Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances classified in Schedule V. Existing law places marijuana cannabis in Schedule I. Cannabidiol is a compound found in marijuana. cannabis.

Existing law restricts the prescription, furnishing, possession, sale, and use of controlled substances, including marijuana cannabis and synthetic cannabinoid compounds, and makes a violation of those laws a crime, except as specified.

This bill, if one of specified changes in federal law regarding the controlled substance cannabidiol occurs, would provide that a physician, pharmacist, or other authorized healing arts licensee who prescribes, furnishes, or dispenses a product composed of cannabidiol, in accordance with federal law, is in compliance with state law governing those acts. The bill would also provide that upon the effective date of one of those changes in federal law regarding cannabidiol, the prescription, furnishing, dispensing, transfer, possession, or use of that product in accordance with federal law is for a legitimate medical purpose and is authorized pursuant to state law.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances classified in Schedule V. Existing law places marijuana in Schedule I. Cannabidiol is a compound found in marijuana.

Existing law restricts the prescription, furnishing, possession, sale, and use of controlled substances, including marijuana and synthetic cannabinoid compounds, and makes a violation of those laws a crime, except as specified.

This bill, if one of specified changes in federal law regarding the controlled substance cannabidiol occurs, would provide that a physician physician, pharmacist, or other authorized healing arts licensee who prescribes and a pharmacist who prescribes, furnishes, or dispenses a product composed of cannabidiol, in accordance with federal law, is in compliance with state law governing those acts. The bill would also provide that upon the effective date of one of those changes in federal law regarding cannabidiol, the prescription, furnishing, dispensing, transfer, possession, or use of that product in accordance with federal law is for a legitimate medical purpose and is authorized pursuant to state law.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances classified in Schedule V. Existing law places marijuana in Schedule I. Cannabidiol is a compound found in marijuana.

Existing law restricts the prescription, furnishing, possession, sale, and use of controlled substances, including marijuana and synthetic cannabinoid compounds, and makes a violation of those laws a crime, except as specified.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances classified in Schedule V. Existing law places marijuana in Schedule I. Cannabidiol is a compound found in marijuana.

Existing law restricts the prescription, furnishing, possession, sale, and use of controlled substances, including marijuana and synthetic cannabinoid compounds, and makes a violation of those laws a crime, except as specified.

This bill would authorize, if federal law authorizes the prescription of a controlled substance containing cannabidiol, a physician to prescribe that substance in accordance with federal law. The bill would also provide that upon the enactment of federal law authorizing the prescription or the furnishing, transferring, possession, or use of a prescription for a controlled substance containing cannabidiol, notwithstanding any other state law, the prescription, furnishing, transferring, possession, or use of that controlled substance in accordance with federal law is for a legitimate medical purpose and is authorized pursuant to state law.

This bill would declare that it is to take effect immediately as an urgency statute.

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2017 - 2018 Regular Session

AB 845 (Wood) - Cannabidiol

This bill does not meet the criteria for referral to the Suspense File.

Bill Summary:

AB 845 would allow a physician to prescribe and a pharmacist to dispense cannabidiol and related products if cannabidiol is excluded from Schedule I of the federal Controlled Substances Act.

Fiscal Impact:

• One-time costs under $50,000 for the adoption of regulations by the Medical Board (Contingent Fund of the Medical Board of California).
• One-time costs under $50,000 for the adoption of regulations by the Osteopathic Medical Board (Osteopathic Medical Board of California Contingent Fund).
• One-time costs under $50,000 for the adoption of regulations by the Board of Pharmacy (Pharmacy Board Contingent Fund).

Background:

The Medical Cannabis Regulation and Safety Act (MCRSA) was enacted by the legislature to regulate the production and sale of medical cannabis. The MCRSA created a regulatory structure and licensing requirements for a variety of entities involved in the production, distribution, and sale of medical cannabis.

The Control, Regulate, and Tax Adult Use of Marijuana Act (AUMA, Proposition 64 of 2016) legalized the sale, possession, and use of marijuana for individuals over the age of 21. The AUMA created a regulatory structure for the recreational marijuana industry, similar to that created under the MCRSA, but with some differences in licensing requirements.

SB 94 (Committee on Budget and Fiscal Review, Statutes of 2017) consolidated and harmonized the requirements of the two bodies of law relating to both medicinal and recreational cannabis (and changed the official terminology to cannabis).

