Florida Board of Pharmacy Draft of Minutes from February 11-12, 2014 Meeting--Includes Discussion Regarding Tech to Pharmacists Ratio and Sterile Compounding

Minutes (PDF)

Florida Board of Pharmacy Rules Committee Minutes From February 11, 2014 Meeting

Minutes (PDF)

Florida Board of Pharmacy Compounding Rules Committee Minutes From February 20, 2014 Meeting

Minutes (PDF)

Flordia Board of Pharmacy Compounding Rules Committee Agenda for February 10, 2014; Rules Committee Agenda on February 11, 2014 and Board Meeting February 11-12, 2014

February 10, 2014 Compounding Rules Committee The Florida Hotel & Conference Center 1500 Sand Lake Road Orlando, FL 32809Get Directions → (407)859-1500

Materials: FAW Notice (PDF) Agenda (PDF)

February 11, 2014 Rules Committee The Florida Hotel & Conference Center 1500 Sand Lake Road Orlando, FL 32809Get Directions → (407)859-1500

Materials: FAW Notice (PDF) Agenda (PDF)

Feb 11 - Feb 12, 2014 Board Meeting The Florida Hotel & Conference Center 1500 Sand Lake Road Orlando, FL 32809Get Directions → (407) 859 - 1500

Materials: FAW Notice (PDF) Agenda (PDF) Materials Deadline: December 20, 2013

Florida Board of Pharmacy Rule that became effective October 20, 2013 regarding compounding pharmacies

can be viewed here

Iowa Board of Pharmacy Takes on Franck's Compounding, Ocala, Florida

Franck's Compounding, Ocala, Florida, nonresident license #3385

The Board issued a Statement of Charges in June 2013 for failure to comply with Iowa rules and compounding requirements and failure to provide notice of pharmacy closing after the pharmacy closed and sold to another company as well as issued a nationwide recall of all sterile compounded products following several cases of fungal eye infections developed after use of its products. The Board approved a Settlement Agreement in August 2013 in which it issued a Citation and Warning, a $250 civil penalty and accepted the pharmacy's voluntary surrender of its license with the agreement that it won't apply for reinstatement for at least 10 years.      [2013]

Looks Well Worth Attending: Great Topics: American Society for Pharmacy Law Developments in Pharmacy Law Seminar XXIV November 14-17, 2013 Omni Amelia Island Plantation Amelia Island, Florida For Seminar information, click here to view the Registration Brochure. Earn up to 15 legal and pharmacy continuing education credits!

for schedule click here

Now Let's See How Florida (Home to Famous Franck's Pharmacy Fiasco) Compared to How the FDA found Florida's Compounding Pharmacies Where Doing

Anazaohealth Corporation, Tampa, FL

•  483 Issued 2/22/2013 (PDF - 857KB)
• Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL
  • Warning Letter (7/16/2013)
  • 483 Issued 3/15/2013 (PDF - 638KB)
     
  Balanced Solutions Compounding Pharmacy, LLC., Lake Mary, FL
• Firm News Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/17/2013)
• 
  The Compounding Shop St. Petersburg, FL
  • 483 Issued 9/3/2013 (PDF - 97KB)
  • Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (05/06/2013)
  • Amended 483 Issued 3/25/2013 (PDF - 10MB)
  • 483 Issued 3/22/2013 (PDF - 1.3MB)
  • FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (03/08/2013)
  • Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL
    • 483 Issued 3/21/2013 (PDF - 717KB)
    • Olympia Pharmacy, Orlando, FL
      • Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (05/29/2013) 
      • Wells Pharmacy Network LLC, Ocala, FL
        • 483 Issued 07/26/2013 (PDF - 1.1MB)

DEA Order dated September 8, 2013 Affirming Order of Immediate Suspension of Registration issued to S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding

view order here

Lowlite Investments Inc, doing business as Olympia Pharmacy in Orlando, Florida, has initiated a voluntary recall of all unexpired sterile drug products compounded by the pharmacy because of a lack of sterility assurance.

Lowlite Investments Inc, doing business as Olympia Pharmacyin Orlando, Florida, has initiated a voluntary recall of all unexpired sterile drug products compounded by the pharmacy because of a lack of sterility assurance.

"The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility," the company says in a press release posted May 29 on the FDAWeb site.

