Saturday, November 30, 2013

Florida Board of Pharmacy Compounding Rules Committee Meeting Scheduled for December 2, 2013


Next Meeting:
Dec 2 , 2013 

Compounding Rules Committee
Meeting Materials 
FAW Notice (PDF) | Agenda (PDF)AGENDA 
DEPARTMENT OF HEALTH 
BOARD OF PHARMACY 
COMPOUNDING RULES COMMITTEE 
DECEMBER 2, 2013 
Hilton Hotel University of Florida 
1714 SW 34th Avenue 
Gainesville, FL 32607 
(352) 371-3600 
 
 
Committee Members: Board Staff: 
Michele Weizer, PharmD, Boca Raton, Chair Tammy Collins, Acting Executive Director 
Debra Glass, BPharm, Tallahassee Christy Robinson, Program Operations Administrator 
 Jay Cumbie, Regulatory Specialist II 
 Board Counsel: 
David Flynn, Assistant Attorney General 
 
Participants in this public meeting should be aware that these proceedings are being recorded. 
 
Monday, December 2, 2013 – 1:00p.m. 
1. Rule 64B16-27.700, F.A.C. 
2. Rule 64B16-27.797, F.A.C. 
3. USP on Compounding 64B16-27.700 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 
finished 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) Compounding includes: 
(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns. 
(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available. 
(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the 
compounded product on a per prescription basis and the patient has been made aware that the compounded product will be prepared 
by the pharmacist. The reconstitution of commercially available products pursuant to the manufacturer’s guidelines is permissible 
without notice to the practitioner. 
(2) The preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or 
distribution is not compounding and is not within the practice of the profession of pharmacy, except that the supply of patient 
specific compounded prescriptions to another pharmacy under the provisions of Section 465.0265, F.S., and Rule 64B16-28.450, 
F.A.C., is authorized. 
(3) Office use compounding, “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 facility 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) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioner’s 
office before the expiration date of the drug; 
(b) The quantity of compounded drug is reasonable considering the intended use of the compounded drug and the nature of the 
practitioner’s practice; 
(c) The quantity of compounded drug for any practitioner and all practitioners as a whole, is not greater than an amount the 
pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the 
compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices. 
(d) The pharmacy and the practitioner enter into a written agreement. The agreement shall specifically provide: 
1. That the compounded drug may only be administered to the patient and may not be dispensed to the patient or sold to any 
other person or entity; 
2. That the practitioner shall include on the patient’s chart, medication order, or medication administration record the lot number 
and the beyond-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 any 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 four (4) years and shall include: 
1. The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the 
order; 
2. The name, strength, and quantity of the compounded drug provided, including the number of containers and quantity in each; 
3. The date the drug was compounded; 
4. The date the compounded drug was provided to the practitioner; 
5. The lot number and beyond 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 pharmacy’s lot number and beyond-use-date; 4. The quantity or amount in the container; 
5. The appropriate ancillary 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, 61F10-
27.700, 59X-27.700, Amended 11-2-03, 10-7-08, 3-21-13. 



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Second Kudos to Florida Board of Pharmacy Regarding Redesigned Website! One of best designed, easiest to use websites for pharmacy boards!!


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Florida Board of Pharmacy Recent Action Against Phamacies

Final Order and Emergency Action Search

Results can be sorted in ascending or descending order by clicking on the column headers. If a link to an image of the final order is available, the case number will be a hyperlink that can be clicked to open and view the order. To view the practitioner's record on the License Verification website, please click on the license number hyperlink in the License Number column.
9  record(s) found.   View my criteria 
NameLicenseProfessionCityStateCountyCase #Action TakenOrder Date
BROTHERS PHARMACY AND DISCOUNT, LLC,23338PharmacyMIAMIFLMIAMI-DADE201301267Voluntary Surrender10/18/2013
WILSON DRUG,18748PharmacyLAKELANDFLPOLK201307691Voluntary Surrender10/18/2013
DRM ENTERPRISES, INC.,16061PharmacyLAKELANDFLPOLK201307692Voluntary Surrender10/18/2013
HEALTHY CHOICE PHARMACY, INC,25637PharmacyTAMPAFLHILLSBOROUGH201307687Voluntary Surrender10/18/2013
PHARMACY RX SOLUTIONS HOLDING LLC,23133PharmacyTAMPAFLHILLSBOROUGH201309974ERO Issued11/05/2013
GOOD SIGHT PHARMACY, INC,25104PharmacyCORAL GABLESFLMIAMI-DADE201300708Revocation10/29/2013
SPEED II PHARMACY INC,26049PharmacyHIALEAHFLMIAMI-DADE201218551Probation10/29/2013
PREMIER COMPOUNDING PHARMACY, INC,23481PharmacyPALM BEACH GARDENSFLPALM BEACH201202690Reimbursement of Costs Paid10/29/2013
FLORIDA SOLUTIONS PHARMACY,21697PharmacyHIALEAHFLMIAMI-DADE201300163Probation10/29/2013
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Florida Board of Pharmacy Recent Action Against Pharmacists

