BILL NUMBER: SB 506 AMENDED
BILL TEXT
AMENDED IN SENATE JANUARY 27, 2014
INTRODUCED BY Senator Hill
FEBRUARY 21, 2013
An act to amend, repeal, and add Section 11100 of, and to add and
repeal Section 11100.02 of, the Health and Safety Code, relating to
controlled substances.
LEGISLATIVE COUNSEL'S DIGEST
SB 506, as amended, Hill. Ephedrine: retail sale.
(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, norpseudoephedrine, or
phenylpropanolamine 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. Existing law prohibits the sale of more than 3
packages or 9 grams of a nonprescription product containing
ephedrine or the other drugs, as specified.
This bill would instead provide that it is a misdemeanor,
punishable as specified, for a retail distributor, except pursuant to
a valid prescription from a licensed practitioner with prescriptive
authority, to sell or distribute to a person specified amounts of
nonprescription products containing ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine within specified time
limits, to sell or distribute any of those substances to a person
whose information has generated an alert, or, except under specified
conditions, to sell or distribute to a purchaser a nonprescription
product containing any amount of those substances. The bill would
contain provisions requiring the secure storage and monitoring of
products containing any amount of ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine, as specified.
The bill would require the Department of Justice to enter
into a memorandum of understanding with the National Association of
Drug Diversion Investigators (NADDI) and the vendor of the system
governing access and oversight of the California
transaction records regarding the transaction records, as specified,
including requiring that NADDI reimburse the department for costs
incurred in executing the memorandum of understanding, including the
competitive bidding process, and for costs incurred in performing
oversight and other duties. The bill would also require ,
if the memorandum of understanding is entered into, retail
distributors to transmit, on and after July 1, 2014,
2015, sale information to the National
Precursor Log Exchange (NPLEx) system
for purposes of determining whether the sale would violate these
provisions. The bill would require the Department of Justice
to enter into a memorandum of understanding with the National
Association of Drug Diversion Investigators regarding the transaction
records in NPLEx, as specified. The bill would
provide that prohibit use of the information in
the system may not be used for any purpose other
than to meet the requirements of, or comply with, this act or a
certain federal act, as specified. The bill would require that the
system be available to the department and state law enforcement at no
charge and would prohibit the Department of Justice or any other
state agency from bearing any cost for the development, installation,
or maintenance of the system. The bill would specify legislative
findings and intent. The
(2) The bill's provisions would
become operative as of February 1, 2015, but only if the NADDI
voluntarily agrees, on or before January 15, 2015, to reimburse the
Department of Justice for costs incurred in the execution of the
memorandum of understanding, including the competitive bidding
process, and for costs incurred in performing oversight and other
duties, as specified. The bill would require the Department of
Justice to post on its Internet Web site on or before January 19,
2015, whether or not NADDI has agreed to reimburse the department for
these costs. The bill's provisions would remain in effect only
until January 1, 2019. By creating a new crime, this bill would
impose a state-mandated local program.
(2)
(3) 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) Thionyl chloride.
(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 Abstracts Service number
(96-48-0) 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 Abstracts
Service number (110-63-4) 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 (i) 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 (ii) 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 State Department of Public Health; registration
number issued by the federal Drug Enforcement Administration;
precursor business permit number issued by the Department of Justice;
driver's license; or other identification issued by a state.
(2) (A) A manufacturer, wholesaler, retailer, or other person or
entity in this state that exports a substance specified in
subdivision (a) to a 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. The
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) A 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 a
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) A pharmacist or other authorized person who sells or furnishes
a substance upon the prescription of a physician, dentist,
podiatrist, or veterinarian.
(2) A physician, dentist, podiatrist, or veterinarian who
administers or furnishes a substance to his or her patients.
(3) A 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, provided that the manufacturer
or wholesaler submits records of any suspicious sales or transfers
as determined by the Department of Justice.
(4) An 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) The sale, transfer, furnishing, or receipt of a product
that contains ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine and 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. 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) Any ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine product subsequently removed from exemption
pursuant to Section 814 of Title 21 of the United States Code shall
similarly no longer be exempt from any state reporting or permitting
requirement, unless otherwise reinstated pursuant to Section 814(d)
of Title 21 of the United States Code as an exempt product.
(7) The sale, transfer, furnishing, or receipt of a betadine or
povidone solution with an iodine content not exceeding 1 percent in
containers of eight ounces or less, or a tincture of iodine not
exceeding 2 percent in containers of one ounce or less, that is sold
over the counter.
