AB 2605,
as amended, Bonilla. begin deletePharmacy: sterile drug products. end deletebegin insertPharmacy: third-party logistics providers.end insert
(1) Under the Pharmacy Law, a violation of which is a crime, the California State Board of Pharmacy licenses and regulates the practice of pharmacy. Existing law restricts the purchase, trade, sale, or transfer of dangerous drugs or dangerous devices, as defined, to licensed wholesalers and other authorized persons. Under the Pharmacy Law, the board licenses and regulates entities, including third-party logistics providers, as wholesalers. The Pharmacy Law defines a “third-party logistics provider” or a “reverse third-party logistics provider” as an entity licensed as a wholesaler that contracts with a dangerous drug manufacturer to provide or coordinate warehousing, distribution, or other similar services on behalf of a manufacturer, but for which there is no change of ownership in the dangerous drugs.
end insertbegin insertThis bill would delete from the definition of “third-party logistics provider” or “reverse third-party logistics provider” the requirement that the entity be a licensed wholesaler, and would require a third-party logistics provider of a dangerous drug or dangerous device to be separately licensed by the board as a third-party logistics provider.
end insertbegin insert(2) The Pharmacy Law requires a person located outside this state that ships, sells, mails, or delivers dangerous drugs or dangerous devices into this state, or sells, brokers, or distributes dangerous drugs or devices within this state to be a licensed nonresident wholesaler.
end insertbegin insertThis bill would, in addition, require a person located outside this state that performs those actions or that warehouses or distributes dangerous drugs or dangerous devices into this state, or warehouses dangerous drugs or devices within this state to be licensed as either a nonresident wholesaler or a nonresident third-party logistics provider. The bill would make conforming changes, and would delete obsolete cross-references and provisions.
end insertbegin insert(3) Existing law sets the fees for the issuance and renewal of licenses for wholesalers and designated representatives at specified amounts and authorizes those fees to be increased to specified higher amounts.
end insertbegin insertThis bill would instead set the fees at the higher amounts.
end insertbegin insert(4) Because a violation of the requirements described in paragraphs (1) and (2) above would be a crime, the bill would impose a state-mandated local program.
end insertbegin insertThe California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
end insertbegin insertThis bill would provide that no reimbursement is required by this act for a specified reason.
end insertThe Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. Existing law requires an applicant for licensure to have, among other things, passed specified national and state examinations. Existing law requires the examination process to be regularly reviewed, as specified, and to meet certain national testing standards. Existing law requires the board to report to the Joint Committee on Boards, Commissions, and Consumer Protection and the Department of Consumer Affairs, as part of its next scheduled review, the pass rates of applicants who sat for the national examination compared with the pass rates of applicants who sat for the prior state examination, as specified.
end deleteThis bill would instead require the board to report the pass rate information described above to the appropriate policy committees of the Legislature and the department.
end deleteVote: majority.
Appropriation: no.
Fiscal committee: begin deleteno end deletebegin insertyesend insert.
State-mandated local program: begin deleteno end deletebegin insertyesend insert.
The people of the State of California do enact as follows:
begin insertSection 4022.5 of the end insertbegin insertBusiness and Professions
2Codeend insertbegin insert is amended to read:end insert
(a) “Designated representative” means an individual
4to whom a license has been granted pursuant to Section 4053. A
5pharmacist fulfilling the duties of Section 4053 shall not be
6required to obtain a license as a designated representative.
7(b) “Designated representative-in-charge” means a designated
8representative or a pharmacist proposed by abegin delete wholesalerend delete
9begin insert wholesaler, third-party logistics provider,end insert or veterinary
10food-animal drug retailer and approved by the board as the
11supervisor or manager responsible for ensuring thebegin delete wholesaler’send delete
12begin insert compliance of the wholesaler, third-party logistics provider,end insert or
13veterinary food-animal drugbegin delete retailer’s complianceend deletebegin insert retailerend insert with all
14state and federal laws and regulations pertaining to practice in the
15applicable license category.
begin insertSection 4040.5 of the end insertbegin insertBusiness and Professions Codeend insert
17begin insert is amended to read:end insert
“Reverse distributor” means every person who acts as
19an agent for pharmacies, drug wholesalers,begin insert third-party logistics
20providers,end insert manufacturers, and other entities by receiving,
21inventorying,begin insert warehousing,end insert and managing the disposition of
22outdated orbegin delete nonsalableend deletebegin insert nonsaleableend insert dangerous drugs.
begin insertSection 4043 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
24amended to read:end insert
begin delete(a)end deletebegin delete end delete“Wholesaler” means and includes a person who acts
26as a wholesale merchant, broker, jobber, customs broker, reverse
27distributor, agent, or a nonresident wholesaler, who sells for resale,
28or negotiates for distribution, or takes possession of, any drug or
29device included in Section 4022. Unless otherwise authorized by
P4 1law, a wholesaler may not store, warehouse, or authorize the
2storage or warehousing of drugs with any person or at any location
3not licensed by the board.
4(b) This section shall become operative January 1, 2006.
end delete
begin insertSection 4045 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
6amended to read:end insert
“Third-party logistics provider” or “reverse third-party
8logistic provider” meansbegin delete an entityend deletebegin delete licensed as a wholesalerend deletebegin insert an
9entityend insert that contracts with a dangerous drug manufacturer to provide
10or coordinate warehousing, distribution, or other similar services
11on behalf of a manufacturer, but for which there is no change of
12ownership in the dangerous drugs.begin delete For purposes of Sections 4034,
134163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, a third-party
14logistics provider shall not be responsible for generating or
15updating pedigree documentation, but shall maintain copies of the
16pedigree.end deletebegin delete To be exempt from documentation for pedigrees, a
17reverse third-party logistic provider may only accept
18decommissioned drugs from pharmacies or wholesalers.end delete
begin insertSection 4053 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
20amended to read:end insert
(a) Notwithstanding Section 4051, the board may issue
22a license as a designated representative to provide sufficient and
23qualified supervision in abegin delete wholesalerend deletebegin insert wholesaler, third-party
24logistics provider,end insert or veterinary food-animal drug retailer. The
25designated representative shall protect the public health and safety
26in the handling, storage,begin insert warehousing, distribution,end insert and shipment
27of dangerous drugs and dangerous devices in thebegin delete wholesalerend delete
28begin insert wholesaler, third-party logistics provider,end insert or veterinary
29food-animal drug retailer.
30(b) An individualbegin insert who is at least 18 years of ageend insert may apply for
31a designated representative license. In order to obtain and maintain
32that license, the individual shall meet all of the following
33requirements:
34(1) He or she shall be a high school graduate or possess a general
35education development certificate equivalent.
36(2) He or she shall have a minimum of one year of paid work
37experience in a licensed pharmacy, or with a drug wholesaler,
38begin insert
third-party logistics provider,end insert drug distributor, or drug
39manufacturer, in the past three years, related to the distribution or
40dispensing of dangerous drugs or dangerous devices or meet all
P5 1of the prerequisites to take the examination required for licensure
2as a pharmacist by the board.
3(3) He or she shall complete a training program approved by
4the board that, at a minimum, addresses each of the following
5subjects:
6(A) Knowledge and understanding of California law and federal
7law relating to the distribution of dangerous drugs and dangerous
8devices.
9(B) Knowledge and understanding of California law and federal
10law relating to the distribution of controlled substances.
