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.

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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

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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

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Florida Department of Health Compounding Survey Report Has Been Published

To read click here

Drug Compounding: Time To Regulate

Published: Tuesday, January 8, 2013 at 2:01 a.m.

Last Modified: Tuesday, January 8, 2013 at 2:01 a.m.

The Florida Board of Pharmacy met for a second time in December, searching for ways to respond to a meningitis outbreak linked to contaminated pain medication from a New England-based compounding lab. The contaminated medication has sickened more than 540 people in 19 states.

In Florida, the Ocala area — Marion County — is the location for 18 of the state's 25 meningitis cases, including all three of the state's outbreak-related fatalities.

Over the course of its two meetings in as many months, the Board of Pharmacy has conceded that there is virtually no regulation of drug-compounding activities in Florida. There are about 8,000 licensed pharmacists in Florida. All of them are permitted to create specialized medications, as long as they have a doctor's prescription. That is the extent of the regulation.

"The board said it wasn't even sure how many pharmacists are engaged in compounding," The Ocala Star-Banner reported, "and ordered a survey to try and determine which ones are compounding and what drugs they are making."

Continue reading here.

Flordia Department of Health November Board Meeting Audio Files of Meeting

To listen to audio file of meeting click here

Florida State Department of Health Meeting Included Extensive Discussion of Compounding Issues

The minutes from the November 20, 2012 board meeting that relate to compounding are below and can be found in toto here