Under the federal Controlled Substance Act, drugs are categorized into five “schedules” based on therapeutic value and their potential for abuse. Cannabis or marijuana is currently included in Schedule I, which is reserved for drugs with the greatest potential for abuse an little or no therapeutic value. Schedule I drugs generally cannot be prescribed for patient use under federal law. In 2016, the Drug Enforcement Agency adopted a rule that includes marijuana extracts in the list of Schedule I controlled substances.

Cannabidiol is a chemical component of cannabis and can be extracted from cannabis. Cannabidiol does not induce the narcotic effects that THC (another constituent of cannabis) does.

Currently, there is a drug under review by the Federal Drug Administration that uses cannabidiol to treat certain forms of childhood epilepsy.

Proposed Law:

AB 845 would allow a physician to prescribe and a pharmacist to dispense cannabidiol and related products if cannabidiol is excluded from Schedule I of the federal Controlled Substances Act.

This bill is an urgency measure.

Related Legislation:

There are a number of other bills that generally relate to cannabis and its regulation that will be heard in this committee.

-- END --

SENATE COMMITTEE ON PUBLIC SAFETY

Senator Nancy Skinner, Chair

2017 - 2018 Regular

Bill No: AB 845 Hearing Date: June 20, 2017

Subject: Cannabidiol

HISTORY

Source: Epilepsy Foundation of Greater Los Angeles

Prior Legislation: SB 643 (McGuire) Ch. 719, Stats. of 2015

AB 266 (Bonta) Ch. 689, Stats. of 2015

AB 243 (Wood) Ch. 688, Stats. of 2015

Support: California Life Sciences Association; Dravet Syndrome Foundation; Epilepsy Foundation; Epilepsy Foundation of Northern California; LGS Foundation; Tuberous Sclerosis Alliance; two individuals

Opposition: None known

Assembly Floor Vote: 76 - 0

PURPOSE

The purpose of this bill is to permit specified health care practitioners to prescribe, furnish, or dispense a product composed of cannabidoil (CBD) under state law, if CBD is excluded from Schedule I of the Federal Controlled Substances Act (Act), or if it is approved by the Federal Food and Drug Administration (FDA) and either placed on a schedule other than Schedule I or is exempted from the Act.

Existing federal law establishes the Controlled Substances Act which regulates the manufacture, importation, possession, use and distribution of controlled substances such as hallucinogens, narcotics, depressants, and stimulants. Categorizes drugs into five schedules or classifications based on their potential for abuse, status in international treaties, and any medical benefits they may provide. Specifies that Schedule I drugs are considered the most harmful with no medical benefits, and includes marijuana in this schedule. Indicates that Schedule V substances are the least restricted. (21 U.S.C. § 812.)

Existing law establishes the California Uniform Controlled Substances Act (UCSA) which regulates controlled substances. (Health & Saf. Code §§ 11000 et seq.)

Existing law classifies controlled substances in five schedules according to their danger and potential for abuse. (Health & Saf. Code §§ 11054-11058.)

Existing law authorizes only a physician, dentist, podiatrist, veterinarian, naturopathic doctor, a registered nurse acting, a certified nurse-midwife, a nurse practitioner, a physician assistant, or an optometrist to write or issue a prescription. (Health & Saf. Code § 11150.)

Existing law specifies that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. Establishes responsibility for proper prescribing of controlled substances upon the prescribing practitioner, and a corresponding responsibility with the pharmacist who fills the prescription. Provides that any person who knowing violates this provision shall result in imprisonment for up to one year, or a fine of up to $20,000, or both. (Health & Saf. Code § 11153.)

Existing law, the Compassionate Use Act of 1996, exempts certain patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana. (Health & Saf. Code § 11362.5.)

Existing law, the Medical Cannabis Regulation and Safety Act (MCRSA), regulates medical cannabis in California, including its cultivation, transportation, storage, distribution, and sale. (Bus. & Prof. Code §§ 19300 et seq.)

Existing law establishes the Bureau of Marijuana Control (Bureau) within the Department of Consumer Affairs for the licensure and regulation of cannabis. (Bus. & Prof. Code § 26010.)

Existing law, the Adult Use of Marijuana Act (AUMA), permits adults 21 years of age or older to legally grow, possess, and use cannabis for non-medical purposes, as specified. Authorizes, beginning January 1, 2018, the selling and distributing of cannabis through a regulated business. (Bus. & Prof. Code §§ 26000 et seq.)

