___________________________________________________________________________________   

                                                                                        

                                   

      

      

California State Board of Pharmacy 1625 North Market Blvd., N219, Sacramento, CA 95834 Phone (916) 574-7900 Fax (916) 574-8618 www.pharmacy.ca.gov

STATE AND CONSUMER SERVICES AGENCY DEPARTMENT OF CONSUMER AFFAIRS

ARNOLD SCHWARZENEGGER, GOVERNOR

NOTICE OF MEETING and AGENDA LEGISLATION AND REGULATION COMMITTEE

Contact Person: Virginia Herold (916) 574‐7911

Date: October 19, 2010 Time: 2:00 p.m. – 5:00 p.m. Location: UC San Diego

Health Sciences Education Center Auditorium 9500 Gilman Drive La Jolla, CA 92093 (Map of campus, including parking areas for the public, follows at the end of the agenda)

This committee meeting is open to the public and is held in a barrier‐free facility in accordance with the Americans with Disabilities Act. Any person with a disability who requires a disability‐related modification or accommodation in order to participate in the public meeting may make a request for such modification or accommodation by contacting Carolyn Klein at (916) 574‐7913, at least five working days prior to the meeting.

Opportunities are provided to the public to address the committee on each open agenda item. Board members who are not on the committee may attend the meeting as observers. Action may be taken on any item on the agenda.

Agenda

Note: Pharmacists and pharmacy technicians who attend the full committee meeting can be awarded two hours of continuing education (CE), in accordance with the board’s CE policy. A maximum of four CE hours can be earned each year by attending the meetings of two different board committees.

Call to Order 2:00 p.m.

A. LEGISLATION REPORT

1. Board‐Sponsored Legislation

http:www.pharmacy.ca.gov

                        

       

                                  

                                                     

                                       

                                 

                                  

              

                            

                                               

                           

                                         

                          

                                                          

    

                                                                                    

 

Notice of Meeting and Agenda – Legislation and Regulation Committee October 19, 2010 Page 2 of 4

SB 1489 Omnibus Provisions (Senate Committee on Business, Professions and Economic Development) – Chapter 653, Statutes of 2010

General Omnibus Provisions Provisions to update references to the Department of Public Health Provision to update a reference to the Physical Therapy Board of California (formerly

known as the Physical Therapy Examining Committee of California) Provisions to update references to the Department of Health Care Services

2. Legislation Impacting the Practice of Pharmacy or the Board’s Jurisdiction

a. Chaptered Board of Pharmacy AB 2104 (Hayashi, Chapter 374, Statutes of 2010) – Board of Pharmacy: DCA Approval

of Appointment of EO

Licensing / General / Other AB 2699 (Bass, Chapter 270, Statutes of 2010) – Licensure exemption: State of

Emergency. SB 1172 (Negrete McLeod, Chapter 517, Statutes of 2010) – Diversion Programs AB 1414 (Hill, Chapter 76, Statutes of 2010) – Controlled Substances: Apomorphine:

Unscheduled.

Sunset Review and Legislative Oversight Proposals AB 1659 (Huber) – State Government, Agency Repeals AB 2130 (Huber) – Joint Committee on Boards, Commissions and Consumer Protection

Distribution of Needles and Syringes AB 1701 (Chesbro) – Hypodermic Needles and Syringes

Other Legislation Impacting the Board’s Jurisdiction SB 294 (Negrete McLeod) – Professions and Vocations: Regulation SB 700 (Negrete McLeod, Chapter 505, Statutes of 2010) – Healing Arts: Peer Review

b. Vetoed AB 1858 (Blumenfield) – Hypodermic Needles and Syringes: Exchange Services AB 2077 (Solorio) – Centralized Hospital Packaging Pharmacies AB 2747 (Lowenthal) – Prisoners: Pharmacy Services SB 971 (Pavley) – Bleeding Disorders: Blood Clotting Products SB 1029 (Yee) – Hypodermic Needles and Syringes

                        

       

                                                                                                   

