SB 294, as introduced, Emmerson. Sterile drug products.
The 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 the board to adopt regulations establishing standards for compounding injectable sterile drug products in a pharmacy. Existing law requires pharmacies to obtain a license from the board, subject to annual renewal, in order to compound injectable sterile drug products. A similar licensing requirement applies to nonresident pharmacies compounding injectable sterile drug products for shipment into California. A violation of the Pharmacy Law is a crime.
This bill would expand these provisions to prohibit a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the board. The bill would specify requirements for the board for issuance or renewal of a license, and requirements for the pharmacy as a licensee. By adding additional requirements to the Pharmacy Law concerning sterile drug products, the violation of which is a crime, the bill would impose a state-mandated local program.
Existing law specifies the fee for issuance or renewal of a nongovernmental license to compound sterile drug products.
This bill would provide that the fee for a nonresident sterile compounding pharmacy license shall also require payment of the travel expenses incurred by the board in inspecting the pharmacy at least once annually.
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:
The heading of Article 7.5 (commencing with
2Section 4127) of Chapter 9 of Division 2 of the Business and
3Professions Code is amended to read:
4
Section 4127 of the Business and Professions Code is
8repealed.
The board shall adopt regulations establishing standards
10for compounding injectable sterile drug products in a pharmacy.
Section 4127 is added to the Business and Professions
12Code, to read:
A pharmacy that compounds sterile drug products for
14injection, administration into the eye, or inhalation shall possess
15a sterile compounding pharmacy license as provided in this article
16before dispensing the compounded medication.
Section 4127.1 of the Business and Professions Code
18 is amended to read:
(a) A pharmacy shall not compoundbegin delete injectableend delete sterile
20drug productsbegin delete in this stateend delete unless the pharmacy has obtained a
21begin insert sterile compounding pharmacyend insert license from the board pursuant to
22this section. The license shall be renewed annually and is not
23transferable.
P3 1(b) A license to compoundbegin delete injectableend delete sterile drug productsbegin delete may begin insert
shallend insert be issued
2onlyend deletebegin delete forend deletebegin insert only toend insert a location that is licensed as a
3pharmacy. Furthermore, the license to compoundbegin delete injectableend delete sterile
4drug productsbegin delete may onlyend deletebegin insert shallend insert be issuedbegin insert onlyend insert to the owner of the
5pharmacybegin delete licenseend deletebegin insert
licensedend insert at that location. A license to compound
6begin delete injectableend delete sterile drug productsbegin delete mayend deletebegin insert shallend insert not be issued until the
7location is inspected by the board and found in compliance with
8this article and regulations adopted by the board.
9(c) A license to compoundbegin delete injectableend delete sterile drug productsbegin delete mayend delete
10begin insert shallend insert not bebegin insert
issued orend insert
renewed until thebegin delete location has been inspected begin insert board does all of the following:end insert
11by the board and found to be in compliance with this article and
12regulations adopted by the board.end delete
13(d) Pharmacies operated by entities that are licensed by either
14the board or the State Department of Public Health and that have
15current accreditation from the Joint Commission on Accreditation
16of Healthcare Organizations, or other private accreditation agencies
17approved by the board, are exempt from the requirement to obtain
18a license pursuant to this section.
19(1) Performs an onsite inspection of the premises, and any
20deficiencies noted are corrected.
21(2) Reviews a current copy of the pharmacy’s policies and
22procedures for sterile compounding.
23(3) Reviews the pharmacy’s completed self-assessment form
24required by Section 1735.2 of Title 16 of the California Code of
25Regulations.
26(4) Is provided with copies of all inspection reports conducted
27of the pharmacy’s premises, and any reports from a private
28accrediting agency, conducted in the prior 12 months documenting
29the pharmacy’s operations.
30(5) Receives a list of all sterile medications compounded by the
31pharmacy since the last license renewal.