(8) The transfer of a substance specified in subdivision (a) for
purposes of lawful disposal as waste.
(f) (1) A 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
pursuant to subdivision (h) of Section 1170 of the Penal Code, 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 is unlawful for a manufacturer,
wholesaler, retailer, or other person 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 is unlawful for any person under 18 years
of age to possess a substance specified in subdivision (a).
(3) (A) A first violation of this subdivision is a misdemeanor.
(B) A 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) This section shall remain in effect only until January 1,
2019, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2019, deletes or extends
that date.
SEC. 2. Section 11100 is added to the Health and Safety Code, 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) Thionyl chloride.
(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 Abstracts Service number
(96-48-0) 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 Abstracts
Service number (110-63-4) 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) A manufacturer, wholesaler, retailer, or other person
or entity in this state, prior to selling, transferring, or otherwise
furnishing a substance specified in subdivision (a) to a person or
business entity in this state or any other state, shall require (i) 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 (ii) 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 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 State Department of Public Health; registration
number issued by the federal Drug Enforcement Administration;
precursor business permit number issued by the Bureau of Narcotic
Enforcement of the Department of Justice; driver's license; or other
identification issued by a state.
(2) (A) A manufacturer, wholesaler, retailer, or other person or
entity in this state that exports a substance specified in
subdivision (a) to a 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. The
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) A 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 a
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) A pharmacist or other authorized person who sells or furnishes
a substance upon the prescription of a physician, dentist,
podiatrist, or veterinarian.
(2) A physician, dentist, podiatrist, or veterinarian who
administers or furnishes a substance to his or her patients.
(3) A 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, provided that the manufacturer
or wholesaler submits records of any suspicious sales or transfers
as determined by the Department of Justice.
(4) An 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) The sale, transfer, furnishing, or receipt of a product
that contains ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine and 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. 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) An ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine product subsequently removed from exemption
pursuant to Section 814 of Title 21 of the United States Code shall
similarly no longer be exempt from state reporting or permitting
requirements, unless otherwise reinstated pursuant to Section 814(d)
of Title 21 of the United States Code as an exempt product.
(7) The sale, transfer, furnishing, or receipt of a betadine or
povidone solution with an iodine content not exceeding 1 percent in
containers of eight ounces or less, or a tincture of iodine not
exceeding 2 percent in containers of one ounce or less, that is sold
over the counter.
(8) Transfer of a substance specified in subdivision (a) for
purposes of lawful disposal as waste.
(f) (1) A 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) A 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
pursuant to subdivision (h) of Section 1170 of the Penal Code, 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 is unlawful for a manufacturer,
wholesaler, retailer, or other person 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 is unlawful for a person under 18 years of
age to possess a substance specified in subdivision (a).
(3) Notwithstanding any other law, it is unlawful for a retail
distributor to (A) 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 (B)
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 (21 U.S.C. Sec. 801 et seq.) by the federal
Drug Enforcement Administration pursuant to Section 814 of Title 21
of the United States Code.
(4) (A) A first violation of this subdivision is a misdemeanor.
(B) A 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 an 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 an 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 an 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
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 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, 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.
(j) This section shall become operative on January 1, 2019.
SEC. 3. Section 11100.02 is added to the Health and Safety Code,
to read:
11100.02. (a) Notwithstanding any other law, it is unlawful for a
retail distributor to knowingly do any of the following, except
pursuant to a valid prescription from a licensed practitioner with
prescriptive authority:
(1) To sell or distribute to the same purchaser within a 30-day
period more than 9 grams, or within a day more than 3.6 grams, of
ephedrine base, pseudoephedrine base, norpseudoephedrine base, or
phenylpropanolamine base contained in a 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 (21 U.S.C. Sec. 801 et seq.) by the federal Drug Enforcement
Administration pursuant to Section 814 of Title 21 of the United
States Code.
(2) To sell or
distribute ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine to a person whose information has generated an
alert as described in paragraph (3) of subdivision (d) regarding that
sale.
(3) To sell or distribute to a purchaser a nonprescription product
containing any amount of ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine, except under the
following conditions:
(A) The purchaser shall produce valid government-issued photo
identification.
(B) The purchaser shall sign a written or electronic log showing
all of the following:
(i) The date and time of the transaction.
(ii) The identification number presented.
(iii) The agency issuing the identification and the type of
identification issued.
(iv) The name, date of birth, and address of the purchaser.
