Hospitals & Asylums
Drug Evaluation Agency Reform of the Controlled Substances Amendments HA-31-10-09
By Tony Sanders
Be the quintupling of the prison population sufficient duplication for the Administrator to initiate rulemaking procedure under 21CFR§1308.43 diverted to the Food and Drug Administration (FDA)
I.Controlled Substances Act
III. Schedules of Psychotropic Substances
VII. Change of Address
VIII. Probable Cause of PTSD
§1317.01 Scope of Part 1317
§1317.05 New Registration and Annual Renewal
§1317.07 Initial Inventory
§1317.08 Patent Cooperation
§1317.10 Type Setting
Type I Poison
Type V Prescription Drugs
Type VI Over-the-Counter Drugs
1.The Comprehensive Drug Abuse Prevention and Control Act, now known as the Controlled Substances Act (CSA), was signed by President Richard Nixon October 27, 1970, it is codified in two subchapters at Title 21 of the United States Code Chapter 13 §801-971. Shortly thereafter the International Convention on Psychotropic Substances signed in Vienna on 11 July 1971 that at the urging of the United States put Marijuana in Schedule I with other narcotic and psychotropic drugs with a high risk of abuse and no medical use. The Drug Enforcement Administration (DEA) was founded by Reorganization No. 2 signed by President Richard Nixon on 28 March 1973, codified at 21CFR§1300-1399.
2. Being the only drug consumers able to tolerate the abuse of power narcotic drugs have been subjected to the jurisdiction of international regulation and prohibition of the torturer, justice, during the 20th century. Unfortunately after consuming a number of mind expanding hallucinogenic psychotropic substances during the 1960s in the 1970s the oppressive drug regulatory regime, particularly that of the United States, rhetorically expanded their control to all controlled substances, but in fact only breached the confidentiality of medical practice and the pharmaceutical industry, at the expense of an addicted jurisdiction that tolerates abuse. Infringing on the free market the United States immediately began to show an international trade deficit and suffered an oil embargo from hashish smoking countries, while civil war broke out in Columbia and Afghanistan. Seeking refuge from justice the US medical establishment underwent several decades of privatization while the rest of the industrialized world progressed towards a national health service. The perversion of the Customs Court Act of 1980 infected southern Africa, the IV drug and gay communities with HIV and the prison population quintupled primarily as the result of mandatory minimum sentencing of drug offenders. Since 2001, after the Taliban had successfully prohibited opium poppy cultivation in 2000 and the subsequent 9-11 attacks, the United States and NATO have been involved in just military operations in Afghanistan, where opium production is higher than ever.
begin to redress three decades of drug slavery, disease and widening income
inequality, now a global economic depression, it is proposed to enact a Drug
Evaluation Agency reform of the Controlled Substances Act to correct this fatal
flaw that has undermined socio-economic progress over the past three
decades. After years hallucinating about
slavery and then pharmacy the truth has been tortured out of me – drugs and
disease are poison (doughnut anyone?) and no comprehensive controlled substance
regulatory system can omit the pathogens used to cause diagnosable disease in
laboratory animals and hypothetically cause the vast majority of disease and
death in the 21st century.
Thus the philosophical principles of pharmacologic jurisprudence are
that pharmacy is a health profession, toxicology is an understudy of
pharmacology and that drug regulation should foster the free trade in
therapeutic drugs and prohibit poison for benefit of public health. To foster the development of a rational
institutional ideology after such a long, strange and delusional trip, the
following reforms are tried, to change the name of the Drug Enforcement
Administration (DEA) to Drug Evaluation Agency (DEA), to transfer the DEA to
the Food and Drug Administration (FDA) and to lead the Customs of the United
Nations to set the Type for a whole new comprehensive method to control and
prohibit bio-medical substances. In Oregon v. Ashcroft No. 02-35587 of
4.In reward for this dissertation of Congress and the transfer of all her mandatory benefit programs to the supervision of the Social Security Administration, the Secretary of Health and Human Services, shall be readmitted to the academic freedom of the Department of Health, Education and Welfare from whence she was expelled for unspeakable things in 1979, a Secretary of Public Health entitled to all the privileges and immunities of the Secretary of the United Nations and Socio-Economic Administration, provided she amend the Public Health Service statute to accept this change in political status from whence she shall graduate upon the restitution of Chapter 6A to Chapter 1 of the Title 42 of the United States Code repealed of all corpses from WWI. For their part the DEA shall be transferred to the Public Health Service, respect the authority of the Commissioner of the FDA and control the pathogens used in bio-medical research. Chapter 13 of Title 21 of the United States Code is amended so that the phrase “Drug Abuse Prevention and Control” is changed to “Substance Abuse Prevention and Customs” and Subchapter I on Control and Enforcement is changed to “Control and Prohibition”. Secretary of Health and Human Services is amended to “Secretary of Public Health” at 21USC(13)§801a (3)(C). 21USC(13)§802 is amended at (4) is amended so that the term “Drug Evaluation Agency” means the Drug Evaluation Agency in the Food and Drug Administration. At (6) after Schedule I-V “ or Type I-VII” is inserted and the second sentence pertaining to the exclusion of alcoholic beverages and tobacco is repealed. At (32) is added ‘A “poison” is a controlled substance that causes death in humans or animals listed as a Type I. A “pathogen” is a controlled substance, whether it be a toxic substance, bacteria, virus or gene, that causes a diagnosable disease or torturous condition in humans or animals and is catalogued with the disease it causes under Type II or III of part B of this subchapter ’. At 32 At (9, B, iii & D) and at (34, 35 & 36) and at (39, A, iii & iv, II and vi) and at (conclusion of 41, A) the Attorney General is stricken and replaced with Secretary of the Public Health Department. At (4,1 B) Secretary of Health and Human Services is stricken and replaced with Administrator of the United States Department of Agriculture. At (44) “or medicinal” before substances.
