Amended in Senate January 27, 2014

Senate BillNo. 506


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 wouldbegin insert 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 alsoend insert requirebegin insert, if the memorandum of understanding is entered into,end insert retail distributors to transmit, on and after July 1,begin delete 2014,end deletebegin insert 2015,end insert sale information to thebegin delete National Precursor Log Exchange (NPLEx)end deletebegin insert end insertbegin insertsystemend insert for purposes of determining whether the sale would violate these provisions.begin delete 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.end delete The bill wouldbegin delete provide thatend deletebegin insert prohibit use ofend insert the information in the systembegin delete may not be usedend delete 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.begin delete Theend delete

begin insert(2)end insertbegin insertend insertbegin insertTheend insert bill’s provisions wouldbegin insert 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 wouldend insert remain in effect only until January 1, 2019. By creating a new crime, this bill would impose a state-mandated local program.

begin delete

(2)

end delete

begin insert(3)end insert 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:

P3    1

SECTION 1.  

Section 11100 of the Health and Safety Code is
2amended to read:

3

11100.  

(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
6in this state or any other state shall submit a report to the
7Department of Justice of all of those transactions:

8(1) Phenyl-2-propanone.

9(2) Methylamine.

10(3) Ethylamine.

11(4) D-lysergic acid.

12(5) Ergotamine tartrate.

13(6) Diethyl malonate.

14(7) Malonic acid.

15(8) Ethyl malonate.

16(9) Barbituric acid.

17(10) Piperidine.

18(11) N-acetylanthranilic acid.

19(12) Pyrrolidine.

20(13) Phenylacetic acid.

21(14) Anthranilic acid.

22(15) Morpholine.

23(16) Ephedrine.

24(17) Pseudoephedrine.

25(18) Norpseudoephedrine.

P4    1(19) Phenylpropanolamine.

2(20) Propionic anhydride.

3(21) Isosafrole.

4(22) Safrole.

5(23) Piperonal.

6(24) Thionyl chloride.

7(25) Benzyl cyanide.

8(26) Ergonovine maleate.

9(27) N-methylephedrine.

10(28) N-ethylephedrine.

11(29) N-methylpseudoephedrine.

12(30) N-ethylpseudoephedrine.

13(31) Chloroephedrine.

14(32) Chloropseudoephedrine.

15(33) Hydriodic acid.

16(34) Gamma-butyrolactone, including butyrolactone;
17butyrolactone gamma; 4-butyrolactone; 2(3H)-furanone dihydro;
18dihydro-2(3H)-furanone; tetrahydro-2-furanone; 1,2-butanolide;
191,4-butanolide; 4-butanolide; gamma-hydroxybutyric acid lactone;
203-hydroxybutyric acid lactone and 4-hydroxybutanoic acid lactone
21with Chemicalbegin delete Abstractend deletebegin insert Abstractsend insert Service numberbegin delete (96-48-0)end delete
22begin insert 96-48-0end insert.

23(35) 1,4-butanediol, including butanediol; butane-1,4-diol;
241,4-butylene glycol; butylene glycol; 1,4-dihydroxybutane;
251,4-tetramethylene glycol; tetramethylene glycol; tetramethylene
261,4-diol with Chemicalbegin delete Abstractend deletebegin insert Abstractsend insert Service number
27begin delete (110-63-4)end deletebegin insert 110-63-4end insert.

28(36) Red phosphorus, including white phosphorus,
29hypophosphorous acid and its salts, ammonium hypophosphite,
30calcium hypophosphite, iron hypophosphite, potassium
31hypophosphite, manganese hypophosphite, magnesium
32hypophosphite, sodium hypophosphite, and phosphorous acid and
33its salts.

34(37) Iodine or tincture of iodine.

35(38) Any of the substances listed by the Department of Justice
36in regulations promulgated pursuant to subdivision (b).

37(b) The Department of Justice may adopt rules and regulations
38in accordance with Chapter 3.5 (commencing with Section 11340)
39of Part 1 of Division 3 of Title 2 of the Government Code that add
40substances to subdivision (a) if the substance is a precursor to a
P5    1controlled substance and delete substances from subdivision (a).
2However, no regulation adding or deleting a substance shall have
3any effect beyond March 1 of the year following the calendar year
4during which the regulation was adopted.

5(c) (1) (A) Any manufacturer, wholesaler, retailer, or other
6person or entity in this state, prior to selling, transferring, or
7otherwise furnishing any substance specified in subdivision (a) to
8any person or business entity in this state or any other state, shall
9require (i) a letter of authorization from that person or business
10entity that includes the currently valid business license number or
11federal Drug Enforcement Administration (DEA) registration
12number, the address of the business, and a full description of how
13the substance is to be used, and (ii) proper identification from the
14purchaser. The manufacturer, wholesaler, retailer, or other person
15 or entity in this state shall retain this information in a readily
16available manner for three years. The requirement for a full
17description of how the substance is to be used does not require the
18person or business entity to reveal their chemical processes that
19are typically considered trade secrets and proprietary information.

