It's Over ! We Won

[peanutbutter]

DOUGH!!

 

Please excuse the brain fart

[Bisharoo]

Well, what to do now...

[MightyMightyMezz]

...

[Grow Thread]

wet with anticipation

[Guest Happy Guy]

Enter stage right... the pharmas. They can actually prescribe cannabis after it is rescheduled. They have a long list of cannabis drugs locked and loaded. Anybody want a mouth spray that is just like pure cannabis oil? Who wouldn't. This fits too well with the political climate we have now.

[peanutbutter]

Thank you, Ms. Leonhart!

 

http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr1101.htm

 

[Federal Register: November 1, 2010 (Volume 75, Number 210)]

[Proposed Rules]

[Page 67054-67059]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr01no10-8]

 

_____

 

DEPARTMENT OF JUSTICE

 

Drug Enforcement Administration

 

21 CFR Part 1308

 

[Docket No. DEA-344P]

 

Listing of Approved Drug Products Containing Dronabinol in Schedule III

 

AGENCY: Drug Enforcement Administration, Department of Justice.

 

ACTION: Notice of proposed rulemaking.

 

_____

 

SUMMARY: This proposed rule is issued by the Deputy Administrator of the

Drug Enforcement Administration (DEA) to modify the listing of the

Marinol[supreg] formulation in schedule III so that certain generic drug

products are also included in that listing.

 

Several products are currently the subject of Abbreviated New Drug

Applications (ANDAs) under review by the U.S. Food and Drug Administration

(FDA). Each product is a generic formulation of Marinol[supreg] and contains

dronabinol, the (-) isomer of delta-9- (trans)-tetrahydrocannabinol (THC),

which is a schedule I controlled substance. Due to variations in

formulation, these generic Marinol[supreg] products do not meet the specific

conditions specified in the current schedule III listing.

 

This proposed action expands the schedule III listing to include

formulations having naturally-derived dronabinol and products encapsulated

in hard gelatin capsules. This would have the effect of transferring the

FDA-approved versions of such generic Marinol[supreg] products from schedule

I to schedule III.

 

DATES: Written comments must be postmarked and electronic comments must be

submitted on or before January 3, 2011. Commenters should be aware that the

electronic Federal Docket Management System will not accept comments after

midnight Eastern Time on the last day of the comment period.

 

ADDRESSES: To ensure proper handling of comments, please reference "Docket

No. DEA-344" on all written and electronic correspondence. Written comments

sent via regular or express

 

[[Page 67055]]

 

mail should be sent to the Drug Enforcement Administration, Attention: DEA

Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA

22152. Comments may be sent to DEA by sending an electronic message to

<mailto:dea.diversion.pol...@usdoj.gov> dea.diversion.pol...@usdoj.gov.

Comments may also be sent electronically through

<http://www.regulations.gov>'>http://www.regulations.gov> http://www.regulations.gov using the electronic

comment form provided on that site. An electronic copy of this document is

also available at the http://www.regulations.gov Web site. DEA will accept

attachments to electronic comments in Microsoft Word, WordPerfect, Adobe

PDF, or Excel file formats only. DEA will not accept any file formats other

than those specifically listed here.

 

Please note that DEA is requesting that electronic comments be submitted

before midnight Eastern Time on the day the comment period closes because

http://www.regulations.gov terminates the public's ability to submit

comments at midnight Eastern Time on the day the comment period closes.

Commenters in time zones other than Eastern Time may want to consider this

so that their electronic comments are received. All comments sent via

regular or express mail will be considered timely if postmarked on the day

the comment period closes.

 

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, Drug and

Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement

Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone

(202) 307-7183 begin_of_the_skype_highlighting (202) 307-7183

end_of_the_skype_highlighting.

 

SUPPLEMENTARY INFORMATION: Posting of Public Comments: Please note that all

comments received are considered part of the public record and made

available for public inspection online at <http://www.regulations.gov>'>http://www.regulations.gov>

http://www.regulations.gov and in the Drug Enforcement Administration's

public docket. Such information includes personal identifying information

(such as your name, address, etc.) voluntarily submitted by the commenter.

 

If you want to submit personal identifying information (such as your name,

address, etc.) as part of your comment, but do not want it to be posted

online or made available in the public docket, you must include the phrase

"PERSONAL IDENTIFYING INFORMATION" in the first paragraph of your comment.

You must also place all the personal identifying information you do not want

posted online or made available in the public docket in the first paragraph

of your comment and identify what information you want redacted.

 

If you want to submit confidential business information as part of your

comment, but do not want it to be posted online or made available in the

public docket, you must include the phrase "CONFIDENTIAL BUSINESS

INFORMATION" in the first paragraph of your comment. You must also

prominently identify confidential business information to be redacted within

the comment. If a comment has so much confidential business information that

it cannot be effectively redacted, all or part of that comment may not be

posted online or made available in the public docket.