Existing law prohibits an individual who possesses a license in good standing to practice medicine or osteopathy, as specified, from recommending medical cannabis to a patient, unless that person is the patient’s attending physician. (Bus. & Prof. Code § 2525.2.)

This bill makes Legislative findings and declarations that both children and adults with epilepsy are in desperate need of new treatment options, and that CBD is showing potential as one of these treatments. If federal laws prohibiting the prescription of medications composed of CBD are repealed or if an exception from the general prohibition is enacted permitting the prescription of drugs composed of CBD, patients should have rapid access to this treatment option. The availability of this new prescription medication is intended to augment, not to restrict or otherwise amend, other cannabinoid treatment modalities currently available under state law.

This bill states that a physician, pharmacist, or other authorized healing arts licensee acting within his or her scope of practice, to prescribe, furnish, or dispense CBD is in compliance with state law if CBD is removed from Schedule I of the Act and placed on a different schedule, or if a product composed of cannabidiol is approved by the federal FDA and either placed on a schedule of the Act other than Schedule I, or exempted from one or more provisions of the Act.

This bill states that, upon the effective date of CBD’s exclusion or exemption from the Act, the prescription, furnishing, dispensing, transfer, possession, or use of a product composed of cannabidiol in accordance with federal law is authorized pursuant to state law, as specified.

This bill contains an urgency clause.

COMMENTS

1. Need for This Bill

According to the author:

Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Approximately 1 in 26 Americans will develop epilepsy at some point in their lifetime. There is no “one size fits all” treatment option and about one million people live with uncontrolled or intractable seizures. Uncontrolled seizures can lead to disability, injury, and even death, and many individuals living with uncontrolled seizures suffer from rare epilepsies characterized by seizures that are difficult to treat with existing treatment options. Access to new treatments is particularly important for these individuals, who live with the continual risk of serious injuries and loss of life.

The FDA is currently reviewing at least one CBD derived therapy that shows promise for the treatment of rare epilepsy conditions. This potential treatment option has both “Orphan Drug Designation” and Fast Track Designation from the FDA. Given the Fast Track Designation, this potential treatment option could be available as soon as early 2018.

Currently, any product that contains any material, compound, mixture, or preparation, which contains any quantity of marijuana is considered a Schedule I Controlled Substance unless specifically exempted. Under current law, should a product derived from CBD, like Epidiolex, be approved and rescheduled, it would still be considered a Schedule I substance under California statute and therefore could not be prescribed by a physician unless specifically exempted.  Individuals suffering from these rare forms of epilepsy and those living with uncontrolled seizures would not be able to access the medication. AB 845 will ensure Californians with uncontrolled seizures have continued access to FDA approved epilepsy treatments derived from CBD. 

2. Cannabidiol

Cannabinoids are chemical components of cannabis that produce pharmacologic effects throughout the body, including the central nervous system and the immune system. The primary active cannabinoid in cannabis is delta-9-tetrahydrocannabinol (THC). Another active cannabinoid is CBD which may provide relief for pain, anxiety, seizures, and other conditions without causing the “high” of THC. Cannabinoids can be taken by mouth, inhaled, or sprayed under the tongue. Two cannabinoids, dronabinol and nabilone, are FDA-approved drugs used for the prevention or treatment of chemotherapy-related nausea and vomiting.

3. FDA Approval Process

The FDA reviews drug applications to determine whether they are safe and effective through scientific investigations, including adequate and well-controlled clinical trials.

The FDA has several programs to facilitate the approval of drugs for certain conditions. The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition which qualifies the sponsor for various development incentives, including tax credits for qualified clinical testing. “Fast track” is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

The drug Epidiolex, referenced by this bill’s sponsors, is a CBD drug candidate by GW Pharmaceuticals and is currently in clinical trials with the FDA. CBD has long been used as a treatment for Dravet syndrome, a rare and severe form of epilepsy in children, and GW Pharmaceuticals sees Epidiolex as useful in treating both Dravet and Lennox-Gastaut syndrome (LGS), another rare form of childhood epilepsy. This bill is intended to facilitate the prescription of any FDA-approved CBD products by stating that federal reclassification or exemption from Schedule I triggers the safe prescription, furnishing, dispensing, transfer, possession, or use of a product composed of CBD in accordance with federal and state law.

4. Related Legislation

SJR 5 (Stone) requests that Congress pass a law to reschedule cannabis, marijuana, and its derivatives from a Schedule I drug, and that the President of the United States sign such legislation. The bill is pending in the Assembly.