11(C) Knowledge and understanding of quality control systems.
12(D) Knowledge and understanding of the United States
13Pharmacopoeia standards relating to the safe storage and handling
14of drugs.
15(E) Knowledge and understanding of prescription terminology,
16abbreviations, dosages, and format.
17(4) The board may, by regulation, require training programs to
18include additional material.
19(5) The boardbegin delete mayend deletebegin insert shallend insert not issue a license as a designated
20representative until the applicant provides proof of completion of
21the required training to the board.
22(c) Thebegin insert wholesaler, third-party logistics provider, orend insert veterinary
23food-animal drug retailerbegin delete or wholesalerend delete shall not operate without
24a pharmacist or a designated representative on its premises.
25(d) Only a pharmacist or a designated representative shall
26prepare and affix the label to veterinary food-animal drugs.
27(e) Section 4051 shall not apply to any laboratory licensed under
28Section 351 of Title III of the Public Health Service Act (Public
29Law 78-410).
begin insertSection 4060 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
31amended to read:end insert
A person shall not possess any controlled substance,
33except that furnished to a person upon the prescription of a
34physician, dentist, podiatrist, optometrist, veterinarian, or
35naturopathic doctor pursuant to Section 3640.7, or furnished
36pursuant to a drug order issued by a certified nurse-midwife
37pursuant to Section 2746.51, a nurse practitioner pursuant to
38Section 2836.1, a physician assistant pursuant to Section 3502.1,
39a naturopathic doctor pursuant to Section 3640.5, or a pharmacist
40pursuant to Section 4052.1, 4052.2, or 4052.6. This section does
P6 1not apply to the possession of any controlled substance by a
2manufacturer, wholesaler,begin insert third-party logistics provider,end insert pharmacy,
3pharmacist, physician, podiatrist, dentist, optometrist, veterinarian,
4
naturopathic doctor, certified nurse-midwife, nurse practitioner,
5or physician assistant, if in stock in containers correctly labeled
6with the name and address of the supplier or producer.
7This section does not authorize a certified nurse-midwife, a nurse
8practitioner, a physician assistant, or a naturopathic doctor, to order
9his or her own stock of dangerous drugs and devices.
begin insertSection 4081 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
11amended to read:end insert
(a) All records of manufacture and of sale, acquisition,
13or disposition of dangerous drugs or dangerous devices shall be
14at all times during business hours open to inspection by authorized
15officers of the law, and shall be preserved for at least three years
16from the date of making. A current inventory shall be kept by every
17manufacturer, wholesaler,begin insert third-party logistics provider,end insert pharmacy,
18veterinary food-animal drug retailer, physician, dentist, podiatrist,
19veterinarian, laboratory, clinic, hospital, institution, or
20establishment holding a currently valid and unrevoked certificate,
21license, permit, registration, or exemption under Division 2
22(commencing with Section 1200) of the Health and Safety Code
23or under Part 4
(commencing with Section 16000) of Division 9
24of the Welfare and Institutions Code who maintains a stock of
25dangerous drugs or dangerous devices.
26(b) The owner, officer, and partner of a pharmacy, wholesaler,
27begin insert third-party logistics provider,end insert or veterinary food-animal drug
28retailer shall be jointly responsible, with the pharmacist-in-charge
29or designated representative-in-charge, for maintaining the records
30and inventory described in this section.
31(c) The pharmacist-in-charge or designated
32representative-in-charge shall not be criminally responsible for
33acts of the owner, officer, partner, or employee that violate this
34section and of which the pharmacist-in-charge or designated
35representative-in-charge had no knowledge, or in which he or she
36did not knowingly
participate.
begin insertSection 4101 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
38amended to read:end insert
(a) A pharmacist may take charge of and act as the
40pharmacist-in-charge of a pharmacy upon application by the
P7 1pharmacy and approval by the board. Any pharmacist-in-charge
2who ceases to act as the pharmacist-in-charge of the pharmacy
3shall notify the board in writing within 30 days of the date of that
4change in status.
5(b) A designated representative or a pharmacist may take charge
6of, and act as, the designated representative-in-charge of a
7begin delete wholesalerend deletebegin insert wholesaler, third-party logistics provider,end insert or veterinary
8food-animal drug retailer upon application by thebegin delete wholesalerend delete
9begin insert wholesaler, third-party logistics provider,end insert or veterinary
10food-animal drug retailer and approval by the board. Any
11designated representative-in-charge who ceases to act as the
12designated representative-in-charge at that entity shall notify the
13board in writing within 30 days of the date of that change in status.
begin insertSection 4105 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
15amended to read:end insert
(a) All records or other documentation of the acquisition
17and disposition of dangerous drugs and dangerous devices by any
18entity licensed by the board shall be retained on the licensed
19premises in a readily retrievable form.
20(b) The licensee may remove the original records or
21documentation from the licensed premises on a temporary basis
22for license-related purposes. However, a duplicate set of those
23records or other documentation shall be retained on the licensed
24premises.
25(c) The records required by this section shall be retained on the
26licensed premises for a period of three years from the date of
27making.
28(d) Any records that are
maintained electronically shall be
29maintained so that the pharmacist-in-charge, the pharmacist on
30duty if the pharmacist-in-charge is not on duty, or, in the case of
31a veterinary food-animal drugbegin delete retailer orend deletebegin insert retailer,end insert wholesaler,
32begin insert third-party logistics provider, orend insert the designated representative on
33duty, shall, at all times during which the licensed premises are
34open for business, be able to produce a hardcopy and electronic
35copy of all records of acquisition or disposition or other drug or
36dispensing-related records maintained electronically.
37(e) (1) Notwithstanding subdivisions (a), (b), and (c), the board,
38may upon written request, grant to a licensee a waiver of the
39requirements that the records described in subdivisions (a), (b),
40and (c) be kept on the licensed premises.
P8 1(2) A
waiver granted pursuant to this subdivision shall not affect
2the board’s authority under this section or any other provision of
3this chapter.
4(f) When requested by an authorized officer of the law or by an
5authorized representative of the board, the owner, corporate officer,
6or manager of an entity licensed by the board shall provide the
7board with the requested records within three business days of the
8time the request was made. The entity may request in writing an
9extension of this timeframe for a period not to exceed 14 calendar
10days from the date the records were requested. A request for an
11extension of time is subject to the approval of the board. An
12extension shall be deemed approved if the board fails to deny the
13extension request within two business days of the time the
14extension request was made directly to the board.
begin insertSection 4120 of the end insertbegin insertBusiness and Professions Codeend insert
16begin insert is amended to read:end insert
(a) A nonresident pharmacy shall not sell or distribute
18dangerous drugs or dangerous devices in this state through any
19person or media other than a wholesalerbegin insert or third-party logistics
20providerend insert who has obtained a license pursuant to this chapter or
21through a selling or distribution outlet that is licensed as a
22wholesalerbegin insert or third-party logistics providerend insert pursuant to this chapter
23without registering as a nonresident pharmacy.
24(b) Applications for a nonresident pharmacy registration shall
25be made on a form furnished
by the board. The board may require
26any information as the board deems reasonably necessary to carry
27out the purposes of this section.
28(c) The Legislature, by enacting this section, does not intend a
29license issued to any nonresident pharmacy pursuant to this section
30to change or affect the tax liability imposed by Chapter 3
31(commencing with Section 23501) of Part 11 of Division 2 of the
32Revenue and Taxation Code on any nonresident pharmacy.