20(B) For the purposes of this paragraph, “proper identification”
21for in-state or out-of-state purchasers includes two or more of the
22following: federal tax identification number; seller’s permit
23identification number; city or county business license number;
24license issued by the State Department of Public Health;
25registration number issued by the federal Drug Enforcement
26Administration; precursor business permit number issued by the
27Department of Justice; driver’s license; or other identification
28issued by a state.

29(2) (A) A manufacturer, wholesaler, retailer, or other person
30or entity in this state that exports a substance specified in
31subdivision (a) to a person or business entity located in a foreign
32country shall, on or before the date of exportation, submit to the
33Department of Justice a notification of that transaction. The
34notification shall include the name and quantity of the substance
35to be exported and the name, address, and, if assigned by the
36foreign country or subdivision thereof, business identification
37number of the person or business entity located in a foreign country
38importing the substance.

39(B) The department may authorize the submission of the
40notification on a monthly basis with respect to repeated, regular
P6    1transactions between an exporter and an importer involving a
2substance specified in subdivision (a), if the department determines
3that a pattern of regular supply of the substance exists between the
4exporter and importer and that the importer has established a record
5of utilization of the substance for lawful purposes.

6(d) (1) A manufacturer, wholesaler, retailer, or other person or
7entity in this state that sells, transfers, or otherwise furnishes a
8substance specified in subdivision (a) to a person or business entity
9in this state or any other state shall, not less than 21 days prior to
10delivery of the substance, submit a report of the transaction, which
11includes the identification information specified in subdivision
12(c), to the Department of Justice. The Department of Justice may
13authorize the submission of the reports on a monthly basis with
14respect to repeated, regular transactions between the furnisher and
15the recipient involving the substance or substances if the
16Department of Justice determines that a pattern of regular supply
17of the substance or substances exists between the manufacturer,
18wholesaler, retailer, or other person or entity that sells, transfers,
19or otherwise furnishes the substance or substances and the recipient
20of the substance or substances, and the recipient has established a
21record of utilization of the substance or substances for lawful
22purposes.

23(2) The person selling, transferring, or otherwise furnishing a
24substance specified in subdivision (a) shall affix his or her signature
25or otherwise identify himself or herself as a witness to the
26identification of the purchaser or purchasing individual, and shall,
27if a common carrier is used, maintain a manifest of the delivery
28to the purchaser for three years.

29(e) This section shall not apply to any of the following:

30(1) A pharmacist or other authorized person who sells or
31furnishes a substance upon the prescription of a physician, dentist,
32podiatrist, or veterinarian.

33(2) A physician, dentist, podiatrist, or veterinarian who
34administers or furnishes a substance to his or her patients.

35(3) A manufacturer or wholesaler licensed by the California
36State Board of Pharmacy that sells, transfers, or otherwise furnishes
37a substance to a licensed pharmacy, physician, dentist, podiatrist,
38or veterinarian, or a retail distributor, provided that the
39manufacturer or wholesaler submits records of any suspicious sales
40or transfers as determined by the Department of Justice.

P7    1(4) An analytical research facility that is registered with the
2federal Drug Enforcement Administration of the United States
3Department of Justice.

4(5)  A state-licensed health care facility that administers or
5furnishes a substance to its patients.

6(6) (A) The sale, transfer, furnishing, or receipt of a product
7that contains ephedrine, pseudoephedrine, norpseudoephedrine,
8or phenylpropanolamine and that is lawfully sold, transferred, or
9furnished over the counter without a prescription pursuant to the
10Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.)
11or regulations adopted thereunder. However, this section shall
12apply to preparations in solid or liquid dosage form, except
13pediatric liquid forms, as defined, containing ephedrine,
14pseudoephedrine, norpseudoephedrine, or phenylpropanolamine
15where the individual transaction involves more than three packages
16or nine grams of ephedrine, pseudoephedrine, norpseudoephedrine,
17or phenylpropanolamine.

18(B) Any ephedrine, pseudoephedrine, norpseudoephedrine, or
19phenylpropanolamine product subsequently removed from
20exemption pursuant to Section 814 of Title 21 of the United States
21Code shall similarly no longer be exempt from any state reporting
22or permitting requirement, unless otherwise reinstated pursuant to
23Section 814(d) of Title 21 of the United States Code as an exempt
24product.

25(7) The sale, transfer, furnishing, or receipt of a betadine or
26povidone solution with an iodine content not exceeding 1 percent
27in containers of eight ounces or less, or a tincture of iodine not
28exceeding 2 percent in containers of one ounce or less, that is sold
29over the counter.  

30(8) The transfer of a substance specified in subdivision (a) for
31purposes of lawful disposal as waste.

32(f) (1) A person specified in subdivision (a) or (d) who does
33not submit a report as required by that subdivision or who
34knowingly submits a report with false or fictitious information
35shall be punished by imprisonment in a county jail not exceeding
36six months, by a fine not exceeding five thousand dollars ($5,000),
37or by both the fine and imprisonment.