 

Personal identifying information and confidential business information

identified and located as set forth above will be redacted and the comment,

in redacted form, will be posted online and placed in the DEA's public

docket file. Please note that the Freedom of Information Act applies to all

comments received. If you wish to inspect the agency's public docket file in

person by appointment, please see the FOR FURTHER INFORMATION CONTACT

paragraph.

 

Background

 

The DEA has received four petitions from companies that have products that

are currently the subject of ANDAs under review by the FDA. Each product is

a generic formulation of Marinol[supreg] and contains dronabinol, the (-)

isomer of delta-9-(trans)- tetrahydrocannabinol (THC), which is a schedule I

controlled substance. These petitions each requests amendments to Controlled

Substances Act (CSA) regulations that would have the effect of transferring

the proposed generic Marinol[supreg] product from schedule I to schedule

III.

 

At present, the only formulation containing dronabinol that is in a schedule

other than schedule I is the following, as set forth in

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_13.htm> 21 CFR

1308.13(g)(1) as schedule III: "Dronabinol (synthetic) in sesame oil and

encapsulated in a soft gelatin capsule in a U.S. Food and Drug

Administration approved product."

 

While the petitioners cite that their generic products are bioequivalent to

Marinol[supreg], their products do not meet schedule III current definition

provided above. Therefore, these firms have requested that 21 CFR

1308.13(g)(1) be expanded to include: (1) Both naturally-derived or

synthetically produced dronabinol; and (2) both hard or soft gelatin

capsules.

 

In response to these petitions, DEA prepared several scheduling review

documents based upon petitioner-provided data. On June 22, 2007, and August

15, 2007, these analyses were submitted to the Department of Health and

Human Services (DHHS) with requests for scientific and medical evaluation

and scheduling recommendations. The submissions to DHHS also requested that

they consider (1) whether dronabinol extracted from Cannabis sativa (i.e.

naturally-derived), is identical to synthetically-produced dronabinol found

in Marinol[supreg]; and (2) whether a formulation encapsulated in hard

gelatin capsules, instead of soft gelatin capsules, changes a product's

abuse potential.

 

On March 17, 2010, and June 1, 2010, the Assistant Secretary for Health,

DHHS, sent the Deputy Administrator of DEA scientific and medical

evaluations and letters recommending that FDA-approved drug products

containing dronabinol (both naturally-derived or synthetic) in sesame oil in

a gelatin capsule (either hard or soft gelatin) be placed into schedule III

of the CSA. Enclosed with the March 17, 2010, letter, was a document

prepared by the FDA entitled, "Basis for the Recommendation to Control

FDA-Approved Drug Products Containing Synthetic Dronabinol in Sesame Oil in

a Hard Gelatin Capsule to Schedule III of the Controlled Substances Act."

The June 1, 2010, letter included a document entitled, "Basis for the

Recommendation to Reschedule FDA-Approved Drug Products Containing

Naturally-Derived Dronabinol in Sesame Oil in a Gelatin Capsule to Schedule

III of the Controlled Substances Act." These documents contained a review of

the factors which the CSA requires the Secretary to consider

<http://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm> 21 U.S.C. 811(b).

 

Therefore, in this rulemaking, DEA is proposing that

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_13.htm> 21 CFR

1308.13(g)(1) be modified to include generic equivalents of Marinol[supreg]

which are (1) both synthetic or naturally-derived dronabinol; and/or (2)

hard or soft gelatin capsules.

 

Background Regarding Dronabinol

 

Dronabinol is a name of a particular isomer of a class of chemicals known as

tetrahydrocannabinols (THC). Specifically, dronabinol is the United States

Adopted Name (USAN) for the (-)-isomer of [Delta]\9\-

(trans)-tetrahydrocannabinol [(-)-[Delta]\9\-(trans)-THC], which is believed

to be the major psychoactive component of the cannabis plant (marijuana).

 

THC, as a general category, is listed in schedule I of the CSA,\1\ while

 

[[Page 67056]]

 

dronabinol contained in the product Marinol[supreg] is listed separately in

schedule III. Any other formulation containing dronabinol (or any other

isomer of THC), that does not meet the definition provided in 21 CFR

1308.13(g)(1), remains a schedule I controlled substance.\2\

 

---------------------------------------------------------------------------

 

\1\ <http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm> 21 U.S.C.

812©, Schedule I©(17). Schedule I contains those controlled substances

with "no currently accepted medical use in treatment in the United States"

and "a lack of accepted safety for use * * * under medical supervision." 21

U.S.C. 812(b)(1). \2\ The introductory language to schedule I© states that

any material, compound, mixture, or preparation that contains any of the

substances listed in schedule I© (including "tetrahydrocannabinols") is a

schedule I controlled substance "nless specifically excepted or unless

listed in another schedule." The only material, compound, mixture, or

preparation that contains THC but is listed in another schedule is the

Marinol[supreg] formulation, which is listed in schedule III.