33(d) The Legislature, by enacting this section, does not intend a
34license issued to any nonresident pharmacy pursuant to this section
35to serve as any evidence that the nonresident pharmacy is doing
36business within this state.
begin insertSection 4126 of the end insertbegin insertBusiness and Professions Codeend insert
38begin insert is amended to read:end insert
(a) Notwithstanding any otherbegin delete provision ofend delete law, a
40covered entity may contract with a pharmacy to provide pharmacy
P9 1services to patients of the covered entity, as defined in Section
2256b of Title 42 of the United States Code, including dispensing
3preferentially priced drugs obtained pursuant to Section 256b of
4Title 42 of the United States Code. Contracts between those
5covered entities and pharmacies shall comply with guidelines
6published by the Health Resources and Services Administration
7and shall be available for inspection by board staff during normal
8business hours.
9(b) Drugs purchased pursuant to Section 256b of Title 42 of the
10United States Code and received by a pharmacy shall be segregated
11from the pharmacy’s other drug stock by either physical or
12electronic means. All records of acquisition and disposition of
13these drugs shall be readily retrievable in a form separate from the
14pharmacy’s other records.
15(c) Drugs obtained by a pharmacy to be dispensed to patients
16of a covered entity pursuant to Section 256b of Title 42 of the
17United States Code that cannot be distributed because of a change
18in circumstances for the covered entity or the pharmacy shall be
19returned to the distributor from which they were obtained. For the
20purposes of this section, a change in circumstances includes, but
21is not limited to, the termination or expiration of the contract
22between the pharmacy and the covered entity, the closure of a
23pharmacy, disciplinary action against the pharmacy, or closure of
24the covered entity.
25(d) A licensee that participates in a contract to dispense
26preferentially priced drugs pursuant to this section shall not have
27both a pharmacy and a wholesalerbegin insert license, or both a pharmacy
28and a third-party
logistics providerend insert license.
29(e) Neither a covered entity nor a pharmacy shall be required
30to obtain a license as a wholesalerbegin insert or a third-party logistics
31providerend insert based on acts reasonably necessary to fully participate
32in the drug purchase program established by Section 256b of Title
3342 of the United States Code.
begin insertSection 4149 of the end insertbegin insertBusiness and Professions Codeend insert
35begin insert is amended to read:end insert
(a) A nonresident distributor shall not sell or distribute
37hypodermic needles or syringes in this state without obtaining a
38license from the board pursuant to Section 4141.
39(b) Notwithstanding subdivision (a),begin delete noend deletebegin insert aend insert licensebegin delete shall beend deletebegin insert is notend insert
40 required if the nonresident distributor sells or distributes solely
P10 1through a person who is licensed as a wholesalerbegin insert or third-party
2logistics providerend insert pursuant to Section 4160.
3(c) The Legislature, by enacting this section, does not intend a
4license issued to any nonresident distributor pursuant to this article
5to serve as evidence that the entity is doing business within this
6state.
begin insertThe heading of Article 11 (commencing with Section
84160) of Chapter 9 of Division 2 of the end insertbegin insertBusiness and Professions
9Codeend insertbegin insert is amended to read:end insert
10
begin insertSection 4160 of the end insertbegin insertBusiness and Professions Codeend insert
15begin insert is amended to read:end insert
(a) A personbegin delete mayend deletebegin insert shallend insert not act as a wholesalerbegin insert or
17third-party logistics providerend insert of any dangerous drug or dangerous
18device unless he or she has obtained a license from the board.
19(b) Upon approval by the board and the payment of the required
20fee, the board shall issue a license to the applicant.
21(c) A separate license shall be required for each place of business
22owned or operated by abegin delete wholesaler.end deletebegin insert wholesaler or third-party
23logistics provider.end insert Each license shall be renewed annually and
24shall not be transferable.
25(d) Every wholesalerbegin insert or third-party logistics providerend insert shall be
26supervised or managed by a designated representative-in-charge.
27The designated representative-in-charge shall be responsible for
28thebegin delete wholesaler’send delete compliancebegin insert of the wholesaler or third-party
29logistics providerend insert with state and federal laws governing
30begin delete wholesalers.end deletebegin insert wholesalers and third-party logistics providers.end insert As
31part of its initial application for a license, and for each renewal,
32each wholesalerbegin insert or third-party logistics providerend insert shall, on a form
33designed by the board, provide identifying information and the
34California license number for a designated representative or
35pharmacist proposed to serve as the designated
36representative-in-charge. The proposed designated
37representative-in-charge shall be subject to approval by the board.
38The board shall not issue or renew a wholesalerbegin insert or third-party
39logistics providerend insert license without identification of an approved
P11 1designated
representative-in-charge for thebegin delete wholesaler.end deletebegin insert wholesaler
2or third-party logistics provider.end insert
3(e) begin deleteEvery end deletebegin insertA end insertwholesalerbegin insert or third-party logistics providerend insert shall
4notify the board in writing, on a form designed by the board, within
530 days of the date when a designated representative-in-charge
6ceases to act as the designated representative-in-charge, and shall
7on the same form propose another designated representative or
8pharmacist to take over as the designated representative-in-charge.
9The proposed replacement designated
representative-in-charge
10shall be subject to approval by the board. If disapproved, the
11wholesalerbegin insert or third-party logistics providerend insert shall propose another
12replacement within 15 days of the date of disapproval, and shall
13continue to name proposed replacements until a designated
14representative-in-charge is approved by the board.
15(f) A drug manufacturer premises licensed by the Food and
16Drug Administration or licensed pursuant to Section 111615 of
17the Health and Safety Code that only distributes dangerous drugs
18and dangerous devices of its own manufacture is exempt from this
19section and Section 4161.
20(g) The board may issue a temporary license, upon conditions
21and for periods of time as the board determines to be in the public
22interest. A temporary license fee shall be required
in an amount
23established by the board as specified in subdivision (f) of Section
244400. When needed to protect public safety, a temporary license
25may be issued for a period not to exceed 180 days, subject to terms
26and conditions that the board deems necessary. If the board
27determines that a temporary license was issued by mistake or denies
28the application for a permanent license, the temporary license shall
29terminate upon either personal service of the notice of termination
30upon the licenseholder or service by certified mail, return receipt
31requested, at the licenseholder’s address of record with the board,
32whichever occurs first. Neither for purposes of retaining a
33temporary license, nor for purposes of any disciplinary or license
34denial proceeding before the board, shall the temporary
35licenseholder be deemed to have a vested property right or interest
36in the license.
begin insertSection 4161 of the end insertbegin insertBusiness and Professions Codeend insert
38begin insert is amended to read:end insert
(a) A person located outside this state that (1) ships,
40sells, mails,begin insert warehouses, distributes,end insert or delivers dangerous drugs
P12 1or dangerous devices into this state or (2) sells, brokers,
2begin insert warehouses,end insert or distributes dangerous drugs or devices within this
3state shall be considered a nonresidentbegin delete wholesaler.end deletebegin insert wholesaler or
4a nonresident third-party logistics provider.end insert
5(b) A nonresident wholesalerbegin insert or nonresident third-party logistics
6providerend insert shall be licensed by the board prior to shipping, selling,
7mailing,begin insert warehousing, distributing,end insert or delivering dangerous drugs
8or dangerous devices to a site located in this state or selling,
9brokering,begin insert warehousing,end insert or distributing dangerous drugs or devices
10within this state.
