AB 2605, as amended, Bonilla. Pharmacy: third-party logistics providers.
(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.begin insert Existing law, the federal Drug Supply Chain Security Act, prohibits a third-party logistics provider, as defined, from conducting any activities in a state unless each facility of the provider is licensed by the state from which drugs are distributed by the provider in accordance with regulations to be promulgated by the Secretary of the United States Department of Health and Human Services.end insert
This bill wouldbegin delete delete fromend deletebegin insert reviseend insert the definition of “third-party logistics provider” or “reverse third-party logistics provider”begin delete the requirement that the entity be a licensed wholesalerend deletebegin insert to
conform to federal law, as specifiedend insert, 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.
(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.
This 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.
(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.
This bill would instead set the fees at the higher amounts.
(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.
The 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.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.
The people of the State of California do enact as follows:
Section 4022.5 of the Business and Professions
2Code is amended to read:
(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 a wholesaler, third-party
9logistics provider, or veterinary food-animal drug retailer and
10approved by the board as the supervisor or manager responsible
11for ensuring the compliance of the wholesaler, third-party logistics
12provider, or veterinary food-animal drug retailer with all state and
13federal laws and regulations pertaining to practice in the applicable
14license category.
begin insertSection 4025.2 is added to the end insertbegin insertBusiness and Professions
16Codeend insertbegin insert, to read:end insert
“Facility manager” means the individual who is
18designated by a third-party logistics provider to oversee the facility
19of the third-party logistics provider and who, in conjunction with
20the quality assurance department of the third-party logistics
21provider, is responsible for ensuring the third-party logistics
22provider’s compliance with state and federal laws and the
23third-party logistics provider’s customer specifications.
Section 4040.5 of the Business and Professions Code
26 is amended to read:
“Reverse distributor” means every person who acts as
28an agent for pharmacies, drug wholesalers, third-party logistics
29providers, manufacturers, and other entities by receiving,
30inventorying, warehousing, and managing the disposition of
31outdated or nonsaleable dangerous drugs.
Section 4043 of the Business and Professions Code is
34amended to read:
“Wholesaler” means and includes a person who acts as
36a wholesale merchant, broker, jobber, customs broker, reverse
37distributor, agent, or a nonresident wholesaler, who sells for resale,
38or negotiates for distribution, or takes possession of, any drug or
P4 1device included in Section 4022. Unless otherwise authorized by
2law, a wholesaler may not store, warehouse, or authorize the
3storage or warehousing of drugs with any person or at any location
4not licensed by the board.
Section 4045 of the Business and Professions Code is
6amended to read:
“Third-party logistics provider” or “reverse third-party
8logistic provider” means an entity that contracts with a dangerous
9drug manufacturer to provide or coordinate warehousing,
10distribution, or other similar services on behalf of a manufacturer,
11but for which there is no change of ownership in the dangerous
12drugs.
begin insertSection 4045 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
14repealed.end insert
“Third-party logistics provider” or “reverse third-party
16logistic provider” means an entity licensed as a wholesaler that
17contracts with a dangerous drug manufacturer to provide or
18coordinate warehousing, distribution, or other similar services on
19behalf of a manufacturer, but for which there is no change of
20ownership in the dangerous drugs. For purposes of Sections 4034,
214163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, a third-party
22logistics provider shall not be responsible for generating or
23updating pedigree documentation, but shall maintain copies of the
24pedigree. To be exempt from documentation for pedigrees, a
25reverse third-party logistic provider may only accept
26decommissioned drugs from pharmacies or wholesalers.
begin insertSection 4045 is added to the end insertbegin insertBusiness and Professions
28Codeend insertbegin insert, to read:end insert
“Third-party logistics provider” or “reverse third-party
30logistic provider” means an entity that provides or coordinates
31warehousing or other logistics services of a product in interstate
32commerce on behalf of a manufacturer, wholesaler, or dispenser
33of a product, but does not take ownership of the product, nor have
34responsibility to direct the sale or disposition of the product.
Section 4053 of the Business and Professions Code is
37amended to read:
(a) Notwithstanding Section 4051, the board may issue
39a license as a designated representative to provide sufficient and
40qualified supervision in a wholesaler, third-party logistics provider,
P5 1or veterinary food-animal drug retailer. The designated
2representative shall protect the public health and safety in the
3handling, storage, warehousing, distribution, and shipment of
4dangerous drugs and dangerous devices in the wholesaler,
5third-party logistics provider, or veterinary food-animal drug
6retailer.
7(b) An individual who is at least 18 years of age may apply for
8a designated representative license. In order to obtain and maintain
9that license, the individual shall meet all of the following
10requirements:
11(1) He or she shall be a high school graduate or possess a general
12education development certificate equivalent.
13(2) He or she shall have a minimum of one year of paid work
14experience in a licensed pharmacy, or with a drug wholesaler,
15third-party logistics provider, drug distributor, or drug
16manufacturer, in the past three years, related to the distribution or
17dispensing of dangerous drugs or dangerous devices or meet all
18of the prerequisites to take the examination required for licensure
19as a pharmacist by the board.
20(3) He or she shall complete a training program approved by
21the board that, at a minimum, addresses each of the following
22subjects:
23(A) Knowledge and understanding of California law and federal
24law relating to the distribution of dangerous drugs and dangerous
25devices.
26(B) Knowledge and understanding of California law and federal
27law relating to the distribution of controlled substances.
28(C) Knowledge and understanding of quality control systems.
29(D) Knowledge and understanding of the United States
30Pharmacopoeia standards relating to the safe storage and handling
31of drugs.
32(E) Knowledge and understanding of prescription terminology,
33abbreviations, dosages, and format.