 

---------------------------------------------------------------------------

 

The current wording of the Marinol[supreg] formulation in schedule III (21

CFR 1308.13(g)(1)) was added to the DEA regulations in 1986, when the

substance was transferred from schedule I to schedule II after the FDA

approved Marinol[supreg] for marketing.\3\ The wording of this listing was

not specific to Marinol[supreg] and thereby could include any generic

product meeting that description that might be approved by the FDA in the

future. However, at the time the regulation was promulgated, DEA did not

anticipate the possibility that a generic formulation could be developed

that did not fit precisely the wording of the listing that currently appears

in schedule III.

 

---------------------------------------------------------------------------

 

\3\ 51 FR 17476 (May 13, 1986). DEA subsequently transferred the

FDA-approved Marinol[supreg] formulation from schedule II to schedule III.

64 FR 35928 (July 2, 1999).

 

---------------------------------------------------------------------------

 

Recently, firms have submitted to FDA ANDAs for their proposed generic

versions of Marinol[supreg]. As these ANDAs remain pending with the FDA, the

precise nature of these formulations is not available for public disclosure.

However, these formulations might differ from the Marinol[supreg]

formulation currently listed in schedule III. Nonetheless, the firms that

have submitted the ANDAs assert that their formulations would meet the

approval requirements under 21 U.S.C. 355(j), because, among other things,

they have the same active ingredient, strength, dosage form, and route of

administration as Marinol[supreg], and are bioequivalent to Marinol[supreg].

 

Products are bioequivalent if there is no significant difference in the rate

and extent to which the active ingredient or active moiety becomes available

at the site of drug action 21 CFR 320.1. There is no requirement under 21

U.S.C. 355(j), or FDA's implementing regulations, that solid oral dosage

forms such as capsules that are proposed for approval in ANDAs contain the

same inactive ingredients as the listed drug referenced. The generic drug,

therefore, would not fall within the scope of the current regulation. This

situation, in which a generic version of a drug would not necessarily fall

within the schedule for the referenced listed drug, is unique among the CSA

schedules in the following respect. The Marinol[supreg] formulation listed

in schedule III is the only listing in the schedules that has the effect of

excluding potential generic versions of the brand name formulation.\4\ As

indicated above, this came about because DEA did not anticipate that other

drug products could be approved by FDA that did not fit the description that

was included in the schedules. Moreover, Congress structured the CSA so that

there would be no distinction--for scheduling purposes--between brand name

drug products and their generic equivalents. The rule being proposed here

would ensure that this aspect of the CSA holds true for generic drug

products approved under 21 U.S.C. 355(j) that reference Marinol[supreg] as

the listed drug.

 

---------------------------------------------------------------------------

 

\4\ Generally, substances are listed in the CSA schedules based on their

chemical classification, rather than any drug product formulation in which

they might appear. Because of this, there have been no other situations in

which a slight variation between the brand name drug formulation and the

generic drug formulation was consequential for scheduling purposes.

 

---------------------------------------------------------------------------

 

In addition, 21 U.S.C. 355(j)(2)© permits applicants to petition FDA for

approval of an ANDA for a drug product that may differ from the listed drug

in certain specified ways, if clinical studies are not necessary to

establish the safety and effectiveness of the drug product. Among the types

of differences permitted is a change in dosage form, or manner in which the

active ingredient is produced.

 

This proposed rule would amend the description in schedule III [

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_13.htm> 21 CFR

1308.13(g)(1)] to include products referencing Marinol[supreg] that are

either (1) naturally derived or synthetic; or (2) in hard or soft gelatin

capsules, as long as the formulations otherwise meet the approval

requirements in 21 U.S.C. 355(j).

 

The CSA Scheduling Structure

 

To understand the legal justification for the rule being proposed here, the

scheduling scheme established by Congress under the CSA must first be

considered. One court has succinctly summarized this scheme as follows:

 

The [CSA] sets forth initial schedules of drugs and controlled substances in

<http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm> 21 U.S.C. 812©.

However, Congress established procedures for adding or removing substances

from the schedules (control or decontrol), or to transfer a drug or

substance between schedules (reschedule).

<http://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm> 21 U.S.C. 811(a).

This responsibility is assigned to the Attorney General in consultation with

the Secretary of Health and Human Services ("HHS") Id. Sec. 811(b). The

Attorney General has delegated his functions to the Administrator of the DEA

28 CFR 0.100(b). Current schedules are published at

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_11.htm> 21 CFR

1308.11- 1308.15.

 

There are three methods by which the DEA may initiate rulemaking proceedings

to revise the schedules: (1) By the DEA's own motion; (2) at the request of

DHHS; (3) on the petition of any interested party. 21 U.S.C. 811(a);

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_43.htm> 21 CFR

1308.43(a). Before initiating rulemaking proceedings, the DEA must request a

scientific and medical evaluation from DHHS and a scheduling recommendation.