38(2) Any person specified in subdivision (a) or (d) who has
39previously been convicted of a violation of paragraph (1) shall,
40upon a subsequent conviction thereof, be punished by
P8    1imprisonment pursuant to subdivision (h) of Section 1170 of the
2Penal Code, or by imprisonment in a county jail not exceeding one
3year, by a fine not exceeding one hundred thousand dollars
4($100,000), or by both the fine and imprisonment.

5(g) (1) Except as otherwise provided in subparagraph (A) of
6paragraph (6) of subdivision (e), it is unlawful for a manufacturer,
7wholesaler, retailer, or other person to sell, transfer, or otherwise
8furnish a substance specified in subdivision (a) to a person under
918 years of age.

10(2) Except as otherwise provided in subparagraph (A) of
11paragraph (6) of subdivision (e), it is unlawful for any person under
1218 years of age to possess a substance specified in subdivision (a).

13(3) (A) A first violation of this subdivision is a misdemeanor.

14(B) A person who has previously been convicted of a violation
15of this subdivision shall, upon a subsequent conviction thereof, be
16punished by imprisonment in a county jail not exceeding one year,
17by a fine not exceeding ten thousand dollars ($10,000), or by both
18the fine and imprisonment.

19(h) This section shall remain in effect only until January 1, 2019,
20and as of that date is repealed, unless a later enacted statute, that
21is enacted before January 1, 2019, deletes or extends that date.

22

SEC. 2.  

Section 11100 is added to the Health and Safety Code,
23to read:

24

11100.  

(a) Any manufacturer, wholesaler, retailer, or other
25person or entity in this state that sells, transfers, or otherwise
26furnishes any of the following substances to any person or entity
27in this state or any other state shall submit a report to the
28Department of Justice of all of those transactions:

29(1) Phenyl-2-propanone.

30(2) Methylamine.

31(3) Ethylamine.

32(4) D-lysergic acid.

33(5) Ergotamine tartrate.

34(6) Diethyl malonate.

35(7) Malonic acid.

36(8) Ethyl malonate.

37(9) Barbituric acid.

38(10) Piperidine.

39(11) N-acetylanthranilic acid.

40(12) Pyrrolidine.

P9    1(13) Phenylacetic acid.

2(14) Anthranilic acid.

3(15) Morpholine.

4(16) Ephedrine.

5(17) Pseudoephedrine.

6(18) Norpseudoephedrine.

7(19) Phenylpropanolamine.

8(20) Propionic anhydride.

9(21) Isosafrole.

10(22) Safrole.

11(23) Piperonal.

12(24) Thionyl chloride.

13(25) Benzyl cyanide.

14(26) Ergonovine maleate.

15(27) N-methylephedrine.

16(28) N-ethylephedrine.

17(29) N-methylpseudoephedrine.

18(30) N-ethylpseudoephedrine.

19(31) Chloroephedrine.

20(32) Chloropseudoephedrine.

21(33) Hydriodic acid.

22(34) Gamma-butyrolactone, including butyrolactone;
23butyrolactone gamma; 4-butyrolactone; 2(3H)-furanone dihydro;
24dihydro-2(3H)-furanone; tetrahydro-2-furanone; 1,2-butanolide;
251,4-butanolide; 4-butanolide; gamma-hydroxybutyric acid lactone;
263-hydroxybutyric acid lactone and 4-hydroxybutanoic acid lactone
27with Chemicalbegin delete Abstractend deletebegin insert Abstractsend insert Service numberbegin delete (96-48-0)end delete
28begin insert 96-48-0end insert.

29(35) 1,4-butanediol, including butanediol; butane-1,4-diol;
301,4-butylene glycol; butylene glycol; 1,4-dihydroxybutane;
311,4-tetramethylene glycol; tetramethylene glycol; tetramethylene
321,4-diol with Chemicalbegin delete Abstractend deletebegin insert Abstractsend insert Service number
33begin delete (110-63-4)end deletebegin insert 110-63-4end insert.

34(36) Red phosphorus, including white phosphorus,
35hypophosphorous acid and its salts, ammonium hypophosphite,
36calcium hypophosphite, iron hypophosphite, potassium
37hypophosphite, manganese hypophosphite, magnesium
38hypophosphite, sodium hypophosphite, and phosphorous acid and
39its salts.

40(37) Iodine or tincture of iodine.

P10   1(38) Any of the substances listed by the Department of Justice
2 in regulations promulgated pursuant to subdivision (b).

3(b) The Department of Justice may adopt rules and regulations
4in accordance with Chapter 3.5 (commencing with Section 11340)
5of Part 1 of Division 3 of Title 2 of the Government Code that add
6substances to subdivision (a) if the substance is a precursor to a
7controlled substance and delete substances from subdivision (a).
8However, no regulation adding or deleting a substance shall have
9any effect beyond March 1 of the year following the calendar year
10during which the regulation was adopted.