Dr. Griffin stated goals to be accomplished within the time frame of the meeting, which were:
• Review and discuss current regulations, rules and guidelines related to compounding and non-resident pharmacies
• Review results of the voluntary survey of Florida compounding pharmacies that was conducted prior to this meeting
• Review current pharmacy inspection processes and discuss proposed changes
• Determine if appropriate rules and regulations are already in place to manage the oversight of the compounding process and to protect the public, while maintaining the value and integrity of the compounding process
• Determine if appropriate guidelines, rules and penalties are in place for disciplinary action against pharmacies and practitioners engaged in the practice of compounding in the event of negative occurrences
• Propose recommendations that can be acted upon immediately to assess current practices as well as helping with the continued review, development, and refining of rules related to compounding
Dr. Armstrong, State Surgeon General, addressed the Board members and audience through a video presentation with recommendations for permitting practice standards which include:
• Non-resident pharmacies should achieve accreditation and periodic re-accreditation in line with in-state pharmacies
• Any pharmacy compounding sterile products should be required to obtain a special permit
• Compounding pharmacies should be required to meet or exceed the most recent USP 797 Guidelines, including a mandatory audit trail of all compounded drug products
• Compounding of non-commercially available drugs should be based upon a patient specific prescription, with some exception limited to drugs not available due to manufacturing shortages
• More precise definitions for non-patient specific compounding should be established
• Recordkeeping requirements should be strengthened to facilitate the rapid response of health care professionals if an adverse event related to compounded medications occurs
• Minimum disciplinary guidelines should be established for compounding violations that hold the owner and the pharmacy manager accountable
TAB 1 COMPOUNDING IN PHARMACIES LICENSED AND REGULATED BY THE FLORIDA BOARD OF PHARMACY AND THE FLORIDA DEPARTMENT OF HEALTH, (Cynthia Griffin, PharmD, Chair & Mark Whitten, Executive Director)
Dr. Griffin opened the floor for discussion on modifications to the current requirements for non-resident pharmacies.
Dr. Fallon stated that non-resident pharmacy applicants should be required to have the same fingerprinting and background checks as required by Florida resident pharmacy applicants.
Dr. Griffin stated that one area for potential concern with non-resident pharmacies is that the pharmacist in charge is not currently required to be a Florida licensed pharmacist; therefore, something to consider is requiring the pharmacist in charge to be specifically licensed in the State of Florida.
Mr. Garcia requested from Board office staff, in regards to Chapter 465, information on legislation or rulemaking processes that have been successful in other states regarding compounding.
Mr. Whitten responded that states who have taken action include Massachusetts who has implemented a survey on compounding, New Jersey has begun rulemaking and Tennessee has formed a focus group to concentrate on compounding.
Ms. Mullins stated that it may be worth the Board’s time to look deeper into what she feels poses the most danger to Florida citizens which is pharmacies working under the guise of (office use) as a cover for manufacturing.
Dr. Mesaros suggested the Board consider some collaboration with other state boards, and potentially the National Association of Boards of Pharmacy, in regards to pharmacy inspections; specifically when it comes to pharmacies not physically located within the state, if resources in all 50 states would allow a successful collaboration.
ACCREDITATION
Dr. Griffin opened the floor for discussion on requiring accreditation for pharmacists or pharmacies that practice compounding to help ensure patient safety and prudent compounding practices.
Ms. Mullins stated that accreditation for sterile compounding makes sense, but that available accrediting bodies might be a concern. She stated that Pharmacy Compounding Accreditation Board’s (PCAB) accreditation standards and compliance indicators crosswalk very nicely with 797, but questions if PCAB can physically produce accreditation or accredited practices in terms of shear volume. Ms. Mullins stated that when accreditation is being discussed, it is important to also bring up hospital pharmacies non-compliance with 797 and the process of looking
at sterile compounding within community pharmacies, physicians offices, clinics, hospice, home IV, and long term care.
Mr. Whitten spoke about his communication with PCAB and stated that they are willing to take on this challenge, and are looking into ramping up their services and increasing their staff. Mr. Whitten mentioned that he has had contact with other entities that may be interested in the possibility of offering accreditation.
Dr. Mesaros expressed concern with the economic impact of requiring accreditation. His concerns included: will accreditation have a positive or negative impact on the pharmacy; what is the usual expense; what would that type of accreditation entail for them; and in turn, is that going to stop some of the pharmacies from being able to provide a product.
Dr. Griffin opened the floor for public comments.
Michael Jackson with the Florida Pharmacy Association, extended his gratitude to the Board for hosting this meeting, and pledged on behalf of the FPA that they will work closely with the Board of Pharmacy as they search to find solutions to this nationwide problem. Mr. Jackson stated the FPA has taken the position that pharmacies who are interested in looking into the accreditation process be allowed to do so on a voluntary bases through PCAB.
Brian Kahan, Esq. approached the Board to remind them that accreditation is voluntary; licensing and permitting of pharmacies is mandatory; and compliance with regulations to maintain those licenses is also mandatory. Mr. Kahan stated that accreditation may or may not prove to assure the public of any higher level of safety, not that accreditation is right or wrong, but the discussion about accreditation should be tempered with the following concept; will accreditation do something more than already existent regulations do to ensure that an organization that is compounding is in compliance with those existing regulations for the purposes of protecting the public. Mr. Kahan requested that the Board consider any improvements that can be made by minimizing resources and work within the infrastructure that already exists and enhance administrative rules.
Attorney David Flynn, Board Counsel, stated that from his review, it appears that there needs to be more rulemaking authority granted when dealing with non-resident pharmacies and the only way to obtain additional rulemaking authority would be through legislation. Attorney Flynn stated that if there are any critical areas that the Board wants to identify, the Legislative session will begin very soon.
Edwin Bayo, Esq. approached the Board and stated that he does not think there is a deficit in Florida compounding regulations, but maybe enhancing inspections would be suitable. Mr. Bayo suggested accreditation would be appropriate for
compounding pharmacies that reach a certain production level of out-of-state shipped compounded medications.
Mr. Garcia reiterated that in lieu of the meningitis outbreak, it would be good practice for the Board to review Rule 64B16-27.797, F.A.C. Mr. Garcia suggested to the Board that they review this rule during the coming year to ensure the Board is on track to better protect the public.
Greg Carter approached the Board and reminded them that any decision made on accreditation should allow enough time for accrediting bodies to ramp up their resources.
Norman Clemon approached the Board and stated that there should be more focus on aseptic technique and proper hygiene to help prevent future breakouts.
Dr. Griffin reminded the audience that the path to getting to the final solution will require a multi-layered approach and that accreditation may not be the only answer to the solution, but one of the many components that might be necessary to help improve the process.
Ms. Mullins stated reasons the outbreak may have happened include trust of the pharmacist to do the right thing, failure of regulatory enforcement, and culpability of the purchasers. Ms. Mullins reiterated that accreditation would not be a simple fix to the problem.
SPECIAL PERMITS
Ms. Mullins questioned that if California is a great model for special permitting and the New England Compounding Company was still allowed to distribute to California; is special permitting going to fix the problem?
Dr. Griffin stated that special permits won’t necessarily fix the problem but will provide an opportunity to know who is engaging in certain practices along with the ability to monitor those practices more closely.
Mr. Garcia suggested the Board look at what other states have in place and consider advantages and disadvantages; the possibility from an inspection and departmental perspective; and the costs involved. Mr. Garcia reminded the Board that now is the time to make legislative recommendations that the Board feels are warranted.
Mr. Kahan, Esq. approached the Board and stated that there is a permit that already exists and the Board has the ability to work within the administrative rules to address those specific rules that speak to the enteral and parenteral special permit and apply additional requirements that can be regulated.
Mr. Garcia stated that bringing in independent inspectors, who are experts in the field, to support our current inspectors may be a good idea.