8  record(s) found.   View my criteria 
NameLicenseProfessionCityStateCountyCase #Action TakenOrder Date
CAIRNS, ERIC34472PharmacistJACKSONVILLEFLDUVAL201305212Voluntary Surrender10/18/2013
CHENOWETH, DEBORAH43436PharmacistLEHIGH ACRESFLLEE201300800Voluntary Surrender10/18/2013
WAHBA, SAMUEL27213PharmacistPALM HARBORFLPINELLAS201307373ESO Issued10/23/2013
LAURENZO, AMANDA45657PharmacistST. PETERSBURGFLPINELLAS201120504Suspension10/04/2013
MARTINEZ FLORES, ADORYS48533PharmacistMIAMIFLMIAMI-DADE201301123Obligations Imposed10/29/2013
GIRGIS, MONIKA38789PharmacistTALLAHASSEEFLLEON201303899Probation10/29/2013
BALLANCE, CODY46832PharmacistSAINT PETE BEACHFLPINELLAS201216677Obligations Imposed10/29/2013
LAURENZO, AMANDA45657PharmacistST. PETERSBURGFLPINELLAS201120504Suspension10/04/2013
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Florida Board of Pharmacy ERO Issued Against Pharmacy RX Solutions Holding LLC on 11/05/2013

NameLicenseProfessionCityStateCountyCase #Action TakenOrder Date
PHARMACY RX SOLUTIONS HOLDING LLC,23133PharmacyTAMPAFLHILLSBOROUGH201309974ERO Issued11/05/2013
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District of Columbia Board of Pharmacy Dual Responsibility Policy Guidlines


Dual Responsibility Policy Guidelines


Monday, June 17, 2013
Dual Responsibility Policy Guidelines
Attachment(s): 
 Dual Liability Policy Guidelines106.23 KB
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KUDOS to National Association of Board of Pharmacy for its Not Recommended Sites List!!


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Did you know that the NABP Has a "Not Recommended Sites" page listing websites that appear to be out of compliance with state and federal law of NABP patient safety and pharmacy practice standards--check it out!!


Not Recommended Sites

Not Recommended Sites are those Internet drug outlets that appear to be out of compliance with state and federal laws or NABP patient safety and pharmacy practice standards. Ordering drugs from these Web sites puts you and your family at risk. NABP has reviewed over 10,500 sites and found 97% of those sites to be out of compliance. NABP recommends that patients use sites accredited through the VIPPS program when purchasing drugs online.
list of sites provided here
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Mark your Calendar: Federation of Association of Regulatory Boards Annual Forum The FARB’s 38th Annual Forum will be held at the Omni Austin Hotel Downtown in Austin, TX, January 24-26, 2014.



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District of Columbia Board of Pharmacy November 7, 2013 Draft of Minutes

read here
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Last Posted Disciplinary Action by the Delaware Board of Pharmacy was in May 2013


2013 Bare, Curtis A1-0003202 Pharmacist 5/15/2013 Letter of Reprimand
Grossett, Kenneth A1-0002160 Pharmacist 5/15/2013 Letter of Reprimand
Marioni, Kay A1-0003674 Pharmacist 5/15/2013 Letter of Reprimand
Stoy-Washington, Faith A1-0002244 Pharmacist 5/15/2013 Letter of Reprimand
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The Pharmacy Commission of Connecticut October 30, 2013 Agenda

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Colorado Board of Pharmacy Continues to Take Aggressive Disciplinary Action Against Compounding Pharmacies


Monthly Board Action Summary
Click on the month/year in the index of the left to view the Board actions for that month. To
check on a specific licensee/registrant licensure/registration status, please reference the
Automated Licensure Information System Online (ALISON). To review public discipline
documents, please reference Registrations Online Documents (ROD).