(v) The amount of ephedrine base, pseudoephedrine base,
norpseudoephedrine base, or phenylpropanolamine base contained in the
material, compound, mixture, or preparation sold.
(b) The retail distributor shall store any product containing any
amount of ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine either behind the counter or in a locked cabinet
so that the customer does not have access to the product.
(c) (1) To facilitate the monitoring of the sales of
nonprescription products containing ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine, the retail distributor
shall record all of the following information at the point of sale
regarding the proposed transaction for the purpose of complying with
this section or the federal Combat Methamphetamine Epidemic Act of
2005, or any regulation adopted pursuant to this section or that act,
and for no other purpose:
(A) The date and time of the transaction.
(B) The identification number of the purchaser, issuing agency of
the identification, and the type of identification used.
(C) The name, date of birth, and address of the purchaser verified
through a photo identification of the purchaser.
(D) The name, quantity of packages, and total gram weight of
ephedrine base, pseudoephedrine base, norpseudoephedrine base, or
phenylpropanolamine base contained in a product or products
purchased, received, or otherwise acquired.
(E) The name or initials of the person making the sale.
(2) (A) On and after July 1, 2014,
2015, the retail distributor shall transmit the
information immediately to the National Precursor Log
Exchange (NPLEx) administered by the National Association of Drug
Diversion Investigators (NADDI) a vendor to collect,
administer, and provide access to the transaction data for
purposes of determining whether the proposed sale would violate this
section and therefore may not proceed, provided that the
NPLEx system is available to retailers in the state without
a charge for accessing the system. The transaction information shall
not be accessed, stored, or used by the retail distributor or law
enforcement for any purpose other than to meet the requirements set
forth in this section or to comply with the provisions of the federal
Combat Methamphetamine Epidemic Act of 2005, or any regulation
adopted pursuant to this section or that act. The retail distributor
shall not maintain a separate copy of the transaction information and
shall not have direct access to individual information or sales
records entered into the NPLEx system, except as
required by the federal Combat Methamphetamine Epidemic Act of 2005.
(B) Subparagraph (A) shall only become operative if the department
executes a memorandum of understanding (MOU) with NADDI and the
vendor of the system governing access and oversight of the California
transaction records pursuant to paragraph (1) of subdivision (d).
Prior to executing the MOU, the Department of Justice shall carry out
a competitive bidding process for a vendor to collect, administer,
and provide access to the transaction data transmitted by retail
distributors.
(3) (A) A retail distributor shall provide notice electronically,
in writing, or by signage to purchasers at the time of purchase that
the information collected pursuant to the federal Combat
Methamphetamine Epidemic Act of 2005 and this section shall be
entered into a single database as specified in paragraph (2) and
provided to law enforcement for purposes of determining the legality
of a proposed sale.
(B) The Legislature finds that it is necessary for
probable Probable cause to
shall be demonstrated to trigger an investigation in
connection with an individual whose requested purchase is denied by
the system a single time.
(C) Access by law enforcement to the data contained in the system
from a location other than the retailer shall be limited to the
records of an individual whose attempted purchase has been denied by
the system.
(4) This subdivision shall not be construed to require a retail
distributor to maintain state-required records relating to the sale
of products containing ephedrine, pseudoephedrine,
norpseudoephedrine, or phenylpropanolamine in a separate location or
log from records required by federal law to be kept with respect to
those products.
(5) The recording requirements specified in this subdivision shall
not apply to the sale of a single package containing not more than
60 milligrams of pseudoephedrine, consistent with the federal Combat
Methamphetamine Epidemic Act of 2005.
(6) If a retail distributor experiences mechanical or electronic
failure of the system and is unable to comply with the recording
requirements of this subdivision, the retail distributor shall
maintain the required records in a written log or an alternative
electronic recordkeeping mechanism until the retail distributor is
able to comply with the recording requirements of this subdivision.
Written logs shall be maintained only for the purpose of compliance
with this subdivision.
(d) (1) Provided that the department executes a
memorandum of understanding (MOU) with NADDI governing access,
pursuant to this subdivision, NADDI shall forward California
transaction records in NPLEx to the Department of Justice weekly and
provide real-time access to NPLEx information through the NPLEx
online portal to law enforcement in the state as authorized by the
department. The MOU shall constitute an enforceable contract.
The MOU described in paragraph (2) of subdivision (c)
between the department, NADDI, and the vendor of the system shall
require NADDI to reimburse the department for costs incurred in
executing the MOU, including the competitive bidding process, and for
costs incurred in performing oversight and other duties required by
this section and the MOU.