Dr. Mesaros requested information on how the Board could expand the rule that is already in place on permits.
Attorney Flynn responded that the Board has much capability to make changes regarding in state pharmacies, but that legislative action would be required to give the Board more authority over non-resident pharmacies, due to the statute being very too specific.
RECORDKEEPING REQUIREMENTS
Dr. Griffin stated that the Board’s rule on recordkeeping currently has specific requirements outlining what the permittee should be doing. However, one item up for discussion is if current regulations have language that allows for tracking the integrity of a product from the beginning of compounding to dispensing of that drug to a patient.
Ms. Mullins stated that she feels the current recordkeeping requirements are sufficient; then questioned if there are any unknown holes or insufficiencies that need to be brought to the Board’s attention.
Fonicia Hutt, a non-sterile/sterile compounding pharmacist, approached the board and stated that the only thing that would be insufficient in recordkeeping is tracking the lot numbers for products that you are using when you are compounding. Ms. Hutt also suggested that a software system that could track and readily pull lot numbers would help with recalls.
Richard Montgomery approached the Board and asked how far of a scope the Board wanted to reach in regards to tracking lot numbers, and brought up the difficulty of that for hospitals.
Dr. Griffin stated that one of the most difficult challenges in the most recent outbreak was identifying where, and to whom, the drug was distributed and administered; and the goal of the Board is to find a way to immediately identify who has a drug in stock and how to get our isolate it if necessary.
Shilish Mane approached the Board and stated that the documentation of lot numbers is not enough; other information that should be documented include what procedure was used to compound the medication, who performed the compound, and who checked the compounded medication.
Attorney Flynn stated that the Board of Pharmacy may need to involve the Boards of Medicine, Osteopathic Medicine, the Board of Dentistry and potentially the Board of
Nursing in order to come up with procedures to track a batch or lot number down to the end consumer when the prescription is non-patient specific.
Mr. Bayo, Esq. approached the Board and requested that they keep in mind that a draft rule, provided on behalf of the Florida Independent Pharmacy Network, further defining compounding for office use is currently undergoing the rule making process, and that this rule specifically requires recordkeeping and tracking of compounded medications.
Holly Neary, a compounding pharmacist, approached the Board and stated that there are states, such as Texas, that require an agreement when you do an office use product; so a pharmacy must be in an agreement with the physician to provide office use products. Ms. Neary also stated that there are states, such as New York, that do not allow non-specific compounds for office use.
RECORDKEEPING REGARDING DISCIPLINARY GUIDELINES
Dr. Griffin opened the floor for discussion on the recently revised disciplinary guidelines; specifically to look at what is already in place regarding discipline for compounding of products, as well as guidelines for penalties associated, and if there are any deficiencies.
Mr. Garcia asked, from a legislative perspective, if there is something the Board could pursue in an effort to hold owners accountable for non-pharmacist owned pharmacies?
Attorney Flynn acknowledged the Prosecution Services Unit as the best department to understand what the Board’s strengths and weaknesses are in dealing with those types of cases. He also stated that he is aware of some weaknesses in the disciplinary guidelines and that this would be a good topic to discuss at the December 11 – 12, 2012 Board meeting.
John Truitt, Assistant General Counsel, stated that with the way the statutes are currently set up, the Board can discipline anyone with a permit or a license. For the non-licensed owner of a pharmacy, the pharmacy permit can be disciplined with the PDM being held accountable for certain things. Mr. Truitt suggested the Board may be interested in recommending legislative action to hold the PDM more accountable.
Ms. Mullins reflected back on a disciplinary case from the October Full Board meeting and suggested that when the Department recommends discipline with education requirements, the Board would need more information on the options and more specificity on what those options are going to look like.
Dr. Mesaros inquired as to what kind of action the Board would need to take at the December Board meeting to move any legislative recommendations they would be interested in making.
Dr. Griffin stated that one of the goals of this meeting was to come up with recommendations that the Board can act on fairly quickly going forward at the December Board meeting.
Attorney Flynn stated that he would prefer to have one assigned committee person from the Board that he can ask questions and discuss changes in order to have language ready to be voted on by Board during their meetings, and hit the goal of having rules done within 90 days.
Dr. Griffin opened the floor for further discussion.
Ms. Mullins stated that one of the goals is to have specific instructions for office use. In terms of definition, the Board has clarity on verbiage; the problem lies in people who are masquerading behind office use and providing injectables that are only appropriate for office use.
Robert Montgomery approached the Board and requested clarity in the rule regarding office use.
Ms. Mullins stated that Mr. Montgomery’s question, and some questions of her own, may not be able to be answered today; but maybe through committee work, we need to have those questions answered for both the pharmacists and their patients. Ms. Mullins also reminded the Board that we need to be very careful when compounding for cost-savings versus compounding for patient need due to a product not being commercially available.
Dr. Griffin stated that the challenge is how to put requirements in place to address compounding for cost savings versus compounding for need.
Mr. Bayo, Esq. approached the Board and stated that it is important that pharmacists exercise due diligence and create a record.
Dr. Griffin stated that an item for discussion that will continue through future Board meetings is addressing the definition of compounding versus manufacturing, which will not only be a challenge for Florida, but the entire nation.
TAB 2 PHARMACY COMPOUNDING SURVEYS, (David Flynn, Assistant Attorney General)
Dr. Griffin asked Attorney Flynn to review the voluntary survey results and to lead us into a discussion on recommendations as a result of the survey.
Attorney Flynn responded that even though these topics are under his tab, the work done on the survey was performed by the State Surgeon General, the Department of
Health, the Board, and various associations. He also stated that he does not speak for the Department of Health and will only advise as the Board Counsel.
Attorney Flynn reported on the number of people affected by the meningitis outbreak, the number of emergency suspension orders issued by the State Surgeon General post-outbreak, and how this will all play into rule making.
Attorney Flynn reported that the Department of Health sent out a voluntary compounding survey to approximately 8,000 people and had a return rate of approximately 700 (10%). He asked the Board if they wanted to engage in rulemaking to make the survey mandatory in order to increase the return rate.
Dr. Griffin stated that she was disappointed in the number of surveys returned and that it is critical for the Board to know what type of practices are happening, as well as other essential information to help make informed decisions on future rules and processes. Dr. Griffin opened the floor to Board members for questions about the survey.
Mr. Garcia spoke to the Board considering an emergency rule.
Ms. Mullins responded that some of the questions in the survey may have brought confusion. She also stated that the Board should be very careful on how the data is used, and maybe with that in mind, will help the Board and the Department design questions that obtain data that will reveal where the dangers lie.
A recess was taken for Board members to review the Emergency Rule.
Dr. Griffin requested that Cassandra Pasley, Chief of the Bureau of Health Care Practitioner Regulation, address the survey process, explain how the survey was developed, and answer Board member questions.
Ms. Pasley explained that the survey came about from questions in news articles after the meningitis outbreak asking “how many compounding pharmacies are in your state”, with the department not being able to give an answer. The only answer that could be given is that there is x-amount of permits that have the legal authority to compound, which may be a number very different from the actual amount of pharmacies compounding. Ms. Pasley stated that the survey would serve the purpose of giving the Board and the Department a better understanding of what going on in our state.
Ms. Pasley answered Dr. Griffin in great detail and stated that the goal for the survey is not to impose discipline, but to assist the Board and the Department with getting the data needed to make informed policy decisions.
Ms. Pasley answered Board member questions for clarity and revised the survey based on suggestions from the Board members.
Motion by: Dr. Fallon, seconded by Mr. Garcia, to accept the compounding survey. Motion carried.
Attorney Flynn led a discussion on the emergency rule and advised the Board to look at the text section of the rule first, which he advised could be approved or denied, then Board could decide if they want to proceed in an emergency rule fashion.