34(4) The board may, by regulation, require training programs to
35include additional material.
36(5) The board shall not issue a license as a designated
37representative until the applicant provides proof of completion of
38the required
training to the board.
P6 1(c) The wholesaler, third-party logistics provider, or veterinary
2food-animal drug retailer shall not operate without a pharmacist
3or a designated representative on its premises.
4(d) Only a pharmacist or a designated representative shall
5prepare and affix the label to veterinary food-animal drugs.
6(e) Section 4051 shall not apply to any laboratory licensed under
7Section 351 of Title III of the Public Health Service Act (Public
8Law 78-410).
Section 4060 of the Business and Professions Code is
11amended to read:
A person shall not possess any controlled substance,
13except that furnished to a person upon the prescription of a
14physician, dentist, podiatrist, optometrist, veterinarian, or
15naturopathic doctor pursuant to Section 3640.7, or furnished
16pursuant to a drug order issued by a certified nurse-midwife
17pursuant to Section 2746.51, a nurse practitioner pursuant to
18Section 2836.1, a physician assistant pursuant to Section 3502.1,
19a naturopathic doctor pursuant to Section 3640.5, or a pharmacist
20pursuant to Section 4052.1, 4052.2, or 4052.6. This section does
21not apply to the possession of any controlled substance by a
22manufacturer, wholesaler, third-party logistics provider, pharmacy,
23pharmacist, physician, podiatrist, dentist, optometrist, veterinarian,
24naturopathic doctor, certified nurse-midwife, nurse practitioner,
25or physician assistant, if in stock in
containers correctly labeled
26with the name and address of the supplier or producer.
27This section does not authorize a certified nurse-midwife, a nurse
28practitioner, a physician assistant, or a naturopathic doctor, to order
29his or her own stock of dangerous drugs and devices.
Section 4081 of the Business and Professions Code is
32amended to read:
(a) All records of manufacture and of sale, acquisition,
34or disposition of dangerous drugs or dangerous devices shall be
35at all times during business hours open to inspection by authorized
36officers of the law, and shall be preserved for at least three years
37from the date of making. A current inventory shall be kept by every
38manufacturer, wholesaler, third-party logistics provider, pharmacy,
39veterinary food-animal drug retailer, physician, dentist, podiatrist,
40veterinarian, laboratory, clinic, hospital, institution, or
P7 1establishment holding a currently valid and unrevoked certificate,
2license, permit, registration, or exemption under Division 2
3(commencing with Section 1200) of the Health and Safety Code
4or under Part 4 (commencing with Section 16000) of Division 9
5of the Welfare and Institutions Code who maintains a stock of
6
dangerous drugs or dangerous devices.
7(b) The owner, officer, and partner of a pharmacy, wholesaler,
8third-party logistics provider, or veterinary food-animal drug
9retailer shall be jointly responsible, with the pharmacist-in-charge
10or designated representative-in-charge, for maintaining the records
11and inventory described in this section.
12(c) The pharmacist-in-charge or designated
13representative-in-charge shall not be criminally responsible for
14acts of the owner, officer, partner, or employee that violate this
15section and of which the pharmacist-in-charge or designated
16representative-in-charge had no knowledge, or in which he or she
17did not knowingly participate.
Section 4101 of the Business and Professions Code
20 is amended to read:
(a) A pharmacist may take charge of and act as the
22pharmacist-in-charge of a pharmacy upon application by the
23pharmacy and approval by the board. Any pharmacist-in-charge
24who ceases to act as the pharmacist-in-charge of the pharmacy
25shall notify the board in writing within 30 days of the date of that
26change in status.
27(b) A designated representative or a pharmacist may take charge
28of, and act as, the designated representative-in-charge of a
29wholesaler, third-party logistics provider, or veterinary food-animal
30drug retailer upon application by the wholesaler, third-party
31logistics provider, or veterinary food-animal drug retailer and
32approval by the board. Any designated representative-in-charge
33who ceases to act as the designated representative-in-charge at that
34
entity shall notify the board in writing within 30 days of the date
35of that change in status.
Section 4105 of the Business and Professions Code
38 is amended to read:
(a) All records or other documentation of the acquisition
40and disposition of dangerous drugs and dangerous devices by any
P8 1entity licensed by the board shall be retained on the licensed
2premises in a readily retrievable form.
3(b) The licensee may remove the original records or
4documentation from the licensed premises on a temporary basis
5for license-related purposes. However, a duplicate set of those
6records or other documentation shall be retained on the licensed
7premises.
8(c) The records required by this section shall be retained on the
9licensed premises for a period of three years from the date of
10making.
11(d) Any records that are
maintained electronically shall be
12maintained so that the pharmacist-in-charge, the pharmacist on
13duty if the pharmacist-in-charge is not on duty, or, in the case of
14a veterinary food-animal drug retailer, wholesaler, third-party
15logistics provider, or the designated representative on duty, shall,
16at all times during which the licensed premises are open for
17business, be able to produce a hardcopy and electronic copy of all
18records of acquisition or disposition or other drug or
19dispensing-related records maintained electronically.
20(e) (1) Notwithstanding subdivisions (a), (b), and (c), the board,
21may upon written request, grant to a licensee a waiver of the
22requirements that the records described in subdivisions (a), (b),
23and (c) be kept on the licensed premises.
24(2) A waiver granted pursuant to this subdivision shall not affect
25the board’s authority under
this section or any other provision of
26this chapter.
