SB 506, as introduced, 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 retail distributors to transmit, on and after July 1, 2014, sale information to the National Precursor Log Exchange (NPLEx) 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 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 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) 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 11100 of the Health and Safety Code is
2amended to read:
(a) Any manufacturer, wholesaler, retailer, or other
4person or entity in this state that sells, transfers, or otherwise
5furnishes any of the following substances to any person or entity
P3 1in this state or any other state shall submit a report to the
2Department of Justice of all of those transactions:
3(1) Phenyl-2-propanone.
4(2) Methylamine.
5(3) Ethylamine.
6(4) D-lysergic acid.
7(5) Ergotamine tartrate.
8(6) Diethyl malonate.
9(7) Malonic acid.
10(8) Ethyl malonate.
11(9) Barbituric acid.
12(10) Piperidine.
13(11) N-acetylanthranilic acid.
14(12) Pyrrolidine.
15(13) Phenylacetic acid.
16(14) Anthranilic acid.
17(15) Morpholine.
18(16) Ephedrine.
19(17) Pseudoephedrine.
20(18) Norpseudoephedrine.
21(19) Phenylpropanolamine.
22(20) Propionic anhydride.
23(21) Isosafrole.
24(22) Safrole.
25(23) Piperonal.
26(24) Thionyl chloride.
27(25) Benzyl cyanide.
28(26) Ergonovine maleate.
29(27) N-methylephedrine.
30(28) N-ethylephedrine.
31(29) N-methylpseudoephedrine.
32(30) N-ethylpseudoephedrine.
33(31) Chloroephedrine.
34(32) Chloropseudoephedrine.
35(33) Hydriodic acid.
36(34) Gamma-butyrolactone, including butyrolactone;
37butyrolactone gamma; 4-butyrolactone; 2(3H)-furanone dihydro;
38dihydro-2(3H)-furanone; tetrahydro-2-furanone; 1,2-butanolide;
391,4-butanolide; 4-butanolide; gamma-hydroxybutyric acid lactone;
P4 13-hydroxybutyric acid lactone and 4-hydroxybutanoic acid lactone
2with Chemical Abstract Service number (96-48-0).
3(35) 1,4-butanediol, including butanediol; butane-1,4-diol;
41,4-butylene glycol; butylene glycol; 1,4-dihydroxybutane;
51,4-tetramethylene glycol; tetramethylene glycol;
tetramethylene
61,4-diol with Chemical Abstract Service number (110-63-4).
7(36) Red phosphorus, including white phosphorus,
8hypophosphorous acid and its salts, ammonium hypophosphite,
9calcium hypophosphite, iron hypophosphite, potassium
10hypophosphite, manganese hypophosphite, magnesium
11hypophosphite, sodium hypophosphite, and phosphorous acid and
12its salts.
13(37) Iodine or tincture of iodine.
14(38) Any of the substances listed by the Department of Justice
15in regulations promulgated pursuant to subdivision (b).
16(b) The Department of Justice may adopt rules and regulations
17in accordance with Chapter 3.5 (commencing with Section 11340)
18of Part 1 of Division 3 of Title 2 of the Government Code that add
19substances to subdivision (a) if the substance is a
precursor to a
20controlled substance and delete substances from subdivision (a).
21However, no regulation adding or deleting a substance shall have
22any effect beyond March 1 of the year following the calendar year
23during which the regulation was adopted.
24(c) (1) (A) Any manufacturer, wholesaler, retailer, or other
25person or entity in this state, prior to selling, transferring, or
26otherwise furnishing any substance specified in subdivision (a) to
27any person or business entity in this state or any other state, shall
28require (i) a letter of authorization from that person or business
29entity that includes the currently valid business license number or
30federal Drug Enforcement Administration (DEA) registration
31number, the address of the business, and a full description of how
32the substance is to be used, and (ii) proper identification from the
33purchaser. The manufacturer, wholesaler, retailer, or other person
34
or entity in this state shall retain this information in a readily
35available manner for three years. The requirement for a full
36description of how the substance is to be used does not require the
37person or business entity to reveal their chemical processes that
38are typically considered trade secrets and proprietary information.
39(B) For the purposes of this paragraph, “proper identification”
40for in-state or out-of-state purchasers includes two or more of the
P5 1following: federal tax identification number; seller’s permit
2identification number; city or county business license number;
3license issued by the State Department of Public Health;
4registration number issued by the federal Drug Enforcement
5Administration; precursor business permit number issued by the
6Department of Justice; driver’s license; or other identification
7issued by a state.
8(2) (A) begin deleteAny
end delete
9person or entity in this state that exports a substance specified in
10subdivision (a) tobegin delete anyend deletebegin insert aend insert person or business entity located in a
11foreign country shall, on or before the date of exportation, submit
12to the Department of Justice a notification of thatbegin delete transaction, begin insert transaction. Theend insert notification shall include the name and
13whichend delete
14quantity of the substance to be exported and the name, address,
15and, if assigned by the foreign country or subdivision thereof,
16business
identification number of the person or business entity
17located in a foreign country importing the substance.