5. Proposed Amendment

In December 2016, the Drug Enforcement Agency (DEA) finalized a rule adding “marihuana extracts” to the list of Schedule I controlled substances under the federal Controlled Substances Act. (21 C.F.R. § 1308, 81 Fed.Reg. 90194 (Dec. 12, 2016) <https://www.federalregister.gov/documents/2016/12/14/2016-29941/establishment-of-a-new-drug-code-for-marihuana-extract> [as of Jun. 12, 2017].) “Marihuana extract” is defined as “an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.” Cannabidiol is considered a “marihuana extract” by the DEA.

Because cannabidiol itself is not explicitly listed under Schedule I, Legislative Counsel has advised that cannabidiol’s removal from Schedule I—the language in the current version of the bill—may be an unascertainable event. As a result, Legislative Counsel suggested an amendment to replace the word “removed” with “excluded” on page 2, line 15 of the bill, and the author intends to make this amendment. The bill as amended would read:

11150.2 (a) “Notwithstanding any other law, if cannabidiol is excluded from Schedule I of the federal Controlled Substances Act and placed on a schedule of the act other than Schedule I…”

6. Argument in Support

California Life Sciences Association supports this bill stating:

This bill would benefit patients in California by allowing access [to] controlled substances containing cannabidiol (CBD) if and when federal law permits such access.

As clinical evaluations of CBD continue, evidence grows of CBD’s anti-seizure effects, though studies have also suggested potential anti-inflammatory, anti-anxiety, anti-psychotic, and analgesic benefits to the compound. One of the most promising applications of CBD is for the prevention and treatment of seizures in children with forms of drug-resistant epilepsy. While legal and regulatory hurdles to CBD access for patients remain at the federal level, we are hopeful that U.S. Food and Drug Administration (FDA) approval of a purified CBD extract for the treatment of pediatric epilepsy could ensure safe and effective access to this compound. With enactment of AB 845, the state will have done its part to facilitate patients/ access to the benefits of safe and effective CBD-based medicines.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2017 - 2018 Regular

Bill No: Hearing Date: June 5, 2017

Subject:

SUMMARY:

Authorizes a physician to prescribe and a pharmacist to dispense cannabidoil (CBD) if it is reclassified at the federal level, or if a product composed of CBD is approved by the federal Food and Drug Administration and either not declared a Schedule I drug, or exempted from the federal Controlled Substances Act.

Existing law:

1. Establishes the federal Controlled Substances Act (Act) which regulates the manufacture, importation, possession, use and distribution of controlled substances such as hallucinogens, narcotics, depressants, and stimulants. Categorizes drugs into five schedules or classifications based on their potential for abuse, status in international treaties, and any medical benefits they may provide. Specifies that Schedule I drugs are considered the most harmful with no medical benefits, and includes marijuana in this schedule. Indicates that Schedule 5 substances are the least restricted. (21 United States Code § 812)
2. Establishes the California Uniform Controlled Substances Act (UCSA), which among other provisions, classifies controlled substances into five designated schedules. (Health and Safety Code (HSC) §§ 11000 et seq.)
3. Authorizes only a physician, dentist, podiatrist, veterinarian, naturopathic doctor, a registered nurse acting, a certified nurse-midwife, a nurse practitioner, a physician assistant, or an optometrist to write or issue a prescription. (HSC § 11150)
4. Requires, under UCSA, a prescription for a controlled substance to only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. Indicates that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. Indicates that any person who knowingly violates this provision shall be punished by imprisonment not exceeding one year, or by a fine not exceeding twenty thousand dollars ($20,000), or by both fine and imprisonment. (HSC § 11153)
5. Establishes Proposition 215, also known as the Compassionate Use Act of 1996, which exempts certain patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana. (HSC § 11362.5)
6. Establishes the Medical Cannabis Regulation and Safety Act (MCRSA) to regulate medical cannabis in California, including its cultivation, transportation, storage, distribution, and sale. (Business and Professions Code (BPC) §§ 19300 et seq.).
7. Establishes within the Department of Consumer Affairs the Bureau of Marijuana Control (Bureau) for the licensure and regulation of cannabis. (BPC § 26010)
8. Establishes the Adult Use of Marijuana Act (AUMA) which permits adults 21 years of age or older to legally grow, possess, and use cannabis for non-medical purposes, as specified. Authorizes, beginning January 1, 2018, the selling and distributing of cannabis through a regulated business. (BPC §§ 26000 et seq.).
9. Declares it unlawful for a physician and surgeon who recommends cannabis to a patient for a medical purpose to accept, solicit, or offer any form of remuneration from or to a licensed medical cannabis facility, if the physician and surgeon or his or her immediate family have a financial interest in that facility. (BPC § 2525)
10. Prohibits a physician and surgeon from recommending medical cannabis to a patient, unless that person is the patient’s attending physician. (BPC § 2525.2)
11. Declares recommending medical cannabis to a patient for a medical purpose without an appropriate prior examination and a medical indication as unprofessional conduct. (BPC § 2525.3)

