sanofi-execs-over-vaccine-plants/

K-V Announces Additional Notification From NYSE Regarding Listing Criteria

http://www.biospace.com/company_profile.aspx?CompanyId=2299

Warning Letter Issued to Brunner Farms

Department of Health and Human Services Public Health Service Food and Drug Administration   Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7133 FAX: (612) 334-4142   July 12, 2012     WARNING LETTER     CERTIFIED MAIL RETURN RECEIPT REQUESTED                           Refer to MIN 12 - 38     Clyde J. Brunner Owner Brunner Farm 4757 Algoma Road New Franken, Wisconsin 54229   Dear Mr. Brunner:   On April 3 and 10, 2012, the Food and Drug Administration (FDA) conducted an investigation of your livestock operation located at 4757 Algoma Road, New Franken, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.    Our investigation documented that you sold prescription veterinary drugs, such as dinoprost tromethamine, dexamethasone, ceftiofur hydrochloride, and flunixin meglumine, without a written prescription or oral order from a licensed veterinarian. Under section 503(f)(1)(C) of the FD&C Act, the dispensing of a prescription drug other than by or upon the lawful written or oral order of a licensed veterinarian results in the drug being misbranded.   In addition, the prescription drugs that you sold/dispensed are misbranded within the meaning of section 502(f)(1) of the FD&C Act because they lack adequate directions for use. Pursuant to Title 21, Code of Federal Regulations, section 201.5, “adequate directions for use” means adequate directions under which the layman can use a drug safely and for the purposes for which it was intended. Such adequate directions for use by laypersons cannot be written for prescription drugs because the drugs can only be used safely at the direction of, and under the supervision of, a licensed veterinarian.   You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.    Our investigation also revealed that you are not keeping complete drug treatment records and that you lack an adequate drug inventory system. Our investigator provided examples of drug treatment and inventory forms to you. In your affidavit dated April 10, 2012, you stated that you would review the forms and try to implement them.   You should notify this office in writing of the steps you have taken to bring your operation into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.   Your written response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.   Sincerely, /S/  Michael Dutcher, D.V.M. Director Minneapolis District     xc:   (b)(4)   Robert Ehlenfeldt, D.V.M. State Veterinarian Wisconsin Department of Agriculture Division of Animal Health P.O. Box 8911 Madison, Wisconsin 53708-8911 - - Page Last Updated: July 25, 2012 Letter is found at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm312617.htm

Many Drugs Remain Legal After "Bath Salts" Ban by THE ASSOCIATED PRESS

http://www.npr.org/templates/story/story.php?storyId=157345017

Hospitals and Health Professionals Ask FDA to Comply With Court Order and to Evaluate Medically Important Antibiotics in Animal Food | Government News

Hospitals and Health Professionals Ask FDA to Comply With Court Order and to Evaluate Medically Important Antibiotics in Animal Food | Government News

Credit Bubble Stocks: Memorandum in Support of FDA's Motion to Dismiss in K-V Pharma Lawsuit ($KV)

Credit Bubble Stocks: Memorandum in Support of FDA's Motion to Dismiss in K-V Pharma Lawsuit ($KV)

Update on Changes to Regulations in California Relating to Compounding

The 15-day comment period for the proposed changes to compounding regulations in California expires July 30, 2012.  The notice of proposed action can be found here.  The proposed Compounding Self-Assessment Form can be find here.  The Initial Statement of Reasons for the Changes can be found here.  The notice of modified text can be found here.  The modified proposed language can be found here.

Prior post on changes to California regulations relating to compounding can be viewed here.

Mississippi State Board of Pharmacy In Process of Revising Regulations

The Mississippi State Board of Pharmacy website indicates that the board is in the process of updating its current regulations.  This appears to include the regulations relating to compounding in Mississippi.  Notice of future changes can be viewed here.  Check back to this blog for future changes in Mississippi Pharmacy Law.


Also note that changes in the Pharmacy Practice Act and Regulations (effective January 1, 2012) require the pharmacist-in-charge of all non-resident pharmacies be licensed as a pharmacist in the State of Mississippi. In addition, all non-resident pharmacies and wholesalers are required to obtain a Mississippi Controlled Substance Registration issued by the Board.  See MS Senate Bill 2455 .

Instruction and Form for Filing for Application for Sterile Compounding Pharmacy Licence in Califorinia

The form for filing for application to compound injectable sterile drug in California is found here.  The form details who may compound injectable sterile drug products in California:

A pharmacy that is specially licensed with the board as a sterile compounding pharmacy, or a pharmacy that is operated by an entity that is licensed by the board or the State Department of Health Services and has a current accreditation from the Joint Commission on Accreditation of Healthcare Organizations or another accreditation agency approved by the board. The following private accreditation agencies have been approved by the board:

Accreditation Commission for Health Care, Inc. (ACHC) through February 2014,

Community Health Accreditation Program (CHAP) through February 2014,
Det Norske Veritas (DNV) through July 2013,
Pharmacy Compounding Accreditation Board (PCAB) through February 2014, or
American Osteopathic Association Healthcare Facilities Accreditation Program
(HFAP) through February 2014.

The form explains that "[a} license to compound injectable sterile drug products may not be issued until the location is inspected by the board and found to be in compliance with Article 7.5 of
Chapter 9, of Division 2 of the Business and Professions Code and regulations adopted
by the board."  The form also contains the following warning:  "All pharmacies that compound injectable sterile drug products must follow board regulations for sterile compounding. These regulations are found in Title 16 of the California Code of Regulations as Article 8, beginning with section 1751."  A $600 fee is required with the application.  Both a state and federal background check are required.  

Indian API production takes hit as APPCB shuts 12 plants

Indian API production takes hit as APPCB shuts 12 plants