The statute requires the DEA and DHHS to consider eight factors with respect

to the drug or controlled substance. 21 U.S.C. 811(b), ©.

 

These factors are:

 

(1) Its actual or relative potential for abuse.

 

(2) Scientific evidence of its pharmacological effect, if known.

 

(3) The state of current scientific knowledge regarding the drug or other

substance.

 

(4) Its history and current pattern of abuse.

 

(5) The scope, duration, and significance of abuse.

 

(6) What, if any, risk there is to the public health.

 

(7) Its psychic or physiological dependence liability.

 

(8) Whether the substance is an immediate precursor of a substance already

controlled under this subchapter.

 

Although the recommendations of DHHS are binding on the DEA as to scientific

and medical considerations involved in the eight- factor test, the ultimate

decision as to whether to initiate rulemaking proceedings to reschedule a

controlled substance is made by the DEA.\5\

 

---------------------------------------------------------------------------

 

\5\ See id. <http://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm> Sec.

811(a), (b).

 

---------------------------------------------------------------------------

 

Gettman v. DEA, 290 F.3d 430, 432 (DC Cir. 2002).

 

The FDA plays an important role within DHHS in the development of the DHHS

scientific and medical determinations that bear on eight- factor analyses

referred to above (required under section 811© for scheduling decisions).

Thus, when it comes to newly developed drug products that contain controlled

substances, FDA makes scientific and medical determinations for purposes of

both the Food Drug and Cosmetic Act (in connection with decisions on whether

to approve drugs for marketing) and the CSA (in connection with scheduling

decisions). As explained below, the eight-factor analysis can be expected to

yield the same conclusions with respect to a brand name drug product and

certain generic drugs referencing that product that meet the approval

requirements under 21 U.S.C. 355(j).

 

[[Page 67057]]

 

The ANDA Approval Process

 

The Drug Price Competition and Patent Term Restoration Act of 1984 (known as

the "Hatch-Waxman Amendments"), codified at 21 U.S.C. 355, 360cc, and 35

U.S.C. 156, 271, 282, permits the submission of ANDAs for approval of

generic versions of approved drug products. 21 U.S.C. 355(j). The ANDA

process shortens the time and effort needed for approval by, among other

things, allowing the applicant to demonstrate its product's bioequivalence

to a drug already approved under a New Drug Application (NDA) (the "listed"

drug) rather than having to reproduce the safety and effectiveness data for

that drug. If an ANDA applicant establishes that its proposed drug product

has the same active ingredient, strength, dosage form, route of

administration, labeling, and conditions of use as a listed drug, and that

it is bioequivalent to that drug, the applicant can rely on FDA's previous

finding that the listed drug is safe and effective [see id].\6\ Once

approved, an ANDA sponsor may manufacture and market the generic drug to

provide a safe, effective, and low cost alternative to the American public.

 

---------------------------------------------------------------------------

 

\6\ See also Approved Drug Products with Therapeutic Equivalence Evaluations

(commonly known as the "Orange Book"), Intro. at p. vi, (27th ed.).

 

---------------------------------------------------------------------------

 

The majority of drugs approved under 21 U.S.C. 355(j) are therapeutically

equivalent to the listed drug they reference. This means that the generic

drug and the referenced innovator drug contain identical amounts of the

active ingredient, and are bioequivalent. Therapeutic equivalents can be

expected to have the same clinical effect and safety profile when

administered to patients under the conditions specified in the labeling.

 

The key point, for purposes of the rule being proposed here, is that the

generic drug can be substituted for the innovator drug with the full

expectation that the generic drug will produce the same clinical effect and

safety profile as the innovator drug. Consequently, for CSA scheduling

purposes, the eight-factor analysis conducted by the FDA and DEA under

<http://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm> 21 U.S.C. 811©

would necessarily result in the same scheduling determination for an

approved generic drug product as for the innovator drug to which the generic

drug is a therapeutic equivalent. This is because, in conducting the

eight-factor analysis, the FDA and DEA would be examining precisely the same

medical, scientific, and abuse data for the generic drug product as would be

considered for the innovator drug. The same would be true of the innovator

drug and a drug product approved pursuant to a petition under 21 U.S.C.

355(j)(2)©, where the drug approved in the ANDA differs from the listed

drug only because it is a hard gelatin capsule and the listed drug is a soft

gelatin capsule; or the active ingredient is naturally-derived, rather than

synthetically produced.

 

As noted earlier, these considerations never previously arose for any other

controlled substance because the regulation citing the Marinol[supreg]

formulation is the only scheduling regulation that is drug product

formulation-specific and thereby (inadvertently) excludes certain generic

versions.\7\ This unintended result is not consistent with the structure and

purposes of the CSA, which generally lists categories of substances in the

schedules, rather than product formulations. Thus, by ensuring that generic

versions of the Marinol[supreg] formulation which might be approved by the

FDA in the future are in the same schedule as Marinol[supreg], the rule

being proposed here would make the DEA regulations more consistent with the

structure and purposes of the CSA.