This bill:

1. Makes Legislative findings and declarations that both children and adults with epilepsy are in desperate need of new treatment options, and that CBD is showing potential as one of these treatments. If federal laws prohibiting the prescription of medications composed of CBD are repealed or if an exception from the general prohibition is enacted permitting the prescription of drugs composed of CBD, patients should have rapid access to this treatment option. The availability of this new prescription medication is intended to augment, not to restrict or otherwise amend, other cannabinoid treatment modalities currently available under state law.
2. States that a physician may prescribe, and a pharmacist may dispense, CBD in compliance with state law if CBD is removed from Schedule I of the Act and placed on a different schedule, or if a product composed of cannabidiol is approved by the federal Food and Drug Administration (FDA) and either placed on a schedule of the Act other than Schedule I, or exempted from one or more provisions of the Act, so as to permit a physician to prescribe and a pharmacist to dispense that product.
3. States that, upon the effective date of the federal reclassification of CBD, the prescription, furnishing, dispensing, transfer, possession, or use of a product composed of cannabidiol in accordance with federal law is for a legitimate medical purpose and is authorized pursuant to state law, as specified.
4. Declares this bill an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of the California Constitution in order to ensure that patients are able to obtain access to a new treatment modality as soon as federal law makes it available.

FISCAL EFFECT:

This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations analysis dated April 26, 2017, the cost to the Medical Board of California, Osteopathic Board of California, and the Board of Pharmacy are expected to be minor and absorbable.

COMMENTS:

1. Purpose. This bill is sponsored by the Epilepsy Foundation. According to the Author’s office, “The FDA is currently reviewing at least one CBD derived therapy that shows promise for the treatment of rare epilepsy conditions. This potential treatment option has both ‘Orphan Drug Designation’ and Fast Track Designation from the FDA. Given the Fast Track Designation, this potential treatment option could be available as soon as early 2018.

“Currently, any product that contains any material, compound, mixture, or preparation, which contains any quantity of marijuana is considered a Schedule I Controlled Substance unless specifically exempted. Under current law, should a product derived from CBD, like Epidiolex, be approved and rescheduled, it would still be considered a Schedule I substance under California statute and therefore could not be prescribed by a physician unless specifically exempted. Individuals suffering from these rare forms of epilepsy and those living with uncontrolled seizures would not be able to access the medication.

“AB 845 will ensure Californians with uncontrolled seizures have continued access to FDA approved epilepsy treatments derived from CBD.”

1. CBD. According to the National Institute of Health, CBD is a compound isolated from cannabis which does not cause psychoactive activity and has pain relief, anti-inflammatory and tumor-inhibiting properties.

There are currently 63 clinical trials of CBD listed on the federal clearinghouse for publicly and privately supported clinical, clinicaltrials.gov.

1. FDA Drug Approval Process. The FDA reviews drug applications to determine whether they are safe and effective through scientific investigations, including adequate and well-controlled clinical trials.

The FDA has several programs to facilitate the approval of drugs for certain conditions. The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition which qualifies the sponsor for various development incentives, including tax credits for qualified clinical testing. “Fast track” is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

According to the FDA, it has not yet approved marijuana for any medical indication. The FDA website states “However, the FDA has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of marijuana. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.”

The drug Epidiolex, referenced by this bill’s sponsors, is a CBD drug candidate by GW Pharmaceuticals and is currently in Phase 3 trials with the FDA.

This bill is intended to facilitate the prescription of any FDA- approved CBD products by stating that federal reclassification from Schedule I triggers the safe prescription, furnishing, dispensing, transfer, possession, or use of a product composed of CBD in accordance with federal and state law.

1. Related Legislation This Year. AB 420 (Wood) would require an advertisement for the sale of nonmedical marijuana or nonmedical marijuana products to include, at a minimum, the license number of the AUMA licensee responsible for its content. (Status: The bill is also pending in this committee.)