27(f) When requested by an authorized officer of the law or by an
28authorized representative of the board, the owner, corporate officer,
29or manager of an entity licensed by the board shall provide the
30board with the requested records within three business days of the
31time the request was made. The entity may request in writing an
32extension of this timeframe for a period not to exceed 14 calendar
33days from the date the records were requested. A request for an
34extension of time is subject to the approval of the board. An
35extension shall be deemed approved if the board fails to deny the
36extension request within two business days of the time the
37extension request was made directly to the board.
Section 4120 of the Business and Professions Code
40 is amended to read:
(a) A nonresident pharmacy shall not sell or distribute
2dangerous drugs or dangerous devices in this state through any
3person or media other than a wholesaler or third-party logistics
4provider who has obtained a license pursuant to this chapter or
5through a selling or distribution outlet that is licensed as a
6wholesaler or third-party logistics provider pursuant to this chapter
7without registering as a nonresident pharmacy.
8(b) Applications for a nonresident pharmacy registration shall
9be made on a form furnished by the board. The board may require
10any information as the board deems reasonably necessary to carry
11out the purposes of this section.
12(c) The
Legislature, by enacting this section, does not intend a
13license issued to any nonresident pharmacy pursuant to this section
14to change or affect the tax liability imposed by Chapter 3
15(commencing with Section 23501) of Part 11 of Division 2 of the
16Revenue and Taxation Code on any nonresident pharmacy.
17(d) The Legislature, by enacting this section, does not intend a
18license issued to any nonresident pharmacy pursuant to this section
19to serve as any evidence that the nonresident pharmacy is doing
20business within this state.
Section 4126 of the Business and Professions Code
23 is amended to read:
(a) Notwithstanding any other law, a covered entity may
25contract with a pharmacy to provide pharmacy services to patients
26of the covered entity, as defined in Section 256b of Title 42 of the
27United States Code, including dispensing preferentially priced
28drugs obtained pursuant to Section 256b of Title 42 of the United
29States Code. Contracts between those covered entities and
30pharmacies shall comply with guidelines published by the Health
31Resources and Services Administration and shall be available for
32inspection by board staff during normal business hours.
33(b) Drugs purchased pursuant to Section 256b of Title 42 of the
34United States Code and received by a pharmacy shall be segregated
35from the pharmacy’s other drug stock by
either physical or
36electronic means. All records of acquisition and disposition of
37these drugs shall be readily retrievable in a form separate from the
38pharmacy’s other records.
39(c) Drugs obtained by a pharmacy to be dispensed to patients
40of a covered entity pursuant to Section 256b of Title 42 of the
P10 1United States Code that cannot be distributed because of a change
2in circumstances for the covered entity or the pharmacy shall be
3returned to the distributor from which they were obtained. For the
4purposes of this section, a change in circumstances includes, but
5is not limited to, the termination or expiration of the contract
6between the pharmacy and the covered entity, the closure of a
7pharmacy, disciplinary action against the pharmacy, or closure of
8the covered entity.
9(d) A licensee that participates in a contract to dispense
10preferentially priced drugs pursuant to this section
shall not have
11both a pharmacy and a wholesaler license, or both a pharmacy and
12a third-party logistics provider license.
13(e) Neither a covered entity nor a pharmacy shall be required
14to obtain a license as a wholesaler or a third-party logistics provider
15based on acts reasonably necessary to fully participate in the drug
16purchase program established by Section 256b of Title 42 of the
17United States Code.
Section 4149 of the Business and Professions Code
20 is amended to read:
(a) A nonresident distributor shall not sell or distribute
22hypodermic needles or syringes in this state without obtaining a
23license from the board pursuant to Section 4141.
24(b) Notwithstanding subdivision (a), a license is not required if
25the nonresident distributor sells or distributes solely through a
26person who is licensed as a wholesaler or third-party logistics
27provider pursuant to Section 4160.
28(c) The Legislature, by enacting this section, does not intend a
29license issued to any nonresident distributor pursuant to this article
30to serve as evidence that the entity is doing business within this
31state.
The heading of Article 11 (commencing with Section
344160) of Chapter 9 of Division 2 of the Business and Professions
35Code is amended to read:
36
Section 4160 of the Business and Professions Code
3 is amended to read:
(a) A person shall not act as a wholesaler or third-party
5logistics provider of any dangerous drug or dangerous device unless
6he or she has obtained a license from the board.
7(b) Upon approval by the board and the payment of the required
8fee, the board shall issue a license to the applicant.
9(c) A separate license shall be required for each place of business
10owned or operated by a wholesaler or third-party logistics provider.
11Each license shall be renewed annually and shall not be
12transferable.
13(d) Every wholesaler or third-party logistics provider shall be
14supervised or managed by a designated representative-in-charge.
15The designated
representative-in-charge shall be responsible for
16the compliance of the wholesaler or third-party logistics provider
17with state and federal laws governing wholesalers and third-party
18logistics providers. As part of its initial application for a license,
19and for each renewal, each wholesaler or third-party logistics
20provider shall, on a form designed by the board, provide identifying
21information and the California license number for a designated
22representative or pharmacist proposed to serve as the designated
23representative-in-charge. The proposed designated
24representative-in-charge shall be subject to approval by the board.
25The board shall not issue or renew a wholesaler or third-party
26logistics provider license without identification of an approved
27designated representative-in-charge for the wholesaler or
28third-party logistics provider.
29(e) A wholesaler or third-party logistics provider shall notify
30the board in writing, on a form designed by
the board, within 30
31days of the date when a designated representative-in-charge ceases
32to act as the designated representative-in-charge, and shall on the
33same form propose another designated representative or pharmacist
34to take over as the designated representative-in-charge. The
35proposed replacement designated representative-in-charge shall
36be subject to approval by the board. If disapproved, the wholesaler
37or third-party logistics provider shall propose another replacement
38within 15 days of the date of disapproval, and shall continue to
39name proposed replacements until a designated
40representative-in-charge is approved by the board.