 

---------------------------------------------------------------------------

 

\7\ When Congress enacted the CSA in 1970, it scheduled codeine and certain

other opiates in three different schedules depending on their respective

concentrations. See <http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm>

21 U.S.C. 812©, schedule II(a)(1), schedule III(d), and schedule V.

However, this differential scheduling for opiates does not specify drug

product formulation in a manner that would result in a generic version of an

opiate drug product being scheduled separately from the innovator drug.

 

---------------------------------------------------------------------------

 

Finally, for additional clarity, the proposed rule would amend

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_13.htm> 21 CFR

1308.13(g)(1) to change the phrase "U.S. Food and Drug Administration

approved product" to "drug product approved for marketing by the U.S. Food

and Drug Administration."

 

On June 22, 2007, and August 15, 2007, DEA submitted scheduling review

documents for several dronabinol generic products to the DHHS, and requested

that DHHS provide scientific and medical evaluation and scheduling

recommendations under the CSA. (These documents are available for review

online at http://www.deadiversion.usdoj.gov.)

 

On March 17, 2010, and June 1, 2010, the Assistant Secretary for Health,

DHHS, sent the Deputy Administrator of DEA scientific and medical

evaluations and letters recommending that FDA-approved drug products

containing dronabinol (naturally-derived or synthetic) in sesame oil in a

gelatin capsule (hard or soft) be placed into schedule III of the CSA.

Enclosed with the March 17, 2010, letter was a document prepared by the FDA

entitled, "Basis for the Recommendation to Control FDA-Approved Drug

Products Containing Synthetic Dronabinol in Sesame Oil in a Hard Gelatin

Capsule to Schedule III of the Controlled Substances Act." The June 1, 2010

letter included a document entitled, "Basis for the Recommendation to

Reschedule FDA-Approved Drug Products Containing Naturally-Derived

Dronabinol in Sesame Oil in a Gelatin Capsule to Schedule III of the

Controlled Substances Act." These documents contained a review of the

factors which the CSA requires the Secretary to consider.

<http://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm> 21 U.S.C. 811(b).

 

Note: The DHHS scheduling recommendations of March 17, 2010, and June 1,

2010, are available for review online at http:// www.deadiversion.usdoj.gov.

 

The factors considered by the Assistant Secretary of Health and DEA with

respect to these products were:

 

(1) Its actual or relative potential for abuse;

 

(2) Scientific evidence of its pharmacological effects;

 

(3) The state of current scientific knowledge regarding the drug;

 

(4) Its history and current pattern of abuse;

 

(5) The scope, duration, and significance of abuse;

 

(6) What, if any, risk there is to the public health;

 

(7) Its psychic or physiological dependence liability; and

 

(8) Whether the substance is an immediate precursor of a substance already

controlled under this subchapter. 21 U.S.C. 811©.

 

The DHHS scheduling recommendation of March 17, 2010, concluded that drug

products containing synthetic dronabinol in sesame oil and encapsulated in a

hard gelatin capsule, have a similar potential for abuse as Marinol[supreg].

"These products contain the same Active Pharmaceutical Ingredient (API),

have similar chemistry and pharmacokinetics and have similar formulations in

sesame oil." FDA and National Institute on Drug Abuse (NIDA), after

reviewing the available information conclude "that drug products approved

for marketing by FDA that contain synthetic dronabinol in sesame oil in a

hard gelatin capsule be controlled in Schedule III of the CSA."

 

The DHHS scheduling recommendation of June 1, 2010, concluded that drug

products that contain naturally-derived dronabinol in sesame oil and in a

gelatin capsule, have a similar potential for abuse as Marinol[supreg]. FDA

and NIDA, after reviewing the available information, concluded "that drug

products approved

 

[[Page 67058]]

 

for marketing by FDA that contain naturally-derived dronabinol in sesame oil

in a gelatin capsule should be rescheduled to Schedule III of the CSA."

 

Based on the recommendations of the Assistant Secretary for Health, received

in accordance with section 201(b) of the Act [

<http://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm> 21 U.S.C. 811(b)],

and the independent review of the available data by DEA, the Deputy

Administrator of DEA, pursuant to sections 201(a) and 201(b) of the Act [21

U.S.C. 811(a) and 811(b)], finds that FDA-approved generic dronabinol

products, both naturally-derived or synthetically produced, in sesame oil

and encapsulated in both hard gelatin or soft gelatin capsules meet the

criteria for placement in schedule III set in

<http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm> 21 U.S.C. 812(b), as

follows:

 

A. The Drug or Other Substance Has a Potential for Abuse Less Than the Drugs

or Other Substances in Schedule II

 

FDA-approved generic drug products that contain dronabinol (both

naturally-derived or synthetically produced) in sesame oil in a gelatin

capsule (both hard or soft gelatin) and reference Marinol[supreg], have a

similar potential for abuse as Marinol[supreg], a schedule III drug product

and have similar chemistry and pharmacokinetics as similar formulations in

sesame oil.