(2) The MOU shall require NADDI to forward California transaction
records in the system to the Department of Justice weekly and provide
real-time access to the information through the vendor's online
portal to law enforcement in the state as authorized by the
department.
(3) The MOU shall constitute an enforceable contract.
(2)
(4) Access to the system shall be available at no
charge to the department and law enforcement in this state as
authorized pursuant to paragraph (1).
(3)
(5) The system shall allow retail distributors of
products containing ephedrine, pseudoephedrine, norpseudoephedrine,
or phenylpropanolamine to enter into the database the information
specified in subdivision (c) regarding the proposed sale of those
products.
(4)
(6) The system shall be capable of providing the retail
distributor with an immediate real-time alert any time a provision
of this section is being violated by a proposed sale.
(5)
(7) Neither the department nor any state agency shall
bear any cost for the development, installation, or maintenance of
the system.
(6)
(8) The MOU shall state that no party to the MOU nor
any entity under contract to provide the electronic authorization and
monitoring system shall be authorized to use the information
contained in the system for any purpose other than those set forth in
this section, the federal Combat Methamphetamine Epidemic Act of
2005, or any regulation adopted pursuant to this section or that act.
However, the system operator shall be authorized to analyze the
information for the sole purpose of assessing and improving the
performance and efficacy of the system. In addition, the MOU shall
require that a retail distributor's access to the electronic
authorization and monitoring system's database is limited solely to
records of sales transactions made by that retail distributor, which
access shall be solely for purposes of complying with the federal
Combat Methamphetamine Epidemic Act of 2005 or this section, or to
respond to a duly authorized law enforcement request or court order
for information collected under that act or this section.
(7)
(9) The system's security program shall comply with the
security standards for the Criminal Justice Information System of
the Federal Bureau of Investigation and may be audited once a year by
the department.
(8)
(10) The use of the system by a retail distributor or
vendor of the NPLEx system shall be subject to
Section 56.101 of the Civil Code , including the purchaser's
right of access or to receive a copy of his or her purchaser records
. A retail distributor or a vendor of the NPLEx
system holding the NPLEx data shall not
maintain any records collected under this system for longer than two
years, or as otherwise required by the federal Combat Methamphetamine
Epidemic Act of 2005 and shall be destroyed pursuant to Section
1798.81 of the Civil Code.
(9)
(11) Law enforcement access to the system shall be
recorded by means of a unique access code for each individual
accessing the system. Each user's history shall be maintained and may
be audited by the department.
(10)
(12) The department may submit recommendations to NADDI
regarding system changes to assist in identifying false
identification cards.
(11)
(13) Disputes relating to compliance with this section
arising against a vendor of the NPLEx system shall
be subject to a court of competent jurisdiction in California and
shall be governed by California law.
(e) The State Board of Equalization shall notify all retailers
about the requirement to submit transactions to NPLEx
the system no later than April 1, 2014.
(f) This section shall not apply to a health care practitioner
with prescriptive authority who is currently licensed in this state.
(g) (1) A first violation of this section is a misdemeanor.
(2) A person who has previously been convicted of a violation of
this section 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 section, the following terms have the
following meanings:
(1) "Department" means the Department of Justice.
(2) "Drug store" is an entity described in Code 5912 of the
Standard Industrial Classification (SIC) Manual published by the
United States Office of Management and Budget, 1987 edition.
(3) "General merchandise store" is an 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.
(4) "Grocery store" is an entity described in Code 5411 of the
Standard Industrial Classification (SIC) Manual published by the
United States Office of Management and Budget, 1987 edition.
(5) "Retail distributor" means a grocery store, general
merchandise store, drugstore, or other related entity, the activities
of which, as 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, 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 amounts at or below that specified in
subdivision (a). "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.
(j) This section shall remain in effect only until January 1,
2019, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2019, deletes or extends
that date.
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.
SEC. 5. (a) This act shall become operative on
February 1, 2015.
(b) This act shall become operative only if the National
Association of Drug Diversion Investigators (NADDI) voluntarily
agrees, on or before January 15, 2015, to reimburse the department
for costs incurred in the execution of the memorandum of
understanding, including the competitive bidding process, and for
costs incurred in performing oversight and other duties as described
in Section 11100.02 of the Health and Safety Code, as amended by this
act. The Department of Justice shall post on its Internet Web site
on or before January 19, 2015, whether or not NADDI has agreed to
reimburse the department for these costs.