Florida: Meningitis Outbreak Shows Gaps in Regulation;Complaints disappear without a trace

By Carol Gentry

Originally published on Mon December 17, 2012 1:56 pm

When the nationwide fungal meningitis outbreak exploded into headlines two months ago, Florida health officials responded quickly, tracking the contaminated drug lots and finding potential victims. At least 25 in Florida were sickened, and three died.
While the response was swift, Florida health officials concede the state failed to foresee the danger and take steps to reduce the risk. New England Compounding Center, identified as the source of the tainted drugs, had a Florida non-resident license that allowed it to send drugs into the state.
Florida relied on Massachusetts to oversee NECC's operations and make sure its drugs were safe. After the extent of its problems were exposed, NECC was shut down.
Florida law gives health officials in this state no power to regulate companies that sell drugs inside Florida but aren’t located here, Assistant Attorney General David Flynn told the Board of Pharmacy at a recent all-day hearing in Orlando.
“In short,” Flynn said, “we’re in a box. We need to get authority so we can get out of the box."
No permit is required
It was mere chance that the meningitis outbreak began in a different state, Board of Pharmacy members discovered. It could just as easily have started in Florida, because the state has no information on how many of the 7,897 licensed pharmacies are compounders. No permit is required.
State officials sent out a survey to all pharmacies in October, trying to learn which ones were making their own drugs, especially drugs that require a super-sterile manufacturing environment. But only 10 percent of the pharmacies filled out the survey.
So the Pharmacy Board passed an emergency rule that requires pharmacies to answer the survey or face punishment. The answers must be in by Monday.

Of all states, Florida should have foreseen trouble with compounding, after the 2009 deaths of 21 polo ponies that were scheduled to compete in a championship in Wellington. The drugs -- supposed to be vitamins -- had been made by a veterinary compounding pharmacy in Ocala.

'I couldn't answer the question'
After the NECC outbreak became big news at the beginning of October, calls started coming in to the Health Department from reporters, asking how many compounding pharmacies Florida has. Cassandra Pasley, chief of the bureau that regulates health care practitioners, saw there was a gap in the state's information.
"I couldn't answer the question as to how many compounding pharmacies we have in Florida because we really don’t have a permit called 'compounding pharmacies,'" she said.
Family doctor Kenneth Woliner says he tried to sound a warning about compounding pharmacies in early 2011 after receiving a marketing flier from Rejuvi Pharmaceuticals Inc. in Boca Raton. The flier touted the profits that doctors could make by buying drugs in bulk from Rejuvi at wholesale prices and then selling them to patients at a mark-up.
To Woliner, that didn't seem right. Compounding pharmacies are allowed to tailor-make a drug for an individual patient who can't use the official mass-produced version -- if they have a doctor's prescription. They're not supposed to mass-produce other companies' patented drugs and sell them in bulk.
Specializing in hormone replacement
Rejuvi's specialty, the flier said, was hormone replacement therapy. It advertised human growth hormone and HCG, a pregnancy hormone, for anti-aging and body-building, purposes for which the drugs are not FDA-approved. While it is legal for doctors to prescribe the drugs for non-approved purposes, drug makers are not supposed to tout them for those uses.
Woliner said he thought what Rejuvi was suggesting might be illegal for the pharmacy, the doctors, or both. He felt it was certainly unethical. He filed a complaint in April 2011.
“I’ve been frustrated because I’ve seen enough of my patients who have come in from other physicians that have been exploited financially and also hurt physically because they are prescribed drugs inappropriately in excessive quantities," he said. "It's mainly because the doctor went for the mark-ups, not because the patients needed therapy.”
A month after submitting his complaint to the Health Department, Woliner got a reply. DOH said there wasn’t enough evidence to warrant action.
Complaints disappear without a trace
Woliner says this type of abuse happens all the time—and he has filed numerous complaints -- but he says the Health Department seldom does anything with them.
"It’s almost like they do not want to do the work to investigate and prosecute these cases or protect the health of the public because it’s work for them to do,” he said.