AB 350 (Salas) would specify that a marijuana product is deemed to be appealing to children or easily confused with commercially sold candy if it is in the shape of a person, animal, insect, fruit, or in another shape normally associated with candy, but would not prohibit a licensee from making an edible marijuana product in the shape of the licensee’s logo. (Status: The bill is also pending in this committee.)

SB 175 (McGuire) expands marijuana appellation of origin protections to advertising and prohibits the use of names that sound similar to a California county in advertising, labeling, marketing, or packaging of marijuana products if it is likely to mislead consumers as to the product’s appellation of origin. (Status: This bill is currently pending in the Assembly Committee Rules Committee awaiting assignment to a policy committee.)

1. Prior Related Legislation. SB 643 (McGuire, Chapter 719, Statutes of 2015) establishes a regulatory framework for the cultivation, sale, and transport of medical cannabis by the Bureau of Medical Marijuana Regulation, the Department of Food and Agriculture, and other state entities. Establishes parameters for the prescription of medical marijuana by physicians and surgeons.
2. Author’s Amendments. The Author would like to expand the universe of providers authorized to prescribe CBD to include those individuals currently authorized to prescribe Schedule II drugs.
   
   Delete existing 11150.2 (a) of the bill and replace with:

“Notwithstanding any other law, it shall not be unlawful for a healing arts licensee authorized to prescribe, furnish, or dispense Schedule II drugs to prescribe, furnish, or dispense cannabidiol or cannabidiol products, if cannabidiol or cannabidiol products are removed from Schedule I of the federal Controlled Substances Act and federal law allows cannabidiol products to be prescribed, furnished, or dispensed.”

1. Arguments in Support. The Epilepsy Foundation, LGS Foundation, and California Life Sciences Association write, “Because CBD is a Schedule I substance under the California state drug schedule, state action is needed to ensure California residents will have access to FDA-approved therapies derived from CBD. This is an issue of creating access to FDA-approved prescription medications and we strongly urge your support for AB 845.”

NOTE:

Double-referral to Public Safety Committee, Second.

SUPPORT AND OPPOSITION:

Support:

Epilepsy Foundation (Sponsor)

California Life Sciences Association

LGS Foundation

Tuberous Sclerosis Alliance

Several individuals

Opposition:

None on file as of May 30, 2017

-- END --

Date of Hearing: April 26, 2017

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 845

Author:(Wood) – As Amended Ver:March 28, 2017

Urgency: Yes State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill, an urgency measure, allows a physician to prescribe and a pharmacist to dispense cannabidiol (CBD) and products composed of CBD, if provided in accordance with federal law and notwithstanding any other state law, upon a federal action removing the prohibition on such products for medical uses.

FISCAL EFFECT:

Cost to the Medical Board of California, Osteopathic Board of California, and the Board of Pharmacy are expected to be minor and absorbable (various fee-supported special funds).

COMMENTS:

1. Purpose. The author indicates children with epilepsy are in dire need of improved treatment options, and the federal Food and Drugs Administration (FDA) is reviewing one such option that contains CBD, an extract of marijuana. This bill provides the specific state-law exemption needed in order to allow the CBD-containing drug to be prescribed and dispensed, if allowed under federal law.
2. Background. Federal and state law designate certain substances as "controlled substances" and classify them according to a five-schedule scale according to their medical benefits (or lack thereof) and potential for abuse. Schedule I drugs have no recognized medical benefit and a high potential for abuse. Marijuana is considered a Schedule I drug under federal law and cannot be legally prescribed or dispensed. In contrast, the state has allowed medical use of marijuana for over 20 years, and in November 2016 legalized recreational use of marijuana. However, an exemption is still needed to allow the prescription and pharmacy dispensing of a CBD-containing drug under California law.

A company called GW Pharmaceuticals is conducting a series of clinical trials designed to obtain safety and efficacy data on a CBD-containing drug called Epidiolex for treatment of various rare conditions. The company has also received "orphan drug" designation from FDA to use CBD for the treatment of seizures associated with a rare condition, which means it will be granted a seven-year exclusive marketing period for that drug and use under certain conditions. The product could potentially receive FDA approval next year.

1. Urgency. This bill is an urgency statute in order to ensure patients are able to obtain access to a new treatment modality as soon as federal law makes it available.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 18, 2017

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 845

Author:(Wood) – As Amended Ver:March 28, 2017

SUBJECT: Cannabidiol.

