Bill Text: CA SB315 | 2011-2012 | Regular Session | Introduced
Bill Title: Ephedrine and pseudoephedrine.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2012-01-31 - Returned to Secretary of Senate pursuant to Joint Rule 56. [SB315 Detail]
Download: California-2011-SB315-Introduced.html
BILL NUMBER: SB 315 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Wright
FEBRUARY 14, 2011
An act to amend Sections 11100 and 11106 of, and to add Section
11375.5 to, the Health and Safety Code, relating to controlled
substances.
LEGISLATIVE COUNSEL'S DIGEST
SB 315, as introduced, Wright. Ephedrine and pseudoephedrine.
(1) Existing law classifies controlled substances into 5
schedules, with the most restrictive limitations placed on controlled
substances classified in Schedule I, and the least restrictive
limitations placed on controlled substances classified in Schedule V.
A controlled substance in any of the schedules may be possessed or
dispensed only upon a lawful prescription, as specified. Existing law
does not classify ephedrine, pseudoephedrine, and specified related
drugs within any of these 5 schedules, but provides that it is a
crime, punishable as specified, for a person in this state who
engages in specified transactions involving those drugs to fail to
submit a report to the Department of Justice of all of those
transactions, or to fail to submit an application to, and obtain a
permit for the conduct of that business from, the Department of
Justice, as specified.
This bill would provide, in addition, that any person who obtains
ephedrine, pseudoephedrine, phenylpropanolamine, and specified
related drugs without a prescription, as specified, shall be guilty
of an infraction or a misdemeanor. The bill would make conforming
changes to related provisions. By creating new crimes or revising the
penalties for existing crimes involving ephedrine, pseudoephedrine,
and specified related drugs, this bill would impose a state-mandated
local program.
(2) 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 1. Section 11100 of the Health and Safety Code is amended
to read:
11100. (a) Any manufacturer, wholesaler, retailer, or other
person or entity in this state that sells, transfers, or otherwise
furnishes any of the following substances to any person or entity in
this state or any other state shall submit a report to the Department
of Justice of all of those transactions:
(1) Phenyl-2-propanone.
(2) Methylamine.
(3) Ethylamine.
(4) D-lysergic acid.
(5) Ergotamine tartrate.
(6) Diethyl malonate.
(7) Malonic acid.
(8) Ethyl malonate.
(9) Barbituric acid.
(10) Piperidine.
(11) N-acetylanthranilic acid.
(12) Pyrrolidine.
(13) Phenylacetic acid.
(14) Anthranilic acid.
(15) Morpholine.
(16) Ephedrine.
(17) Pseudoephedrine.
(18) Norpseudoephedrine.
(19) Phenylpropanolamine.
(20) Propionic anhydride.
(21) Isosafrole.
(22) Safrole.
(23) Piperonal.
(24) Thionylchloride.
(25) Benzyl cyanide.
(26) Ergonovine maleate.
(27) N-methylephedrine.
(28) N-ethylephedrine.
(29) N-methylpseudoephedrine.
(30) N-ethylpseudoephedrine.
(31) Chloroephedrine.
(32) Chloropseudoephedrine.
(33) Hydriodic acid.
(34) Gamma-butyrolactone, including butyrolactone; butyrolactone
gamma; 4-butyrolactone; 2(3H)-furanone dihydro; dihydro-2
(3H)-furanone; tetrahydro-2-furanone; 1,2-butanolide; 1,4-butanolide;
4-butanolide; gamma-hydroxybutyric acid lactone; 3-hydroxybutyric
acid lactone and 4-hydroxybutanoic acid lactone with Chemical
Abstract Service number (96-48-0).
(35) 1,4-butanediol, including butanediol; butane-1,4-diol;
1,4-butylene glycol; butylene glycol; 1,4-dihydroxybutane;
1,4-tetramethylene glycol; tetramethylene glycol; tetramethylene
1,4-diol with Chemical Abstract Service number (110-63-4).
(36) Red phosphorus, including white phosphorus, hypophosphorous
acid and its salts, ammonium hypophosphite, calcium hypophosphite,
iron hypophosphite, potassium hypophosphite, manganese hypophosphite,
magnesium hypophosphite, sodium hypophosphite, and phosphorous acid
and its salts.
(37) Iodine or tincture of iodine.
(38) Any of the substances listed by the Department of Justice in
regulations promulgated pursuant to subdivision (b).
(b) The Department of Justice may adopt rules and regulations in
accordance with Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code that add substances
to subdivision (a) if the substance is a precursor to a controlled
substance and delete substances from subdivision (a). However, no
regulation adding or deleting a substance shall have any effect
beyond March 1 of the year following the calendar year during which
the regulation was adopted.