                          

                                             

                 

                

                                           

                             

                                 

                                                    

                              

                              

                 

                                                 

                

                                             

                                             

 

Notice of Meeting and Agenda – Legislation and Regulation Committee October 19, 2010 Page 3 of 4

c. Legislation That Failed Passage SB 1390 (Corbett) – Patient‐Centered Prescription Labels AB 1455 (Hill) –Ephedrine; retail sale SB 1071 (DeSaulnier) – CURES SB 1106 (Yee) – Prescribers – Dispensing of Samples AB 2551 (Hernandez) – Pharmacy Technician: Scholarship & Loan Repayment Program AB 1310 (Hernandez) – Healing Arts Database

3. Legislation for Sponsorship During 2011‐12 Session

a. Previously‐Approved Board‐Sponsored Legislation for 2011‐2012 Section 4362 – Entry Into Pharmacists Recovery Program (Omnibus provision) Sections 4040.5, 4081 and 4126.5 – Proposal Regarding Return of Medicine to Reverse

Distributors Sections 4104, 4105 and 4112 – Enforcement Enhancements

b. Legislation for Consideration During 2011‐2012 Legislative Session Section 4200 – Pharmacist Examination (Omnibus provision) Section 4301.1 – To Allow the Board to Suspend the License of a Pharmacist or

Pharmacist Intern for a Felony Conviction for a Crime of Unprofessional Conduct

B. REGULATION REPORT Note: All section references are to Title 16 of the California Code of Regulations unless otherwise

stated 1. Discussion and Possible Action to Initiate a Rulemaking to Adopt §1707.6. – Notices to

Consumers, and to Amend §1707.2. Notice to Consumers and Duty to Consult

2. Proposal to Initiate a Rulemaking to Update 16 CCR Section 1715 Self‐Assessment of a Pharmacy by the Pharmacist‐in‐Charge and 16 CCR 1784 Self‐Assessment by a Wholesaler by the Designated Representative‐in‐Charge

3. Board Adopted Regulations – Approved by OAL New Sections 1721 and 1723.1 in Division 17 of Title 16 of the Code of Regulations Regarding Dishonest Conduct During a Pharmacist’s Licensure Exam/Confidentiality (effective 9/17/2010)

4. Board Adopted Regulations – Undergoing Administrative Review Proposed Adoption of New Section 1707.5. in Title 16 of the California Code of Regulations – Requirements For Patient‐Centered Prescription Drug Container Labels

5. Board Approved Regulations – Recently Noticed (Not for Discussion at this Committee Meeting) Proposed Amendments to § 1732.2. – Board Accredited Continuing Education

                        

       

                                                                        

        

                                           

                                  

                                      

            

                                            

                                                  

                                                 

                   

                                                          

                               

                  

                            

Notice of Meeting and Agenda – Legislation and Regulation Committee October 19, 2010 Page 4 of 4

6. Board Approved Regulations – Awaiting Notice Proposed Amendments to §1728, §1728.2, and §1793.5., and Application Forms To Require Applicants to Submit a Self‐Query from the National Practitioner Data Bank – Healthcare Integrity & Protection Data Bank (NPDB/HIPDB)

7. Regulations Under Development a. Proposed Amendments to § 1746 – Emergency Contraception Protocol b. Proposed Amendments to § 1751.9 – Accreditation Agencies for Pharmacies that

Compound Injectable Sterile Drug Products c. Proposed Amendments to § 1780 – Update the USP Standards Reference Manual

(Minimum Standards for Drug Wholesalers) [referred to subcommittee] d. Proposed Amendments to § 1785 – Self‐Assessment of a Veterinary Food‐Animal

Drug Retailer [referred to Licensing Committee]

8. Notification of Temporary Delay in Implementing New Section at Title 16 California Code of Regulation Section 1702 – Fingerprint Submissions for Pharmacists

C. First Quarterly Report on Legislation / Regulations Committee Goals for 2010/2011

D. Request for Legislative and Regulation Changes Submitted by the Public or Staff The committee will consider future legislative and regulatory proposals. Stakeholders are encouraged to submit these proposals in writing to the committee before or during the meeting.