11(c) A separate license shall be required for each place of business
12owned or operated by a nonresident wholesalerbegin insert or nonresident
13third-party logistics providerend insert from or through which dangerous
14drugs or dangerous devices are shipped, sold, mailed,begin insert warehoused,
15distributed,end insert or delivered to a site located in this state or sold,
16brokered,begin insert warehoused,end insert or distributed within this state. A license
17shall be renewed annually and shall not be transferable.
18(d) The following information shall be reported, in writing, to
19the board at the time of initial application for licensure by a
20
nonresidentbegin delete wholesaler,end deletebegin insert wholesaler or a nonresident third-party
21logistics provider,end insert on renewal of a nonresident wholesalerbegin insert or
22nonresident third-party logistics providerend insert license, or within 30
23days of a change in that information:
24(1) Its agent for service of process in this state.
25(2) Its principal corporate officers, as specified by the board, if
26any.
27(3) Its general partners, as specified by the board, if any.
28(4) Its owners if the applicant is not a corporation or partnership.
29(e) A report containing the information in subdivision (d) shall
30be made within 30 days of any change of ownership, office,
31corporate officer, or partner.
32(f) A nonresident wholesalerbegin insert or nonresident third-party logistics
33providerend insert shall comply with all directions and requests for
34information from the regulatory or licensing agency of the state
35in which it is licensed, as well as with all requests for information
36made by the board.
37(g) A nonresident wholesalerbegin insert or nonresident third-party logistics
38providerend insert shall maintain records of dangerous drugs and dangerous
39devices sold, traded,begin insert
transferred, warehoused,end insert orbegin delete transferredend delete
P13 1begin insert distributedend insert to persons in this state or within this state, so that the
2records are in a readily retrievable form.
3(h) A nonresident wholesalerbegin insert or nonresident third-party logistics
4providerend insert shall at all times maintain a valid, unexpired license,
5permit, or registration to conduct the business of the wholesaler
6begin insert or nonresident third-party logistics providerend insert in compliance with
7the laws of the state in which it is a resident. An application for a
8nonresident wholesalerbegin insert or nonresident
third-party logistics providerend insert
9 license in this state shall include a license verification from the
10licensing authority in the applicant’s state of residence.
11(i) The boardbegin delete mayend deletebegin insert shallend insert not issue or renew a nonresident
12wholesalerbegin insert or nonresident third-party logistics providerend insert license
13until the nonresident wholesalerbegin insert or nonresident third-party logistics
14providerend insert identifies a designated representative-in-charge and
15notifies the board in writing of the identity and license number of
16the designated representative-in-charge.
17(j) The designated representative-in-charge shall be responsible
18for thebegin insert compliance of theend insert nonresidentbegin delete wholesaler’s complianceend delete
19begin insert wholesaler or nonresident third-party logistics providerend insert with state
20and federal laws governingbegin delete wholesalers.end deletebegin insert wholesalers and
21third-party logistics providers.end insert A nonresident wholesalerbegin insert or
22nonresident third-party logistics providerend insert shall identify and notify
23the board of a new designated representative-in-charge within 30
24days of the date that the prior designated representative-in-charge
25ceases to be the designated representative-in-charge.
26(k) The board may issue a temporary license, upon conditions
27and for periods of time as the board determines to be in the public
28interest. A temporary license fee shall be five hundred fifty dollars
29($550) or another amount established by the board not to exceed
30the annual fee for renewal of a license to compound injectable
31sterile drug
products. When needed to protect public safety, a
32temporary license may be issued for a period not to exceed 180
33days, subject to terms and conditions that the board deems
34necessary. If the board determines that a temporary license was
35issued by mistake or denies the application for a permanent license,
36the temporary license shall terminate upon either personal service
37of the notice of termination upon the licenseholder or service by
38certified mail, return receipt requested, at the licenseholder’s
39address of record with the board, whichever occurs first. Neither
40for purposes of retaining a temporary license, nor for purposes of
P14 1any disciplinary or license denial proceeding before the board,
2shall the temporary licenseholder be deemed to have a vested
3property right or interest in the license.
4(l) The registration fee shall be the fee specified in subdivision
5(f) of Section 4400.
begin insertSection 4162 of the end insertbegin insertBusiness and Professions Codeend insert
7begin insert is amended to read:end insert
(a) (1) Anbegin delete applicant, that is not a government owned begin insert applicantend insert for the issuance or renewal of
9and operated wholesaler,end delete
10a wholesalerbegin delete licenseend deletebegin insert or third-party logistics provider license, which
11is not government owned and operated,end insert shall submit a surety bond
12of one hundred thousand dollars ($100,000) or other equivalent
13means of security acceptable to the board payable to the Pharmacy
14Board Contingent Fund. The purpose of the surety bond is to secure
15payment of any administrative fine imposed by the board and any
16cost recovery ordered pursuant to Section 125.3.
17(2) For purposes of paragraph (1), the board may accept a surety
18bond less than one hundred thousand dollars ($100,000) if the
19annual gross receipts of the previous tax year for the wholesaler
20begin insert or third-party logistics providerend insert is ten million dollars
($10,000,000)
21or less, in which case the surety bond shall be twenty-five thousand
22dollars ($25,000).
23(3) A person to whom an approved new drug application has
24been issued by the United States Food and Drug Administration
25who engages in the wholesale distribution of only the dangerous
26drug specified in the new drug application, and is licensed or
27applies for licensure as abegin delete wholesaler,end deletebegin insert wholesaler or third-party
28logistics provider,end insert shall not be required to post a surety bond as
29provided in paragraph (1).
30(4) For licensees subject to paragraph (2) or (3), the board may
31require a bond up to one hundred thousand dollars ($100,000) for
32any licensee who has been disciplined by any state or federal
33agency or has been issued an administrative fine pursuant to this
34chapter.
35(b) The board may make a claim against the bond if the licensee
36fails to pay a fine within 30 days after the order imposing the fine,
37or costs become final.
38(c) A single surety bond or other equivalent means of security
39acceptable to the board shall satisfy the
requirement of subdivision
P15 1 (a) for all licensed sites under common control as defined in
2Section 4126.5.
begin insertSection 4162.5 of the end insertbegin insertBusiness and Professions Codeend insert
4begin insert is amended to read:end insert
(a) (1) An applicant for the issuance or renewal of a
6nonresident wholesalerbegin insert or third-party logistics providerend insert license
7shall submit a surety bond of one hundred thousand dollars
8($100,000), or other equivalent means of security acceptable to
9the board, such as an irrevocable letter of credit, or a deposit in a
10trust account or financial institution, payable to the Pharmacy
11Board Contingent Fund. The purpose of the surety bond is to secure
12payment of any administrative fine imposed by the board and any
13cost recovery ordered pursuant to Section 125.3.
14(2) For purposes of paragraph (1), the board may
accept a surety
15bond less than one hundred thousand dollars ($100,000) if the
16annual gross receipts of the previous tax year for the nonresident
17wholesalerbegin insert or third-party logistics providerend insert is ten million dollars
18($10,000,000) orbegin delete lessend deletebegin insert less,end insert in whichbegin insert caseend insert the surety bond shall be
19twenty-five thousand dollars ($25,000).