18(B) The department may authorize the submission of the
19notification on a monthly basis with respect to repeated, regular
20transactions between an exporter and an importer involving a
21substance specified in subdivision (a), if the department determines
22that a pattern of regular supply of the substance exists between the
23exporter and importer and that the importer has established a record
24of utilization of the substance for lawful purposes.
25(d) (1) begin deleteAny end deletebegin insertA end insertmanufacturer, wholesaler, retailer, or other person
26or entity in this state that sells, transfers, or otherwise
furnishes a
27substance specified in subdivision (a) to a person or business entity
28in this state or any other state shall, not less than 21 days prior to
29delivery of the substance, submit a report of the transaction, which
30includes the identification information specified in subdivision
31(c), to the Department of Justice. The Department of Justice may
32authorize the submission of the reports on a monthly basis with
33respect to repeated, regular transactions between the furnisher and
34the recipient involving the substance or substances if the
35Department of Justice determines that a pattern of regular supply
36of the substance or substances exists between the manufacturer,
37wholesaler, retailer, or other person or entity that sells, transfers,
38or otherwise furnishes the substance or substances and the recipient
39of the substance or substances, and the recipient has established a
P6 1record of utilization of the substance or substances for lawful
2purposes.
3(2) The person selling, transferring, or otherwise furnishingbegin delete anyend delete
4begin insert
aend insert substance specified in subdivision (a) shall affix his or her
5signature or otherwise identify himself or herself as a witness to
6the identification of the purchaser or purchasing individual, and
7shall, if a common carrier is used, maintain a manifest of the
8delivery to the purchaser for three years.
9(e) This section shall not apply to any of the following:
10(1) begin deleteAny end deletebegin insertA end insertpharmacist or other authorized person who sells or
11furnishes a substance upon the prescription of a physician, dentist,
12podiatrist, or veterinarian.
13(2) begin deleteAny end deletebegin insertA
end insertphysician, dentist, podiatrist, or veterinarian who
14administers or furnishes a substance to his or her patients.
15(3) begin deleteAny end deletebegin insertA end insertmanufacturer or wholesaler licensed by the California
16State Board of Pharmacy that sells, transfers, or otherwise furnishes
17a substance to a licensed pharmacy, physician, dentist, podiatrist,
18or veterinarian, or a retail distributorbegin delete as defined in subdivision (h)end delete,
19provided that the manufacturer or wholesaler submits records of
20any suspicious sales or transfers as determined by the Department
21of Justice.
22(4) begin deleteAny end deletebegin insertAn
end insertanalytical research facility that is registered with
23the federal Drug Enforcement Administration of the United States
24Department of Justice.
25(5) A state-licensed health care facility that administers or
26furnishes a substance to its patients.
27(6) (A) begin deleteAny end deletebegin insertThe end insertsale, transfer, furnishing, or receipt ofbegin delete anyend deletebegin insert aend insert
28 product that contains ephedrine, pseudoephedrine,
29norpseudoephedrine, or phenylpropanolamine andbegin delete whichend deletebegin insert
thatend insert is
30lawfully sold, transferred, or furnished over the counter without a
31prescription pursuant to thebegin delete federalend deletebegin insert Federalend insert Food, Drug, and
32Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or regulations adopted
33thereunder. However, this section shall apply to preparations in
34solid or liquid dosage form, except pediatric liquid forms, as
35defined, containing ephedrine, pseudoephedrine,
36norpseudoephedrine, or phenylpropanolamine where the individual
37transaction involves more than three packages or nine grams of
38ephedrine, pseudoephedrine, norpseudoephedrine, or
39phenylpropanolamine.
P7 1(B) Any ephedrine, pseudoephedrine, norpseudoephedrine, or
2phenylpropanolamine product subsequently removed from
3exemption pursuant to Section 814 of
Title 21 of the United States
4Code shall similarly no longer be exempt from any state reporting
5or permitting requirement, unless otherwise reinstated pursuant to
6begin delete subdivision (d) or (e) ofend delete Sectionbegin delete 814end deletebegin insert 814(d)end insert of Title 21 of the
7United States Code as an exempt product.
8(7) The sale, transfer, furnishing, or receipt ofbegin delete anyend deletebegin insert aend insert betadine
9or povidone solution with an iodine content not exceeding 1 percent
10in containers of eight ounces or less, orbegin delete anyend deletebegin insert
aend insert tincture of iodine
11not exceeding 2 percent in containers of one ounce or less, that is
12sold over the counter.
13(8) begin deleteAny end deletebegin insertThe end inserttransfer of a substance specified in subdivision (a)
14for purposes of lawful disposal as waste.
15(f) (1) begin deleteAny end deletebegin insertA end insertperson specified in subdivision (a) or (d) who
16does not submit a report as required by that subdivision or who
17knowingly submits a report with false or fictitious information
18shall be
punished by imprisonment in a county jail not exceeding
19six months, by a fine not exceeding five thousand dollars ($5,000),
20or by both the fine and imprisonment.