32(d) A pharmacy licensed pursuant to this section shall do all of
33the following:
34(1) Provide to the board a copy of any disciplinary or other
35action taken by another state within 10 days of the action.
36(2) Notify the board within 10 days of the suspension of any
37accreditation held by the pharmacy.
38(3) Provide to the board, within 24 hours, any recall notice
39issued by the pharmacy for sterile drug products it has
40compounded.
P4 1(e) Adverse effects reported or potentially attributable to a
2pharmacy’s sterile drug product shall be immediately reported to
3the board and the MedWatch program of the federal Food and
4Drug Administration.
5(e)
end delete
6begin insert(f)end insert The reconstitution of a sterile powder shall not require a
7license pursuant to this section if both of the following are met:
8(1) The sterile powder was obtained from a manufacturer.
9(2) The drug is reconstituted for administration to patients by
10a health care professional licensed to administer drugs by injection
11pursuant to this division.
Section 4127.2 of the Business and Professions Code
13 is amended to read:
(a) A nonresident pharmacybegin delete mayend deletebegin insert shallend insert not compound
15begin delete injectableend delete sterile drug products for shipment intobegin delete the State of begin insert this stateend insert without abegin insert sterile compounding pharmacyend insert
16Californiaend delete
17 license issued by the board pursuant to this
section. The license
18shall be renewed annually and shall not be transferable.
19(b) A license to compoundbegin delete injectableend delete sterile drug productsbegin delete may begin insert shallend insert be issued
20onlyend deletebegin delete forend deletebegin insert only toend insert a location that is licensed as a
21nonresident pharmacy. Furthermore, the license to compound
22begin delete injectableend delete sterile drug productsbegin delete may onlyend deletebegin insert
shallend insert be issuedbegin insert onlyend insert to
23the owner of the nonresident pharmacybegin delete licenseend deletebegin insert licensedend insert at that
24location. A license to compoundbegin delete injectableend delete sterile drug products
25begin delete mayend deletebegin insert shallend insert not be issuedbegin delete or
renewed until the board receives the
26following from the nonresident pharmacy:end delete
27inspected by the board and found in compliance with this article
28and any regulations adopted by the board.end insert
29(1) A copy of an inspection report issued by the pharmacy’s
30licensing agency, or
a report from a private accrediting agency
31approved by the board, in the prior 12 months documenting the
32pharmacy’s compliance with board regulations regarding the
33compounding of injectable sterile drug products.
34(2) A copy of the nonresident pharmacy’s proposed policies
35and procedures for sterile compounding.
36(c) Nonresident pharmacies operated by entities that are licensed
37as a hospital, home health agency, or a skilled nursing facility and
38have current accreditation from the Joint Commission on
39Accreditation of Healthcare Organizations, or other private
P5 1accreditation agencies approved by the board, are exempt from
2the requirement to obtain a license pursuant to this section.
3(d) This section shall become effective on the earlier of July 1,
42003, or the effective date of regulations adopted by the board
5pursuant to Section 4127.
6(c) A license to compound sterile drug products shall not be
7issued or renewed until the board does all of the following:
8(1) Performs an onsite inspection of the premises, and any
9deficiencies noted are corrected. The nonresident pharmacy shall
10be responsible for payment of reasonable travel expenses incurred
11by the board in connection with inspecting the pharmacy at least
12once annually pursuant to subdivision (v) of Section 4400.
13(2) Reviews a current copy of the nonresident pharmacy’s
14policies and procedures for sterile compounding.
15(3) Reviews the pharmacy’s completed self-assessment form
16required by Section 1735.2 of Title 16 of the California Code of
17Regulations.
18(4) Is provided with
copies of all inspection reports conducted
19of the nonresident pharmacy’s premises, and any reports from a
20private accrediting agency, conducted in the prior 12 months
21documenting the nonresident pharmacy’s operations.
22(5) Receives a list of all sterile drug products compounded by
23the pharmacy within the prior 12 months.
