"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 dea.diversion.policy@usdoj.gov. Comments may also be sent electronically through 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.
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 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 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 21 U.S.C. 811(b).
Therefore, in this rulemaking, DEA is proposing that 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 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\
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.
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\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).
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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.
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\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.
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In addition, 21 U.S.C. 355(j)(2)(C) 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 [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 21 U.S.C. 812(c). 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). 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 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); 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), (c).
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\
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 dea.diversion.policy@usdoj.gov. Comments may also be sent electronically through 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.
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 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 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 21 U.S.C. 811(b).
Therefore, in this rulemaking, DEA is proposing that 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 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\
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.
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\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.
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In addition, 21 U.S.C. 355(j)(2)(C) 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 [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 21 U.S.C. 812(c). 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). 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 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); 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), (c).
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\
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