21(2) Any person specified in subdivision (a) or (d) who has
22previously been convicted of a violation of paragraph (1) shall,
23upon a subsequent conviction thereof, be punished by
24imprisonment pursuant to subdivision (h) of Section 1170 of the
25Penal Code, or by imprisonment in a county jail not exceeding one
26year, by a fine not exceeding one hundred thousand dollars
27($100,000), or by both the fine and imprisonment.
28(g) (1) Except as otherwise provided in subparagraph (A) of
29paragraph (6) of subdivision (e), it is unlawful forbegin delete anyend deletebegin insert aend insert
30
manufacturer, wholesaler, retailer, or other person to sell, transfer,
31or otherwise furnish a substance specified in subdivision (a) to a
32person under 18 years of age.
33(2) Except as otherwise provided in subparagraph (A) of
34paragraph (6) of subdivision (e), it is unlawful for any person under
3518 years of age to possess a substance specified in subdivision (a).
36(3) Notwithstanding any other law, it is unlawful for any retail
37distributor to (i) sell in a single transaction more than three
38packages of a product that he or she knows to contain ephedrine,
39pseudoephedrine, norpseudoephedrine, or phenylpropanolamine,
40or (ii) knowingly sell more than nine grams of ephedrine,
P8 1pseudoephedrine, norpseudoephedrine, or phenylpropanolamine,
2other than pediatric liquids as defined. Except as otherwise
3provided in this section, the three package per transaction limitation
4or nine gram per transaction limitation imposed by this paragraph
5shall apply to any
product that is lawfully sold, transferred, or
6furnished over the counter without a prescription pursuant to the
7federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.),
8or regulations adopted thereunder, unless exempted from the
9requirements of the federal Controlled Substances Act by the
10federal Drug Enforcement Administration pursuant to Section 814
11of Title 21 of the United States Code.
12(4)
end delete13begin insert(3)end insert (A) A first violation of this subdivision is a misdemeanor.
14(B) begin deleteAny end deletebegin insertA end insertperson
who has previously been convicted of a
15violation of this subdivision shall, upon a subsequent conviction
16thereof, be punished by imprisonment in a county jail not exceeding
17one year, by a fine not exceeding ten thousand dollars ($10,000),
18or by both the fine and imprisonment.
19(h) For the purposes of this article, the
following terms have
20the following meanings:
21(1) “Drug store” is any entity described in Code 5912 of the
22Standard Industrial Classification (SIC) Manual published by the
23United States Office of Management and Budget, 1987 edition.
24(2) “General merchandise store” is any entity described in Codes
255311 to 5399, inclusive, and Code 5499 of the Standard Industrial
26Classification (SIC) Manual published by the United States Office
27of Management and Budget, 1987 edition.
28(3) “Grocery store” is any entity described in Code 5411 of the
29Standard Industrial Classification (SIC) Manual published by the
30United States Office of Management and Budget, 1987 edition.
31(4) “Pediatric liquid” means a nonencapsulated liquid whose
32unit measure according to product labeling
is stated in milligrams,
33ounces, or other similar measure. In no instance shall the dosage
34units exceed 15 milligrams of phenylpropanolamine or
35pseudoephedrine per five milliliters of liquid product, except for
36liquid products primarily intended for administration to children
37under two years of age for which the recommended dosage unit
38does not exceed two milliliters and the total package content does
39not exceed one fluid ounce.
P9 1(5) “Retail distributor” means a grocery store, general
2merchandise store, drugstore, or other related entity, the activities
3of which, as a distributor of ephedrine, pseudoephedrine,
4norpseudoephedrine, or phenylpropanolamine products, are limited
5exclusively to the sale of ephedrine, pseudoephedrine,
6norpseudoephedrine, or phenylpropanolamine products for personal
7use both in number of sales and volume of sales, either directly to
8walk-in customers or in face-to-face transactions by direct sales.
9“Retail distributor”
includes an entity that makes a direct sale, but
10does not include the parent company of that entity if the company
11is not involved in direct sales regulated by this article.
12(6) “Sale for personal use” means the sale in a single transaction
13to an individual customer for a legitimate medical use of a product
14containing ephedrine, pseudoephedrine, norpseudoephedrine, or
15phenylpropanolamine in dosages at or below that specified in
16paragraph (3) of subdivision (g). “Sale for personal use” also
17includes the sale of those products to employers to be dispensed
18to employees from first-aid kits or medicine chests.
19(i) It is the intent of the Legislature that this section shall
20preempt all local ordinances or regulations governing the sale by
21a retail distributor of over-the-counter products containing
22ephedrine, pseudoephedrine, norpseudoephedrine, or
23
phenylpropanolamine.
24(h) This section shall remain in effect only until January 1, 2019,
25and as of that date is repealed, unless a later enacted statute, that
26is enacted before January 1, 2019, deletes or extends that date.