P12 1(f) A drug manufacturer premises licensed by the Food and
2Drug Administration or licensed pursuant to Section 111615 of
3the Health and Safety Code that only distributes dangerous drugs
4and dangerous devices of its own manufacture is exempt from this
5section and Section 4161.
6(g) The board may issue a temporary license, upon conditions
7and for periods of time as the board determines to be in the public
8interest. A temporary license fee shall be required in an amount
9established by the board as specified in subdivision (f) of Section
104400. When needed to protect public safety, a temporary license
11may be issued for a period not to exceed 180 days, subject to terms
12and conditions that the board deems necessary. If the board
13determines that a temporary license was issued by mistake or denies
14the application for a permanent license, the temporary license shall
15terminate upon either personal service of the notice of termination
16upon the licenseholder or service by certified mail, return receipt
17requested, at the licenseholder’s address of record with the board,
18whichever occurs first. Neither for purposes of retaining a
19temporary license, nor for purposes of any disciplinary or license
20denial proceeding before the board,
shall the temporary
21licenseholder be deemed to have a vested property right or interest
22in the license.
Section 4161 of the Business and Professions Code
25 is amended to read:
(a) A person located outside this state that (1) ships,
27sells, mails, warehouses, distributes, or delivers dangerous drugs
28or dangerous devices into this state or (2) sells, brokers,
29warehouses, or distributes dangerous drugs or devices within this
30state shall be considered a nonresident wholesaler or a nonresident
31third-party logistics provider.
32(b) A nonresident wholesaler or nonresident third-party logistics
33provider shall be licensed by the board prior to shipping, selling,
34mailing, warehousing, distributing, or delivering dangerous drugs
35or dangerous devices to a site located in this state or selling,
36brokering, warehousing, or distributing dangerous drugs or devices
37within this state.
38(c) A
separate license shall be required for each place of business
39owned or operated by a nonresident wholesaler or nonresident
40third-party logistics provider from or through which dangerous
P13 1drugs or dangerous devices are shipped, sold, mailed, warehoused,
2distributed, or delivered to a site located in this state or sold,
3brokered, warehoused, or distributed within this state. A license
4shall be renewed annually and shall not be transferable.
5(d) The following information shall be reported, in writing, to
6the board at the time of initial application for licensure by a
7nonresident wholesaler or a nonresident third-party logistics
8provider, on renewal of a nonresident wholesaler or nonresident
9third-party logistics provider license, or within 30 days of a change
10in that information:
11(1) Its agent for service of process in this state.
12(2) Its principal corporate officers, as specified by the board, if
13any.
14(3) Its general partners, as specified by the board, if any.
15(4) Its owners if the applicant is not a corporation or partnership.
16(e) A report containing the information in subdivision (d) shall
17be made within 30 days of any change of ownership, office,
18corporate officer, or partner.
19(f) A nonresident wholesaler or nonresident third-party logistics
20provider shall comply with all directions and requests for
21information from the regulatory or licensing agency of the state
22in which it is licensed, as well as with all requests for information
23made by the board.
24(g) A nonresident wholesaler or nonresident
third-party logistics
25provider shall maintain records of dangerous drugs and dangerous
26devices sold, traded, transferred, warehoused, or distributed to
27persons in this state or within this state, so that the records are in
28a readily retrievable form.
29(h) A nonresident wholesaler or nonresident third-party logistics
30provider shall at all times maintain a valid, unexpired license,
31permit, or registration to conduct the business of the wholesaler
32or nonresident third-party logistics provider in compliance with
33the laws of the state in which it is a resident. An application for a
34nonresident wholesaler or nonresident third-party logistics provider
35license in this state shall include a license verification from the
36licensing authority in the applicant’s state of residence.
37(i) The board shall not issue or renew a nonresident wholesaler
38or nonresident third-party logistics provider
license until the
39nonresident wholesaler or nonresident third-party logistics provider
40identifies a designated representative-in-charge and notifies the
P14 1board in writing of the identity and license number of the
2designated representative-in-charge.
3(j) The designated representative-in-charge shall be responsible
4for the compliance of the nonresident wholesaler or nonresident
5third-party logistics provider with state and federal laws governing
6wholesalers and third-party logistics providers. A nonresident
7wholesaler or nonresident third-party logistics provider shall
8identify and notify the board of a new designated
9representative-in-charge within 30 days of the date that the prior
10designated representative-in-charge ceases to be the designated
11representative-in-charge.
12(k) The board may issue a temporary license, upon conditions
13and for periods of time as the board determines to
be in the public
14interest. A temporary license fee shall be five hundred fifty dollars
15($550) or another amount established by the board not to exceed
16the annual fee for renewal of a license to compound injectable
17sterile drug products. When needed to protect public safety, a
18temporary license may be issued for a period not to exceed 180
19days, subject to terms and conditions that the board deems
20necessary. If the board determines that a temporary license was
21issued by mistake or denies the application for a permanent license,
22the temporary license shall terminate upon either personal service
23of the notice of termination upon the licenseholder or service by
24certified mail, return receipt requested, at the licenseholder’s
25address of record with the board, whichever occurs first. Neither
26for purposes of retaining a temporary license, nor for purposes of
27any disciplinary or license denial proceeding before the board,
28shall the temporary licenseholder be deemed to have a vested
29property right or interest in the
license.
30(l) The registration fee shall be the fee specified in subdivision
31(f) of Section 4400.