 

B. The Drug or Other Substance Has a Currently Accepted Medical Use in

Treatment in the United States

 

Marinol[supreg] was initially approved by FDA in 1985. When drug products

that reference Marinol[supreg] receive FDA approval, they will have a

currently accepted medical use in the United States.

 

C. Abuse of the Drug or Other Substance May Lead to Moderate or Low Physical

Dependence or Psychological Dependence and Such Dependence Would Be Less

Than the Drugs or Other Substances in Schedule II

 

The withdrawal syndrome associated with dronabinol, the API in

Marinol[supreg], produces symptoms in humans such as restlessness,

irritability, mild agitation, anxiety, anger, insomnia, sleep EEG

disturbances, nausea, decreased appetite, and decreased weight. Since a

withdrawal syndrome is indicative of physical dependence, it is reasonable

to conclude that generic dronabinol products (both naturally-derived or

synthetically produced, and in hard or soft gelatin capsules) in sesame oil,

will also produce physical dependence similar to those produced by

Marinol[supreg].

 

Therefore, in this rulemaking, DEA is proposing that

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_13.htm> 21 CFR

1308.13(g)(1) be modified to include generic equivalents of Marinol[supreg]

which are (1) naturally-derived or synthetically produced dronabinol; and/or

(2) hard or soft gelatin capsules. These products, once approved by FDA,

shall meet the criteria for inclusion in schedule III of the CSA.

 

Comments and Requests for Hearing

 

In accordance with the provisions of the CSA (

<http://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm> 21 U.S.C. 811(a)),

this action is a formal rulemaking "on the record after opportunity for a

hearing." Such proceedings are conducted pursuant to the provisions of the

Administrative Procedure Act 5 U.S.C. 556 and 557. All persons are invited

to submit their comments or objections with regard to this proposal.

Requests for a hearing may be submitted by interested persons and must

conform to the requirements of

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_44.htm> 21 CFR

1308.44 and <http://www.deadiversion.usdoj.gov/21cfr/cfr/1316/1316_47.htm>

1316.47. The request should state, with particularity, the issues concerning

which the person desires to be heard and the requestor's interest in the

proceeding. Only interested persons, defined in the regulations as those

"adversely affected or aggrieved by any rule or proposed rule issuable

pursuant to section 201 of the Act (21 U.S.C. 811)," may request a hearing

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_42.htm> 21 CFR

1308.42. Please note that DEA may grant a hearing only "for the purpose of

receiving factual evidence and expert opinion regarding the issues involved

in the issuance, amendment or repeal of a rule issuable" pursuant to 21

U.S.C. 811(a). All correspondence regarding this matter should be submitted

to the DEA using the address information provided above.

 

Regulatory Certifications

 

Executive Order 12866

 

In accordance with the provisions of the CSA [21 U.S.C. 811(a)], this action

is a formal rulemaking "on the record after opportunity for a hearing." Such

proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557

and, as such, are exempt from review by the Office of Management and Budget

pursuant to Executive Order 12866, section 3(d)(1).

 

Regulatory Flexibility Act

 

The Deputy Administrator hereby certifies that this rulemaking has been

drafted in accordance with the Regulatory Flexibility Act (5 U.S.C.

601-612), has reviewed this regulation, and by approving it certifies that

this regulation will not have a significant economic impact on a substantial

number of small entities. DEA is hereby proposing to modify the listing of

the Marinol[supreg] formulation in schedule III so that certain generic drug

products are also included in that listing.

 

Executive Order 12988

 

This regulation meets the applicable standards set forth in Sections 3(a)

and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

 

Executive Order 13132

 

This rulemaking does not preempt or modify any provision of state law; nor

does it impose enforcement responsibilities on any state; nor does it

diminish the power of any state to enforce its own laws. Accordingly, this

rulemaking does not have federalism implications warranting the application

of Executive Order 13132.

 

Unfunded Mandates Reform Act of 1995

 

This rule will not result in the expenditure by state, local, and tribal

governments, in the aggregate, or by the private sector, of $126,000,000 or

more (adjusted for inflation) in any one year, and will not significantly or

uniquely affect small governments. Therefore, no actions were deemed

necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

 

Congressional Review Act

 

This rule is not a major rule as defined by section 804 of the Small

Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review

Act). This rule will not result in an annual effect on the economy of

$100,000,000 or more; a major increase in costs or prices: or significant

adverse effects on competition, employment, investment, productivity,

innovation, or on the ability of United States-based companies to compete

with foreign based companies in domestic and export markets.