Section 11100 is added to the Health and Safety Code,
28to read:
(a) Any manufacturer, wholesaler, retailer, or other
30person or entity in this state that sells, transfers, or otherwise
31furnishes any of the following substances to any person or entity
32in this state or any other state shall submit a report to the
33Department of Justice of all of those transactions:
34(1) Phenyl-2-propanone.
35(2) Methylamine.
36(3) Ethylamine.
37(4) D-lysergic acid.
38(5) Ergotamine tartrate.
39(6) Diethyl malonate.
40(7) Malonic acid.
P10 1(8) Ethyl malonate.
2(9) Barbituric acid.
3(10) Piperidine.
4(11) N-acetylanthranilic acid.
5(12) Pyrrolidine.
6(13) Phenylacetic acid.
7(14) Anthranilic acid.
8(15) Morpholine.
9(16) Ephedrine.
10(17) Pseudoephedrine.
11(18) Norpseudoephedrine.
12(19) Phenylpropanolamine.
13(20) Propionic anhydride.
14(21) Isosafrole.
15(22) Safrole.
16(23) Piperonal.
17(24) Thionyl chloride.
18(25) Benzyl cyanide.
19(26) Ergonovine maleate.
20(27) N-methylephedrine.
21(28) N-ethylephedrine.
22(29) N-methylpseudoephedrine.
23(30) N-ethylpseudoephedrine.
24(31) Chloroephedrine.
25(32) Chloropseudoephedrine.
26(33) Hydriodic acid.
27(34) Gamma-butyrolactone, including butyrolactone;
28butyrolactone gamma; 4-butyrolactone; 2(3H)-furanone dihydro;
29dihydro-2(3H)-furanone; tetrahydro-2-furanone; 1,2-butanolide;
301,4-butanolide; 4-butanolide; gamma-hydroxybutyric acid lactone;
313-hydroxybutyric acid lactone and 4-hydroxybutanoic acid lactone
32with Chemical Abstract Service number (96-48-0).
33(35) 1,4-butanediol, including butanediol; butane-1,4-diol;
341,4-butylene glycol; butylene glycol; 1,4-dihydroxybutane;
351,4-tetramethylene glycol; tetramethylene glycol;
tetramethylene
361,4-diol with Chemical Abstract Service number (110-63-4).
37(36) Red phosphorus, including white phosphorus,
38hypophosphorous acid and its salts, ammonium hypophosphite,
39calcium hypophosphite, iron hypophosphite, potassium
40hypophosphite, manganese hypophosphite, magnesium
P11 1hypophosphite, sodium hypophosphite, and phosphorous acid and
2its salts.
3(37) Iodine or tincture of iodine.
4(38) Any of the substances listed by the Department of Justice
5in regulations promulgated pursuant to subdivision (b).
6(b) The Department of Justice may adopt rules and regulations
7in accordance with Chapter 3.5 (commencing with Section 11340)
8of Part 1 of Division 3 of Title 2 of the Government Code that add
9substances to subdivision (a) if the substance is a
precursor to a
10controlled substance and delete substances from subdivision (a).
11However, no regulation adding or deleting a substance shall have
12any effect beyond March 1 of the year following the calendar year
13during which the regulation was adopted.
14(c) (1) (A) A manufacturer, wholesaler, retailer, or other person
15or entity in this state, prior to selling, transferring, or otherwise
16furnishing a substance specified in subdivision (a) to a person or
17business entity in this state or any other state, shall require (i) a
18letter of authorization from that person or business entity that
19includes the currently valid business license number or federal
20Drug Enforcement Administration (DEA) registration number, the
21address of the business, and a full description of how the substance
22is to be used, and (ii) proper identification from the purchaser. The
23manufacturer, wholesaler, retailer, or other person or
entity in this
24state shall retain this information in a readily available manner for
25three years. The requirement for a full description of how the
26substance is to be used does not require the person or business
27entity to reveal chemical processes that are typically considered
28trade secrets and proprietary information.
29(B) For the purposes of this paragraph, “proper identification”
30for in-state or out-of-state purchasers includes two or more of the
31following: federal tax identification number; seller’s permit
32identification number; city or county business license number;
33license issued by the State Department of Public Health;
34registration number issued by the federal Drug Enforcement
35Administration; precursor business permit number issued by the
36Bureau of Narcotic Enforcement of the Department of Justice;
37driver’s license; or other identification issued by a state.
38(2) (A) A manufacturer, wholesaler, retailer, or other person
39or entity in this state that exports a substance specified in
40subdivision (a) to a person or business entity located in a foreign
P12 1country shall, on or before the date of exportation, submit to the
2Department of Justice a notification of that transaction. The
3notification shall include the name and quantity of the substance
4to be exported and the name, address, and, if assigned by the
5foreign country or subdivision thereof, business identification
6number of the person or business entity located in a foreign country
7importing the substance.
8(B) The department may authorize the submission of the
9notification on a monthly basis with respect to repeated, regular
10transactions between an exporter and an importer involving a
11substance specified in subdivision (a), if the department determines
12that a pattern of regular supply of the substance exists between the
13exporter and importer
and that the importer has established a record
14of utilization of the substance for lawful purposes.