A Health Department inspector finally visited Rejuvi in early October, 18 months after Woliner filed his complaint. The inspector found a long list of problems, as Health News Florida reported. They included mouse droppings, dead insects, dirty water standing in the sink, and a covering of dust all through the compounding area.

In addition, information on patients and prescriptions was missing from the pharmacy, and drug labels were missing crucial information on the dose, lot number, and prescribing physician, the report said. Without that information it would be impossible to track down and recall the drugs if a lot were contaminated, the report said.
'Never been as horrified'
The pharmacy had been cited for problems before, the report said, but this time was worse. The inspector “has never been as horrified by the conditions of a pharmacy department as he was by the conditions of Rejuvi,” the report said.
Surgeon General John Armstrong issued an emergency suspension order on Rejuvi, shutting it down along with another compounding pharmacy.
The owner of Rejuvi declined to speak with Health News Florida; his attorney, Julie Gallagher, said of the Woliner complaint that went nowhere: “I have no comment on hearsay and speculation. If a case was closed for lack of legal sufficiency, that should tell you something. “
The Health Department can’t explain why Dr. Woliner’s complaint was so quickly shelved; in fact, officials can’t even confirm they ever got the complaint. Unless formal charges are brought, under the law the complaint remains confidential.
Gallagher says Rejuvi will appeal the suspension unless it reaches an amicable settlement.

Copyright 2012 WUSF-FM. To see more, visit http://www.wusf.usf.edu/.

Fla. pharmacy board wants drug compounders to get permits

By Fred Hiers
Staff writer

Published: Tuesday, December 11, 2012 at 2:39 p.m.

Last Modified: Tuesday, December 11, 2012 at 2:39 p.m.

State regulators on Tuesday began the task of imposing greater oversight over pharmacies that engage in drug compounding, ordering a committee of pharmacists to recommend permitting procedures for pharmacies that make their own medications.

As it stands now, any pharmacist in Florida can create specialized medications for patients who have a doctor's prescription. But recent mistakes by so-called pharmaceutical compounders — pharmacists who produce these kinds of medications in large quantities — have brought intense public scrutiny on the practice, along with calls for greater regulation.

So on Tuesday, the State Board of Pharmacy ordered a committee of its colleagues to come up with a series of state permits that pharmacists would have to be granted before they could create and sell specialized medicines. The three-person committee will come back with recommendations at a later date.

"It helps us as a regulatory body to know exactly what type of practices … are occurring in any kind of pharmacy," said Board of Pharmacy Chairwoman Cynthia Griffin of the proposed new rules.

She and other board members met in Tallahassee to explore other ways to best protect Florida consumers from bad drugs, like the contaminated pain medication that was manufactured by a Boston-area compounding lab and is blamed for an outbreak of fungal meningitis that has sickened nearly 600 people and killed 37 across 19 states.

The proposed permits would allow state health inspectors to keep track of medications being created by pharmacists.

Currently, Florida's pharmacy license and permitting process doesn't give regulators much information about what medicines are being made by the state's 8,000 pharmacists.

Continue reading here 

In addition to creating a permitting process, the Board of Pharmacy also wants the committee to consider requiring compounders to use a consulting pharmacist to ensure they follow guidelines for making sterile drugs, and it wants to require out-of-state pharmacies doing business in Florida to provide proof of their latest health inspections.

Tuesday's meeting was the second in two months for the Board of Pharmacy, which has acknowledged that compounders operate without enough oversight of the drugs they make and sell. Last month, the board said it wasn't even sure how many pharmacists are engaged in compounding and ordered a survey to try to determine which ones are compounding and what drugs they are making.

The Florida Department of Health reported Tuesday that more than 90 percent of Florida pharmacies completed the mandatory survey. A voluntary survey previously ordered by health officials garnered only a 10 percent response rate from pharmacists.

The recent meningitis outbreak was traced to contaminated lots of methylprednisolone acetate from the New England Compounding Center (NECC) in Massachusetts. Most of the Florida contamination cases were in Marion County involving three local clinics that injected the medicine into patients, mostly to relieve back pain.

Compounding pharmacies make medications and other medical preparations from scratch. They cannot make copies of commercially available medications and can only make medications when they are ordered by a doctor. Most make uniquely formulated medicines required by patients who are unable to use medications manufactured by commercial producers. But more recently, pharmacies are mass producing drugs, especially medicines for which there are otherwise shortages.