September 2013

Pharmacy Interns

Rooney, Miles R. IN 2006026
Stipulation and Final Agency Order effective 09/26/13


Pharmacists

Medina, Joy PHA 11300
Stipulation and Final Agency Order effective 09/05/13

Rasmussen, Terry PHA 10057
Amended Stipulation and Final Agency Order effective 09/26/13

Ricklefs, Brendan J. PHA 17609
Amended Stipulation effective 09/26/13

IN-STATE PRESCRIPTION DRUG OUTLETS

Pencol Compounding Pharmacy PDO 154
Stipulation and Final Agency Order effective 09/26/13

Walgreen Pharmacy #4610 PDO 7-55
Letter of Admonition effective 09/18/2013

OUT OF STATE PRESCRIPTION DRUG OUTLETS

Advantage Pharmacy, LLC OSP 6266
Stipulation and Final Agency Order effective 09/23/13

Post Oak Pharmacy, LP DBA Lifechek Drug #19 OSP 6126
LOA effective 09/9/13

Unregistered

Central Ohio Compounding Pharmacy
Cease and Desist effective 09/12/13

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Colorado Compounding Task Force--Matters Considered During November 2013 Meeting


Colorado Compounding Task Force Meeting
Location:1560 Broadway, Ste 110D, Denver,CO 80202
Special Meeting:  First Meeting of the Colorado Compounding Task Force
Attachment(s):
File
Compounding Task Force Nov 2013 Agenda.pdf
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California Board of Pharmacy Disciplinary Action from October 2013 to present

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Pacifica Pharmacy Corp; Thang Tran--No. 2013-01 --precedential decision from California Board of Pharmacy


Precedential Decisions

Under the Administrative Procedure Act (APA) a decision that contains a significant legal or policy determination of general application that is likely to recur may be designated as precedential (see Government Code section 11425.60). Once a decision is designated as precedential, the California State Board of Pharmacy (hereinafter "Board") may rely on it, and parties may cite to such decision in their argument to the Board and courts.

INDEX BY PRECEDENTIAL DECISION NUMBER

Precedential Decision NumberRespondentCase Numbers
Precedential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang TranCase No. 3802
OAH No. 2011010644


INDEX BY SUBJECT MATTER

Basis of DisciplineRespondentPrecedential Decision Number
Standard of Care for Corresponding ResponsibilityPacifica Pharmacy Corp.; Thang TranPrecedential Decision No. 2013-01


INDEX BY VIOLATION CODE SECTION

Code SectionsPrecedential Decision NumberRespondent
Health and Safety Code (H&S)  
11153Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
Business and Professions Code (B&P)  
1718Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
4076(a)(11)Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
4081Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
4301Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
4301(c)Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
4301(d)Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
4301(j)Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
4332Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
4342Precdential Decision No. 2013-01Pacifica Pharmacy Corp.; Thang Tran
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Enforcement Action Recently Filed by California Board of Pharmacy Against Pharmacies


Site Licenses
PMC Pharmacy, PHY 48762, Administrative Case AC 4496
Daly City, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
PMC Pharmacy, PHY 50377, Administrative Case AC 4528
Burlingame, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation

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Enforcement Action Recently Filed by California Board of Pharmacy Against Pharmacists