 

List of Subjects in

<http://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm> 21 CFR Part 1308

 

Administrative practice and procedure, Drug traffic control, Narcotics,

Prescription drugs.

 

Pursuant to the authority vested in the Attorney General under sections 201,

202, and 501(b) of the CSA (

<http://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm> 21 U.S.C. 811,

<http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm> 812, and

<http://www.deadiversion.usdoj.gov/21cfr/21usc/871.htm> 871(b)), delegated

to the Administrator and Deputy Administrator pursuant to section 501(a) (21

U.S.C. 871(a)) and as specified in 28 CFR 0.100 and 0.104, and appendix to

subpart R, sec. 12, the Deputy Administrator hereby orders that Title 21 of

the Code of Federal Regulations, part 1308, is proposed to be amended as

follows:

 

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

 

1. The authority citation for 21 CFR part 1308 continues to read as follows:

 

[[Page 67059]]

 

Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.

 

2. Section 1308.13 is amended by revising paragraph (g) to read as follows:

 

<http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_13.htm> Sec. 1308.13

Schedule III.

 

* * * * *

 

(g) Hallucinogenic substances. (1)(i) Dronabinol in sesame oil and

encapsulated in a gelatin capsule in a drug product approved for marketing

by the U.S. Food and Drug Administration (FDA)--7369.

 

(ii) Any drug product in hard or soft gelatin capsule form containing

natural dronabinol (derived from the cannabis plant) or synthetic dronabinol

(produced from synthetic materials) in sesame oil, for which an abbreviated

new drug application (ANDA) has been approved by the FDA under section

505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) which

references as its listed drug the drug product referred to in the preceding

paragraph (g)(1)(i) of this section--7369.

 

Note to paragraph (g)(1): Some other names for dronabinol: (6a

R-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6 H-dibenzo

[b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahydrocannabinol]

 

(2) [Reserved]

 

* * * * *

 

Dated: October 19, 2010.

 

Michele M. Leonhart,

Deputy Administrator.

 

[FR Doc. 2010-27502 Filed 10-29-10; 8:45 am]

 

BILLING CODE 4410-09-P

 

NOTICE: This is an unofficial version. An official version of this

publication may be obtained directly from the

<http://www.deadiversion.usdoj.gov/exit_pages/gpo.htm> Government Printing

Office (GPO).

[freemannabis]

IT'S OVER

MEDICAL MARIJUANA WON THE WAR

 

The DEA is rescheduling natural cannabis compounds as Marinol

 

More as I edit

 

Say that again!?

[brbud]

Anybody want a mouth spray that is just like pure cannabis oil? Who wouldn't.

 

you'll get there ....and likey you say "Who wouldnt"

its a legal can do , no?

[peanutbutter]

OUR NEW JOB

 

IS TO FILL THE STREETS OF WASHINGTON DC AND DEMAND A HEARING BASED ON SCIENCE AND MEDICINE. NOT A HEARING BASED ON FALSE PROPAGANDA.

[Nemosity]

Personally, I wouldn't want a cannabis-like substance from the pharmacy. I don't like buying corn from the grocery either, especially when I can grow my own in my garden. If big pharma takes over cannabis, we're screwed.

[DenturesLost]

IT'S OVER

MEDICAL MARIJUANA WON THE WAR

 

The DEA is rescheduling natural cannabis compounds as Marinol

 

More as I edit

I read what you posted but even given that as fact how is it over? There's a difference between rescheduling mj and the scheduling of a compound IN mj. Presumably the other compounds are still schedule I.?

I don't know, I'm asking.

[Guest Happy Guy]

you'll get there ....and likey you say "Who wouldnt"its a legal can do , no?

Only thing is, who can afford it? Our law says insurance companies do not pay for it.

This is the second shoe to fall. The first was Kuipers Bills.

[MightyMightyMezz]

The only law should be there shall be no laws prohibiting Cannabis sativa in any way. Screw it - make it a constitutional amendment.

[brbud]

Personally, I wouldn't want a cannabis-like substance from the pharmacy. I don't like buying corn from the grocery either, especially when I can grow my own in my garden. If big pharma takes over cannabis, we're screwed.

heck yeah when you can make your own

keep it bout the patient and his right to his OWN meds

[peanutbutter]

[drtarzanmd]

ASA Weighs in on DEA Rescheduling

November 28th, 2007

Posted by Rebecca Saltzman

 

From our friends at MAPS:

 

In late September, DEA proposed a new rule that would effectively place dronabinol (the active chemical in MARINOL) in Schedule III.

 

Wait a second, isn’t MARINOL already in Schedule III?

 

It is. When MARINOL was first marketed, it was placed in Schedule II. Once DEA was shown that it had a low potential for abuse, they agreed to place it in Schedule III. But the narrow language only places in Schedule III MARINOL’s specific formulation (synthetically derived dronabinol, suspended in sesame oil). All other formulations remain in Schedule I.