11(c) (1) (A) A manufacturer, wholesaler, retailer, or other person
12or entity in this state, prior to selling, transferring, or otherwise
13furnishing a substance specified in subdivision (a) to a person or
14business entity in this state or any other state, shall require (i) a
15letter of authorization from that person or business entity that
16includes the currently valid business license number or federal
17Drug Enforcement Administration (DEA) registration number, the
18address of the business, and a full description of how the substance
19is to be used, and (ii) proper identification from the purchaser. The
20manufacturer, wholesaler, retailer, or other person or entity in this
21state shall retain this information in a readily available manner for
22three years. The requirement for a full description of how the
23substance is to be used does not require the person or business
24entity to reveal chemical processes that are typically considered
25trade secrets and proprietary information.

26(B) For the purposes of this paragraph, “proper identification”
27for in-state or out-of-state purchasers includes two or more of the
28following: federal tax identification number; seller’s permit
29identification number; city or county business license number;
30license issued by the State Department of Public Health;
31registration number issued by the federal Drug Enforcement
32Administration; precursor business permit number issued by the
33Bureau of Narcotic Enforcement of the Department of Justice;
34driver’s license; or other identification issued by a state.

35(2) (A) A manufacturer, wholesaler, retailer, or other person
36or entity in this state that exports a substance specified in
37subdivision (a) to a person or business entity located in a foreign
38country shall, on or before the date of exportation, submit to the
39Department of Justice a notification of that transaction. The
40notification shall include the name and quantity of the substance
P11   1to be exported and the name, address, and, if assigned by the
2foreign country or subdivision thereof, business identification
3number of the person or business entity located in a foreign country
4importing the substance.

5(B) The department may authorize the submission of the
6notification on a monthly basis with respect to repeated, regular
7transactions between an exporter and an importer involving a
8substance specified in subdivision (a), if the department determines
9that a pattern of regular supply of the substance exists between the
10exporter and importer and that the importer has established a record
11of utilization of the substance for lawful purposes.

12(d) (1) A manufacturer, wholesaler, retailer, or other person or
13entity in this state that sells, transfers, or otherwise furnishes a
14substance specified in subdivision (a) to a person or business entity
15in this state or any other state shall, not less than 21 days prior to
16delivery of the substance, submit a report of the transaction, which
17includes the identification information specified in subdivision
18(c), to the Department of Justice. The Department of Justice may
19authorize the submission of the reports on a monthly basis with
20respect to repeated, regular transactions between the furnisher and
21the recipient involving the substance or substances if the
22Department of Justice determines that a pattern of regular supply
23of the substance or substances exists between the manufacturer,
24wholesaler, retailer, or other person or entity that sells, transfers,
25or otherwise furnishes the substance or substances and the recipient
26of the substance or substances, and the recipient has established a
27record of utilization of the substance or substances for lawful
28purposes.

29(2) The person selling, transferring, or otherwise furnishing a
30substance specified in subdivision (a) shall affix his or her signature
31or otherwise identify himself or herself as a witness to the
32identification of the purchaser or purchasing individual, and shall,
33if a common carrier is used, maintain a manifest of the delivery
34to the purchaser for three years.

35(e) This section shall not apply to any of the following:

36(1) A pharmacist or other authorized person who sells or
37furnishes a substance upon the prescription of a physician, dentist,
38podiatrist, or veterinarian.

39(2) A physician, dentist, podiatrist, or veterinarian who
40administers or furnishes a substance to his or her patients.

P12   1(3) A manufacturer or wholesaler licensed by the California
2State Board of Pharmacy that sells, transfers, or otherwise furnishes
3a substance to a licensed pharmacy, physician, dentist, podiatrist,
4or veterinarian, or a retail distributor, provided that the
5manufacturer or wholesaler submits records of any suspicious sales
6or transfers as determined by the Department of Justice.

7(4) An analytical research facility that is registered with the
8federal Drug Enforcement Administration of the United States
9Department of Justice.

10(5) A state-licensed health care facility that administers or
11furnishes a substance to its patients.

12(6) (A) The sale, transfer, furnishing, or receipt of a product
13that contains ephedrine, pseudoephedrine, norpseudoephedrine,
14or phenylpropanolamine and that is lawfully sold, transferred, or
15furnished over the counter without a prescription pursuant to the
16Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.)
17or regulations adopted thereunder. However, this section shall
18apply to preparations in solid or liquid dosage form, except
19pediatric liquid forms, as defined, containing ephedrine,
20pseudoephedrine, norpseudoephedrine, or phenylpropanolamine
21where the individual transaction involves more than three packages
22or nine grams of ephedrine, pseudoephedrine, norpseudoephedrine,
23or phenylpropanolamine.

24(B) An ephedrine, pseudoephedrine, norpseudoephedrine, or
25phenylpropanolamine product subsequently removed from
26exemption pursuant to Section 814 of Title 21 of the United States
27Code shall similarly no longer be exempt from state reporting or
28permitting requirements, unless otherwise reinstated pursuant to
29Section 814(d) of Title 21 of the United States Code as an exempt
30product.