The affected product was compounded between December 17, 2012, and March 27, 2013. The recall includes all sterile products that Lowlite supplied to patients and offices of licensed medical professionals with a use-by date of September 25, 2013, or earlier.

A complete list of the recalled products, lot numbers and expiration dates can be found on the FDA Web site.

The recall is being conducted as a "precautionary measure," the company says. To date, they have not received any reports of injury or illness associated with the recalled product. However, "in the event a sterile product is compromised patients are at risk for serious and possible life threatening infections."

Lowlite is notifying customers by telephone, fax, or mail to return the products to the pharmacy.

Source found here

Florida Compounding Rule Committee Meeting Set for March 22, 2013 at 10:00 Agenda Posted

Notice of Meeting/Workshop Hearing
DEPARTMENT OF HEALTH Board of Pharmacy
RULE NO.: RULE TITLE: 64B16-28.800: Special Pharmacies 64B16-28.802: Special-Parenteral, Enteral and Compounding Pharmacies The Board of Pharmacy announces a workshop to which all persons are invited. DATE AND TIME: Friday, March 22, 2013, 10:00 a.m. PLACE: The Peabody Orlando, 9801 International Drive, Orlando, Florida 32819, (407)352-4000 GENERAL SUBJECT MATTER TO BE CONSIDERED: To discuss the proposed text of rules. 64B16-28.800 Rule Development was published on January 9, 2013, in Vol. 39, No. 06; and 64B16-28.802 Rule Development was published on January 11, 2013, in Vol. 39, No. 08. A copy of the agenda may be obtained by contacting: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254. Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least seven days before the workshop/meeting by contacting: the Board, (850)245-4292. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, (800)955-8771 (TDD) or (800)955-8770 (Voice). If any person decides to appeal any decision made by the Board with respect to any matter considered at this meeting or hearing, he/she will need to ensure that a verbatim record of the proceeding is made, which record includes the testimony and evidence from which the appeal is to be issued.

To view agenda click here

Reminder: New Office USe Rules Adopted in Florida--Effective Date March 31, 2013

64816-27.700 Definition of Compounding.
"Compounding" is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any
branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for
administration by a practitioner or the practitioner's agent; and shall specifically include the professional act of preparing a unique
fmished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. The term also includes the
preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term "commercially
available products," as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are
legally distributed in the State of Florida by a drug manufacturer or wholesaler.
(1) through (2) No change.
(3) Office use compoundin&; "Office use" means the provision and administration of a compounded drug to a patient by a
practitioner in the practitioner's office or by the practitioner in a health care facil ity or treatment setting, including a hospital,
ambulatory surgical center, or pharmacy. A pharmacist may dispense and deliver a quantity of a compounded drug to a practitioner
for office use by the practitioner in accordance with this section provided:
(a) through (c) No change.
(d) The pharmacy and the practitioner enter into a written agreement. The acreement shall specifically provide:
l. That the compounded drug mav only be administered to the patient and may not be dispensed to the patient or sold to
any other person or entitv:
2. That the practitioner shall include on the patient's chart, medication order, or medication administration record the Jot
number and the bevond-use-date of any compounded drug administered to the patient that was provided by the pharmacy;
3. That the practitioner will provide notification to the patient for the reporting of any adverse reaction or complaint in
order to facilitate anv recall of batches of compounded drugs.
(e) The pharmacy shall maintain readily retrievable records of all compounded drugs ordered by practitioners for office use.
The records must be maintained for a minimum of two (4) years and shall include:
l. The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the
2. The name, strength. and quantity of the compounded drug provided, including the number of containers and quantity in
3. The date the drug was compounded;
4. The date the compounded drug was provided to the practitioner:
5. The Jot number and bevond use date.
(f) The pharmacy shall affix a label to any compounded drug that is provided for office use. The label shall include:
1. The name, address. and phone number of the compounding pharmacy:
2. The name and strength of the preparation of a list of active ingredients and strengths;
3. The phannacy's Jot nwnber and beyond-use-date;
4. The quantitv or amount in the container:
5. The appropriate ancillarv instructions such as storage instructions. cautionary statements. or hazardous drug warning
labels were appropriate; and
6. The statement "For Institutional or Office Use Only - Not for Resale." or if the drug is provided to a veterinarian the
statement "Compounded Drug."
Rulemaking ~Authority 465.005 FS. Law Implemented 465.003(12), 465.0155, 465.0265 FS. History-New 10-1-92, Formerly 21S-27.700,
6 1F J0-27.700, 59X-27.700, Amended 11-2-03, 10-7-08,__ ___ _