20(3) For applicants who satisfy paragraph (2), the board may
21require a bond up to one hundred thousand dollars ($100,000) for
22any nonresident wholesalerbegin insert or third-party logistics providerend insert who
23has been disciplined by any state or federal agency or has been
24issued an administrative fine pursuant to this chapter.
25(4) A person to whom an approved new drug application or a
26biologics license application has been issued by the
United States
27Food and Drug Administration who engages in the wholesale
28distribution of only the dangerous drug specified in the new drug
29application or biologics license application, and is licensed or
30applies for licensure as a nonresidentbegin delete wholesaler,end deletebegin insert wholesaler or
31third-party logistics provider,end insert shall not be required to post a surety
32bond as provided in this section.
33(b) The board may make a claim against the bond if the licensee
34fails to pay a fine within 30 days of the issuance of the fine or
35when the costs become final.
36(c) A single surety bond or other equivalent means of security
37acceptable to the board shall satisfy the requirement of subdivision
38(a) for all licensed sites under common control as defined in
39Section 4126.5.
begin insertSection 4164 of the end insertbegin insertBusiness and Professions Codeend insert
2begin insert is amended to read:end insert
(a) A wholesalerbegin insert or third-party logistics providerend insert
4 licensed by the board that distributes controlled substances,
5dangerous drugs, or dangerous devices within or into this state
6shall report to the board allbegin delete salesend deletebegin insert distributionsend insert of dangerous drugs
7and controlled substances that are subject to abuse, as determined
8by the board.
9(b) Each wholesaler shall develop and maintain a system for
10tracking individual sales of dangerous drugs at preferential or
11contract prices to pharmacies that primarily or solely dispense
12prescription drugs to patients of long-term care facilities. The
13system shall be capable of identifying purchases of any dangerous
14drug at preferential or contract prices by customers that vary
15significantly from prior ordering patterns for the same customer,
16including by identifying purchases in the preceding 12 calendar
17months by that customer or similar customers and identifying
18current purchases that exceed prior purchases by either that
19customer or similar customers by a factor
of 20 percent.begin delete Each
20wholesaler shall have the tracking system required by this
21subdivision in place no later than January 1, 2006.end delete
22(c) Upon written, oral, or electronic request by the board, a
23wholesaler shall furnish data tracked pursuant to subdivision (b)
24to the board in written, hardcopy, or electronic form. The board
25shall specify the dangerous drugs, the customers, or both the
26dangerous drugs and customers for which data are to be furnished,
27and the wholesaler shall have 30 calendar days to comply with the
28request.
29(d) As used in this section, “preferential or contract prices”
30means and refers to purchases by contract of dangerous drugs at
31prices below the market wholesale price for those drugs.
32(e) This section shall become operative on January 1, 2006.
end delete
begin insertSection 4165 of the end insertbegin insertBusiness and Professions Codeend insert
34begin insert is amended to read:end insert
A wholesalerbegin insert or third-party logistics providerend insert licensed
36by the board who sells or transfers any dangerous drug or
37dangerous device into this state or who receives, by sale or
38otherwise, any dangerous drug or dangerous device from any
39person in this state shall, on request, furnish an authorized officer
P17 1of the law with all records or other documentation of that sale or
2transfer.
begin insertSection 4166 of the end insertbegin insertBusiness and Professions Codeend insert
4begin insert is amended to read:end insert
(a) Any wholesaler that uses the services of any
6begin insert third-party logistics provider orend insert carrier, including, but not limited
7to, the United States Postal Service or any common carrier, shall
8be liable for the security and integrity of any dangerous drugs or
9dangerous devices through thatbegin insert provider orend insert carrier until the drugs
10or devices are delivered to the transferee at its board-licensed
11premises.
12(b) Nothing in this section is intended to affect the liability of
13abegin delete wholesalerend deletebegin insert wholesaler, third-party logistics provider,end insert or other
14distributor for dangerous drugs or dangerous devices after their
15delivery to the transferee.
begin insertSection 4167 of the end insertbegin insertBusiness and Professions Codeend insert
17begin insert is amended to read:end insert
A wholesalerbegin insert or third-party logistics providerend insert shall not
19obtain, by purchase or otherwise, any dangerous drugs or dangerous
20devices that it cannot maintain, in a secure manner, on the premises
21licensed by the board.
begin insertSection 4168 of the end insertbegin insertBusiness and Professions Codeend insert
23begin insert is amended to read:end insert
A county or municipalitybegin delete mayend deletebegin insert shallend insert not issue a business
25license for any establishment that requires a wholesalerbegin insert or
26third-party logistics providerend insert license unless the establishment
27possesses a current wholesalerbegin insert or third-party logistics providerend insert
28 license issued by the board. For purposes of this section, an
29“establishment” is the licensee’s physical location in California.
begin insertSection 4169 of the end insertbegin insertBusiness and Professions Codeend insert
31begin insert is amended to read:end insert
(a) A person or entitybegin delete mayend deletebegin insert shallend insert not do any of the
33following:
34(1) Purchase, trade, sell,begin insert warehouse, distribute,end insert or transfer
35dangerous drugs or dangerous devices at wholesale with a person
36or entity that is not licensed with the board as abegin delete wholesalerend delete
37begin insert wholesaler, third-party logistics provider,end insert or pharmacy.
38(2) Purchase, trade, sell, or transfer dangerous drugs that the
39person knew or reasonably should have known were adulterated,
P18 1as set forth in Article 2 (commencing with Section 111250) of
2Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.
3(3) Purchase, trade, sell, or transfer dangerous drugs that the
4person knew or reasonably should have known were misbranded,
5as defined in Section 111335 of the Health and Safety Code.
6(4) Purchase, trade, sell, or transfer dangerous drugs or
7dangerous devices after the beyond use date on the label.
8(5) Fail to maintain records of the acquisition or disposition of
9dangerous drugs or dangerous devices for at least three years.
10(b) Notwithstanding any otherbegin delete provision ofend delete law, a violation of
11this sectionbegin delete or of subdivision (c) or (d) of Section 4163end delete may subject
12the person or entity that has committed the violation to a fine not
13to exceed the amount specified in Section 125.9 for each
14occurrence, pursuant to a citation issued by the board.
15(c) Amounts due from any person under this section shall be
16offset as provided under Section 12419.5 of the Government Code.
17Amounts received by the board under this section shall be deposited
18into the Pharmacy Board Contingent Fund.
19(d) This section shall not apply to a pharmaceutical manufacturer
20licensed by the Food and Drug Administration or by the State
21Department of Public Health.
begin insertSection 4201 of the end insertbegin insertBusiness and Professions Codeend insert
23begin insert is amended to read:end insert
(a) Each application to conduct a pharmacy, wholesaler,
25begin insert third-party logistics provider,end insert or veterinary food-animal drug
26retailer, shall be made on a form furnished by the board, and shall
27state the name, address, usual occupation, and professional
28qualifications, if any, of the applicant. If the applicant is other than
29a natural person, the application shall state the information as to
30each person beneficially interested therein.
31(b) As used in this section, and subject to subdivision (c), the
32term “person beneficially interested” means and includes:
33(1) If
the applicant is a partnership or other unincorporated
34association, each partner or member.
35(2) If the applicant is a corporation, each of its officers, directors,
36and stockholders, provided that no natural person shall be deemed
37to be beneficially interested in a nonprofit corporation.