31(7) The sale, transfer, furnishing, or receipt of a betadine or
32povidone solution with an iodine content not exceeding 1 percent
33in containers of eight ounces or less, or a tincture of iodine not
34exceeding 2 percent in containers of one ounce or less, that is sold
35over the counter.

36(8) Transfer of a substance specified in subdivision (a) for
37purposes of lawful disposal as waste.

38(f) (1) A person specified in subdivision (a) or (d) who does
39not submit a report as required by that subdivision or who
40knowingly submits a report with false or fictitious information
P13   1 shall be punished by imprisonment in a county jail not exceeding
2six months, by a fine not exceeding five thousand dollars ($5,000),
3or by both the fine and imprisonment.

4(2) A person specified in subdivision (a) or (d) who has
5previously been convicted of a violation of paragraph (1) shall,
6upon a subsequent conviction thereof, be punished by
7imprisonment pursuant to subdivision (h) of Section 1170 of the
8Penal Code, or by imprisonment in a county jail not exceeding one
9year, by a fine not exceeding one hundred thousand dollars
10($100,000), or by both the fine and imprisonment.

11(g) (1) Except as otherwise provided in subparagraph (A) of
12paragraph (6) of subdivision (e), it is unlawful for a manufacturer,
13wholesaler, retailer, or other person to sell, transfer, or otherwise
14furnish a substance specified in subdivision (a) to a person under
1518 years of age.

16(2) Except as otherwise provided in subparagraph (A) of
17paragraph (6) of subdivision (e), it is unlawful for a person under
1818 years of age to possess a substance specified in subdivision (a).

19(3) Notwithstanding any other law, it is unlawful for a retail
20distributor to (A) sell in a single transaction more than three
21packages of a product that he or she knows to contain ephedrine,
22pseudoephedrine, norpseudoephedrine, or phenylpropanolamine,
23or (B) knowingly sell more than nine grams of ephedrine,
24pseudoephedrine, norpseudoephedrine, or phenylpropanolamine,
25other than pediatric liquids as defined. Except as otherwise
26provided in this section, the three package per transaction limitation
27or nine gram per transaction limitation imposed by this paragraph
28shall apply to any product that is lawfully sold, transferred, or
29furnished over the counter without a prescription pursuant to the
30Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et
31seq.), or regulations adopted thereunder, unless exempted from
32the requirements of the federal Controlled Substances Act (21
33U.S.C. Sec. 801 et seq.) by the federal Drug Enforcement
34Administration pursuant to Section 814 of Title 21 of the United
35States Code.

36(4) (A) A first violation of this subdivision is a misdemeanor.

37(B) A person who has previously been convicted of a violation
38of this subdivision shall, upon a subsequent conviction thereof, be
39punished by imprisonment in a county jail not exceeding one year,
P14   1by a fine not exceeding ten thousand dollars ($10,000), or by both
2the fine and imprisonment.

3(h) For the purposes of this article, the following terms have
4the following meanings:

5(1) “Drug store” is an entity described in Code 5912 of the
6Standard Industrial Classification (SIC) Manual published by the
7United States Office of Management and Budget, 1987 edition.

8(2) “General merchandise store” is an entity described in Codes
95311 to 5399, inclusive, and Code 5499 of the Standard Industrial
10Classification (SIC) Manual published by the United States Office
11of Management and Budget, 1987 edition.

12(3) “Grocery store” is an entity described in Code 5411 of the
13Standard Industrial Classification (SIC) Manual published by the
14United States Office of Management and Budget, 1987 edition.

15(4) “Pediatric liquid” means a nonencapsulated liquid whose
16unit measure according to product labeling is stated in milligrams,
17ounces, or other similar measure. In no instance shall the dosage
18units exceed 15 milligrams of phenylpropanolamine or
19pseudoephedrine per five milliliters of liquid product, except for
20liquid products primarily intended for administration to children
21under two years of age for which the recommended dosage unit
22does not exceed two milliliters and the total package content does
23not exceed one fluid ounce.

24(5) “Retail distributor” means a grocery store, general
25merchandise store, drugstore, or other related entity, the activities
26of which, as a distributor of ephedrine, pseudoephedrine,
27norpseudoephedrine, or phenylpropanolamine products, are limited
28exclusively to the sale of ephedrine, pseudoephedrine,
29norpseudoephedrine, or phenylpropanolamine products for personal
30use both in number of sales and volume of sales, either directly to
31walk-in customers or in face-to-face transactions by direct sales.
32“Retail distributor” includes an entity that makes a direct sale, but
33 does not include the parent company of that entity if the company
34is not involved in direct sales regulated by this article.

35(6) “Sale for personal use” means the sale, in a single
36transaction, to an individual customer for a legitimate medical use
37of a product containing ephedrine, pseudoephedrine,
38norpseudoephedrine, or phenylpropanolamine in dosages at or
39below that specified in paragraph (3) of subdivision (g). “Sale for
P15   1personal use” also includes the sale of those products to employers
2to be dispensed to employees from first aid kits or medicine chests.