(c) (1) (A) Any manufacturer, wholesaler, retailer, or other
person or entity in this state, prior to selling, transferring, or
otherwise furnishing any substance specified in subdivision (a) to
any person or business entity in this state or any other state, shall
require (A) a letter of authorization from that person or business
entity that includes the currently valid business license number or
federal Drug Enforcement Administration (DEA) registration number,
the address of the business, and a full description of how the
substance is to be used, and (B) proper identification from the
purchaser. The manufacturer, wholesaler, retailer, or other person or
entity in this state shall retain this information in a readily
available manner for three years. The requirement for a full
description of how the substance is to be used does not require the
person or business entity to reveal their chemical processes that are
typically considered trade secrets and proprietary information.
(B) For the purposes of this paragraph, "proper identification"
for in-state or out-of-state purchasers includes two or more of the
following: federal tax identification number; seller's permit
identification number; city or county business license number;
license issued by the California Department of Health
Services State Department of Public Health ;
registration number issued by the Federal
federal Drug Enforcement Administration; precursor business
permit number issued by the Bureau of Narcotic Enforcement of the
California Department of Justice; driver's
license; or other identification issued by a state.
(2) (A) Any manufacturer, wholesaler, retailer, or other person or
entity in this state that exports a substance specified in
subdivision (a) to any person or business entity located in a foreign
country shall, on or before the date of exportation, submit to the
Department of Justice a notification of that transaction, which
notification shall include the name and quantity of the substance to
be exported and the name, address, and, if assigned by the foreign
country or subdivision thereof, business identification number of the
person or business entity located in a foreign country importing the
substance.
(B) The department may authorize the submission of the
notification on a monthly basis with respect to repeated, regular
transactions between an exporter and an importer involving a
substance specified in subdivision (a), if the department determines
that a pattern of regular supply of the substance exists between the
exporter and importer and that the importer has established a record
of utilization of the substance for lawful purposes.
(d) (1) Any manufacturer, wholesaler, retailer, or other person or
entity in this state that sells, transfers, or otherwise furnishes a
substance specified in subdivision (a) to a person or business
entity in this state or any other state shall, not less than 21 days
prior to delivery of the substance, submit a report of the
transaction, which includes the identification information specified
in subdivision (c), to the Department of Justice. The Department of
Justice may authorize the submission of the reports on a monthly
basis with respect to repeated, regular transactions between the
furnisher and the recipient involving the substance or substances if
the Department of Justice determines that a pattern of regular supply
of the substance or substances exists between the manufacturer,
wholesaler, retailer, or other person or entity that sells,
transfers, or otherwise furnishes the substance or substances and the
recipient of the substance or substances, and the recipient has
established a record of utilization of the substance or substances
for lawful purposes.
(2) The person selling, transferring, or otherwise furnishing any
substance specified in subdivision (a) shall affix his or her
signature or otherwise identify himself or herself as a witness to
the identification of the purchaser or purchasing individual, and
shall, if a common carrier is used, maintain a manifest of the
delivery to the purchaser for three years.
(e) This section shall not apply to any of the following:
(1) Any pharmacist or other authorized person who sells or
furnishes a substance upon the prescription of a physician, dentist,
podiatrist, or veterinarian.
(2) Any physician, dentist, podiatrist, or veterinarian who
administers or furnishes a substance to his or her patients.
(3) Any manufacturer or wholesaler licensed by the California
State Board of Pharmacy that sells, transfers, or otherwise furnishes
a substance to a licensed pharmacy, physician, dentist, podiatrist,
or veterinarian, or a retail distributor as defined in subdivision
(h), provided that the manufacturer or wholesaler submits records of
any suspicious sales or transfers as determined by the Department of
Justice.
(4) Any analytical research facility that is registered with the
federal Drug Enforcement Administration of the United States
Department of Justice.
(5) A state-licensed health care facility that administers or
furnishes a substance to its patients.
(6) (A) Any sale, transfer, furnishing, or receipt of any product
that contains ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine and which is lawfully sold, transferred, or
furnished over the counter without a prescription pursuant to the
federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or
regulations adopted thereunder. However, this section shall apply to
preparations in solid or liquid dosage form, except pediatric liquid
forms, as defined, containing ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine where the individual
transaction involves more than three packages or nine grams of
ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine.