38(3) If the applicant is a limited liability company, each officer,
39manager, or member.
P19 1(c) begin deleteIn any case where end deletebegin insertIf end insertthe applicant is a partnership or other
2unincorporated association,begin delete isend delete a limited liability company, orbegin delete isend delete a
3corporation, andbegin delete whereend delete the number of partners, members, or
4stockholders, as the case may be, exceeds five, the application
5shall so state, and shall further state the information required by
6subdivision (a) as to each of the five partners, members, or
7stockholders who own the five largest interests in the applicant
8entity. Upon request by the executive officer, the applicant shall
9furnish the board with the information required by subdivision (a)
10as to partners, members, or stockholders not named in the
11application, or shall refer the board to an appropriate source of
12that information.
13(d) The application shall contain a statement to the effect that
14the applicant has not been convicted of a felony and has not
15violated any of the provisions of this chapter. If the applicant
16cannot make this statement, the application shall contain a
17statement of the violation, if any, or reasons which will prevent
18the
applicant from being able to comply with the requirements
19with respect to the statement.
20(e) Upon the approval of the application by the board and
21payment of the fee required by this chapter for each pharmacy,
22wholesaler,begin insert third-party logistics provider,end insert or veterinary food-animal
23drug retailer, the executive officer of the board shall issue a license
24to conduct a pharmacy, wholesaler,begin insert third-party logistics provider,end insert
25 or veterinary food-animal drug retailer, if all of the provisions of
26this chapter have been complied with.
27(f) Notwithstanding any otherbegin delete provision ofend delete law, the pharmacy
28license shall authorize the holder to conduct a pharmacy. The
29license shall be renewed annually and shall not be transferable.
30(g) Notwithstanding any otherbegin delete provision ofend delete law, thebegin delete wholesaleend delete
31begin insert wholesalerend insert license shall authorize the holder to wholesale
32dangerous drugs and dangerous devices. The license shall be
33renewed annually and shall not be transferable.
34(h) Notwithstanding any other law, the third-party logistics
35provider license shall authorize the holder to provide or coordinate
36warehousing, distribution, or other similar services of dangerous
37drugs and dangerous devices. The license shall be renewed
38annually and shall not be transferable.
39(h)
end delete
P20 1begin insert(i)end insert Notwithstanding any otherbegin delete provision ofend delete law, the veterinary
2food-animal drug retailer license shall authorize the holderbegin delete thereofend delete
3 to conduct a veterinary food-animal drug retailer and to sell and
4dispense veterinary food-animal drugs as defined in Section 4042.
5(i)
end delete
6begin insert(j)end insert For licenses referred to in subdivisions (f), (g),begin insert (h),end insert andbegin delete (h),end delete
7begin insert (i),end insert any change in the proposed beneficial ownership interest shall
8be reported to the board within 30 days thereafter upon a form to
9be furnished by the board.
10(j) This section shall become operative on July 1, 2001.
end delete
begin insertSection 4305.5 of the end insertbegin insertBusiness and Professions Codeend insert
12begin insert is amended to read:end insert
(a) A personbegin delete who has obtainedend deletebegin insert that is licensed asend insert a
14begin delete license to conduct a wholesalerend deletebegin insert wholesaler, third-party logistics
15provider,end insert or veterinary food-animal drug retailer, shall notify the
16board within 30 days of the termination of employment of the
17designated representative-in-charge. Failure to notify the board
18within the 30-day period shall constitute grounds for disciplinary
19action.
20(b) A personbegin delete who has obtainedend deletebegin insert that is licensed asend insert abegin delete license to begin insert wholesaler, third-party logistics provider,end insert
21conduct a wholesalerend delete
22 or veterinary food-animal drug retailer,begin delete whoend deletebegin insert thatend insert willfully fails to
23notify the board of the termination of employment of the designated
24begin delete representative-in-charge,end deletebegin insert representative-in-charge at its licensed
25place of business,end insert andbegin delete whoend deletebegin insert thatend insert continues to operate thebegin delete licenseeend delete
26begin insert place of businessend insert in the absence of the designated
27representative-in-charge for thatbegin delete location,end deletebegin insert place of businessend insert shall
28be subject to summary suspension or revocation ofbegin delete his or herend deletebegin insert itsend insert
29 licensebegin delete to conductend deletebegin insert asend insert abegin delete wholesalerend deletebegin insert wholesaler, third-party logistics
30provider,end insert or veterinary food-animal drugbegin delete retailer.end deletebegin insert retailer at that
31place of business.end insert
32(c) A designated representative-in-charge of abegin delete wholesalerend delete
33begin insert wholesaler, third-party logistics provider,end insert or veterinary
34food-animal drug retailer, who terminates his or her employment
35at thebegin delete licensee,end deletebegin insert licensed place of business,end insert shall notify the board
36within 30 days of the termination of employment. Failure to notify
37the board within the 30-day period shall constitute grounds for
38disciplinary action.
39(d) This section shall become operative on January 1, 2006.
end delete
begin insertSection 4312 of the end insertbegin insertBusiness and Professions Codeend insert
2begin insert is amended to read:end insert
(a) The board may cancel the license of a wholesaler,
4begin insert third-party logistics provider,end insert pharmacy, or veterinary food-animal
5drug retailer if the licensed premises remain closed, as defined in
6subdivision (e), other than by order of the board. For good cause
7shown, the board may cancel a license after a shorter period of
8closure. To cancel a license pursuant to this subdivision, the board
9shall make a diligent, good faith effort to give notice by personal
10service on the licensee. If a written objection is not received within
1110 days after personal service is made or a diligent, good faith
12effort to give notice by personal service on the licensee has failed,
13the board may cancel the
license without the necessity of a hearing.
14If the licensee files a written objection, the board shall file an
15accusation based on the licensee remaining closed. Proceedings
16shall be conducted in accordance with Chapter 5 (commencing
17with Section 11500) of Part 1 of Division 3 of Title 2 of the
18Government Code, and the board shall have all the powers granted
19in that chapter.
20(b) begin deleteIn end deletebegin insertIf end insertthebegin delete event that theend delete license of a wholesaler,begin insert third-party
21logistics provider,end insert pharmacy, or veterinary food-animal drug
22retailer isbegin delete cancelledend deletebegin insert canceledend insert pursuant to subdivision (a) or revoked
23pursuant to Article 19 (commencing with Section 4300), or a
24wholesaler,begin insert third-party logistics provider,end insert pharmacy, or veterinary
25food-animal drug retailer notifies the board of its intent to remain
26closed or to discontinue business, the licensee shall, within 10 days
27thereafter, arrange for the transfer of all dangerous drugs and
28controlled substances or dangerous devices to another licensee
29authorized to possess the dangerous drugs and controlled
30substances or dangerous devices. The licensee transferring the
31dangerous drugs and controlled substances or dangerous devices
32shall immediately confirm in writing to the board that the transfer
33has taken place.
34(c) If a wholesaler,begin insert third-party logistics provider,end insert pharmacy, or
35veterinary food-animal drug retailer fails to comply with
36subdivision (b), the board may seek and obtain an order from the
37superior court in the county in which the wholesaler,begin insert third-party
38logistics provider,end insert pharmacy, or veterinary food-animal drug
39retailer is located, authorizing the board to enter the wholesaler,
40begin insert third-party logistics provider,end insert pharmacy, or veterinary food-animal
P22 1drug retailer and inventory and store, transfer, sell, or arrange for
2the sale of, all dangerous drugs and controlled substances and
3dangerous devices found in the wholesaler,begin insert
third-party logistics
4provider,end insert pharmacy, or veterinary food-animal drug retailer.