E. Public Comment for Items Not On the Agenda* *Note: The committee may not discuss or take action on any matter raised during the Public

Comment section that is not included on this agenda, except to decide whether to place the matter on the agenda of a future meeting. Government Code Sections 11125 and 11125.7(a).

Adjournment (Note: Adjournment time is approximate) 5:00 p.m.

Committee materials will be available on the board’s Web site by October 13, 2010.

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

3

116

10

4

7

1

1

2

8

14

5

9

13

15

16

F

F

F

F

F

F

S

B

A

A

B

S

S

B

S

B

B

B

V

V

V

V

V

$

$

$

$

$

$

5

GASPUMP

?

?

Underground “B” Parking

To Sorrento ValleyCoaster Station

EMERGENCY

EleanorRoosevelt

CollegeAdministration

ThrowingField

Trackand

Field

Bui

ldin

g B

Pol

ice

SocialSciences

Sequoyah Hall

Economics

EucalyptusPoint

Media Center/Communication

ThurgoodMarshallCollege

Administration

OceanviewTerrace

Tenaya

Tioga

StewartCommons

McGill Hall

Biology

NatatoriumMain

Gymnasium

RecreationGymnasium

Pacific Hall

Blake

Argo

BeagleChallenger

Discovery

AtlantisMeteor

Galathea

WagnerDance

Building

Che Cafe

Revelle CollegeAdministration

CentralUtilitiesPlant

York Hall

Mayer Hall

BonnerHall

PetersonHall

ChemistryResearch

Cognitive Science

Bui

ldin

g D

Bui

ldin

g C

Building AMail Services

Engineering II

LiteratureWarrenLecture

Hall

Engineering I

MagneticRecordingResearch

PowellStructuralSystems

Laboratory

High BayPhysics

Laboratory

Urey Hall

Urey HallAddition

BiomedicalSciences

MedicalTeachingFacility

VisualArts

Facility

SteinClinical

Research

AshMedicalGenetics

BeechClub Med

Date

Evergreen

Fir

ClinicalResearch

StudentHealth

andWellness

CareerServices

InternationalCenter

Humanitiesand

SocialSciences

Galbraith Hall

Cedar

CenterHall

ThurgoodMarshallCollege

ResidenceHalls

Frankfurter

Canyon Vista

Black

LeichtagBiomedicalResearch

Bioengineering

NaturalSciences

Glaucoma/Retina

Main Entrance

Patientand

VisitorParking

Ratner

Great Hall

Cafe VentanasAfrica

Asia

Europe

Latin America

North America

Earth North

Earth South

Geneva

Mesa Verde

Kathmandu

Cuzco

Asante

Potiker Theatre

PharmaceuticalSciences

PepperCanyon

Hall

Matthews Apartments

Pepper Canyon Apartments

ComputerScience

andEngineering

StudentCenter B

Pool

Guava

TuolumneApartments

Plaza Cafe

ThurgoodMarshallCollegeUpper

Apartments

ThurgoodMarshallCollegeLower

Apartments

Solis Hall

Oceania

Middle East

SpanosAthleticTrainingFacility

Harlan

Stewart

Brown

Bates

Brennan

Douglas

Goldberg

FleetServices

EnvironmentalManagement

OutbackAdventures

SixthCollege

ResidenceHalls

PaladeLaboratories

Cellularand

MolecularMedicine

East

MolecularGenetics

Building 2

Building 1

Building 4

Kalmia

LaurelMagnolia

AtkinsonHall

Ivy Holly

Jacaranda

Science andEngineering Research

MandlerHall

Pool

La Jolla Institute forAllergy and Immunology,

Gemini Science

BiomedicalLibrary

Applied Physicsand Mathematics

MesaParking

Structure

3883

3891

3875

3851 3867

3859

38433827

38353819

3803

3811

37153725

3755