(B)
(6) Any ephedrine, pseudoephedrine,
norpseudoephedrine, or
phenylpropanolamine product sale,
transfer, furnishing, or receipt of a product specified in
Section 11375.5 pursuant to prescription shall not be subject to the
reporting or permitting requirements of this section, unless a
product is subsequently removed from exemption pursuant to
Section 814 of Title 21 of the United States Code
Code, in which case the product shall similarly no longer
be exempt from any state reporting or permitting
requirement, requirement unless otherwise
reinstated pursuant to subdivision (d) or (e) of
Section 814 of Title 21 of the United States Code as an exempt
product.
(7) The sale, transfer, furnishing, or receipt of any betadine or
povidone solution with an iodine content not exceeding 1 percent in
containers of eight ounces or less, or any tincture of iodine not
exceeding 2 percent in containers of one ounce or less, that is sold
over the counter.
(8) Any transfer of a substance specified in subdivision (a) for
purposes of lawful disposal as waste.
(f) (1) Any person specified in subdivision (a) or (d) who does
not submit a report as required by that subdivision or who knowingly
submits a report with false or fictitious information shall be
punished by imprisonment in a county jail not exceeding six months,
by a fine not exceeding five thousand dollars ($5,000), or by both
the fine and imprisonment.
(2) Any person specified in subdivision (a) or (d) who has
previously been convicted of a violation of paragraph (1) shall, upon
a subsequent conviction thereof, be punished by imprisonment in the
state prison, or by imprisonment in a county jail not exceeding one
year, by a fine not exceeding one hundred thousand dollars
($100,000), or by both the fine and imprisonment.
(g) (1) Except as otherwise provided in subparagraph (A)
of paragraph (6) of subdivision (e), it It
is unlawful for any manufacturer, wholesaler, retailer, or
other person or entity in this state to sell, transfer, or
otherwise furnish a substance specified in subdivision (a) to a
person under 18 years of age.
(2) Except as otherwise provided in subparagraph (A) of
paragraph (6) of subdivision (e), it It is
unlawful for any person under 18 years of age to possess a substance
specified in subdivision (a).
(3) Notwithstanding any other law, it is unlawful for any retail
distributor to (i) sell in a single transaction more than three
packages of a product that he or she knows to contain ephedrine,
pseudoephedrine, norpseudoephedrine, or phenylpropanolamine, or (ii)
knowingly sell more than nine grams of ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine, other than pediatric
liquids as defined. Except as otherwise provided in this section, the
three package per transaction limitation or nine gram per
transaction limitation imposed by this paragraph shall apply to any
product that is lawfully sold, transferred, or furnished over the
counter without a prescription pursuant to the federal Food, Drug,
and Cosmetic Act (21 U.S.C. Sec. 301 et seq.), or regulations adopted
thereunder, unless exempted from the requirements of the federal
Controlled Substances Act by the federal Drug Enforcement
Administration pursuant to Section 814 of Title 21 of the United
States Code.
(4)
(3) (A) A first violation of this subdivision is a
misdemeanor.
(B) Any person who has previously been convicted of a violation of
this subdivision shall, upon a subsequent conviction thereof, be
punished by imprisonment in a county jail not exceeding one year, by
a fine not exceeding ten thousand dollars ($10,000), or by both the
fine and imprisonment.
(h) For the purposes of this article, the following terms have the
following meanings:
(1) "Drug store" is any entity described in Code 5912 of the
Standard Industrial Classification (SIC) Manual published by the
United States Office of Management and Budget, 1987 edition.
(2) "General merchandise store" is any entity described in Codes
5311 to 5399, inclusive, and Code 5499 of the Standard Industrial
Classification (SIC) Manual published by the United States Office of
Management and Budget, 1987 edition.
(3) "Grocery store" is any entity described in Code 5411 of the
Standard Industrial Classification (SIC) Manual published by the
United States Office of Management and Budget, 1987 edition.
(4) "Pediatric liquid" means a nonencapsulated liquid whose unit
measure according to product labeling is stated in milligrams,
ounces, or other similar measure. In no instance shall the dosage
units exceed 15 milligrams of phenylpropanolamine or
pseudoephedrine any product specified in Section
11375.5 per five milliliters of liquid product, except for
liquid products primarily intended for administration to children
under two years of age for which the recommended dosage unit does not
exceed two milliliters and the total package content does not exceed
one fluid ounce.
(5) "Retail distributor" means a grocery store, general
merchandise store, drugstore, or other related entity, the activities
of which, as which include being a
distributor of ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine products, are limited
exclusively to the sale of ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine products for personal use
both in number of sales and
volume of sales, any product specified in Section
11375.5 upon p rescription only, except for pediatric
liquids, either directly to walk-in customers or in
face-to-face transactions by direct sales. "Retail distributor"
includes an entity that makes a direct sale, but does not include the
parent company of that entity if the company is not involved in
direct sales regulated by this article.