5(d) begin deleteIn end deletebegin insertIf end insertthebegin delete event that theend delete board sells or arranges for the sale of
6any dangerous drugs, controlled substances, or dangerous devices
7pursuant to subdivision (c), the board may retain from the proceeds
8of the sale an amount equal to the cost to the board of obtaining
9and enforcing an order issued pursuant to subdivision (c), including
10the cost of disposing of the dangerous drugs, controlled substances,
11or dangerous devices. The remaining proceeds, if any, shall be
12returned to the licensee from whose premises the dangerous drugs
13or controlled substances or dangerous devices were removed.
14(1) The licensee shall be notified of his or her right to the
15remaining proceeds by personal service or by certified mail,
16postage prepaid.
17(2) If a statute or regulation requires the licensee to file with
18the board his or her address, and any change of
address, the notice
19required by this subdivision may be sent by certified mail, postage
20prepaid, to the latest address on file with the board and service of
21notice in this manner shall be deemed completed on the 10th day
22after the mailing.
23(3) If the licensee is notified as provided in this subdivision,
24and the licensee fails to contact the board for the remaining
25proceeds within 30 calendar days after personal service has been
26made or service by certified mail, postage prepaid, is deemed
27completed, the remaining proceeds shall be deposited by the board
28into the Pharmacy Board Contingent Fund. These deposits shall
29be deemed to have been received pursuant to Chapter 7
30(commencing with Section 1500) of Title 10 of Part 3 of the Code
31of Civil Procedure and shall be subject to claim or other disposition
32as provided in that chapter.
33(e) For the purposes of this section, “closed” means
not engaged
34in the ordinary activity for which a license has been issued for at
35least one day each calendar week during any 120-day period.
36(f) Nothing in this section shall be construed as requiring a
37pharmacy to be open seven days a week.
begin insertSection 4331 of the end insertbegin insertBusiness and Professions Codeend insert
39begin insert is amended to read:end insert
(a) A person who is neither a pharmacist nor a
2designated representative and whobegin delete takes chargeend deletebegin insert does eitherend insert ofbegin delete a begin insert the following,end insert except
3wholesaler or veterinary food-animal drug retailer or who dispenses
4a prescription or furnishes dangerous devicesend delete
5as otherwise provided in thisbegin delete chapterend deletebegin insert chapter,end insert is guilty of a
6begin delete misdemeanor.end deletebegin insert misdemeanor:end insert
7(1) Takes charge of a wholesaler, third-party logistics provider,
8or veterinary food-animal drug retailer.
9 (2) Coordinates the warehousing or distribution of dangerous
10drugs or dangerous devices or dispenses a prescription or furnishes
11dangerous devices.
12(b) A personbegin delete who has obtainedend deletebegin insert licensed asend insert abegin delete license to conduct veterinary food-animal drug retailer
13aend deletebegin delete and whoend deletebegin insert thatend insert fails to place
14in charge of that veterinary food-animal drug retailer a pharmacist
15or designated representative, or any person who, by himself or
16herself, or by any other person, permits the dispensing of
17prescriptions, except by a pharmacist or designated representative,
18or as otherwise provided in this chapter, is guilty of a misdemeanor.
19(c) A personbegin delete who has obtainedend deletebegin insert licensed asend insert abegin delete license to conduct wholesaler
20aend deletebegin delete and whoend deletebegin insert or third-party logistics provider thatend insert fails
21to place in charge of that wholesalerbegin insert or third-party logistics
22providerend insert a pharmacist or designated representative, or any person
23who, by himself or herself, or by any other person, permits the
24furnishing of dangerous drugs or dangerous devices, except by a
25pharmacist or designated representative, or as otherwise provided
26in this chapter, is guilty of a misdemeanor.
27(d) This section shall become operative on January 1, 2006.
end delete
begin insertSection 4400 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert,
29as added by Section 9 of Chapter 565 of the Statutes of 2013, is
30amended to read:end insert
The amount of fees and penalties prescribed by this
32chapter, except as otherwise provided, is that fixed by the board
33according to the following schedule:
34(a) The fee for a nongovernmental pharmacy license shall be
35four hundred dollars ($400) and may be increased to five hundred
36twenty dollars ($520). The fee for the issuance of a temporary
37nongovernmental pharmacy permit shall be two hundred fifty
38dollars ($250) and may be increased to three hundred twenty-five
39dollars ($325).
P24 1(b) The fee for a nongovernmental pharmacy license annual
2renewal shall be two hundred fifty dollars ($250) and may be
3increased to three hundred twenty-five dollars ($325).
4(c) The fee
for the pharmacist application and examination shall
5be two hundred dollars ($200) and may be increased to two
6hundred sixty dollars ($260).
7(d) The fee for regrading an examination shall be ninety dollars
8($90) and may be increased to one hundred fifteen dollars ($115).
9If an error in grading is found and the applicant passes the
10examination, the regrading fee shall be refunded.
11(e) The fee for a pharmacist license and biennial renewal shall
12be one hundred fifty dollars ($150) and may be increased to one
13hundred ninety-five dollars ($195).
14(f) The fee for a nongovernmental wholesalerbegin insert or third-party
15logistics providerend insert license and annual renewal shall bebegin delete six hundred
seven hundred eighty
16dollars ($600), and may be increased toend delete
17dollars ($780)begin insert and may be decreased to no less than six hundred
18dollars ($600)end insert. The application fee for any additional location after
19licensure of the first 20 locations shall bebegin delete two hundred twenty-five three hundred dollars ($300)
20dollars ($225) and may be increased toend delete
21begin insert and may be decreased to no less than two hundred twenty-five
22dollars ($225)end insert. A temporary license fee shall bebegin delete five hundred fifty seven hundred fifteen
23dollars ($550) and may be increased toend delete
24dollars ($715)begin insert and may be decreased to no less than five
hundred
25fifty dollars ($550)end insert.
26(g) The fee for a hypodermic license and renewal shall be one
27hundred twenty-five dollars ($125) and may be increased to one
28hundred sixty-five dollars ($165).
29(h) (1) The fee for application, investigation, and issuance of
30license as a designated representative pursuant to Section 4053
31shall bebegin delete two hundred fifty-five dollars ($255) and may be increased
three hundred thirty dollars ($330)begin insert and may be decreased to no
32toend delete
33less than two hundred fifty-five dollars ($255)end insert.
34(2) The fee for the annual renewal of a license as a designated
35representative shall bebegin delete one hundred fifty dollars ($150) and may one hundred ninety-five dollars ($195)begin insert and may
36be increased toend delete
37be decreased to no less than one hundred fifty dollars ($150)end insert.
38(i) (1) The fee for the application, investigation, and issuance
39of a license as a designated representative for a veterinary
40food-animal drug retailer pursuant to Section 4053 shall bebegin delete two
three
P25 1hundred fifty-five dollars ($255) and may be increased toend delete
2hundred thirty dollars ($330)begin insert and may be decreased to no less than
3two hundred fifty-five dollars ($255)end insert.