For complete PDJ with letter re: adoption click here

Florida Department of Health Restricts Permit for Village Fertility; Florida Inspectors Receive Comprehensive Training

March 5, 2012

Contact: DOH Communications
(850) 245-4111

FLORIDA DEPARTMENT OF HEALTH RESTRICTS PERMIT FOR VILLAGE FERTILITY
~Pharmacy restricted from shipping or dispensing in Florida~

TALLAHASSEE- On February 26, 2013 the Florida Department of Health executed a voluntary agreement to restrict practice with Village Fertility Pharmacy in Waltham, MA. The state of Massachusetts issued a Cease and Desist order and a notice of Quarantine against the pharmacy on February 20 after possible contamination of vials of progesterone, a hormone used to aid in fertility. Village Fertility is a sterile compounding pharmacy which also holds a non-resident pharmacy permit in Florida.

Black particulate matter was observed in 10 ml multi-use vials of the intramuscular progesterone oleate. Particulates have not been observed in other products manufactured by the company, however, the Massachusetts Board of Pharmacy has advised Village Fertility to recall all products based on the common production involved. Vials containing contaminant have been sent for testing to a Food and Drug Administration lab and after five days of culture there has been no growth of any biological material. Final results will be available March 7, 2013. There have been no reported adverse reactions to these products.

The notice issued by the state of Massachusetts requires Village Fertility to cease and desist all sterile compounding, quarantine all compounded sterile products on its premises and notify all patients who received certain vials. The voluntary agreement to restrict practice instructs Village Fertility Pharmacy to immediately cease compounding medications for Florida residents and to cease dispensing or shipping medications it has previously compounded to Florida residents.

There were 95 patients in Florida who received the recalled compounded products, leuprolide acetate and progesterone oleate. The Department of Health is proactively reaching out to recipients of these products to insure they were in fact notified by Village Fertility and that they are no longer in possession of any of the recalled products.

The Department remains vigilant to assure the safety of Florida’s drug supply. The Department’s inspectors receive comprehensive training in sterile compounding and carry out a prioritized inspection schedule based upon the results of a mandatory pharmacy compounding survey. That survey resulted in 55 complaints being opened and two emergency suspension orders being issued. The Florida Board of Pharmacy is also conducting a series of workshops to amend its rules governing the practice of compounding. The next workshop is scheduled for March 22, 2013 in Orlando.

Follow us on Twitter at @HealthyFla and on Facebook. For news story ideas, interviews, videos and more from DOH Communications visit the DOH Online Newsroom.

source found here

Floridia Proposed Legislations, HB 365

Drug bill receives boost in House

02/20/2013 

by Jim Saunders, The News Service of Florida

With lobbyists crowding the room, a House panel Tuesday approved a bill that is part of a broader pharmaceutical-industry fight about complex drugs used to treat patients with cancer and other diseases.

The measure, HB 365, deals with a growing market for what are known as "biologic" drugs that are developed by using living cells instead of making chemical compounds. The debate centers on patients who receive substitutes for the original version of the drugs, an issue somewhat akin to the longstanding practice of substituting cheaper generic drugs for name-brand chemical drugs.

The measure, which was approved by the House Health Quality Subcommittee, would set guidelines for the dispensing of substitutes in Florida. Among other things, it would require pharmacists to notify prescribing doctors within five days and keep records for at least four years of making the substitutions.

Sponsor Matt Hudson (R-Naples) said such requirements would help protect patients, as the types of drugs are more complex than chemical compounds. He said biologic drugs are used to treat various types of cancers, along with ailments such as rheumatoid arthritis.

"They are used for some very difficult conditions of the humankind,'' Hudson said.

Major players in the pharmaceutical industry are divided on the bill. While it is supported by the Pharmaceutical Research and Manufacturers of America, it faced opposition Tuesday from pharmacy-benefits manager Express Scripts and the drug company Novartis.

At least part of the opposition stems from arguments that the requirements in the bill could place barriers to pharmacists dispensing the substitutes — an argument Hudson rejects. The opponents also said the state should not approve the bill before the federal Food and Drug Administration provides guidance about the drugs. 