These medicines, critics say, are created without the same stringent oversight that commercial drug makers endure.

Currently, licensed Florida pharmacists are allowed to compound medications without any additional accreditation. Pharmacists making non-sterile medicines encounter minimal inspections while those making sterile medicines for injection purposes — such as the contaminated medicines behind the outbreak — require a higher level of regulation.

In addition to the meningitis outbreak, compounders have been blamed for other high-profile errors that caused serious health problems. In recent years, two such episodes were traced to Franck's Compounding Lab in Ocala.

In one case, Franck's mixed a bad dose of vitamin supplements that killed two dozen prized polo horses. In another, it was blamed for creating bad batches of eye medications that blinded eye surgery patients in several states.

That last mistake caused owner Paul Franck to sell his business to Wells Pharmacy.

While the Board of Pharmacy works on creating a permitting process for compounders, a key state health official admitted Tuesday that health inspectors may not be up to the task of inspecting compounders to ensure the medicines they are making are safe.

Jeane Clyne, with the Florida Department of Health, told the board that some of her inspectors had little experience inspecting compounding pharmacies. The board recommended she consider hiring consultants to create an inspection process that better takes into account the type of compounding the businesses are performing and creating the necessary records of their findings.

Board members during the meeting also expressed frustration with how to ensure out-of-state pharmacies remain safe and follow good practices. Florida law doesn't allow for Florida inspectors to travel outside the state for inspections nor can they force other states to conduct more frequent inspections or meet Florida compounding standards.

Contact Fred Hiers at 867-4157 or fred.hiers@starbanner.com.

Florida Board will Revisit Franck's Lab and Anazao Health Corp cases at Dec. 11-12th meeting

Here is a summary:

A. Chair's Report - Cynthia Griffin, PharmD, Chair
1. Dr. Cynthia Griffin – Short Term Priority List
a. Emergency Rule
b. Re-visit Cases with Sterile Compounding Issues
i.
Franck’s Lab, Inc d/b/a Franck’s Compounding Pharmacy
ii.
Anazao Health Corp
c. Inspector Training
d. Non-Resident Pharmacies Compliance with Florida Law
e. Possible Requirement of FL Pharmacist in Non-Resident Pharmacy
f. USP Standards – Physician Exemptiong. Collaboration with other Professional Boards
h. Proposed Legislation
i. Disciplinary Guidelines
2. Dr. Michele Weizer
a. USP 797 Beyond Use Date (BUD)

To view complete agenda click here

State might further scrutinize compounding pharmacies after meningitis outbreak

Orlando Business Journal by Abraham Aboraya, Reporter

Date Friday, December 7, 2012, 1:18pm EST
Abraham Aboraya

Reporter- Orlando Business Journal

 

If you’re a compounding pharmacy in Central Florida, be warned: The state may take a harder look at regulating the industry after a fungal meningitis outbreak killed three people in Florida.

The problem is this: In Florida, there is no separate permit for a pharmacy or a compounding pharmacy. So the state has no way to track or regulate the industry and, potentially, make sure outbreaks don’t happen.

A pharmacy sells bulk drugs (think Walgreens). A compounding pharmacy is designed to mix a special compound not commercially available.

Central Florida has a huge cluster of specialty pharmacy companies. According to the Metro Orlando Economic Development Commission, 70 percent of the country’s specialty pharmaceuticals are distributed through Central Florida.

According to Health News Florida, the Pharmacy Board sent out a survey in October to all of the state’s pharmacies, asking who compounds their own drugs. They got a paltry return rate of 20 percent.

So the board passed an emergency rule threatening to punish pharmacies that don’t return the survey, which is due Dec. 10.

According to the same article, Assistant Attorney General David Flynn told the Board of Pharmacy at an all-day hearing in Orlando that the state has no power to regulate companies selling drugs in Florida that aren’t located here.

“In short,” Flynn said, “we’re in a box. We need to get authority so we can get out of the box.”

