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1 STATE OF OKLAHOMA

2 2nd Session of the 53rd Legislature (2012)

3 COMMITTEE SUBSTITUTE FOR 4 HOUSE BILL NO. 2808 By: Roberts (Sean)

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7 COMMITTEE SUBSTITUTE

8 An Act relating to public health and safety; amending 63 O.S. 2011, Section 2-210, which relates to 9 Schedule IV controlled substances; prohibiting the sale of certain products except by certain 10 individuals; requiring determination be made prior to dispensing certain products; providing basis of 11 determination; permitting State Board of Pharmacy to adopt certain rules, review determinations, and take 12 disciplinary action; excluding civil liability from certain determination; prohibiting certain 13 individuals from selling certain products to certain underage individuals; requiring proof of age and 14 identity prior to sale of certain products; defining term; permitting Board to adopt rules which add to 15 list of certain ; and providing an effective date. 16

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19 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:

20 SECTION 1. AMENDATORY 63 O.S. 2011, Section 2-210, is

21 amended to read as follows:

22 Section 2-210. A. Any material, compound, mixture, or

23 preparation which contains any quantity of the following substances

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1 having a potential for abuse associated with a stimulant or

2 effect on the central nervous system:

3 1. betaine;

4 2. ;

5 3. ;

6 4. ;

7 5. ;

8 6. ;

9 7. ;

10 8. Diethylpropion;

11 9. Phentermine;

12 10. Pemoline;

13 11. ;

14 12. Chlordiazepoxide and its salts, but not including

15 chlordiazepoxide hydrochloride and clidinium or

16 chlordiazepoxide and water-soluble esterified estrogens;

17 13. ;

18 14. ;

19 15. ;

20 16. and its salts;

21 17. ;

22 18. ;

23 19. ;

24 20. ;

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1 21. ;

2 22. ;

3 23. Fenfluramine;

4 24. Pentazocine;

5 25. Propoxyphene;

6 26. Butorphanol;

7 27. ;

8 28. ;

9 29. ;

10 30. ;

11 31. ;

12 32. ;

13 33. ;

14 34. Ephedrine, its salts, optical isomers, and salts of optical

15 isomers as the only active ingredient, or in combination with other

16 active ingredients;

17 35. ;

18 36. ;

19 37. ;

20 38. ;

21 39. Modafinil;

22 40. ; or

23 41. .

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1 B. 1. The following nonnarcotic substances, which may, under

2 the Federal Food, , and Cosmetic Act (21 U.S.C., Section 301),

3 be lawfully sold over the counter without a prescription, are

4 excluded from all schedules of controlled substances under this

5 title:

6 a. Breathe-Aid,

7 b. BronCare,

8 c. Bronchial Congestion,

9 d. Bronkaid Tablets,

10 e. Bronkaid Dual Action Caplets,

11 f. Bronkotabs,

12 g. Bronkolixir,

13 h. NeoRespin,

14 i. Pazo Hemorrhoid Ointment and Suppositories,

15 j. Primatene Tablets,

16 k. Primatene "Dual Action" Formula,

17 l. Quelidrine,

18 m. Resp, and

19 n. Vatronal Nose Drops.

20 2. At the request of any person, the Director may exempt any

21 other drug product containing ephedrine from being included as a

22 Schedule IV controlled substance if such product:

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1 a. is labeled and marketed in a manner consistent with

2 the pertinent OTC tentative final or final monograph

3 issued by the FDA, and

4 b. is manufactured and distributed for legitimate

5 medicinal use and in a manner that reduces or

6 eliminates the likelihood of abuse.

7 3. In making a determination regarding a drug product, the

8 Director, after notice and hearing, shall consider the following:

9 a. the history and current pattern of abuse,

10 b. the name and labeling of the product,

11 c. the intended manner of distribution, advertising and

12 promotion of the product, and

13 d. other factors as may be relevant to and consistent

14 with the public health and safety.

15 4. The hearing shall be held in accordance with the

16 Administrative Procedures Act.

17 5. A list of current drug products meeting exemption

18 requirements under this subsection may be obtained from the Bureau

19 upon written request.

20 C. The State Board of Pharmacy may except by rule any compound,

21 mixture, or preparation containing any depressant substance listed

22 in subsection A of this section from the application of all or any

23 part of the Uniform Controlled Dangerous Substances Act, Section 2-

24 101 et seq. of this title, if the compound, mixture, or preparation

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1 contains one or more active medicinal ingredients not having a

2 depressant effect on the central nervous system, and if the

3 admixtures are included therein in combinations, quantity,

4 proportion, or concentration that vitiate the potential for abuse of

5 the substances which have a depressant effect on the central nervous

6 system.

7 D. 1. It shall be unlawful for any person to knowingly

8 dispense, sell, transfer, or otherwise furnish in a single

9 transaction a product containing ephedrine, pseudoephedrine, or

10 phenylpropanolamine except in a licensed pharmacy by a licensed

11 pharmacist or a registered pharmacy technician.

12 2. Except under a valid prescription, before dispensing a

13 product containing ephedrine, pseudoephedrine, or

14 phenylpropanolamine, a pharmacist shall make a professional

15 determination, based on a pharmacist-patient relationship, as to

16 whether or not there is a legitimate medical and pharmaceutical need

17 for the drug.

18 3. The determination under paragraph 2 of this subsection may

19 be based on factors including without limitation:

20 a. prior -filling history,

21 b. patient screening, and

22 c. other tools that provide professional assurance to the

23 pharmacist that a legitimate medical and

24 pharmaceutical need exists.

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1 4. The State Board of Pharmacy may:

2 a. adopt rules regarding determinations made under

3 paragraphs 2 and 3 of this subsection,

4 b. review determinations made under paragraphs 2 and 3 of

5 this subsection, and

6 c. take appropriate disciplinary action as required.

7 5. A pharmacy or pharmacist is not civilly liable for a

8 determination made for any refusal to dispense, sell, transfer, or

9 otherwise furnish ephedrine, pseudoephedrine, or phenylpropanolamine

10 based on a determination of need, age or identity.

11 6. Unless pursuant to a valid prescription, it is unlawful for

12 a licensed pharmacist or a registered pharmacy technician to

13 knowingly dispense, sell, transfer, or otherwise furnish in a single

14 transaction any product containing ephedrine, pseudoephedrine, or

15 phenylpropanolamine to any person who fails to present proof of age

16 and identity and to any individual under eighteen (18) years of age.

17 The person making the sale shall require proof of age and

18 identity from the purchaser prior to completing the sale. For

19 purposes of this paragraph, “proof of age and identity” means any

20 official document which establishes proof of age and identity issued

21 by a state agency or an identification card issued by the United

22 States Department of Defense to active duty military personnel that

23 contains a description of the person or a photograph of the person,

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1 or both, and gives the person’s date of birth, and a functioning

2 magnetic stripe or bar code.

3 7. The State Board of Pharmacy may adopt rules adding to a list

4 additional nonprescription drugs that are subject to the same

5 restrictions as are imposed for ephedrine, pseudoephedrine, or

6 phenylpropanolamine.

7 SECTION 2. This act shall become effective November 1, 2012.

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9 53-2-9906 GRS 02/29/12

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