(6) "Sale for personal use" means the sale in a single transaction
to an individual customer for a legitimate medical use of a product
containing ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine in dosages at or below that specified in
paragraph (3) of subdivision (g). "Sale for personal use" also
includes the sale of those products to employers to be dispensed to
employees from first-aid kits or medicine chests.
(i) It is the intent of the Legislature that this section shall
preempt all local ordinances or regulations governing the sale by a
retail distributor of over-the-counter products containing ephedrine,
pseudoephedrine, norpseudoephedrine, or phenylpropanolamine.
SEC. 2. Section 11106 of the Health and Safety Code is amended to
read:
11106. (a) (1) (A) Any manufacturer, wholesaler, retailer, or
any other person or entity in this state that
sells, transfers, or otherwise furnishes any substance specified in
subdivision (a) of Section 11100 to a person or business entity in
this state or any other state or who obtains from a source outside of
the state any substance specified in subdivision (a) of Section
11100 shall submit an application to, and obtain a permit for the
conduct of that business from, the Department of Justice. For any
substance added to the list set forth in subdivision (a) of Section
11100 on or after January 1, 2002, the Department of Justice may
postpone the effective date of the requirement for a permit for a
period not to exceed six months from the listing date of the
substance.
(B) An intracompany transfer does not require a permit if the
transferor is a permittee. Transfers between company partners or
between a company and an analytical laboratory do not require a
permit if the transferor is a permittee and a report as to the nature
and extent of the transfer is made to the Department of Justice
pursuant to Section 11100 or 11100.1.
(C) This paragraph shall not apply to any manufacturer,
wholesaler, or wholesale distributor who is licensed by the
California State Board of Pharmacy and also registered with the
federal Drug Enforcement Administration of the United States
Department of Justice; any pharmacist or other authorized person who
sells or furnishes a substance upon the prescription of a physician,
dentist, podiatrist, or veterinarian; any state-licensed health care
facility, physician, dentist, podiatrist, veterinarian, or veterinary
food-animal drug retailer licensed by the California State Board of
Pharmacy that administers or furnishes a substance to a patient; or
any analytical research facility that is registered with the federal
Drug Enforcement Administration of the United States Department of
Justice.
(D) This paragraph shall not apply to the sale, transfer,
furnishing, or receipt of any betadine or povidone solution with an
iodine content not exceeding 1 percent in containers of eight ounces
or less, or any tincture of iodine not exceeding 2 percent in
containers of one ounce or less, that is sold over the counter.
(2) Except as provided in paragraph (3), no permit shall be
required of any manufacturer, wholesaler, retailer, or other person
or entity for the sale, transfer, furnishing, or obtaining of any
product which contains ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine and which is lawfully
sold, transferred, or furnished over the counter without a
prescription or by a prescription pursuant to the federal Food, Drug,
and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or regulations adopted
thereunder.
(3)
(2) A permit shall be required for the sale, transfer,
furnishing, or obtaining of preparations in solid or liquid dosage
form containing ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine, unless (A) the
transaction involves the sale of ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine products by retail
distributors as defined by this
article over the counter and without a prescription, or (B) the
transaction is made by a person or business entity exempted from the
permitting requirements of this subdivision under paragraph (1).
any product as specified in Section 11375.5.
(b) (1) The department shall provide application forms, which are
to be completed under penalty of perjury, in order to obtain
information relating to the identity of any applicant applying for a
permit, including, but not limited to, the business name of the
applicant or the individual name, and if a corporate entity, the
names of its board of directors, the business in which the applicant
is engaged, the business address of the applicant, a full description
of any substance to be sold, transferred, or otherwise furnished or
to be obtained, the specific purpose for the use, sale, or transfer
of those substances specified in subdivision (a) of Section 11100,
the training, experience, or education relating to this use, and any
additional information requested by the department relating to
possible grounds for denial as set forth in this section, or by
applicable regulations adopted by the department.
(2) The requirement for the specific purpose for the use, sale, or
transfer of those substances specified in subdivision (a) of Section
11100 does not require applicants or permittees to reveal their
chemical processes that are typically considered trade secrets and
proprietary business information.
(c) Applicants and permittees shall authorize the department, or
any of its duly authorized representatives, as a condition of being
permitted, to make any examination of the books and records of any
applicant, permittee, or other person, or visit and inspect the
business premises of any applicant or permittee during normal
business hours, as deemed necessary to enforce this chapter.
(d) An application may be denied, or a permit may be revoked or
suspended, for reasons which include, but are not limited to, the
following:
(1) Materially falsifying an application for a permit or an
application for the renewal of a permit.