3775

3765

3745

3735

9172

91809184

9192

9224

9226

92289230

9232

9234

9236

9238

9240

9242

916291689176

9188 91189126

91389146

9152

9252

92569254

9248 92509260

9258 9264

92629268

9270

9266

9106

9122

9130

91349142

9156

91489160

9114

92449246

4051

40674083

4099

40914075

4059

40433991

3975

39993967

39833959

3951

3935

3943

3927

3919

3903

3911

3899

9100

9405

9350

9300

560

505

500

525

380

345

463

455 470

481

451

453

375

350

305

370

360

391390

386

325

301

435

395

397393

399

215

225

246

249

210

259

270

261 263

280 285

293

990

995

999

900

299

230250

970

392

191

123

114

113

292291

137

133

150

805

801

984

982

265

111

127

125

131

141

803

128

880

173

161

149

175

171

853

862 866

865

861

860

857

820

830

854 855

856

852851850

843

822

867

869

868

790

985

986

955

960

950

783958

965

770

771

776

777

772

774

775

773

764

762

746

747 748

788

789

731

942

711

911

720

700

930

627625

623

620

742741

610

744743

726725

719

935

600

645

640

648

655

650

601

696

695694

693692

691690

677

675 676

680

674

673

671 672

670

751

750

752

761

763

745

760758

757

756

754

753

490

3350

3750

419

420

421

422

423426

425

429

428

430440

441

443

444

445

446

447

448

361

245

804

870

871872

3855

9414

93209330

9310

177

873

780

603

602

9369

9355

9331

9321

9310

9334

9344

9350

9366

9383

9388

9393

424

442

765

226

561

611

624

678

681

697

729

728727

730

749

961

9410

9415

9416

9420

9417

821

732

962

963

klaW egdi

R

Libr

ary

Wal

k

klaW egdi

Rkla

W egdiR

klaW egdi

R

Health Sciences Walk

RevellePlaza

Warren Mall

P383

P359

P352

P394

P357

P358

P354

P310

P304

P308

P302P303

P306

P309

P501

P206

P207P208

P414

P415

P416

P203

P202

P204P205

P301

P113

P112

P108

P201P413

P606

P114

P115

P101

P116

P104

P107

P103P106

P102

P604

P608

P412

P408

P602 P406

P411

P601

P404

P508

P503

P509

P403

P505 P418

P504

P502

P510

P401

P701

P402

P752

P759

P758

P753

P703

P705

P704

P760

P756

P757

P754

P755

P751

P702

P507

P105

P405

P607

P609

P371–P376

P603

P451–P456

P353

P381–P382

P391–P393

P762

P782

P781

P783

P761

P109

P506

P605

P341–P347

P351

evirD na

mliG

evirD alloJ aL alliV

Reg

ents

Roa

d

Northpoint Drive

Genesee Avenue

daoR seni

P yerroT htroN

daoR seni

P yerroT htroN

evirD serohS alloJ aL

La Jolla Village Drive La Jolla Village Drive

La Jol

la Villa

ge Dri

ve

Reg

ents

Roa

d

Genesee Avenue

Genesee Avenue

evirD alloJ aL alliV

Gilman Drive

daoR seni

P yerroT htroN

Pangea Drive

Camp

usPo

int D

r ive

Gilm

an Drive

La Jolla Farms Road

Torrey Pines Scenic Drive

htroN evir

D sralohcS

evi rD sni kpo

H

Muir Lane

Myers D

rive

Lebo

n Dr

ive

Russell LaneScholars Lane

Medic

al Cent

er Dri

ve

enaL t ni ophtr oN

htuoS evir

D sralohcS

Revelle

College

Drive

Gilm

an D

rive

Voigt Drive

Executive Drive

Miramar Street

Medica

l Cente

r Drive

Voigt Drive

Matthews Lane

La Jolla Farms Road

Regents Park Row