3(i) It is the intent of the Legislature that this section shall
4preempt all local ordinances or regulations governing the sale by
5a retail distributor of over-the-counter products containing
6ephedrine, pseudoephedrine, norpseudoephedrine, or
7phenylpropanolamine.

8(j) This section shall become operative on January 1, 2019.

9

SEC. 3.  

Section 11100.02 is added to the Health and Safety
10Code
, to read:

11

11100.02.  

(a) Notwithstanding any other law, it is unlawful
12for a retail distributor to knowingly do any of the following, except
13pursuant to a valid prescription from a licensed practitioner with
14prescriptive authority:

15(1) To sell or distribute to the same purchaser within a 30-day
16period more than 9 grams, or within a day more than 3.6 grams,
17of ephedrine base, pseudoephedrine base, norpseudoephedrine
18base, or phenylpropanolamine base contained in a product that is
19lawfully sold, transferred, or furnished over the counter without a
20prescription pursuant to the Federal Food, Drug, and Cosmetic
21Act (21 U.S.C. Sec. 301 et seq.), or regulations adopted thereunder,
22unless exempted from the requirements of the federal Controlled
23Substances Act (21 U.S.C. Sec. 801 et seq.) by the federal Drug
24Enforcement Administration pursuant to Section 814 of Title 21
25of the United States Code.

26(2) To sell or distribute ephedrine, pseudoephedrine,
27norpseudoephedrine, or phenylpropanolamine to a person whose
28information has generated an alert as described in paragraph (3)
29of subdivision (d) regarding that sale.

30(3) To sell or distribute to a purchaser a nonprescription product
31containing any amount of ephedrine, pseudoephedrine,
32norpseudoephedrine, or phenylpropanolamine, except under the
33following conditions:

34(A) The purchaser shall produce valid government-issued photo
35identification.

36(B) The purchaser shall sign a written or electronic log showing
37all of the following:

38(i) The date and time of the transaction.

39(ii) The identification number presented.

P16   1(iii) The agency issuing the identification and the type of
2identification issued.

3(iv) The name, date of birth, and address of the purchaser.

4(v) The amount of ephedrine base, pseudoephedrine base,
5norpseudoephedrine base, or phenylpropanolamine base contained
6in the material, compound, mixture, or preparation sold.

7(b) The retail distributor shall store any product containing any
8amount of ephedrine, pseudoephedrine, norpseudoephedrine, or
9phenylpropanolamine either behind the counter or in a locked
10cabinet so that the customer does not have access to the product.

11(c) (1) To facilitate the monitoring of the sales of
12nonprescription products containing ephedrine, pseudoephedrine,
13norpseudoephedrine, or phenylpropanolamine, the retail distributor
14shall record all of the following information at the point of sale
15regarding the proposed transaction for the purpose of complying
16with this section or the federal Combat Methamphetamine
17Epidemic Act of 2005, or any regulation adopted pursuant to this
18section or that act, and for no other purpose:

19(A) The date and time of the transaction.

20(B) The identification number of the purchaser, issuing agency
21of the identification, and the type of identification used.

22(C) The name, date of birth, and address of the purchaser
23verified through a photo identification of the purchaser.

24(D) The name, quantity of packages, and total gram weight of
25ephedrine base, pseudoephedrine base, norpseudoephedrine base,
26or phenylpropanolamine base contained in a product or products
27purchased, received, or otherwise acquired.

28(E) The name or initials of the person making the sale.

29(2) begin insert(A)end insertbegin insertend insertOn and after July 1,begin delete 2014,end deletebegin insert 2015,end insert the retail distributor
30shall transmit the information immediately tobegin delete the National
31Precursor Log Exchange (NPLEx) administered by the National
32Association of Drug Diversion Investigators (NADDI)end delete
begin insert a vendor
33to collect, administer, and provide access to the transaction dataend insert

34 for purposes of determining whether the proposed sale would
35violate this section and therefore may not proceed, provided that
36thebegin delete NPLExend delete system is available to retailers in the state without a
37charge for accessing the system. The transaction information shall
38not be accessed, stored, or used by the retail distributor or law
39enforcement for any purpose other than to meet the requirements
40set forth in this section or to comply with the provisions of the
P17   1federal Combat Methamphetamine Epidemic Act of 2005, or any
2regulation adopted pursuant to this section or that act. The retail
3distributor shall not maintain a separate copy of the transaction
4information and shall not have direct access to individual
5information or sales records entered into thebegin delete NPLExend delete system, except
6as required by the federal Combat Methamphetamine Epidemic
7Act of 2005.

begin insert

8(B) Subparagraph (A) shall only become operative if the
9department executes a memorandum of understanding (MOU)
10with NADDI and the vendor of the system governing access and
11oversight of the California transaction records pursuant to
12paragraph (1) of subdivision (d). Prior to executing the MOU, the
13Department of Justice shall carry out a competitive bidding process
14for a vendor to collect, administer, and provide access to the
15transaction data transmitted by retail distributors.

end insert

16(3) (A) A retail distributor shall provide notice electronically,
17in writing, or by signage to purchasers at the time of purchase that
18the information collected pursuant to the federal Combat
19Methamphetamine Epidemic Act of 2005 and this section shall be
20entered into a single database as specified in paragraph (2) and
21provided to law enforcement for purposes of determining the
22legality of a proposed sale.