Section 4162 of the Business and Professions Code
34 is amended to read:
(a) (1) An applicant for the issuance or renewal of a
36wholesaler or third-party logistics provider license, which is not
37government owned and operated, shall submit a surety bond of
38one hundred thousand dollars ($100,000) or other equivalent means
39of security acceptable to the board payable to the Pharmacy Board
40Contingent Fund. The purpose of the surety bond is to secure
P15 1payment of any administrative fine imposed by the board and any
2cost recovery ordered pursuant to Section 125.3.
3(2) For purposes of paragraph (1), the board may accept a surety
4bond less than one hundred thousand dollars ($100,000) if the
5annual gross receipts of the previous tax year for the wholesaler
6or third-party logistics provider
is ten million dollars ($10,000,000)
7or less, in which case the surety bond shall be twenty-five thousand
8dollars ($25,000).
9(3) A person to whom an approved new drug application has
10been issued by the United States Food and Drug Administration
11who engages in the wholesale distribution of only the dangerous
12drug specified in the new drug application, and is licensed or
13applies for licensure as a wholesaler or third-party logistics
14provider, shall not be required to post a surety bond as provided
15in paragraph (1).
16(4) For licensees subject to paragraph (2) or (3), the board may
17require a bond up to one hundred thousand dollars ($100,000) for
18any licensee who has been disciplined by any state or federal
19agency or has been issued an administrative fine pursuant to this
20chapter.
21(b) The board may make a claim against the
bond if the licensee
22fails to pay a fine within 30 days after the order imposing the fine,
23or costs become final.
24(c) A single surety bond or other equivalent means of security
25acceptable to the board shall satisfy the requirement of subdivision
26(a) for all licensed sites under common control as defined in
27Section 4126.5.
Section 4162.5 of the Business and Professions Code
30 is amended to read:
(a) (1) An applicant for the issuance or renewal of a
32nonresident wholesaler orbegin insert nonresidentend insert third-party logistics provider
33license shall submit a surety bond of one hundred thousand dollars
34($100,000), or other equivalent means of security acceptable to
35the board, such as an irrevocable letter of credit, or a deposit in a
36trust account or financial institution, payable to the Pharmacy
37Board Contingent Fund. The purpose of the surety bond is to secure
38payment of any administrative fine imposed by the board and any
39cost recovery ordered pursuant to Section 125.3.
P16 1(2) For purposes of paragraph (1),
the board may accept a surety
2bond less than one hundred thousand dollars ($100,000) if the
3annual gross receipts of the previous tax year for the nonresident
4wholesaler orbegin insert the nonresidentend insert third-party logistics provider is ten
5million dollars ($10,000,000) or less, in which case the surety bond
6shall be twenty-five thousand dollars ($25,000).
7(3) For applicants who satisfy paragraph (2), the board may
8require a bond up to one hundred thousand dollars ($100,000) for
9any nonresident wholesaler orbegin insert nonresidentend insert third-party logistics
10provider who has been disciplined by any state or federal agency
11or has been issued an administrative fine pursuant to this chapter.
12(4) A
person to whom an approved new drug application or a
13biologics license application has been issued by the United States
14Food and Drug Administration who engages in the wholesale
15distribution of only the dangerous drug specified in the new drug
16application or biologics license application, and is licensed or
17applies for licensure as a nonresident wholesaler orbegin insert a nonresidentend insert
18 third-party logistics provider, shall not be required to post a surety
19bond as provided in this section.
20(b) The board may make a claim against the bond if the licensee
21fails to pay a fine within 30 days of the issuance of the fine or
22when the costs become final.
23(c) A single surety bond or other equivalent means of security
24acceptable to the board shall satisfy the requirement of subdivision
25(a) for all
licensed sites under common control as defined in
26Section 4126.5.
Section 4164 of the Business and Professions Code
29 is amended to read:
(a) A wholesaler or third-party logistics provider licensed
31by the board that distributes controlled substances, dangerous
32drugs, or dangerous devices within or into this state shall report
33to the board all distributions of dangerous drugs and controlled
34substances that are subject to abuse, as determined by the board.
35(b) Each wholesaler shall develop and maintain a system for
36tracking individual sales of dangerous drugs at preferential or
37contract prices to pharmacies that primarily or solely dispense
38prescription drugs to patients of long-term care facilities. The
39system shall be capable of identifying purchases of any dangerous
40drug at preferential or contract prices by customers that vary
P17 1significantly from prior ordering
patterns for the same customer,
2including by identifying purchases in the preceding 12 calendar
3months by that customer or similar customers and identifying
4current purchases that exceed prior purchases by either that
5customer or similar customers by a factor of 20 percent.
6(c) Upon written, oral, or electronic request by the board, a
7wholesaler shall furnish data tracked pursuant to subdivision (b)
8to the board in written, hardcopy, or electronic form. The board
9shall specify the dangerous drugs, the customers, or both the
10dangerous drugs and customers for which data are to be furnished,
11and the wholesaler shall have 30 calendar days to comply with the
12request.
13(d) As used in this section, “preferential or contract prices”
14means and refers to purchases by contract of dangerous drugs at
15prices below the market wholesale price for those drugs.
Section 4165 of the Business and Professions Code
18 is amended to read:
A wholesaler or third-party logistics provider licensed
20by the board who sells or transfers any dangerous drug or
21dangerous device into this state or who receives, by sale or
22otherwise, any dangerous drug or dangerous device from any
23person in this state shall, on request, furnish an authorized officer
24of the law with all records or other documentation of that sale or
25transfer.