24(d) A pharmacy licensed pursuant to this section shall do all of
25the following:
26(1) Provide to the board a copy of any disciplinary or other
27action taken by its state of residence or another state within 10
28days of the action.
29(2) Notify the board within 10 days of the suspension of any
30accreditation held by the pharmacy.
31(3) Provide to the board, within 24 hours, any
recall notice
32issued by the pharmacy for sterile drug products it has compounded
33that have been shipped into, or dispensed in, California.
34(4) Advise the board of any complaint it receives from a
35provider, pharmacy, or patient in California.
36(e) Adverse effects reported or potentially attributable to a
37nonresident pharmacy’s sterile compounded drug products shall
38be immediately reported to the board and the MedWatch program
39of the federal Food and Drug Administration.
Section 4400 of the Business and Professions Code is
2amended to read:
The amount of fees and penalties prescribed by this
4chapter, except as otherwise provided, is that fixed by the board
5according to the following schedule:
6(a) The fee for a nongovernmental pharmacy license shall be
7four hundred dollars ($400) and may be increased to five hundred
8twenty dollars ($520). The fee for the issuance of a temporary
9nongovernmental pharmacy permit shall be two hundred fifty
10dollars ($250) and may be increased to three hundred twenty-five
11dollars ($325).
12(b) The fee for a nongovernmental pharmacy license annual
13renewal shall be two hundred fifty dollars ($250) and may be
14increased to three hundred twenty-five dollars ($325).
15(c) The fee
for the pharmacist application and examination shall
16be two hundred dollars ($200) and may be increased to two
17hundred sixty dollars ($260).
18(d) The fee for regrading an examination shall be ninety dollars
19($90) and may be increased to one hundred fifteen dollars ($115).
20If an error in grading is found and the applicant passes the
21examination, the regrading fee shall be refunded.
22(e) The fee for a pharmacist license and biennial renewal shall
23be one hundred fifty dollars ($150) and may be increased to one
24hundred ninety-five dollars ($195).
25(f) The fee for a nongovernmental wholesaler license and annual
26renewal shall be six hundred dollars ($600), and may be increased
27to seven hundred eighty dollars ($780). The application fee for
28any additional location after licensure of the first 20 locations shall
29be two hundred
twenty-five dollars ($225) and may be increased
30to three hundred dollars ($300). A temporary license fee shall be
31five hundred fifty dollars ($550) and may be increased to seven
32hundred fifteen dollars ($715).
33(g) The fee for a hypodermic license and renewal shall be one
34hundred twenty-five dollars ($125) and may be increased to one
35hundred sixty-five dollars ($165).
36(h) (1) The fee for application, investigation, and issuance of
37license as a designated representative pursuant to Section 4053
38shall be two hundred fifty-five dollars ($255) and may be increased
39to three hundred thirty dollars ($330).
P7 1(2) The fee for the annual renewal of a license as a designated
2representative shall be one hundred fifty dollars ($150) and may
3be increased to one hundred ninety-five dollars ($195).
4(i) (1) The fee for the application, investigation, and issuance
5of a license as a designated representative for a veterinary
6food-animal drug retailer pursuant to Section 4053 shall be two
7hundred fifty-five dollars ($255) and may be increased to three
8hundred thirty dollars ($330).
9(2) The fee for the annual renewal of a license as a designated
10representative for a veterinary food-animal drug retailer shall be
11one hundred fifty dollars ($150) and may be increased to one
12hundred ninety-five dollars ($195).
13(j) (1) The application fee for a nonresident wholesaler’s license
14issued pursuant to Section 4161 shall be six hundred dollars ($600)
15and may be increased to seven hundred eighty dollars ($780).