While the substitutes are used in places such as Europe, they still need FDA approval. The federal agency has to determine whether substitutes are "biosimilar" to the original drugs and can be interchangeable.

"Let's let the expertise of the FDA govern this area,'' said David Dederichs, a lobbyist for Express Scripts.

Continue Reading here

Florida's Department of Health Board of Pharmacy Minutes and Audio of December 2012 Meeting

To read the draft of minutes, click here
To hear the audio of the meeting click here

Florida Department of Health Board of Pharmacy Jan. 13, 2013 audio of Compounding Rules Committee

http://ww10.doh.state.fl.us/pub/bop/Audio/Compounding%20Rules%20Committee/January%2016,%202013%20Compounding%20Rules%20Committee%20Meeting.WMA

If above, direct link does not work for you, click here

Florida Department of Health Pharmacy Meeting-Materials for Public for Feb. 6-7, 2013 meeting

This is a large download. To begin the download of materials for this meeting, click here for link to materials

Florida Department of Health Board of Pharmacy Meeting Feb. 6-7, 2013 Agenda Contains A Lot of Compounding Items

AGENDA
DEPARTMENT OF HEALTH BOARD OF PHARMACY FULL BOARD MEETING
February 6-7, 2013
Renaissance World Golf Village Resort
500 South Legacy Trail
St. Augustine, Florida 32092 (904) 940-8000
PLEASE TURN OFF ALL CELL PHONES, PAGERS, AND BEEPERS DURING THE MEETING. THANK YOU.
Board Members:
Albert Garcia, BPharm, MHL, Chair, Miami Jeffrey J. Mesaros, PharmD, Vice Chair, Tampa Cynthia Griffin, PharmD, Jacksonville
Michele Weizer, PharmD, Boca Raton
Gavin Meshad, Consumer Member, Sarasota Lorena Risch, Consumer Member, Bradenton DeAnn Mullins, BPharm, Lynn Haven
Debra B. Glass, BPharm, Tallahassee
Leo J. “Lee” Fallon, BPharm, PhD, The Villages
Board Staff:
Mark Whitten, Executive Director
Tammy Collins, Program Operations Administrator
Board Counsel:
David Flynn, Assistant Attorney General
Department of Health Staff:
John J. Truitt, Assistant General Counsel
Participants in this public meeting should be aware that these proceedings are being recorded and that an audio file of the meeting will be posted to the board’s website.
Wednesday, February 6, 2013 – 9:00 a.m.
TAB 1 REPORTS
A. Chairs Report - Albert Garcia, BPharm, MHL, Chair
1. 2013 Committee Member Assignments
2. 2013 Association Meeting Assignments
B. Executive Director's Report - Mark Whitten
1. Gavin Meshad
i. Prescription Drug Abuse Committee Update
2. Dr. Michele Weizer
i. Compounding Rules Committee Update ii. Budget Liaison Update
3. Dr. Jeffrey Mesaros
i. Approval of HIV and Med Errors CE Course and Nov. 2012 Retroactive
Approval for CE Participants
4. Update on “Abandoned Pharmacy”
5. Compounding Survey Results
6. State-by-State Comparison of Board Actions resulting from NECC
7. Survey of Pharmacy Law
8. NABP
9. Board of Pharmacy Delegation of Authority
10. April Board Meeting Location Change
11. Request for Modification of Business Hours
i. LMC Pharmacy
12. Legislative Update
C. Attorney General's Report - David Flynn, Assistant Attorney General
1. Rules Report
2. Rule 64B16-28.100 - Determination of Rule Language
3. Rule 64B16-26.206
i. Form 1196
4. Rule 64B16-27.700
i. JAPC Correspondence
5. Rule 64B16-28.108
6. Chapter 456.0635, Florida Statutes - Informational Update
D. Prosecuting Attorney's Report - John Truitt, Assistant General Counsel