Section 4166 of the Business and Professions Code
28 is amended to read:
(a) Any wholesaler that uses the services of any
30third-party logistics provider or carrier, including, but not limited
31to, the United States Postal Service or any common carrier, shall
32be liable for the security and integrity of any dangerous drugs or
33dangerous devices through that provider or carrier until the drugs
34or devices are delivered to the transferee at its board-licensed
35premises.
36(b) Nothing in this section is intended to affect the liability of
37a wholesaler, third-party logistics provider, or other distributor for
38dangerous drugs or dangerous devices after their delivery to the
39transferee.
Section 4167 of the Business and Professions Code
3 is amended to read:
A wholesaler or third-party logistics provider shall not
5obtain, by purchase or otherwise, any dangerous drugs or dangerous
6devices that it cannot maintain, in a secure manner, on the premises
7licensed by the board.
Section 4168 of the Business and Professions Code
10 is amended to read:
A county or municipality shall not issue a business
12license for any establishment that requires a wholesaler or
13third-party logistics provider license unless the establishment
14possesses a current wholesaler or third-party logistics provider
15license issued by the board. For purposes of this section, an
16“establishment” is the licensee’s physical location in California.
Section 4169 of the Business and Professions Code
19 is amended to read:
(a) A person or entity shall not do any of the following:
21(1) Purchase, trade, sell, warehouse, distribute, or transfer
22dangerous drugs or dangerous devices at wholesale with a person
23or entity that is not licensed with the board as a wholesaler,
24third-party logistics provider, or pharmacy.
25(2) Purchase, trade, sell, or transfer dangerous drugs that the
26person knew or reasonably should have known were adulterated,
27as set forth in Article 2 (commencing with Section 111250) of
28Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.
29(3) Purchase, trade, sell, or transfer dangerous drugs that the
30person knew or reasonably should
have known were misbranded,
31as defined in Section 111335 of the Health and Safety Code.
32(4) Purchase, trade, sell, or transfer dangerous drugs or
33dangerous devices after the beyond use date on the label.
34(5) Fail to maintain records of the acquisition or disposition of
35dangerous drugs or dangerous devices for at least three years.
36(b) Notwithstanding any other law, a violation of this section
37may subject the person or entity that has committed the violation
38to a fine not to exceed the amount specified in Section 125.9 for
39each occurrence, pursuant to a citation issued by the board.
P19 1(c) Amounts due from any person under this section shall be
2offset as provided under Section 12419.5 of the Government Code.
3Amounts received by the board under this section
shall be deposited
4into the Pharmacy Board Contingent Fund.
5(d) This section shall not apply to a pharmaceutical manufacturer
6licensed by the Food and Drug Administration or by the State
7Department of Public Health.
Section 4201 of the Business and Professions Code
10 is amended to read:
(a) Each application to conduct a pharmacy, wholesaler,
12third-party logistics provider, or veterinary food-animal drug
13retailer, shall be made on a form furnished by the board, and shall
14state the name, address, usual occupation, and professional
15qualifications, if any, of the applicant. If the applicant is other than
16a natural person, the application shall state the information as to
17each person beneficially interested therein.
18(b) As used in this section, and subject to subdivision (c), the
19term “person beneficially interested” means and includes:
20(1) If the applicant is a partnership or other unincorporated
21association, each partner or member.
22(2) If the applicant is a corporation, each of its officers, directors,
23and stockholders, provided that no natural person shall be deemed
24to be beneficially interested in a nonprofit corporation.
25(3) If the applicant is a limited liability company, each officer,
26manager, or member.
27(c) If the applicant is a partnership or other unincorporated
28association, a limited liability company, or a corporation, and the
29number of partners, members, or stockholders, as the case may
30be, exceeds five, the application shall so state, and shall further
31state the information required by subdivision (a) as to each of the
32five partners, members, or stockholders who own the five largest
33interests in the applicant entity. Upon request by the executive
34officer, the applicant shall furnish the board with the information
35required by
subdivision (a) as to partners, members, or stockholders
36not named in the application, or shall refer the board to an
37appropriate source of that information.
38(d) The application shall contain a statement to the effect that
39the applicant has not been convicted of a felony and has not
40violated any of the provisions of this chapter. If the applicant
P20 1cannot make this statement, the application shall contain a
2statement of the violation, if any, or reasons which will prevent
3the applicant from being able to comply with the requirements
4with respect to the statement.
5(e) Upon the approval of the application by the board and
6payment of the fee required by this chapter for each pharmacy,
7wholesaler, third-party logistics provider, or veterinary food-animal
8drug retailer, the executive officer of the board shall issue a license
9to conduct a pharmacy, wholesaler, third-party logistics
provider,
10or veterinary food-animal drug retailer, if all of the provisions of
11this chapter have been complied with.
12(f) Notwithstanding any other law, the pharmacy license shall
13authorize the holder to conduct a pharmacy. The license shall be
14renewed annually and shall not be transferable.
15(g) Notwithstanding any other law, the wholesaler license shall
16authorize the holder to wholesale dangerous drugs and dangerous
17devices. The license shall be renewed annually and shall not be
18transferable.
19(h) Notwithstanding any other law, the third-party logistics
20provider license shall authorize the holder to provide or coordinate
21warehousing, distribution, or other similar services of dangerous
22drugs and dangerous devices. The license shall be renewed annually
23and shall not be transferable.
24(i) Notwithstanding any other law, the veterinary food-animal
25drug retailer license shall authorize the holder to conduct a
26veterinary food-animal drug retailer and to sell and dispense
27veterinary food-animal drugs as defined in Section 4042.
28(j) For licenses referred to in subdivisions (f), (g), (h), and (i),
29any change in the proposed beneficial ownership interest shall be
30reported to the board within 30 days thereafter upon a form to be
31furnished by the board.