23(B) begin deleteThe Legislature finds that it is necessary for probable end delete
24begin insertProbable end insertcausebegin delete toend deletebegin insert shallend insert be demonstrated to trigger an investigation
25in connection with an individual whose requested purchase is
26denied by the system a single time.

27(C) Access by law enforcement to the data contained in the
28system from a location other than the retailer shall be limited to
29the records of an individual whose attempted purchase has been
30denied by the system.

31(4) This subdivision shall not be construed to require a retail
32distributor to maintain state-required records relating to the sale
33of products containing ephedrine, pseudoephedrine,
34norpseudoephedrine, or phenylpropanolamine in a separate location
35or log from records required by federal law to be kept with respect
36to those products.

37(5) The recording requirements specified in this subdivision
38shall not apply to the sale of a single package containing not more
39than 60 milligrams of pseudoephedrine, consistent with the federal
40Combat Methamphetamine Epidemic Act of 2005.

P18   1(6) If a retail distributor experiences mechanical or electronic
2failure of the system and is unable to comply with the recording
3requirements of this subdivision, the retail distributor shall maintain
4the required records in a written log or an alternative electronic
5recordkeeping mechanism until the retail distributor is able to
6comply with the recording requirements of this subdivision. Written
7logs shall be maintained only for the purpose of compliance with
8this subdivision.

9(d) (1)  begin deleteProvided that the department executes a memorandum
10of understanding (MOU) with NADDI governing access, pursuant
11to this subdivision, NADDI shall forward California transaction
12records in NPLEx to the Department of Justice weekly and provide
13real-time access to NPLEx information through the NPLEx online
14portal to law enforcement in the state as authorized by the
15department. The MOU shall constitute an enforceable contract. end delete

16begin insertThe MOU described in paragraph (2) of subdivision (c) between
17the department, NADDI, and the vendor of the system shall require
18NADDI to reimburse the department for costs incurred in executing
19the MOU, including the competitive bidding process, and for costs
20incurred in performing oversight and other duties required by this
21section and the MOU.end insert

begin insert

22(2) The MOU shall require NADDI to forward California
23transaction records in the system to the Department of Justice
24weekly and provide real-time access to the information through
25the vendor’s online portal to law enforcement in the state as
26authorized by the department.

end insert
begin insert

27(3) The MOU shall constitute an enforceable contract.

end insert
begin delete

8 28(2)

end delete

29begin insert(4)end insert Access to the system shall be available at no charge to the
30department and law enforcement in this state as authorized pursuant
31to paragraph (1).

begin delete

11 32(3)

end delete

33begin insert(5)end insert The system shall allow retail distributors of products
34containing ephedrine, pseudoephedrine, norpseudoephedrine, or
35phenylpropanolamine to enter into the database the information
36specified in subdivision (c) regarding the proposed sale of those
37products.

begin delete

16 38(4)

end delete

P19   1begin insert(6)end insert The system shall be capable of providing the retail distributor
2with an immediate real-time alert any time a provision of this
3section is being violated by a proposed sale.

begin delete

19 4(5)

end delete

5begin insert(7)end insert Neither the department nor any state agency shall bear any
6cost for the development, installation, or maintenance of the
7system.

begin delete

22 8(6)

end delete

9begin insert(8)end insert The MOU shall state that no party to the MOU nor any entity
10under contract to provide the electronic authorization and
11monitoring system shall be authorized to use the information
12contained in the system for any purpose other than those set forth
13in this section, the federal Combat Methamphetamine Epidemic
14Act of 2005, or any regulation adopted pursuant to this section or
15that act. However, the system operator shall be authorized to
16analyze the information for the sole purpose of assessing and
17improving the performance and efficacy of the system. In addition,
18the MOU shall require that a retail distributor’s access to the
19 electronic authorization and monitoring system’s database is
20limited solely to records of sales transactions made by that retail
21distributor, which access shall be solely for purposes of complying
22with the federal Combat Methamphetamine Epidemic Act of 2005
23or this section, or to respond to a duly authorized law enforcement
24request or court order for information collected under that act or
25this section.

begin delete

39 26(7)

end delete

27begin insert(9)end insert The system’s security program shall comply with the security
28standards for the Criminal Justice Information System of the
29Federal Bureau of Investigation and may be audited once a year
30by the department.

