FAQ: Naturopathic Prescribing of Codeine and Testosterone Products

This is a reprint of an FAQ from the Washington Department of Health.

Frequently Asked Questions
Naturopathic Physicians Prescribing Codeine and Testosterone Products

Since the passage of 2005 House Bill 1546 and the completion of the rule implementation that became effective November 2, 2007, the following questions have been raised regarding licensed naturopathic physicians prescribing the two controlled substances codeine and testosterone products authorized by law. Chapter 18.36A.040 Revised Code of Washington (RCW) governs scope of practice for naturopathic physicians, citing “naturopathic medicines.” Those medicines are defined in Chapter 18.36A.020 (10) RCW. Washington Administrative Code (WAC) 246- 836-210 and 246-836-211 are the rules implementing this expansion. Please see the links below:

RCW 18.36A.040: RCW 18.36A.020: WAC 246-836-210: WAC 246-836-211:

http://apps.leg.wa.gov/RCW/default.aspx?cite=18.36A.040         http://apps.leg.wa.gov/RCW/default.aspx?cite=18.36A.020    http://apps.leg.wa.gov/WAC/default.aspx?cite=246-836-210 http://apps.leg.wa.gov/WAC/default.aspx?cite=246-836-211

Q1.  What is the difference between a controlled substance and a schedule medication?

A. There is no difference. A controlled substance is a drug or chemical whose manufacture, possession, or use is regulated by the federal Drug Enforcement Administration (DEA). Controlled substances are subject to legislative control and may include illegal drugs and prescription medications. Substances are classified into a list of five schedules according to their potential for abuse. At the most restrictive, Schedule I substances are those deemed as having no accepted medical use; at the least restrictive, Schedule V substances are those deemed to have the lowest potential for abuse.

Q2. What do I need to do in order to prescribe codeine and testosterone products?

A. First a licensed naturopathic physician must have completed at least four hours of instruction as part of a graduate level course at a department-approved school that grants a graduate degree as an ND, MD, DO, or a graduate school approved by the department under Chapter RCW 18.79 (RN). There are then two steps to complete before prescribing:

Get authorization from the Department of Health by submitting an attestation of training approval.

Get DEA registration. Federal law requires practitioners to get registration through the DEA prior to approval for prescribing codeine and testosterone products.

Q3. What typical courses meet the regulation requirements?

A.  Typical courses include pre-degree pharmacology or post-degree extended education courses that meet the criteria in WAC 246-836-211: Authorization regarding controlled substances.

Q4.  Where do I get the attestation forms?

A.  The attestation form can be downloaded from the Department of Health website.

Q5.  How do I obtain a DEA registration?

A. Licensed naturopathic physicians may apply to the DEA on its website at the following address (please note the correct spelling in the website “deadiversion”):

http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms.htm

Q6.  What schedules do I mark on the DEA application?

A.  Schedules III, IV, and V” so those are the schedules you will mark on your DEA application.

Q7.  So may I prescribe any medication in Schedules III, IV, and V?

A. No, RCW 18.36A.020 (10) limits the medications naturopathic physicians may prescribe to codeine and testosterone products. The law states (in part): “Controlled substances are codeine and testosterone products. The law states (in part): “Controlled substances are limited to codeine and testosterone products that are contained in Schedules III, IV, and V in chapter 69.50 RCW.” While DEA registrations are issued based on categories, referred to as schedules, they aren’t issued down to the level of specific medications. Even if your DEA registration states Schedule III, you may not prescribe for a medication that is beyond the Washington State scope of practice for prescribing by naturopathic physicians.

Q8. Where can I find codeine and testosterone products in the law?

A. RCW 69.50, also known as the Uniform Controlled Substance Act, lists controlled substance medications by schedule. Codeine products are listed under Schedules III and V, and testosterone products under Schedule III. You may access them as follows:

Schedule III: http://apps.leg.wa.gov/RCW/default.aspx?cite=69.50.208

Schedule V: http://apps.leg.wa.gov/RCW/default.aspx?cite=69.50.212

Q9.  Why does the statute list Schedule IV if neither medication is in it?

A. Washington law (RCW 69.50.201) allows the Board of Pharmacy to reclassify medications between schedules if it finds sufficient evidence to support such a reclassification. For information purposes, Schedule IV medications list can be accessed as follows:

Schedule IV: http://apps.leg.wa.gov/RCW/default.aspx?cite=69.50.210

Q10. May I prescribe hydrocodone?

A. No. First, hydrocodone is a synthetic opioid – dihydrocodeinone. Second, it is listed under Schedule II. These circumstances mean it cannot be prescribed by naturopathic physicians. You may access the Schedule II medications list as follows:

Schedule II: http://apps.leg.wa.gov/RCW/default.aspx?cite=69.50.206

Q11. What about Vicodin; isn’t it a Schedule III medication?

A. No. Effective October 6, 2014, the FDA reclassified Vicodin as a Schedule II medication. Q. Then what codeine medications may I prescribe?

Q12. Then what codeine medications may I prescribe?

A. Under Schedule III, RCW 69.50.208(d) states: “Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof calculated as the free anhydrous base or alkaloid, in limited quantities as set forth in this subsection: (1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium; (2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts; (3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium; (4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts; (5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts;”

Examples:

  •  Acetaminophen and codeine (acetaminophen ranging from 300 to 1,000 mg, codeine phosphate ranging from 15 to 60 mg). Brand names include Tylenol #3®; Tylenol #4®.
  •  Aspirin and codeine (acetylsalicylic acid 325 mg; codeine phosphate ranging from 30 to60 mg). Brand names include Empirin Codeine®.
  •  Expectorant syrups which are combination products containing codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride (i.e. codeine 20 mg, guiafenesin 200 mg, pseudoephedrine 60 mg per 5 ml). Brand names include Cheratussin DAC; Codafed® Expectorant; GuiatussTM DAC®; Mytussin® DAC; Nucofed® Expectorant; Nucotuss®.Under Schedule V, RCW 69.50.212 states: “Unless specifically excepted by state or federal law or regulation or more specifically included in another schedule, the following controlled substances are listed in Schedule V: (b) Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth in this subsection, which also contains one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation, valuable medicinal qualities other than those possessed by the narcotic drug alone: (1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams; (2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams;”Example: Cough syrup combination products containing codeine phosphate and guaifenesin (i.e. codeine 10 mg, guaifenesin 100 mg). Brand names include Brontex®; Cheracol®; Cheratussin AC; Kolephrin® #1; Mytussin® AC; Robafen® AC; Romilar® AC.

Q13. The information about whether a medication is or isn’t a codeine product in Schedule III or V is not readily available, even online. And the information that is there is very confusing. Is there a reliable resource so I can find the information and stay compliant with state law?

A. While not an exhaustive list as new medications are developed on an ongoing basis, the DEA website has an alphabetical listing of controlled substances, which includes the individual medications as well as other names for which they are known:

http://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf

For additional information, please contact: Susan Gragg, Program Manager Board of Naturopathy
360-236-4941 or susan.gragg@doh.wa.gov

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