15(d) (1) A manufacturer, wholesaler, retailer, or other person or
16entity in this state that sells, transfers, or otherwise furnishes a
17substance specified in subdivision (a) to a person or business entity
18in this state or any other state shall, not less than 21 days prior to
19delivery of the substance, submit a report of the transaction, which
20includes the identification information specified in subdivision
21(c), to the Department of Justice. The Department of Justice may
22authorize the submission of the reports on a monthly basis with
23respect to repeated, regular transactions between the furnisher and
24the recipient involving the substance or substances if the
25Department of Justice determines that a pattern of regular supply
26of the substance or substances exists between the manufacturer,
27wholesaler, retailer, or other person or
entity that sells, transfers,
28or otherwise furnishes the substance or substances and the recipient
29of the substance or substances, and the recipient has established a
30record of utilization of the substance or substances for lawful
31purposes.
32(2) The person selling, transferring, or otherwise furnishing a
33substance specified in subdivision (a) shall affix his or her signature
34or otherwise identify himself or herself as a witness to the
35identification of the purchaser or purchasing individual, and shall,
36if a common carrier is used, maintain a manifest of the delivery
37to the purchaser for three years.
38(e) This section shall not apply to any of the following:
P13 1(1) A pharmacist or other authorized person who sells or
2furnishes a substance upon the prescription of a physician, dentist,
3podiatrist, or veterinarian.
4(2) A physician, dentist, podiatrist, or veterinarian who
5administers or furnishes a substance to his or her patients.
6(3) A manufacturer or wholesaler licensed by the California
7State Board of Pharmacy that sells, transfers, or otherwise furnishes
8a substance to a licensed pharmacy, physician, dentist, podiatrist,
9or veterinarian, or a retail distributor, provided that the
10manufacturer or wholesaler submits records of any suspicious sales
11or transfers as determined by the Department of Justice.
12(4) An analytical research facility that is registered with the
13federal Drug Enforcement Administration of the United States
14Department of Justice.
15(5) A state-licensed health care facility that administers or
16furnishes a substance to its patients.
17(6) (A) The sale, transfer, furnishing, or receipt of a product
18that contains ephedrine, pseudoephedrine, norpseudoephedrine,
19or phenylpropanolamine and that is lawfully sold, transferred, or
20furnished over the counter without a prescription pursuant to the
21Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.)
22or regulations adopted thereunder. However, this section shall
23apply to preparations in solid or liquid dosage form, except
24pediatric liquid forms, as defined, containing ephedrine,
25pseudoephedrine, norpseudoephedrine, or phenylpropanolamine
26where the individual transaction involves more than three packages
27or nine grams of ephedrine, pseudoephedrine, norpseudoephedrine,
28or phenylpropanolamine.
29(B) An ephedrine, pseudoephedrine, norpseudoephedrine, or
30phenylpropanolamine product subsequently removed from
31exemption pursuant to Section 814 of
Title 21 of the United States
32Code shall similarly no longer be exempt from state reporting or
33permitting requirements, unless otherwise reinstated pursuant to
34Section 814(d) of Title 21 of the United States Code as an exempt
35product.
36(7) The sale, transfer, furnishing, or receipt of a betadine or
37povidone solution with an iodine content not exceeding 1 percent
38in containers of eight ounces or less, or a tincture of iodine not
39exceeding 2 percent in containers of one ounce or less, that is sold
40over the counter.
P14 1(8) Transfer of a substance specified in subdivision (a) for
2purposes of lawful disposal as waste.
3(f) (1) A person specified in subdivision (a) or (d) who does
4not submit a report as required by that subdivision or who
5knowingly submits a report with false or fictitious information
6
shall be punished by imprisonment in a county jail not exceeding
7six months, by a fine not exceeding five thousand dollars ($5,000),
8or by both the fine and imprisonment.
9(2) A person specified in subdivision (a) or (d) who has
10previously been convicted of a violation of paragraph (1) shall,
11upon a subsequent conviction thereof, be punished by
12imprisonment pursuant to subdivision (h) of Section 1170 of the
13Penal Code, or by imprisonment in a county jail not exceeding one
14year, by a fine not exceeding one hundred thousand dollars
15($100,000), or by both the fine and imprisonment.
16(g) (1) Except as otherwise provided in subparagraph (A) of
17paragraph (6) of subdivision (e), it is unlawful for a manufacturer,
18wholesaler, retailer, or other person to sell, transfer, or otherwise
19furnish a substance specified in subdivision (a) to a person under
2018 years of
age.
21(2) Except as otherwise provided in subparagraph (A) of
22paragraph (6) of subdivision (e), it is unlawful for a person under
2318 years of age to possess a substance specified in subdivision (a).