Outbreak Shows Gaps in Regulation in Florida

By Carol Gentry

Originally published on Thu December 6, 2012 11:07 am

When the nationwide fungal meningitis outbreak exploded into headlines two months ago, Florida health officials responded quickly, tracking the contaminated drug lots and finding potential victims. On Wednesday, they announced the 25th case, including three who died.
While the response was swift, Florida health officials concede the state failed to foresee the danger and take steps to reduce the risk. New England Compounding Center, identified as the source of the tainted drugs, had a Florida non-resident license that allowed it to send drugs into the state.
Florida relied on Massachusetts to oversee NECC's operations and make sure its drugs were safe. After the extent of its problems were exposed, NECC was shut down.
Florida law gives health officials in this state no power to regulate companies that sell drugs inside Florida but aren’t located here, Assistant Attorney General David Flynn told the Board of Pharmacy at a recent all-day hearing in Orlando.
“In short,” Flynn said, “we’re in a box. We need to get authority so we can get out of the box."
No permit is required
It was mere chance that the meningitis outbreak began in a different state, Board of Pharmacy members discovered. It could just as easily have started in Florida, because the state has no information on how many of the 7,897 licensed pharmacies are compounders. No permit is required.
State officials sent out a survey to all pharmacies in October, trying to learn which ones were making their own drugs, especially drugs that require a super-sterile manufacturing environment. But only 10 percent of the pharmacies filled out the survey.
So the Pharmacy Board passed an emergency rule that requires pharmacies to answer the survey or face punishment. The answers must be in by Monday.
Of all states, Florida should have foreseen trouble with compounding, after the 2009 deaths of 21 polo ponies that were scheduled to compete in a championship in Wellington. The drugs -- supposed to be vitamins -- had been made by a veterinary compounding pharmacy in Ocala.
'I couldn't answer the question'
After the NECC outbreak became big news at the beginning of October, calls started coming in to the Health Department from reporters, asking how many compounding pharmacies Florida has. Cassandra Pasley, chief of the bureau that regulates health care practitioners, saw there was a gap in the state's information.
"I couldn't answer the question as to how many compounding pharmacies we have in Florida because we really don’t have a permit called 'compounding pharmacies,'" she said.
Family doctor Kenneth Woliner says he tried to sound a warning about compounding pharmacies in early 2011 after receiving a marketing flier from Rejuvi Pharmaceuticals Inc. in Boca Raton. The flier touted the profits that doctors could make by buying drugs in bulk from Rejuvi at wholesale prices and then selling them to patients at a mark-up.
To Woliner, that didn't seem right. Compounding pharmacies are allowed to tailor-make a drug for an individual patient who can't use the official mass-produced version -- if they have a doctor's prescription. They're not supposed to mass-produce other companies' patented drugs and sell them in bulk.
Specializing in hormone replacement
Rejuvi's specialty, the flier said, was hormone replacement therapy. It advertised human growth hormone and HCG, a pregnancy hormone, for anti-aging and body-building, purposes for which the drugs are not FDA-approved. While it is legal for doctors to prescribe the drugs for non-approved purposes, drug makers are not supposed to tout them for those uses.
Woliner said he thought what Rejuvi was suggesting might be illegal for the pharmacy, the doctors, or both. He felt it was certainly unethical. He filed a complaint in April 2011.
“I’ve been frustrated because I’ve seen enough of my patients who have come in from other physicians that have been exploited financially and also hurt physically because they are prescribed drugs inappropriately in excessive quantities," he said. "It's mainly because the doctor went for the mark-ups, not because the patients needed therapy.”
A month after submitting his complaint to the Health Department, Woliner got a reply. DOH said there wasn’t enough evidence to warrant action.
Complaints disappear without a trace
Woliner says this type of abuse happens all the time—and he has filed numerous complaints -- but he says the Health Department seldom does anything with them.
"It’s almost like they do not want to do the work to investigate and prosecute these cases or protect the health of the public because it’s work for them to do,” he said.
A Health Department inspector finally visited Rejuvi in early October, 18 months after Woliner filed his complaint. The inspector found a long list of problems, as Health News Florida reported. They included mouse droppings, dead insects, dirty water standing in the sink, and a covering of dust all through the compounding area.
In addition, information on patients and prescriptions was missing from the pharmacy, and drug labels were missing crucial information on the dose, lot number, and prescribing physician, the report said. Without that information it would be impossible to track down and recall the drugs if a lot were contaminated, the report said.
'Never been as horrified'
The pharmacy had been cited for problems before, the report said, but this time was worse. The inspector “has never been as horrified by the conditions of a pharmacy department as he was by the conditions of Rejuvi,” the report said.
Surgeon General John Armstrong issued an emergency suspension order on Rejuvi, shutting it down along with another compounding pharmacy.
The owner of Rejuvi declined to speak with Health News Florida; his attorney, Julie Gallagher, said of the Woliner complaint that went nowhere: “I have no comment on hearsay and speculation. If a case was closed for lack of legal sufficiency, that should tell you something. “
The Health Department can’t explain why Dr. Woliner’s complaint was so quickly shelved; in fact, officials can’t even confirm they ever got the complaint. Unless formal charges are brought, under the law the complaint remains confidential.
Gallagher says Rejuvi will appeal the suspension unless it reaches an amicable settlement.
Friday: Making compounding safer.

Source found here

Florida's Mandatory Pharmacy Compounding Survey, FAQ, and Emergency Rule

Mandatory Pharmacy Compounding Survey
FAQs for Pharmacy Compounding Survey - (pdf- 36kb)
Emergency Rule 64B16ER12-1
With the recent nationwide fungal meningitis outbreak caused by contaminated compounded products, the Florida Board of Pharmacy adopted Emergency Rule 64B16ER12-1, Florida Administrative Code This Emergency Rule requires all Florida licensed pharmacy permit holders, including non-residents, to complete a mandatory survey to inform the Board of its compounding activities. The goal of this mandatory survey is to determine the scope of sterile and non-sterile compounding within Florida licensed pharmacies --whether physically located in or out-of-state.

Failure to timely complete the mandatory survey is grounds for disciplinary action; however the goal is not to discipline, only to obtain critical data. Your cooperation in this matter is important to the department’s public protection mission.