Scholars Drive South

Scho

lars

Driv

eSo

uth

Osler

Lane

Campus

Point Dri

ve

Sch

olar

sD

rive

Nor

th

Sch

olar

sD

rive

Sou

ht

Salk Institute Road

enaL ecitsuJ

Equa

lityLan

e

Mandeville Lane

Lyman Lane

Voigt Dr

ive

Almahurst Row

Inte

rnat

iona

l Lan

e

Sixth LaneHealth Sciences Drive

Discovery Way

Red

woo

d D

rive

Azul Street

Poo

le S

treet

Horizon Way

Blackgold Road

Inyaha Lane

La Jolla

Shores

Drive

Torr

ey P

ines

Roa

d

rD

cine

cS a

lloJ

aL

Estancia La Jolla

Voigt Drive

Eucalyptus Grove Lane

enaL kroY trebreH

Athena Circle

evirD retne

C lacideM

Scien

ce C

enter

Driv

e

evirD sni kpo

H yaJ nhoJ

Expe

dition

Way

Muir College Drive

Rupertus

Way

Artists Lane

Engineers Lane

enaL snikpoH

Regents Road

Thurgood Marshall Lane

Rupertus Lane

Mand

ell W

eiss L

ane

PreussSchool

Thornton

Hospital PerlmanAmbulatory

Care

VisitorInformation

Center

TorreyPinesCenterSouth

TorreyPinesCenterNorth

NorthCampus

RecreationArea

PangeaParking

Structure

ExtendedStudies

andPublic

Programs

MarshallCollege

Field

GeiselLibrary

Instituteof the

Americas

FacultyClub

Chancellor’sComplex

MandevilleCenter

StudentCenter

MuirField

PriceCenter

VisitorInformation

Center

MandellWeissForum

MandellWeiss

Theatre

CanyonviewAthletics

andRecreation

WarrenField

EcologicalPark

FitnessPar

Course

VAMedicalCenter

Moores

CancerCenter

GilmanParkingStructure

La JollaPlayhouse

San DiegoSupercomputer

Center

BookDrop

ParkingOffice

RopesCourse

Shiley

Eye Center

Jacobs School of Engineering

RIMAC Arena

InternationalRelations

andPacificStudies

Bookstore

Hopkins ParkingStructure

StudentServicesCenter

Rady Schoolof

Management

NorthCampusHousing

UCSDMedical Center

La Jolla

WarrenCollege

School ofMedicine

TheatreDistrict

SixthCollege

NorthCampus

EleanorRooseveltCollege

MuirCollege

RevelleCollege

University Center

ScienceResearch

Park

ThurgoodMarshallCollege

CampusServicesComplex

CoastApartments

MesaHousing

Motorcycle Parking (M Permit Required)

S

B

A

F

$

?

Metered Parking

Accessible Parking

A Carpool Parking

B Carpool Parking

S Carpool Parking

Flexcar Parking

Permit Machine

Change Machine

ATM

Public Transit Stop

Visitor Information Center

Future Facility

V Visitor Parking

12

Stuart Collection

Transportation & Parking Services

M o v i n g i n t h e r i g h t d i r e c t i o n .

1

2

3

4

5

6

7

8

9

10

11

D E F G H I J K L M N O

1

2

3

4

5

6

7

8

9

10

11

D E F G H I J K L M N O

P357

P351

11/2007

lkcrossCallout3. Skaggs School of Pharmacy & Pharmaceutical Sciences

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossRectangle

lkcrossRectangle

lkcrossRectangle

lkcrossTypewritten TextConstruction

lkcrossLine

lkcrossRectangle

lkcrossLine

lkcrossRectangle

lkcrossRectangle

lkcrossLine

lkcrossTypewritten TextNew Structure

lkcrossRectangle

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossLine

lkcrossRectangle

lkcrossCallout2. Park in "V" White Visitor Spots

lkcrossOval

lkcrossCallout1. Purchase $6.00 Parking Permit Here

lkcrossLine

rxvpereTypewritten TextLa Jolla Village Drive

Agenda