 

Marinol’s patent is almost up, which will open up the market to generic dronabinol, as long as the rule change goes through.

 

ASA submitted a Public Comment in support of the proposed rule change. Here are some highlights:

 

Primarily, the proposed rule is a positive step because in it, the DEA acknowledges, only for the second time (Marinol was the first in 1986), the obvious medical benefits of THC/dronabinol. These proposed changes also represent progress because they implicitly recognize the value of whole-plant cannabis and its capacity to extract naturally occurring THC that is bioequivalent to synthetic THC…

 

This proposed change is also a positive development because its will likely result in greater access for patients to less expensive, naturally derived cannabis-based drugs in the short term… Generic drugs, drugs that are produced and distributed without patent protection (and approved by the FDA under 21 U.S.C. 355 § 505(j)), are generally much cheaper than brand-name drugs, such as Marinol.

 

We go on to argue that the rule change does not go far enough, and that the DEA needs to consider rescheduling other cannabinoids:

 

…the DEA should initiate another proposed rule change that reschedules a wide array of natural, non-psychoactive phytocannabinoids to support the research and development of a wider variety of cannabis-based medicines. Research suggests that the beneficial therapeutic effects of cannabis may result from the interaction, or synergy, among various cannabinoids. This helps to explain why medicines developed from whole-plant extracts may be more effective than single cannabinoid drugs developed from synthetic compounds. For instance, Sativex is a cannabis-based medicine, which combines both THC and CBD to produce an entirely different therapeutic potential than THC alone, has been developed by UK-based GW Pharmaceuticals, and has been approved for use in Canada and is undergoing clinical trials in Europe and the United States…

 

And we further argue that the DEA should end the obstructions to medical cannabis research:

 

…the DEA should accept the opinion of its own U.S. Department of Justice-appointed Administrative Law Judge (ALJ) Mary Ellen Bittner, who urges the DEA to grant a license to Professor Lyle Craker to cultivate research-grade cannabis for distribution exclusively to federally approved researchers, which would greatly facilitate research on the therapeutic value of cannabis and access to its naturally derived constituent cannabinoids, specifically THC.Copy & Paste from : http://safeaccessnow.org/blog/?p=42

[KuRAK]

Now that this is available, you don't need any...

[wingnut]

Yep, we wanted medical marijuana. Now that is what we will get, just not the whole plant form, that we have today.

[Grow Thread]

…the DEA should accept the opinion of its own U.S. Department of Justice-appointed Administrative Law Judge (ALJ) Mary Ellen Bittner, who urges the DEA to grant a license to Professor BUBBLEGROWER & Dr. Tarzan M.D. to cultivate research-grade cannabis for distribution exclusively to federally approved researchers, which would greatly facilitate research on the therapeutic value of cannabis and access to its naturally derived constituent cannabinoids, specifically THC.

 

MODS FIXED

 

lil joke

[peanutbutter]

Crap!!

 

I've been waiting to see that headline for far to long now ..

 

Yep .. I misunderstood the headline.

 

sorry folks ..

 

fun while it lasted ..

[Grow Thread]

lol

[Guest finallyfree09]

kuipers is going to pounce on this one. by this time next year all the lights will be cold and the pots will be empty and we will be lining up at the pharmacy to recieve our expensive, weak, tasteless little thc pills. they are going to use this rescheduling to take the plant away from us again people.

 

peanutbutter, i respect your opinions quite a bit but i do have one little thing i disagree with (and only partly)...

 

"OUR NEW JOB

 

 

IS TO FILL THE STREETS OF WASHINGTON DC AND DEMAND A HEARING BASED ON SCIENCE AND MEDICINE. NOT A HEARING BASED ON FALSE PROPAGANDA."

 

we gotta do somethin here in michigan or none of us will be able to grow our meds and keep big pharma out of our wallets.

 

this is a good thing for the country but potentially a VERY bad thing for those of us that rely on the michigan medical marijuana act and ourselves for our medicine. they are going to take it away.

 

work on washington but PLEASE..... make sure the main focus of the michigan medical marijuana association is MICHIGAN.

 

[Guest finallyfree09]

Crap!!

 

I've been waiting to see that headline for far to long now ..

 

Yep .. I misunderstood the headline.

 

sorry folks ..

 

fun while it lasted ..

O THAT AINT FREEKIN FAIR!!!!!!!!!!!

 

HOW THE HECK DID YOU KNOW I WASN'T GONNA READ THAT ENTIRE THING?!

 

good one!

[brbud]

Head Rush

[peanutbutter]

O THAT AINT FREEKIN FAIR!!!!!!!!!!!

 

HOW THE HECK DID YOU KNOW I WASN'T GONNA READ THAT ENTIRE THING?!

 

good one!

 

Have to double check which plane of reality I'm currently on before posting ..