Source found here

Updated: 11/24/2012 9:55:47 AM EST Health Dept. Takes Action Against Pharmacy A compounding pharmacy in Tamarac has been suspended, following a less than glowing inspection.

by Alan McBride

Florida Department of Health issued an Emergency Suspension Order of People's Choice Pharmacy, a compounding pharmacy located in Tamarac.

The order immediately suspended People's from operating as a community, sterile products, and special compounding pharmacy in the state of Florida.

The order comes after the department had conducted a routine pharmacy inspection of People's Choice Pharmacy in mid-October.

The inspection revealed that the pharmacy lacked quality assurance in high-risk sterile compounding.

It was also found that the pharmacy's use of unlicensed personnel for high-risk sterile compounding endangered the public.

The Department found further that People's Choice Pharmacy's failure to maintain adequate sanitation increased the likelihood that the medications compounded at this facility may become contaminated.

The issues inspectors reported finding gain substantially more public attention in the wake of a scandal involving tainted steroidal compounds.

the company NECC has been all but shuttered after medicine it compounded was traced to cases of fungal meningitis.

There have been three deaths in Florida as a result of fungal meningitis.

Emergency suspension or restriction orders are not considered final agency action but are imposed when the subject's actions pose an immediate serious danger to public health, as specified by section 456.074, Florida Statutes.

The subject is entitled to a hearing before final action is taken by a regulatory board or by DOH.

The suspension, however, will remain in effect until final disciplinary action is taken, the suspension is lifted, or the case is successfully appealed.

Florida Taking Closer Look at Compounding Pharmacies

Wednesday, November 21, 2012 at 6:19 by Robin Adams

In the wake of multiple meningitis deaths in Florida and elsewhere, stemming from problems with an out-of-state New England Compounding Pharmacy, the Florida Board of Pharmacy will be reviewing its laws and regulations for compounding pharmacies licensed in Florida.
At a meeting this week, the board said those pharmacies must notify them of any compounding activities they conduct. That applies to those actually in the state and those with Florida licenses that are out of the state.
The board will continue discussing this at its regular meeting in December.

Source found here

Florida Department of Health Board of Pharmacy Full Board Meeting November 20, 2012 Extensive Coverage of Compounding

AGENDA
DEPARTMENT OF HEALTH
BOARD OF PHARMACY
FULL BOARD MEETING
November 20, 2012
Renaissance at SeaWorld
6677 Sea Harbor Drive
Orlando, FL 32821
(407) 351-5555
PLEASE TURN OFF ALL CELL PHONES, PAGERS, AND BEEPERS DURING THE MEETING. THANK YOU.
Board Members:
Cynthia Griffin, PharmD, Chair, Jacksonville
Albert Garcia, BPharm, MHL, Vice-Chair, Miami
Michele Weizer, PharmD, Boca Raton
Gavin Meshad, Consumer Member, Sarasota
Jeffrey J. Mesaros, PharmD, Tampa
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
William Miller, 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.
Tuesday, November 20, 2012 – 9:00 a.m. time p.m.
TAB 1 COMPOUNDING IN PHARMACIES LICENSED AND REGULATED BY THE FLORIDA BOARD OF PHARMACY AND THE FLORIDA DEPARTMENT OF HEALTH, (Cynthia Griffin, PharmD, Chair & Mark Whitten, Executive Director)
1. Overview of Pharmacy Compounding
a. Chapter 465, Florida Statutes
b. Rule 64B16-27.700, Florida Administrative Code, Definition of Compounding
2. Compounding of Sterile Preparations
a. United States Pharmacopeia (USP) 797
b. Rule 64B16-27.797, Florida Administrative Code, Standards of Practice for Compounding Sterile Preparations
c. Rule 64B16-28.820, Florida Administrative Code, Sterile Products and Special Parenteral/Enteral Compounding3. Compounding of Non-sterile Preparations
a. United States Pharmacopeia (USP) 795
b. Rule 64B16-28.450, Florida Administrative Code, Centralized Prescription Filling, Delivering and Returning
4. Non-resident Pharmacies
TAB 2 PHARMACY COMPOUNDING SURVEYS, (David Flynn, Assistant Attorney General)
1. Florida Pharmacy Compounding Survey, October 2012 Survey
2. Proposed Florida Mandatory Pharmacies Compounding Survey
TAB 3 DOH PHARMACY INSPECTION PROCESS, (Jeane Clyne, Chief of Investigative Services Unit)
1. Inspection Forms
2. Inspector Education and Training
TAB 4 DEPARTMENT OF HEALTH’S PUBLIC PROTECTION CONCERNS, (Cassandra Pasley, BSN, JD, Chief, Bureau of Health Care Practitioner Regulation)
1. Representative from the Department of Health
TAB 5 ADDITIONAL REFERENCE MATERIALS
1. Chapter 499, Florida Statutes
2. Federal Food, Drug, and Cosmetic Act
3. The Committee On Energy And Commerce – Briefing Document- Hearing on “The Fungal Meningitis Outbreak: Could It Have Been Prevented?”
4. Massachusetts Compounding Survey
5. Correspondence, Florida Pharmacy Association