(2) If any individual owner, manager, agent, representative, or
employee for the applicant who has direct access, management, or
control for any substance listed under subdivision (a) of Section
11100, is or has been convicted of a misdemeanor or felony relating
to any of the substances listed under subdivision (a) of Section
11100, any misdemeanor drug-related offense, or any felony under the
laws of this state or the United States.
(3) Failure to maintain effective controls against the diversion
of precursors to unauthorized persons or entities.
(4) Failure to comply with this article or any regulations of the
department adopted thereunder.
(5) Failure to provide the department, or any duly authorized
federal or state official, with access to any place for which a
permit has been issued, or for which an application for a permit has
been submitted, in the course of conducting a site investigation,
inspection, or audit; or failure to promptly produce for the official
conducting the site investigation, inspection, or audit any book,
record, or document requested by the official.
(6) Failure to provide adequate documentation of a legitimate
business purpose involving the applicant's or permittee's use of any
substance listed in subdivision (a) of Section 11100.
(7) Commission of any act which would demonstrate actual or
potential unfitness to hold a permit in light of the public safety
and welfare, which act is substantially related to the
qualifications, functions, or duties of a permitholder.
(8) If any individual owner, manager, agent, representative, or
employee for the applicant who has direct access, management, or
control for any substance listed under subdivision (a) of Section
11100, willfully violates or has been convicted of violating, any
federal, state, or local criminal statute, rule, or ordinance
regulating the manufacture, maintenance, disposal, sale, transfer, or
furnishing of any of those substances.
(e) Notwithstanding any other provision of law, an investigation
of an individual applicant's qualifications, or the qualifications of
an applicant's owner, manager, agent, representative, or employee
who has direct access, management, or control of any substance listed
under subdivision (a) of Section 11100, for a permit may include
review of his or her summary criminal history information pursuant to
Sections 11105 and 13300 of the Penal Code, including, but not
limited to, records of convictions, regardless of whether those
convictions have been expunged pursuant to Section 1203.4 of the
Penal Code, and any arrests pending adjudication.
(f) The department may retain jurisdiction of a canceled or
expired permit in order to proceed with any investigation or
disciplinary action relating to a permittee.
(g) The department may grant permits on forms prescribed by it,
which shall be effective for not more than one year from the date of
issuance and which shall not be transferable. Applications and
permits shall be uniform throughout the state, on forms prescribed by
the department.
(h) Each applicant shall pay at the time of filing an application
for a permit a fee determined by the department which shall not
exceed the application processing costs of the department.
(i) A permit granted pursuant to this article may be renewed one
year from the date of issuance, and annually thereafter, following
the timely filing of a complete renewal application with all
supporting documents, the payment of a permit renewal fee not to
exceed the application processing costs of the department, and a
review of the application by the department.
(j) Selling, transferring, or otherwise furnishing or obtaining
any substance specified in subdivision (a) of Section 11100 without a
permit is a misdemeanor or a felony.
(k) (1) No person under 18 years of age shall be eligible for a
permit under this section.
(2) No business for which a permit has been issued shall employ a
person under 18 years of age in the capacity of a manager, agent, or
representative.
( l ) (1) An applicant, or an applicant's employees who
have direct access, management, or control of any substance listed
under subdivision (a) of Section 11100, for an initial permit shall
submit with the application one set of 10-print fingerprints for each
individual acting in the capacity of an owner, manager, agent, or
representative for the applicant, unless the applicant's employees
are exempted from this requirement by the Department of Justice.
These exemptions may only be obtained upon the written request of the
applicant.
(2) In the event of subsequent changes in ownership, management,
or employment, the permittee shall notify the department in writing
within 15 calendar days of the changes, and shall submit one set of
10-print fingerprints for each individual not previously
fingerprinted under this section.
SEC. 3. Section 11375.5 is added to the Health and Safety Code, to
read:
11375.5. (a) Any person who obtains any substance specified in
subdivision (b), unless upon the prescription of a physician,
dentist, podiatrist, or veterinarian, licensed to practice in this
state, shall be guilty of an infraction or a misdemeanor.
(b) This section shall apply to any material, compound, mixture,
or preparation containing ephedrine, pseudoephedrine,
norpseudoephedrine, phenylpropanolamine, N-methylephedrine,
N-ethylephedrine, N-methylpseudoephedrine, N-ethylpseudoephedrine,
chloroephedrine, or chloropseudoephedrine, except for pediatric
liquid forms as specified in subdivision (h) of Section 11100.
(c) This section shall not be
construed to prevent prosecution under any other applicable law.
SEC. 4. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.