24(3) Notwithstanding any other law, it is unlawful for a retail
25distributor to (A) sell in a single transaction more than three
26packages of a product that he or she knows to contain ephedrine,
27pseudoephedrine, norpseudoephedrine, or phenylpropanolamine,
28or (B) knowingly sell more than nine grams of ephedrine,
29pseudoephedrine, norpseudoephedrine, or phenylpropanolamine,
30other than pediatric liquids as defined. Except as otherwise
31provided in this section, the three package per transaction limitation
32or nine gram per transaction limitation imposed by this paragraph
33shall apply to any product that is lawfully sold, transferred, or
34furnished over the counter without a prescription pursuant
to the
35Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et
36seq.), or regulations adopted thereunder, unless exempted from
37the requirements of the federal Controlled Substances Act (21
38U.S.C. Sec. 801 et seq.) by the federal Drug Enforcement
39Administration pursuant to Section 814 of Title 21 of the United
40States Code.
P15 1(4) (A) A first violation of this subdivision is a misdemeanor.
2(B) A person who has previously been convicted of a violation
3of this subdivision shall, upon a subsequent conviction thereof, be
4punished by imprisonment in a county jail not exceeding one year,
5by a fine not exceeding ten thousand dollars ($10,000), or by both
6the fine and imprisonment.
7(h) For the purposes of this article, the following terms have
8the following meanings:
9(1) “Drug store” is an entity described in Code 5912 of the
10Standard Industrial Classification (SIC) Manual published by the
11United States Office of Management and Budget, 1987 edition.
12(2) “General merchandise store” is an entity described in Codes
135311 to 5399, inclusive, and Code 5499 of the Standard Industrial
14Classification (SIC) Manual published by the United States Office
15of Management and Budget, 1987 edition.
16(3) “Grocery store” is an entity described in Code 5411 of the
17Standard Industrial Classification (SIC) Manual published by the
18United States Office of Management and Budget, 1987 edition.
19(4) “Pediatric liquid” means a nonencapsulated liquid whose
20unit measure according to product labeling is stated in milligrams,
21ounces, or other similar
measure. In no instance shall the dosage
22units exceed 15 milligrams of phenylpropanolamine or
23pseudoephedrine per five milliliters of liquid product, except for
24liquid products primarily intended for administration to children
25under two years of age for which the recommended dosage unit
26does not exceed two milliliters and the total package content does
27not exceed one fluid ounce.
28(5) “Retail distributor” means a grocery store, general
29merchandise store, drugstore, or other related entity, the activities
30of which, as a distributor of ephedrine, pseudoephedrine,
31norpseudoephedrine, or phenylpropanolamine products, are limited
32exclusively to the sale of ephedrine, pseudoephedrine,
33norpseudoephedrine, or phenylpropanolamine products for personal
34use both in number of sales and volume of sales, either directly to
35walk-in customers or in face-to-face transactions by direct sales.
36“Retail distributor” includes an entity that makes a direct sale, but
37
does not include the parent company of that entity if the company
38is not involved in direct sales regulated by this article.
39(6) “Sale for personal use” means the sale, in a single
40transaction, to an individual customer for a legitimate medical use
P16 1of a product containing ephedrine, pseudoephedrine,
2norpseudoephedrine, or phenylpropanolamine in dosages at or
3below that specified in paragraph (3) of subdivision (g). “Sale for
4personal use” also includes the sale of those products to employers
5to be dispensed to employees from first aid kits or medicine chests.
6(i) It is the intent of the Legislature that this section shall
7preempt all local ordinances or regulations governing the sale by
8a retail distributor of over-the-counter products containing
9ephedrine, pseudoephedrine, norpseudoephedrine, or
10phenylpropanolamine.
11(j) This section shall become operative on January 1, 2019.
Section 11100.02 is added to the Health and Safety
13Code, to read:
(a) Notwithstanding any other law, it is unlawful
15for a retail distributor to knowingly do any of the following, except
16pursuant to a valid prescription from a licensed practitioner with
17prescriptive authority:
18(1) To sell or distribute to the same purchaser within a 30-day
19period more than 9 grams, or within a day more than 3.6 grams,
20of ephedrine base, pseudoephedrine base, norpseudoephedrine
21base, or phenylpropanolamine base contained in a product that is
22lawfully sold, transferred, or furnished over the counter without a
23prescription pursuant to the Federal Food, Drug, and Cosmetic
24Act (21 U.S.C. Sec. 301 et seq.), or regulations adopted thereunder,
25unless exempted from the requirements of the federal Controlled
26Substances Act (21 U.S.C.
Sec. 801 et seq.) by the federal Drug
27Enforcement Administration pursuant to Section 814 of Title 21
28of the United States Code.
29(2) To sell or distribute ephedrine, pseudoephedrine,
30norpseudoephedrine, or phenylpropanolamine to a person whose
31information has generated an alert as described in paragraph (3)
32of subdivision (d) regarding that sale.
33(3) To sell or distribute to a purchaser a nonprescription product
34containing any amount of ephedrine, pseudoephedrine,
35norpseudoephedrine, or phenylpropanolamine, except under the
36following conditions:
37(A) The purchaser shall produce valid government-issued photo
38identification.
39(B) The purchaser shall sign a written or electronic log showing
40all of the following:
P17 1(i) The date and time of the transaction.