1. Prosecuting Services Report
E. Chief Investigative Services Report - Jeane Clyne
TAB 2 BUSINESS - Albert Garcia, BPharm, MHL, Chair
A. Ratification of Issued Licenses/Certificates & Staffing Ratios
1. Pharmacist (Licensure)(Client 2201) – 115
2. Pharmacist (Exam Eligibility)(Client 2202) – 83
3. Pharmacist Interns (Client 2202) – 74
4. Registered Pharmacy Technicians (Client 2208) - 1,016
5. Consultant Pharmacist (Client 2203) – 20
6. Nuclear Pharmacist (2204) – 1
7. Pharmacist/Facilities (2205) – 131
8. Registered Pharmacy Technician Ratios (2:1 or 3:1) – 44
9. Pharmacy Technician Training Program (Client 2209) – 23
10. CE Providers – 17
11. CE Courses – 33
12. CE Individual Request (Approved) – 8
13. CE Individual Request (Denied) - 0
B. Review and Approval of Minutes
1. December 11-12, 2012 Meeting Minutes
Thursday, February 7, 2013 at 8:00 a.m.
TAB 2 BUSINESS (continued) - Albert Garcia, BPharm, MHL, Chair
C. Presentations
1. Karla Kiriako - Transitions of Care Upon Hospital Discharge for Patients who are
Receiving Multi-dose Meds
TAB 3 DISCIPLINARY CASES - John Truitt, Esq. & Albert Garcia, BPharm, MHL, Chair
A. SETTLEMENT AGREEMENTS - APPEARANCE REQUIRED
A-1 Debra Lee Campbell, PS 37100, Parrish, FL – Second Request
Case No. 2011-13921 – PCP Weizer/Mesaros
A-2 Randolph E. McEwen, PS 25912, Tampa, FL Case No. 2010-12676 – PCP Mullins/Risch
A-3 Fletcher Discount Pharmacy, PH 22386, Tampa, FL Case No. 2010-13599 – PCP Mullins/Risch
A-4 Richard Alonso, PS 39780, Safety Harbor, FL Case No. 2012-06981 – PCP Meshad/Glass
A-5 Kenneth S. Ginsburg, PS 25202, Lake Worth, FL Case No. 2011-14869 – PCP Meshad/Glass
A-6 Premier Compounding Pharmacy, Inc., PH 23481, Palm Beach Gardens, FL Case No. 2012-02690 – PCP Weizer/Mesaros
A-7 Rejuvi Pharmaceuticals, Inc., PH 23297, Boca Raton, FL Case No. 2012-14670 – PCP Mullins/Mesaros
Case No. 2010-08677 – PCP Garcia/Glass
B. DETERMINATION OF WAIVERS
DOW-1 Garcia Pharmacy & Discount Corp., PH 25079, Miami, FL Case No. 2012-03329 – PCP Garcia/Risch
DOW-2 Complete Pharmacy & Discount, Corp., PH 25466, Miami, FL Case No. 2012-05211 – PCP Garcia/Risch
DOW-3 Garcia Pharmacy & Discount Corp., PH 25078, Miami, FL Case No. 2012-03364 – PCP Garcia/Risch
DOW-4 Ben Todd Fruge, RPT 16311, Jacksonville, FL Case No. 2012-04933 – PCP Meshad/Glass
DOW-5 Mehrdad Hariri, PS 21339, Maitland, FL Case No. 2011-18154 – PCP Meshad/Glass
DOW-6 Jeffrey Lee Williams, PS 15810, Orlando, FL Case No. 2011-19646 – PCP Glass/Risch
C. VOLUNTARY RELINQUISHMENTS
VR-1 Jarrod John Kirkpatrick, RPT 11115, Gainesville, FL Case No. 2012-02985 – PCP Glass/Risch
VR-2
Yun Pharma, Inc., PH 25843, Miami, FL Case No. 2012-13121 – PCP N/A
VR-3
Deborah Ann Hahn, RPT 23664, Gainesville, FL Case No. 2012- 13494 – PCP Waived
VR-4
Justin Wayne Buffington, RPT 43983, Tampa, FL Case No. 2012-16940 – PCP Waived
VR-5
Haroun T. El-Nil, PS 32583, Royal Palm Beach, FL Case No. 2008-25455 – PCP Waived
VR-6
Michael C. Lomangino, PS 28489, Edgewater, FL Case No. 2012-02056 – PCP Weizer/Meshad
VR-7
Med Express, LLC, PH 25533, Lakeland, FL Case No. 2012-14602 – PCP Mullins/Mesaros
VR-8
People's Choice Pharmacy, LLC, PH 24693, Tamarac, FL Case No. 2012-15877 – PCP Waived
VR-9
Shannon Roddenberry, RPT 17888, Floral City, FL Case No. 2012-01444 – PCP Waived
VR-10
AJ Cargo Express, Inc., PH 24290, Miami, FL
Case No. 2012-12176 & 2012-11578 – PCP Waived
VR-11
Carrie Ann Ivey, RPT 13274, Hillard, FL