4(2) The fee for the annual renewal of a license as a designated
5representative for a veterinary food-animal drug retailer shall be
6begin delete one hundred fifty dollars ($150) and may be increased toend delete
one
7hundred ninety-five dollars ($195)begin insert and may be decreased to no
8less than one hundred fifty dollars ($150)end insert.
9(j) (1) The application fee for a nonresidentbegin delete wholesaler’send delete
10begin insert wholesaler or third-party logistics providerend insert license issued pursuant
11to Section 4161 shall bebegin delete six hundred dollars ($600) and may be seven hundred eighty dollars ($780)begin insert and may be
12increased toend delete
13decreased to no less than six hundred dollars ($600)end insert.
14(2) For nonresident wholesalersbegin delete whoend deletebegin insert or third-party logistics
15providers thatend insert have 21 or more facilities operating nationwide the
16application fees for the first 20 locations shall bebegin delete six hundred seven hundred eighty
17dollars ($600) and may be increased toend delete
18dollars ($780)begin insert and may be decreased to no less than six hundred
19dollars ($600)end insert. The application fee for any additional location after
20licensure of the first 20 locations shall bebegin delete two hundred twenty-five three hundred dollars ($300)
21dollars ($225) and may be increased toend delete
22begin insert and may
be decreased to no less than two hundred twenty-five
23dollars ($225)end insert. A temporary license fee shall bebegin delete five hundred fifty seven hundred fifteen
24dollars ($550) and may be increased toend delete
25dollars ($715)begin insert and may be decreased to no less than five hundred
26fifty dollars ($550)end insert.
27(3) The annual renewal fee for a nonresidentbegin delete wholesaler’send delete
28begin insert wholesalerend insert licensebegin insert or third-party logistics provider licenseend insert issued
29pursuant to Section 4161 shall bebegin delete six hundred dollars ($600) and seven hundred eighty dollars ($780)begin insert and may
30may be increased toend delete
31be decreased to no less than six hundred dollars ($600)end insert.
32(k) The fee for evaluation of continuing education courses for
33accreditation shall be set by the board at an amount not to exceed
34forty dollars ($40) per course hour.
35(l) The fee for an intern pharmacist license shall be ninety dollars
36($90) and may be increased to one hundred fifteen dollars ($115).
37The fee for transfer of intern hours or verification of licensure to
38another state shall be twenty-five dollars ($25) and may be
39increased to thirty dollars ($30).
P26 1(m) The board may waive or refund the additional fee for the
2issuance of a license where the license is issued less than 45 days
3before the next regular renewal date.
4(n) The fee for the reissuance of any license, or renewal thereof,
5that has been lost or destroyed or reissued due to a name change
6shall be thirty-five dollars ($35) and may be increased to forty-five
7dollars ($45).
8(o) The fee for the reissuance of any license, or renewal thereof,
9that must be reissued because of a change in the information,
shall
10be one hundred dollars ($100) and may be increased to one hundred
11thirty dollars ($130).
12(p) It is the intent of the Legislature that, in setting fees pursuant
13to this section, the board shall seek to maintain a reserve in the
14Pharmacy Board Contingent Fund equal to approximately one
15year’s operating expenditures.
16(q) The fee for any applicant for a nongovernmental clinic
17license shall be four hundred dollars ($400) and may be increased
18to five hundred twenty dollars ($520) for each license. The annual
19fee for renewal of the license shall be two hundred fifty dollars
20($250) and may be increased to three hundred twenty-five dollars
21($325) for each license.
22(r) The fee for the issuance of a pharmacy technician license
23shall be eighty dollars ($80) and may be increased to one hundred
24five dollars ($105). The fee
for renewal of a pharmacy technician
25license shall be one hundred dollars ($100) and may be increased
26to one hundred thirty dollars ($130).
27(s) The fee for a veterinary food-animal drug retailer license
28shall be four hundred five dollars ($405) and may be increased to
29four hundred twenty-five dollars ($425). The annual renewal fee
30for a veterinary food-animal drug retailer license shall be two
31hundred fifty dollars ($250) and may be increased to three hundred
32twenty-five dollars ($325).
33(t) The fee for issuance of a retired license pursuant to Section
344200.5 shall be thirty-five dollars ($35) and may be increased to
35forty-five dollars ($45).
36(u) The fee for issuance or renewal of a nongovernmental sterile
37compounding pharmacy license shall be six hundred dollars ($600)
38and may be increased to seven hundred eighty
dollars ($780). The
39fee for a temporary license shall be five hundred fifty dollars ($550)
40and may be increased to seven hundred fifteen dollars ($715).
P27 1(v) The fee for the issuance or renewal of a nonresident sterile
2compounding pharmacy license shall be seven hundred eighty
3dollars ($780). In addition to paying that application fee, the
4nonresident sterile compounding pharmacy shall deposit, when
5submitting the application, a reasonable amount, as determined by
6the board, necessary to cover the board’s estimated cost of
7performing the inspection required by Section 4127.2. If the
8required deposit is not submitted with the application, the
9application shall be deemed to be incomplete. If the actual cost of
10the inspection exceeds the amount deposited, the board shall
11provide to the applicant a written invoice for the remaining amount
12and shall not take action on the application until the full amount
13has been paid to the board. If the amount
deposited exceeds the
14amount of actual and necessary costs incurred, the board shall
15remit the difference to the applicant.
16(w) This section shall become operative on July 1, 2014.
No reimbursement is required by this act pursuant
18to Section 6 of Article XIII B of the California Constitution because
19the only costs that may be incurred by a local agency or school
20district will be incurred because this act creates a new crime or
21infraction, eliminates a crime or infraction, or changes the penalty
22for a crime or infraction, within the meaning of Section 17556 of
23the Government Code, or changes the definition of a crime within
24the meaning of Section 6 of Article XIII B of the California
25Constitution.
Section 4200.3 of the Business and Professions
27Code is amended to read:
(a) The examination process shall be regularly
29reviewed pursuant to Section 139.
30(b) The examination process shall meet the standards and
31guidelines set forth in the Standards for Educational and
32Psychological Testing and the Federal Uniform Guidelines for
33Employee Selection Procedures. The board shall work with the
34Office of Professional Examination Services of the department or
35with an equivalent organization who shall certify at minimum once
36every five years that the examination process meets these national
37testing standards. If the department determines that the examination
38process fails to meet these standards, the board shall terminate its
39use of the North American Pharmacy Licensure Examination and
P28 1shall use only the written and practical examination
developed by
2the board.
3(c) The examination shall meet the mandates of subdivision (a)
4of Section 12944 of the Government Code.
5(d) The board shall work with the Office of Professional
6Examination Services or with an equivalent organization to develop
7the state jurisprudence examination to ensure that applicants for
8licensure are evaluated on their knowledge of applicable state laws
9and regulations.
10(e) The board shall annually publish the pass and fail rates for
11the pharmacist’s licensure examination administered pursuant to
12Section 4200, including a comparison of historical pass and fail
13rates before utilization of the North American Pharmacist Licensure
14Examination.
15(f) The board shall report to the appropriate policy committees
16of the Legislature and the department, as part of its next scheduled
17review, the pass rates of applicants who sat for the national
18examination compared with the pass rates of applicants who sat
19for the prior state examination. This report shall be a component
20of the evaluation of the examination process that is based on
21psychometrically sound principles for establishing minimum
22qualifications and levels of competency.
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