begin delete

3 31(8)

end delete

32begin insert(10)end insert The use of the system by a retail distributor or vendor of
33the begin deleteNPLExend delete system shall be subject to Section 56.101 of the Civil
34Codebegin insert, including the purchaser’s right of access or to receive a
35copy of his or her purchaser recordsend insert
. A retail distributor or a
36vendor of thebegin delete NPLExend delete system holding thebegin delete NPLExend delete data shall not
37maintain any records collected under this system for longer than
38two years, or as otherwise required by the federal Combat
39Methamphetamine Epidemic Act of 2005 and shall be destroyed
40pursuant to Section 1798.81 of the Civil Code.

begin delete

10 P20   1(9)

end delete

2begin insert(11)end insert Law enforcement access to the system shall be recorded
3by means of a unique access code for each individual accessing
4the system. Each user’s history shall be maintained and may be
5audited by the department.

begin delete

14 6(10)

end delete

7begin insert(12)end insert The department may submit recommendations to NADDI
8regarding system changes to assist in identifying false identification
9cards.

begin delete

17 10(11)

end delete

11begin insert(13)end insert Disputes relating to compliance with this section arising
12against a vendor of thebegin delete NPLExend delete system shall be subject to a court
13of competent jurisdiction in California and shall be governed by
14California law.

15(e) The State Board of Equalization shall notify all retailers
16about the requirement to submit transactions tobegin delete NPLExend deletebegin insert the systemend insert
17 no later than April 1, 2014.

18(f) This section shall not apply to a health care practitioner with
19prescriptive authority who is currently licensed in this state.

20(g) (1) A first violation of this section is a misdemeanor.

21(2) A person who has previously been convicted of a violation
22of this section shall, upon a subsequent conviction thereof, be
23punished by imprisonment in a county jail not exceeding one year,
24by a fine not exceeding ten thousand dollars ($10,000), or by both
25the fine and imprisonment.

26(h) For the purposes of this section, the following terms have
27the following meanings:

28(1) “Department” means the Department of Justice.

29(2) “Drug store” is an entity described in Code 5912 of the
30Standard Industrial Classification (SIC) Manual published by the
31United States Office of Management and Budget, 1987 edition.

32(3) “General merchandise store” is an entity described in Codes
335311 to 5399, inclusive, and Code 5499 of the Standard Industrial
34Classification (SIC) Manual published by the United States Office
35of Management and Budget, 1987 edition.

36(4) “Grocery store” is an entity described in Code 5411 of the
37Standard Industrial Classification (SIC) Manual published by the
38United States Office of Management and Budget, 1987 edition.

39(5) “Retail distributor” means a grocery store, general
40merchandise store, drugstore, or other related entity, the activities
P21   1of which, as a distributor of ephedrine, pseudoephedrine,
2norpseudoephedrine, or phenylpropanolamine products, are limited
3exclusively to the sale of ephedrine, pseudoephedrine,
4norpseudoephedrine, or phenylpropanolamine products for personal
5use both in number of sales and volume of sales, either directly to
6walk-in customers or in face-to-face transactions by direct sales.
7“Retail distributor” includes an entity that makes a direct sale, but
8does not include the parent company of that entity if the company
9is not involved in direct sales regulated by this article.

10(6) “Sale for personal use” means the sale in a single transaction
11to an individual customer for a legitimate medical use of a product
12containing ephedrine, pseudoephedrine, norpseudoephedrine, or
13phenylpropanolamine in amounts at or below that specified in
14subdivision (a). “Sale for personal use” also includes the sale of
15those products to employers to be dispensed to employees from
16first aid kits or medicine chests.

17(i) It is the intent of the Legislature that this section shall
18preempt all local ordinances or regulations governing the sale by
19a retail distributor of over-the-counter products containing
20ephedrine, pseudoephedrine, norpseudoephedrine, or
21phenylpropanolamine.

22(j) This section shall remain in effect only until January 1, 2019,
23and as of that date is repealed, unless a later enacted statute, that
24is enacted before January 1, 2019, deletes or extends that date.

25

SEC. 4.  

No reimbursement is required by this act pursuant to
26Section 6 of Article XIII B of the California Constitution because
27the only costs that may be incurred by a local agency or school
28district will be incurred because this act creates a new crime or
29infraction, eliminates a crime or infraction, or changes the penalty
30for a crime or infraction, within the meaning of Section 17556 of
31the Government Code, or changes the definition of a crime within
32the meaning of Section 6 of Article XIII B of the California
33Constitution.

34begin insert

begin insertSEC. 5.end insert  

end insert
begin insert

(a) This act shall become operative on February 1,
352015.

end insert
begin insert

36(b) This act shall become operative only if the National
37Association of Drug Diversion Investigators (NADDI) voluntarily
38agrees, on or before January 15, 2015, to reimburse the department
39for costs incurred in the execution of the memorandum of
40understanding, including the competitive bidding process, and for
P22   1costs incurred in performing oversight and other duties as
2described in Section 11100.02 of the Health and Safety Code, as
3amended by this act. The Department of Justice shall post on its
4Internet Web site on or before January 19, 2015, whether or not
5NADDI has agreed to reimburse the department for these costs.

end insert


O

    98