2(ii) The identification number presented.
3(iii) The agency issuing the identification and the type of
4identification issued.
5(iv) The name, date of birth, and address of the purchaser.
6(v) The amount of ephedrine base, pseudoephedrine base,
7norpseudoephedrine base, or phenylpropanolamine base contained
8in the material, compound, mixture, or preparation sold.
9(b) The retail distributor shall store any product containing any
10amount of ephedrine, pseudoephedrine, norpseudoephedrine, or
11phenylpropanolamine either behind the counter or in a locked
12cabinet so that the customer does not have
access to the product.
13(c) (1) To facilitate the monitoring of the sales of
14nonprescription products containing ephedrine, pseudoephedrine,
15norpseudoephedrine, or phenylpropanolamine, the retail distributor
16shall record all of the following information at the point of sale
17regarding the proposed transaction for the purpose of complying
18with this section or the federal Combat Methamphetamine
19Epidemic Act of 2005, or any regulation adopted pursuant to this
20section or that act, and for no other purpose:
21(A) The date and time of the transaction.
22(B) The identification number of the purchaser, issuing agency
23of the identification, and the type of identification used.
24(C) The name, date of birth, and address of the purchaser
25verified
through a photo identification of the purchaser.
26(D) The name, quantity of packages, and total gram weight of
27ephedrine base, pseudoephedrine base, norpseudoephedrine base,
28or phenylpropanolamine base contained in a product or products
29purchased, received, or otherwise acquired.
30(E) The name or initials of the person making the sale.
31(2) On and after July 1, 2014, the retail distributor shall transmit
32the information immediately to the National Precursor Log
33Exchange (NPLEx) administered by the National Association of
34Drug Diversion Investigators (NADDI) for purposes of determining
35whether the proposed sale would violate this section and therefore
36may not proceed, provided that the NPLEx system is available to
37retailers in the state without a charge for accessing the system. The
38transaction information shall not be
accessed, stored, or used by
39the retail distributor or law enforcement for any purpose other than
40to meet the requirements set forth in this section or to comply with
P18 1the provisions of the federal Combat Methamphetamine Epidemic
2Act of 2005, or any regulation adopted pursuant to this section or
3that act. The retail distributor shall not maintain a separate copy
4of the transaction information and shall not have direct access to
5individual information or sales records entered into the NPLEx
6system, except as required by the federal Combat
7Methamphetamine Epidemic Act of 2005.
8(3) (A) A retail distributor shall provide notice electronically,
9in writing, or by signage to purchasers at the time of purchase that
10the information collected pursuant to the federal Combat
11Methamphetamine Epidemic Act of 2005 and this section shall be
12entered into a single database as specified in paragraph (2) and
13provided to law enforcement for
purposes of determining the
14legality of a proposed sale.
15(B) The Legislature finds that it is necessary for probable cause
16to be demonstrated to trigger an investigation in connection with
17an individual whose requested purchase is denied by the system a
18single time.
19(C) Access by law enforcement to the data contained in the
20system from a location other than the retailer shall be limited to
21the records of an individual whose attempted purchase has been
22denied by the system.
23(4) This subdivision shall not be construed to require a retail
24distributor to maintain state-required records relating to the sale
25of products containing ephedrine, pseudoephedrine,
26norpseudoephedrine, or phenylpropanolamine in a separate location
27or log from records required by federal law to be kept with respect
28to those products.
29(5) The recording requirements specified in this subdivision
30shall not apply to the sale of a single package containing not more
31than 60 milligrams of pseudoephedrine, consistent with the federal
32Combat Methamphetamine Epidemic Act of 2005.
33(6) If a retail distributor experiences mechanical or electronic
34failure of the system and is unable to comply with the recording
35requirements of this subdivision, the retail distributor shall maintain
36the required records in a written log or an alternative electronic
37recordkeeping mechanism until the retail distributor is able to
38comply with the recording requirements of this subdivision. Written
39logs shall be maintained only for the purpose of compliance with
40this subdivision.
P19 1(d) (1) Provided that the department executes a memorandum
2of understanding (MOU)
with NADDI governing access, pursuant
3to this subdivision, NADDI shall forward California transaction
4records in NPLEx to the Department of Justice weekly and provide
5real-time access to NPLEx information through the NPLEx online
6portal to law enforcement in the state as authorized by the
7department. The MOU shall constitute an enforceable contract.
8(2) Access to the system shall be available at no charge to the
9department and law enforcement in this state as authorized pursuant
10to paragraph (1).
11(3) The system shall allow retail distributors of products
12containing ephedrine, pseudoephedrine, norpseudoephedrine, or
13phenylpropanolamine to enter into the database the information
14specified in subdivision (c) regarding the proposed sale of those
15products.
16(4) The system shall be capable of providing the retail
distributor
17with an immediate real-time alert any time a provision of this
18section is being violated by a proposed sale.
19(5) Neither the department nor any state agency shall bear any
20cost for the development, installation, or maintenance of the
21system.