SUMMARY: Authorizes a physician to prescribe and a pharmacist to dispense a product containing cannabidiol (CBD), if permitted under federal law. Contains an urgency clause to ensure that the provisions of this bill go into effect immediately upon enactment. Specifically, this bill:

1. Provides that if CBD is removed from Schedule I of the federal Controlled Substances Act (the Act) and placed on a schedule of the act other than Schedule I, or if a product composed of CBD is approved by the federal Food and Drug Administration (FDA) and either placed on a schedule of the act other than Schedule I, or exempted from one or more provisions of the act, so as to permit a physician to prescribe and a pharmacist to dispense that product, a physician who prescribes, and a pharmacist who dispenses, that product in accordance with federal law shall be deemed to be in compliance with state law governing those acts.
2. Indicates that upon the effective dates of the changes specified in 1) above, the prescription, furnishing, dispensing, transfer, possession, or use of a product composed of CBD in accordance with federal law is for a legitimate medical purpose and is authorized pursuant to state law.
3. Finds and declares that both children and adults with epilepsy are in desperate need of new treatment options and that CBD is showing potential as one of these treatments.

EXISTING LAW:

1. Establishes the federal Controlled Substances Act which regulates the manufacture, importation, possession, use and distribution of controlled substances such as hallucinogens, narcotics, depressants, and stimulants. Categorizes drugs into five schedules or classifications based on their potential for abuse, status in international treaties, and any medical benefits they may provide. Specifies that Schedule I drugs are considered the most harmful with no medical benefits, and includes marijuana in this schedule. Indicates that Schedule 5 substances are the least restricted.
2. Establishes the California Uniform Controlled Substances Act (UCSA), which among other provisions, classifies controlled substances into five designated schedules.
3. Requires, under UCSA, a prescription for a controlled substance to only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. Indicates that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. Indicates that any person who knowingly violates this provision shall be punished by imprisonment not exceeding one year, or by a fine not exceeding twenty thousand dollars ($20,000), or by both fine and imprisonment.
4. Establishes Proposition 215, also known as the Compassionate Use Act of 1996, which exempts certain patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana.
5. Establishes the Medical Cannabis Regulation and Safety Act (MCRSA) to regulate medical cannabis in California, including its cultivation, transportation, storage, distribution, and sale, as specified in AB 243 (Wood), Chapter 688, Statutes of 2015; AB 266 (Bonta), Chapter 689, Statutes of 2015; and, SB 643 (McGuire), Chapter 719, Statutes of 2015.
6. Establishes within the Department of Consumer Affairs the Bureau of Medical Cannabis Regulation (Bureau) for the licensure and regulation of medical cannabis.
7. Establishes, through the voter initiative process, Proposition 64 or the Adult Use of Marijuana Act (AUMA) which permits adults 21 years of age or older to legally grow, possess, and use cannabis for non-medical purposes, as specified. Authorizes, beginning January 1, 2018, the selling and distributing of cannabis through a regulated business.

FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Approximately one in 26 Americans will develop epilepsy at some point in their lifetime. There is no “one size fits all” treatment option and about one million people live with uncontrolled or intractable seizures. Uncontrolled seizures can lead to disability, injury, and even death, and many individuals living with uncontrolled seizures suffer from rare epilepsies characterized by seizures that are difficult to treat with existing treatment options. Access to new treatments is particularly important for these individuals, who live with the continual risk of serious injuries and loss of life.
   
   The FDA is currently reviewing at least one CBD derived therapy that shows promise for the treatment of rare epilepsy conditions. This potential treatment option has both “Orphan Drug Designation” and Fast Track Designation from the FDA. Given the Fast Track Designation, this potential treatment option could be available as soon as early 2018.
   