Section 4305.5 of the Business and Professions Code
34 is amended to read:
(a) A person that is licensed as a wholesaler,
36third-party logistics provider, or veterinary food-animal drug
37retailer, shall notify the board within 30 days of the termination
38of employment of the designated representative-in-charge. Failure
39to notify the board within the 30-day period shall constitute grounds
40for disciplinary action.
P21 1(b) A person that is licensed as a wholesaler, third-party logistics
2provider, or veterinary food-animal drug retailer, that willfully
3fails to notify the board of the termination of employment of the
4designated representative-in-charge at its licensed place of business,
5and that continues to operate the place of business in the absence
6of the designated representative-in-charge for that place
of business
7shall be subject to summary suspension or revocation of its license
8as a wholesaler, third-party logistics provider, or veterinary
9food-animal drug retailer at that place of business.
10(c) A designated representative-in-charge of a wholesaler,
11third-party logistics provider, or veterinary food-animal drug
12retailer, who terminates his or her employment at the licensed
13place of business, shall notify the board within 30 days of the
14termination of employment. Failure to notify the board within the
1530-day period shall constitute grounds for disciplinary action.
Section 4312 of the Business and Professions Code
18 is amended to read:
(a) The board may cancel the license of a wholesaler,
20third-party logistics provider, pharmacy, or veterinary food-animal
21drug retailer if the licensed premises remain closed, as defined in
22subdivision (e), other than by order of the board. For good cause
23shown, the board may cancel a license after a shorter period of
24closure. To cancel a license pursuant to this subdivision, the board
25shall make a diligent, good faith effort to give notice by personal
26service on the licensee. If a written objection is not received within
2710 days after personal service is made or a diligent, good faith
28effort to give notice by personal service on the licensee has failed,
29the board may cancel the license without the necessity of a hearing.
30If the licensee files a written objection, the board shall file an
31
accusation based on the licensee remaining closed. Proceedings
32shall be conducted in accordance with Chapter 5 (commencing
33with Section 11500) of Part 1 of Division 3 of Title 2 of the
34Government Code, and the board shall have all the powers granted
35in that chapter.
36(b) If the license of a wholesaler, third-party logistics provider,
37pharmacy, or veterinary food-animal drug retailer is canceled
38pursuant to subdivision (a) or revoked pursuant to Article 19
39(commencing with Section 4300), or a wholesaler, third-party
40logistics provider, pharmacy, or veterinary food-animal drug
P22 1retailer notifies the board of its intent to remain closed or to
2discontinue business, the licensee shall, within 10 days thereafter,
3arrange for the transfer of all dangerous drugs and controlled
4substances or dangerous devices to another licensee authorized to
5possess the dangerous drugs and controlled substances or dangerous
6devices. The licensee transferring the
dangerous drugs and
7controlled substances or dangerous devices shall immediately
8confirm in writing to the board that the transfer has taken place.
9(c) If a wholesaler, third-party logistics provider, pharmacy, or
10veterinary food-animal drug retailer fails to comply with
11subdivision (b), the board may seek and obtain an order from the
12superior court in the county in which the wholesaler, third-party
13logistics provider, pharmacy, or veterinary food-animal drug
14retailer is located, authorizing the board to enter the wholesaler,
15third-party logistics provider, pharmacy, or veterinary food-animal
16drug retailer and inventory and store, transfer, sell, or arrange for
17the sale of, all dangerous drugs and controlled substances and
18dangerous devices found in the wholesaler, third-party logistics
19provider, pharmacy, or veterinary food-animal drug retailer.
20(d) If the board sells or arranges
for the sale of any dangerous
21drugs, controlled substances, or dangerous devices pursuant to
22subdivision (c), the board may retain from the proceeds of the sale
23an amount equal to the cost to the board of obtaining and enforcing
24an order issued pursuant to subdivision (c), including the cost of
25disposing of the dangerous drugs, controlled substances, or
26dangerous devices. The remaining proceeds, if any, shall be
27returned to the licensee from whose premises the dangerous drugs
28or controlled substances or dangerous devices were removed.
29(1) The licensee shall be notified of his or her right to the
30remaining proceeds by personal service or by certified mail,
31postage prepaid.
32(2) If a statute or regulation requires the licensee to file with
33the board his or her address, and any change of address, the notice
34required by this subdivision may be sent by certified mail, postage
35prepaid,
to the latest address on file with the board and service of
36notice in this manner shall be deemed completed on the 10th day
37after the mailing.
38(3) If the licensee is notified as provided in this subdivision,
39and the licensee fails to contact the board for the remaining
40proceeds within 30 calendar days after personal service has been
P23 1made or service by certified mail, postage prepaid, is deemed
2completed, the remaining proceeds shall be deposited by the board
3into the Pharmacy Board Contingent Fund. These deposits shall
4be deemed to have been received pursuant to Chapter 7
5(commencing with Section 1500) of Title 10 of Part 3 of the Code
6of Civil Procedure and shall be subject to claim or other disposition
7as provided in that chapter.
8(e) For the purposes of this section, “closed” means not engaged
9in the ordinary activity for which a license has been issued for at
10least one day
each calendar week during any 120-day period.
11(f) Nothing in this section shall be construed as requiring a
12pharmacy to be open seven days a week.
Section 4331 of the Business and Professions Code
15 is amended to read:
(a) A person who is neither a pharmacist nor a
17designated representative and who does either of the following,
18except as otherwise provided in this chapter, is guilty of a
19misdemeanor:
20(1) Takes charge of a wholesaler, third-party logistics provider,
21or veterinary food-animal drug retailer.