Case No. 2012-14416 – PCP Mullins/Mesaros
VR-12
Karla Dianne Calhoun, RPT 42465, Abbeville, AL Case No. 2012-14343 – PCP Weizer/Risch
I-1
D.
INFORMALS
David E. Muforo, PS 24082, Brandon, FL Case No. 2010-14846 – PCP Fallon/Mesaros
I-2
Apothecure, Inc., PH 21213, Dallas, TX Case No. 2012-12302 – PCP Meshad/Glass
I-3
Ronald Jacobs, PS 18373, Lake Worth, FL Case No. 2011-17701 – PCP Fallon/Weizer
I-4
Meds Rx Pharmacy, LLC, PH 24081, Deerfield Beach, FL Case No. 2011-17700 – PCP Fallon/Weizer
I-5
Jessica Cobo Barroso, PS 41346, Key West, FL Case No. 2012-09645 – PCP Meshad/Glass
I-6 James Rodney Raines, PS 15205, Coral Springs, FL Case No. 2011-17290 – PCP Garcia/Mesaros
TAB 4 APPLICATIONS REQUIRING BOARD REVIEW
A. Registered Pharmacy Technician Applicant
1. Marlene Desimone, File No. 47350, West Chapel, FL
B. Pharmacist Endorsement Applicant
1. Matthew Kolb, File No. 42476, Chicago, IL
C. Pharmacist Examination Applicant
1. Catherine Crowe, File No. 23418, Jacksonville, FL
2. Lauren Dickinson, File No. 42063, West Palm Beach, FL
TAB 5 LICENSURE ISSUES
A. Request for Termination of Probation
1. William Wood , PS 31383, Jacksonville, FL
2. Michelle Salkey , PS 23286, Port Orange, FL
3. Kenneth Marsh , PS 25269, Seminole, FL
B. Request for Reconsideration
1. Veronica Taran & Pharmacy Doctors Enterprises, Inc. PS 39928 & Pharmacy Doctors
Enterprises, Inc., PH 23558, Hallandale, FL
C. Request for Modification of Probation and Release from PRN Monitoring Contract
1. Brian Bulfer, PS 21587, Miami Shores, FL
TAB 6 REFERENCE MATERIALS
A. Florida Statutes
B. Rules
C. United States Pharmacopeia (USP) 797
D. Federal Food, Drug, and Cosmetic Act
E. The Committee On Energy And Commerce - Briefing Document- Hearing on “The Fungal
Meningitis Outbreak: Could It Have Been Prevented?” F. Massachusetts Compounding Survey
G. Correspondence, Florida Pharmacy Association
H. United States Senate Committee on Health, Education, Labor, and Pensions' Staff Report for November 15, 2012 Hearing on Meningitis

Source found here

Florida Article Is a Must Read: Gives Ideas for States to Improve Regulation and It Notes Anytime FDA Has attempted to Rein In Compounders Who Act As Manufacturers Courts Have Blocked IT

See prior post or read article entitled 950 FL Pharmacies Called High-Risk Compounders
  here 

950 FL Pharmacies Called High-Risk Compounders

By Carol Gentry

Originally published on Thu January 31, 2013 1:19 pm

Almost 950 Florida-licensed pharmacies engage in “sterile compounding,” the type of high-risk drug-making that led to a deadly fungal meningitis epidemic last year, according to a Department of Health survey released last week.
Sterile compounders are now given priority for state inspections, but it’s going to be a daunting task to check them all, judging from the survey report and interviews with pharmacists and health department officials. There are  two reasons:
--One-third of the 950 are based out of state, like the New England Compounding Center, the source of contaminated drugs that caused the epidemic. Florida law doesn’t give health officials any authority over out-of-state licensees.
--While the state has 18 inspectors for pharmacies, the health department said, only five of them are licensed pharmacists. And even the pharmacists need extra training to inspect the high-risk sterile compounders, officials said

Continue reading here