   Currently, any product that contains any material, compound, mixture, or preparation, which contains any quantity of marijuana is considered a Schedule I Controlled Substance unless specifically exempted. Under current law, should a product derived from CBD, like Epidiolex, be approved and rescheduled, it would still be considered a Schedule I substance under California statute and therefore could not be prescribed by a physician unless specifically exempted. Individuals suffering from these rare forms of epilepsy and those living with uncontrolled seizures would not be able to access the medication. This bill will ensure Californians with uncontrolled seizures have continued access to FDA approved epilepsy treatments derived from CBD.
2. BACKGROUND.
   1. Cannabidiol. According to the National Cancer Institute at the National Institutes of Health, cannabis, also known as marijuana, produces resin containing compounds called cannabinoids. Cannabinoids are active chemicals in cannabis that cause drug-like effects throughout the body, including the central nervous system and the immune system. The main active cannabinoid in Cannabis is delta-9-THC. Another active cannabinoid is CBD which may relieve pain, lower inflammation, and decrease anxiety without causing the “high” of delta-9-THC. Cannabinoids can be taken by mouth, inhaled, or sprayed under the tongue. Cannabis and CBD may have benefits in treating the symptoms of cancer of the side effects of cancer therapies. Two cannabinoids (dronabinol and nabilone) are drugs approved by the FDA for the prevention or treatment of chemotherapy-related nausea and vomiting The FDA has not approved Cannabis as a treatment for cancer or any other medical condition.

b) Epidiolex. As the author indicated, the FDA has granted orphan drug designation for a cannabis-based drug developed by GW Pharmaceutical to treat childhood-onset epilepsy. Although it does not have FDA approval (the manufacturer must demonstrate the efficacy of the drug in clinical trials), the orphan drug designation represents a tremendous step forward for cannabis-based medicine. The FDA grants the orphan drug designation to drugs intended to treat rare disorders. It qualifies the maker of the drug for certain tax incentives related to clinical testing as well as an exclusive marketing period for the drug.

Epidiolex contains a highly purified, plant-derived form of CBD, a non-psychoactive compound found in cannabis that doesn’t produce the “high” sensation associated with THC, the plant’s main psychoactive ingredient. CBD has long been used as a treatment for Dravet syndrome, a rare and severe form of epilepsy in children, and GW Pharmaceuticals sees Epidiolex as useful in treating both Dravet and Lennox-Gastaut syndrome (LGS), another rare form of childhood epilepsy.

c) 2016 Federal Rule. In December 2016, the Drug Enforcement Administration (DEA) finalized a federal rule entitled “Establishment of a New Drug Code for Marihuana Extract” and the DEA revealed a new identification number for marijuana extract, which is defined as "an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant." The final rule states that the new identification number will help the DEA better track scientific studies on marijuana separately from CBD and other extracts. By making this distinction, DEA states it hopes to comply with international drug control treaties.

• 1. Governor’s Budget Trailer Proposal. With the passage of AUMA, many inconsistencies were created between implementation of MCRSA and implementation of AUMA. The Governor, through a proposed budget trailer bill, is recommending several proposals to address the differences between MCRSA and AUMA. Among other provisions, the proposed trailer bill provides for: i) maintenance of local autonomy of zoning and planning decisions while providing state regulators with local compliance information; ii) adoption of AUMA’s vertical integrated licensing structure for both adult use and medicinal cannabis licensees; iii) maintenance of AUMA’s open distribution model allowing for a business to hold multiple licenses; iv) limitations on the number of Type 3 (medium size) cultivation licenses consistent with MCRSA; v) amendment of AUMA to include the same environmental protection requirements as MCRSA; and, vii) moving licensure of testing laboratories from the Department of Public Health to the Bureau.

3) SUPPORT. The Epilepsy Foundation of Greater Los Angeles, sponsor of this bill, states that passage of this bill would allow therapies derived from cannabidiol (CBD) and approved by the FDA to become available to patients. The FDA is currently reviewing at least one CBD derived therapy that show promise for the treatment of Dravet and Lennox Gastaut syndromes, tuberous sclerosis complex and potentially other rare epilepsies. The passing of this will would ensure Californians with uncontrolled seizures have continued access to FDA approved epilepsy treatment derived from CBD.

The California Life Sciences Association states that as clinical evaluations of CBD continue, evidence grows of CBD’s anti-seizure effects, though studies have also suggested potential anti-inflammatory, anti-anxiety, anti-psychotic, and analgesic benefits to the compound. One of the most promising applications for CBD is for the prevention and treatment of seizures in children with forms of drug-resistant epilepsy.

4) RELATED LEGISLATION. SJR 5 (Stone), which is pending in the Assembly, requests the United States Congress to pass a law to reschedule cannabis, marijuana, and its derivatives from a Schedule I drug, and for the President of the United States to sign such legislation.

REGISTERED SUPPORT / OPPOSITION:

Support

Epilepsy Foundation of Greater Los Angeles (sponsor)

California Life Sciences Association

Dravert Syndrome

Epilepsy Foundation of Northern California

LGS Foundation

Tuberous Sclerosis Alliance

Opposition

None on file.

Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097