16(2) For
nonresident wholesalers who have 21 or more facilities
17operating nationwide the application fees for the first 20 locations
18shall be six hundred dollars ($600) and may be increased to seven
19hundred eighty dollars ($780). The application fee for any
20additional location after licensure of the first 20 locations shall be
21two hundred twenty-five dollars ($225) and may be increased to
22three hundred dollars ($300). A temporary license fee shall be five
23hundred fifty dollars ($550) and may be increased to seven hundred
24fifteen dollars ($715).
25(3) The annual renewal fee for a nonresident wholesaler’s license
26issued pursuant to Section 4161 shall be six hundred dollars ($600)
27and may be increased to seven hundred eighty dollars ($780).
28(k) The fee for evaluation of continuing education courses for
29accreditation shall be set by the board at an amount not to exceed
30forty dollars ($40) per
course hour.
31(l) The fee for an intern pharmacist license shall be ninety dollars
32($90) and may be increased to one hundred fifteen dollars ($115).
33The fee for transfer of intern hours or verification of licensure to
34another state shall be twenty-five dollars ($25) and may be
35increased to thirty dollars ($30).
36(m) The board may waive or refund the additional fee for the
37issuance of a license where the license is issued less than 45 days
38before the next regular renewal date.
39(n) The fee for the reissuance of any license, or renewal thereof,
40that has been lost or destroyed or reissued due to a name change
P8 1shall be thirty-five dollars ($35) and may be increased to forty-five
2dollars ($45).
3(o) The fee for the reissuance of any license, or renewal thereof,
4
that must be reissued because of a change in the information, shall
5be one hundred dollars ($100) and may be increased to one hundred
6thirty dollars ($130).
7(p) It is the intent of the Legislature that, in setting fees pursuant
8to this section, the board shall seek to maintain a reserve in the
9Pharmacy Board Contingent Fund equal to approximately one
10year’s operating expenditures.
11(q) The fee for any applicant for a nongovernmental clinic
12license shall be four hundred dollars ($400) and may be increased
13to five hundred twenty dollars ($520) for each license. The annual
14fee for renewal of the license shall be two hundred fifty dollars
15($250) and may be increased to three hundred twenty-five dollars
16($325) for each license.
17(r) The fee for the issuance of a pharmacy technician license
18shall be eighty dollars ($80) and
may be increased to one hundred
19five dollars ($105). The fee for renewal of a pharmacy technician
20license shall be one hundred dollars ($100) and may be increased
21to one hundred thirty dollars ($130).
22(s) The fee for a veterinary food-animal drug retailer license
23shall be four hundred five dollars ($405) and may be increased to
24four hundred twenty-five dollars ($425). The annual renewal fee
25for a veterinary food-animal drug retailer license shall be two
26hundred fifty dollars ($250) and may be increased to three hundred
27twenty-five dollars ($325).
28(t) The fee for issuance of a retired license pursuant to Section
294200.5 shall be thirty-five dollars ($35) and may be increased to
30forty-five dollars ($45).
31(u) The fee for issuance or renewal of a nongovernmentalbegin insert
sterile
32compounding pharmacyend insert
licensebegin delete to compound sterile drug productsend delete
33 shall be six hundred dollars ($600) and may be increased to seven
34hundred eighty dollars ($780). The fee for a temporary license
35shall be five hundred fifty dollars ($550) and may be increased to
36seven hundred fifteen dollars ($715).
37(v) The fee for a nonresident sterile compounding pharmacy
38license shall also require payment of the travel expenses incurred
39by the board in inspecting the pharmacy at least once annually.
P9 1Failure to pay this fee within 30 days shall result in the suspension
2of the nonresident sterile compounding pharmacy license.
No reimbursement is required by this act pursuant to
4Section 6 of Article XIII B of the California Constitution because
5the only costs that may be incurred by a local agency or school
6district will be incurred because this act creates a new crime or
7infraction, eliminates a crime or infraction, or changes the penalty
8for a crime or infraction, within the meaning of Section 17556 of
9the Government Code, or changes the definition of a crime within
10the meaning of Section 6 of Article XIII B of the California
11Constitution.
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