Individual Licenses
Acevedo, Edgar, Applicant, Statement of Issues Case SI 4845
El Monte, CA
Statement of Issues Filed 10/21/2013; Case Pending.
View the accusation
Antognazzi, Brittany, TCH 83750, Administrative Case AC 4777
Berkeley, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Azevedo, Danny Sousa, EXV 21320, Administrative Case AC 4705
Visalia, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Bartee, Gary, RPH 43085, Administrative Case AC 4654
Albany, OR
Accusation Filed 10/23/2013; Case Pending.
View the accusation
Bartlett, Brett, EXC 17211, Administrative Case AC 4779
Grass Valley, CA
Accusation Filed 10/3/2013; Case Pending.
View the accusation
Bechle, Stephanie, TCH 30272, Administrative Case AC 4807
Murrieta, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Carnario, Rosela, TCH 111201, Administrative Case AC 4519
Compton, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Cashpal, Alejandro, TCH 84051, Administrative Case AC 4553
Bakersfield, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Chambers, Brian, RPH 44303, Administrative Case AC 4817
Boise, ID
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Cruz, Sacarias, TCH 111111, Administrative Case AC 4788
Salinas, CA
Accusation Filed 10/3/2013; Case Pending.
View the accusation
Dean, Carl, RPH 37053, Administrative Case AC 4793
Erdenheim, PA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
De Luna, Kimberly, RPH 61593, Administrative Case AC 4528
Daly City, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Dhruv, Ravi, TCH 88006, Administrative Case AC 4401
Los Angeles, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Durden, Jason, TCH 97362, Administrative Case AC 4321
Los Angeles, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Estrada, Ana, TCH 59881, Administrative Case AC 4765
Fresno, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Fulinara, Brandon, TCH 94185, Administrative Case AC 4820
Yorba Linda, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Garcia, Alfonso, Applicant, Statement of Issues Case SI 4834
Imperial Beach, CA
Statement of Issues Filed 10/7/2013; Case Pending.
View the accusation
Garcia, Judith, TCH 112357, Administrative Case AC 4609
Oxnard, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Garcia, Luis, Applicant, Statement of Issues Case SI 4676
San Leandro, CA
Statement of Issues Filed 10/3/2013; Case Pending.
View the accusation
Godbold, Gara, TCH 61514, Administrative Case AC 4640
Pacifica, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Gordon, Michelle, TCH 89567, Administrative Case AC 4730
Salinas, CA
Accusation Filed 10/3/2013; Case Pending.
View the accusation
Governski, Robert, RPH 47933, Administrative Case AC 4725
Telluride, CA
Accusation Filed 10/1/2013; Case Pending.
View the accusation
Gutierrez, Mike Anthony Jr., TCH 67717, Administrative Case AC 4731
San Diego, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Hathaway, Suzanne, TCH 85560, Administrative Case AC 4913
Anderson, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Hoover, Rian, TCH 107183, Administrative Case AC 4719
San Diego, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Jaspal, Jagdip, RPH 55129, Administrative Case AC 4922
Kerman, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Jiang, Barbara, TCH 52663, Administrative Case AC 4496
Daly City, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Johnstone, Crystal, TCH 104667, Administrative Case AC 4902
Paradise, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Knowles, Justin, RPH 63427, Administrative Case AC 4857
Dover NH
Accusation Filed 10/3/2013; Case Pending.
View the accusation
Medina, Elizabeth, Applicant, Statement of Issues Case SI 4843
American Canyon, CA
Statement of Issues Filed 10/21/2013; Case Pending.
View the accusation
Menchaca, Richard, TCH 97927, Administrative Case AC 4900
South Gate, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Mendoza, Corinne, TCH 33289, Administrative Case AC 4824
Angels Camp, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Mobley, Krystle, TCH 69734, Administrative Case AC 4741
Escalon, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Navarrete, Oscar, TCH 102265, Administrative Case AC 4417
Palmdale, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Nyblade, Dawn, Applicant, Statement of Issues Case SI 4675
Escondido, CA
Statement of Issues Case Filed 10/3/2013; Case Pending.
View the accusation
Opatz, Daniel, RPH 37645, Administrative Case AC 4788
Buena Park, CA
Accusation Filed 10/3/2013; Case Pending.
View the accusation
Orpilla, Michelle, Applicant, Statement of Issues Case SI 4844
Riverside, CA
Statement of Issues Filed 10/21/2013; Case Pending.
View the accusation
Ozimy, Eric, RPH 36956, Administrative Case AC 4746
Stockton, CA
Petition to Revoke Probation Filed 10/24/2013; Case Pending.
View the accusation
Perez, Jason, TCH 73032, Administrative Case AC 4481
Panorama City, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Poole, George, RPH 23729, Administrative Case AC 4528
Millbrae, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Rich, Edwin, TCH 4902, Administrative Case AC 4703
Pomona, CA
Accusation Filed 10/31/2013; Case Pending.
View the accusation
Romanolo, Lisa, RPH 37131, Administrative Case AC 4827
Prunedale, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Salas, Armando, TCH 127899, Administrative Case AC 4742
Corona, CA
Accusation Filed 10/3/2013; Case Pending.
View the accusation
Salinas-Sanchez, Jonathan, TCH 116074, Administrative Case AC 4739
Modesto, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Schmidt, Drahnier Del Rosario, TCH 122982, Administrative Case AC 4720
Arleta, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Shubin, Kathleen, TCH 35276, Administrative Case AC 4847
Santa Ana, CA
Accusation Filed 10/24/2013; Case Pending.
View the accusation
Simone, Jeffrey, RPH 62894, Administrative Case AC 4885
Santa Monica, CA
Accusation Filed 10/31/2013; Case Pending.
View the accusation
Soltero, Carlos, TCH 94675, Administrative Case AC 4768
El Monte, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Vaitai, Christina, TCH 105602, Administrative Case AC 4808
San Bruno, CA
Accusation Filed 21/2013; Case Pending.
View the accusation
Vergara, Crystal, TCH 108318, Administrative Case AC 4811
Ramona, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Waddle, Eric, Applicant, Statement of Issues Case SI 4596
Bakersfield, CA
Statement of Issues Filed 10/21/2013; Case Pending.
View the accusation
Yeung Wong, Angela Po-Chu, RPH 31278, Administrative Case AC 4496
San Francisco, CA
Accusation Filed 10/21/2013; Case Pending.
View the accusation
Zimmerman, William, RPH 37352, Administrative Case AC 4750
San Jose, CA
Petition to Revoke Probation Filed 10/3/2013; Case Pending.
View the accusation


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