22(6) The MOU shall state that no party to the MOU nor any entity
23under contract to provide the electronic authorization and
24monitoring system shall be authorized to use the information
25contained in the system for any purpose other than those set forth
26in this section, the federal Combat Methamphetamine Epidemic
27Act of 2005, or any regulation adopted pursuant to this section or
28that act. However, the system operator shall be authorized to
29analyze the information for the sole purpose of assessing and
30improving the performance and efficacy of the system. In addition,
31the MOU shall require that a retail distributor’s access to the
32
electronic authorization and monitoring system’s database is
33limited solely to records of sales transactions made by that retail
34distributor, which access shall be solely for purposes of complying
35with the federal Combat Methamphetamine Epidemic Act of 2005
36or this section, or to respond to a duly authorized law enforcement
37request or court order for information collected under that act or
38this section.
39(7) The system’s security program shall comply with the security
40standards for the Criminal Justice Information System of the
P20 1Federal Bureau of Investigation and may be audited once a year
2by the department.
3(8) The use of the system by a retail distributor or vendor of the
4NPLEx system shall be subject to Section 56.101 of the Civil Code.
5A retail distributor or a vendor of the NPLEx system holding the
6NPLEx data shall not maintain any records collected under this
7system for
longer than two years, or as otherwise required by the
8federal Combat Methamphetamine Epidemic Act of 2005 and shall
9be destroyed pursuant to Section 1798.81 of the Civil Code.
10(9) Law enforcement access to the system shall be recorded by
11means of a unique access code for each individual accessing the
12system. Each user’s history shall be maintained and may be audited
13by the department.
14(10) The department may submit recommendations to NADDI
15regarding system changes to assist in identifying false identification
16cards.
17(11) Disputes relating to compliance with this section arising
18against a vendor of the NPLEx system shall be subject to a court
19of competent jurisdiction in California and shall be governed by
20California law.
21(e) The State Board of
Equalization shall notify all retailers
22about the requirement to submit transactions to NPLEx no later
23than April 1, 2014.
24(f) This section shall not apply to a health care practitioner with
25prescriptive authority who is currently licensed in this state.
26(g) (1) A first violation of this section is a misdemeanor.
27(2) A person who has previously been convicted of a violation
28of this section shall, upon a subsequent conviction thereof, be
29punished by imprisonment in a county jail not exceeding one year,
30by a fine not exceeding ten thousand dollars ($10,000), or by both
31the fine and imprisonment.
32(h) For the purposes of this section, the following terms have
33the following meanings:
34(1) “Department” means the Department of Justice.
35(2) “Drug store” is an entity described in Code 5912 of the
36Standard Industrial Classification (SIC) Manual published by the
37United States Office of Management and Budget, 1987 edition.
38(3) “General merchandise store” is an entity described in Codes
395311 to 5399, inclusive, and Code 5499 of the Standard Industrial
P21 1Classification (SIC) Manual published by the United States Office
2of Management and Budget, 1987 edition.
3(4) “Grocery store” is an entity described in Code 5411 of the
4Standard Industrial Classification (SIC) Manual published by the
5United States Office of Management and Budget, 1987 edition.
6(5) “Retail distributor” means a grocery store, general
7merchandise store, drugstore, or
other related entity, the activities
8of which, as a distributor of ephedrine, pseudoephedrine,
9norpseudoephedrine, or phenylpropanolamine products, are limited
10exclusively to the sale of ephedrine, pseudoephedrine,
11norpseudoephedrine, or phenylpropanolamine products for personal
12use both in number of sales and volume of sales, either directly to
13walk-in customers or in face-to-face transactions by direct sales.
14“Retail distributor” includes an entity that makes a direct sale, but
15does not include the parent company of that entity if the company
16is not involved in direct sales regulated by this article.
17(6) “Sale for personal use” means the sale in a single transaction
18to an individual customer for a legitimate medical use of a product
19containing ephedrine, pseudoephedrine, norpseudoephedrine, or
20phenylpropanolamine in amounts at or below that specified in
21subdivision (a). “Sale for personal use” also includes the sale of
22those products to
employers to be dispensed to employees from
23first aid kits or medicine chests.
24(i) It is the intent of the Legislature that this section shall
25preempt all local ordinances or regulations governing the sale by
26a retail distributor of over-the-counter products containing
27ephedrine, pseudoephedrine, norpseudoephedrine, or
28phenylpropanolamine.
29(j) This section shall remain in effect only until January 1, 2019,
30and as of that date is repealed, unless a later enacted statute, that
31is enacted before January 1, 2019, deletes or extends that date.
No reimbursement is required by this act pursuant to
33Section 6 of Article XIII B of the California Constitution because
34the only costs that may be incurred by a local agency or school
35district will be incurred because this act creates a new crime or
36infraction, eliminates a crime or infraction, or changes the penalty
37for a crime or infraction, within the meaning of Section 17556 of
38the Government Code, or changes the definition of a crime within
P22 1the meaning of Section 6 of Article XIII B of the California
2Constitution.
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