22 (2) Coordinates the warehousing or distribution of dangerous
23drugs or dangerous devices or dispenses a prescription or furnishes
24dangerous devices.
25(b) A person licensed as a veterinary food-animal drug retailer
26that fails to place in charge of that veterinary food-animal drug
27retailer a pharmacist or designated
representative, or any person
28who, by himself or herself, or by any other person, permits the
29dispensing of prescriptions, except by a pharmacist or designated
30representative, or as otherwise provided in this chapter, is guilty
31of a misdemeanor.
32(c) A person licensed as a wholesaler or third-party logistics
33provider that fails to place in charge of that wholesaler or
34third-party logistics provider a pharmacist or designated
35representative, or any person who, by himself or herself, or by any
36other person, permits the furnishing of dangerous drugs or
37dangerous devices, except by a pharmacist or designated
38representative, or as otherwise provided in this chapter, is guilty
39of a misdemeanor.
Section 4400 of the Business and Professions Code,
3as added by Section 9 of Chapter 565 of the Statutes of 2013, is
4amended to read:
The amount of fees and penalties prescribed by this
6chapter, except as otherwise provided, is that fixed by the board
7according to the following schedule:
8(a) The fee for a nongovernmental pharmacy license shall be
9four hundred dollars ($400) and may be increased to five hundred
10twenty dollars ($520). The fee for the issuance of a temporary
11nongovernmental pharmacy permit shall be two hundred fifty
12dollars ($250) and may be increased to three hundred twenty-five
13dollars ($325).
14(b) The fee for a nongovernmental pharmacy license annual
15renewal shall be two hundred fifty dollars ($250) and may be
16increased to three hundred twenty-five dollars ($325).
17(c) The fee
for the pharmacist application and examination shall
18be two hundred dollars ($200) and may be increased to two
19hundred sixty dollars ($260).
20(d) The fee for regrading an examination shall be ninety dollars
21($90) and may be increased to one hundred fifteen dollars ($115).
22If an error in grading is found and the applicant passes the
23examination, the regrading fee shall be refunded.
24(e) The fee for a pharmacist license and biennial renewal shall
25be one hundred fifty dollars ($150) and may be increased to one
26hundred ninety-five dollars ($195).
27(f) The fee for a nongovernmental wholesaler or third-party
28logistics provider license and annual renewal shall be seven
29hundred eighty dollars ($780) and may be decreased to no less
30than six hundred dollars ($600). The application fee for any
31additional location after licensure
of the first 20 locations shall be
32three hundred dollars ($300) and may be decreased to no less than
33two hundred twenty-five dollars ($225). A temporary license fee
34shall be seven hundred fifteen dollars ($715) and may be decreased
35to no less than five hundred fifty dollars ($550).
36(g) The fee for a hypodermic license and renewal shall be one
37hundred twenty-five dollars ($125) and may be increased to one
38hundred sixty-five dollars ($165).
39(h) (1) The fee for application, investigation, and issuance of
40license as a designated representative pursuant to Section 4053
P25 1shall be three hundred thirty dollars ($330) and may be decreased
2to no less than two hundred fifty-five dollars ($255).
3(2) The fee for the annual renewal of a license as a designated
4representative shall be one hundred ninety-five
dollars ($195) and
5may be decreased to no less than one hundred fifty dollars ($150).
6(i) (1) The fee for the application, investigation, and issuance
7of a license as a designated representative for a veterinary
8food-animal drug retailer pursuant to Section 4053 shall be three
9hundred thirty dollars ($330) and may be decreased to no less than
10two hundred fifty-five dollars ($255).
11(2) The fee for the annual renewal of a license as a designated
12representative for a veterinary food-animal drug retailer shall be
13one hundred ninety-five dollars ($195) and may be decreased to
14no less than one hundred fifty dollars ($150).
15(j) (1) The application fee for a nonresident wholesaler or
16third-party logistics provider license issued pursuant to Section
174161 shall be seven hundred
eighty dollars ($780) and may be
18decreased to no less than six hundred dollars ($600).
19(2) For nonresident wholesalers or third-party logistics providers
20that have 21 or more facilities operating nationwide the application
21fees for the first 20 locations shall be seven hundred eighty dollars
22($780) and may be decreased to no less than six hundred dollars
23($600). The application fee for any additional location after
24licensure of the first 20 locations shall be three hundred dollars
25($300) and may be decreased to no less than two hundred
26twenty-five dollars ($225). A temporary license fee shall be seven
27hundred fifteen dollars ($715) and may be decreased to no less
28than five hundred fifty dollars ($550).
29(3) The annual renewal fee for a nonresident wholesaler license
30or third-party logistics provider license issued pursuant to Section
314161 shall be seven hundred eighty dollars
($780) and may be
32decreased to no less than six hundred dollars ($600).
33(k) The fee for evaluation of continuing education courses for
34accreditation shall be set by the board at an amount not to exceed
35forty dollars ($40) per course hour.
36(l) The fee for an intern pharmacist license shall be ninety dollars
37($90) and may be increased to one hundred fifteen dollars ($115).
38The fee for transfer of intern hours or verification of licensure to
39another state shall be twenty-five dollars ($25) and may be
40increased 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
19to Section 6 of Article XIII B of the California Constitution because
20the only costs that may be incurred by a local agency or school
21district will be incurred because this act creates a new crime or
22infraction, eliminates a crime or infraction, or changes the penalty
23for a crime or infraction, within the meaning of Section 17556 of
24the Government Code, or changes the definition of a crime within
25the meaning of Section 6 of Article XIII B of the California
26Constitution.
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96