5.21USC(13)§811 is amended at (a) four times from Attorney General to “Secretary of Public Health” the first and “Secretary” thereafter. At (b) the first sentence is amended so, “The Secretary shall, before initiating proceedings under subsection (a) of this section to control a drug or other substance or to remove a drug or other substance entirely from the schedules or Types, and after gathering the necessary data, request a scientific and medical evaluation, as to whether such drug or other substance should be so controlled or removed as a controlled substance.” Sentences three, four and five are repealed and the final sentence is amended so Attorney General reads, “Secretary”. At (c & d, 1) Attorney General is amended to “Secretary”. At (d, 2, A & B) Secretary of Health and Human Services is twice changed to, “Secretary of Public Health” in both subsections. At (d, 3) Secretary of Health and Human Services is changed to Secretary of Public Health. At both (d, 3, A & B) Secretary of Health and Human Services is changed to “Attorney General”, Secretary to “Attorney General” and Attorney General to “Secretary of Public Health” and “or she” is appended to he. At (d, 3, C) Secretary of Health and Human Services is changed to “Attorney General”, Secretary to “Attorney General” and at (i) Attorney General is changed to “Secretary of Public Health” and “or she” appended to he. At (d, 4, A) Attorney General is changed to “Secretary of Public Health”, Secretary of Health and Human Services to “Attorney General” thrice. At (d, 4, B) “the Attorney General, after consultation with the Secretary of Health and Human Services” is stricken and replaced with “Secretary of Public Health” where after Attorney General is twice changed to “Secretary” where after “after consultation with the Secretary” is repealed and “or she” appended to he. At (d, 5) Secretary of Health and Human Services is changed to “Secretary of Public Health”. At (e) Attorney General is once changed to “Secretary of Public Health” and once to “Secretary”. At (f) “or toxic” is inserted before stimulant. At (g, 1 & 3) Attorney General is changed to “Secretary of Public Health” and at (g, 3, C) “Upon the recommendation of the Secretary of Health and Human Services” is repealed. At (h) Attorney General is changed to “Secretary” “or she” is added after he; “by order and without regard to the requirements of subsection (b) of this section relating to the Secretary of Health and Human Services”, is repealed. Attorney General is changed to “Secretary” in (h, 1A, 1B, 2, 3, and twice in 4). –General is repealed from Secretary of the United Nations at (d, 2, A & 3, C, ii & 4, A & B). Economic and Social Council is changed to Socio-Economic Administration at (d, 3, iii).
6. It was attempted to reschedule the psychotropic drug schedules to incorporate everything but it was previously noted that Schedule is not really as funny with torturous tinctures as it is with narcotic addiction and after discovering the List Chemicals decided it would be simpler and of less impact upon the existing laws to write a whole new list classifying bio-medical substances without poisoning the entire class. The Title of Part B is amended so it reads, “Authority to Control, Standards, Schedules and Types” The caption of Schedules of Controlled Substances at 21USC(13)§812 is amended so it reads “Schedules of Psychotropic Substances” in (a) controlled is changed to “psychotropic”. Under the scheduling authority of the Administrator in consultation with the Secretary at 21CFR§1308.43(d) at Schedule I (c, 10) and at 21CFR§1308.11(d, 22 ) Marihuana (DEA # 7360) is removed and subsequent numbering is changed correspondingly and Marihuana is inserted at Schedule III at §812(f) and in the reservation at 21CFR§1308.13(g, 2). At 21USC(13)§813 the fist reference to controlled is changed to “psychotropic”. At 21USC(13)§814 Attorney General is changed to “Secretary of Public Health” once at (a) and a second time to “Secretary” and to “Secretary” in (b, c. d, 1, 2, & 3). At 21USC(13)§821 Attorney General is changed to “Secretary of Public Health”. Attorney General is changed to “Secretary of Public Health at 21USC(13)§822 and to “Secretary” at (b, d & f) and at (c, 1 & 2) controlled is changed to “psychotropic”. Attorney General is changed to “Secretary” at 21USC(13)§823(a) and at (b, d, e, f, g, 1, A, B, 2, D, ii, iii, E, i, g, 1, C & g, 2, C, ii). (after consultation with the Attorney General) is repealed, at (g, 2, ii, I), “both the Secretary and the Attorney General are” is repealed and replaced with “the Secretary is”. At (g, 2, H, i & ii) Drug Enforcement Administration is changed to “Drug Evaluation Agency” and Substance Abuse Mental Health Services Administration to Social Work Administration. At (J) (i & ii) are repealed and (I & II) are changed to (i & ii). At (h) Attorney General is changed thrice to Secretary.
5.Attorney General is changed to “Secretary of Public Health” at 21USC(13)§824(a) and thereafter to “Secretary” at (a, b, c, d, f, g). At (f & g) controlled substances is changed to “psychotropic”. There is appended (h) Destruction of Type II & III Pathogens in Controversy. When the possession of Type II or III chemical is determined to be suspicious by the regional Poison Control Center, Institutional Ethics Committee, local, state or federal law enforcement those pathogenic substances shall be promptly destroyed or properly disposed of and this destruction or disposal shall be documented and witnessed. (1) Courts and law enforcement officers shall never possess Type I, II or III controlled substances and if the registered chemical analysts are not themselves able to document the destruction of the substance, or it is seized from an unregistered possessor, licensed hazardous material handlers shall be summoned to document the seizure and destruction of the substance(s). (2) If the registered chemical analysts wish to defend their possession and use of the Type II or III substance(s) in question they shall be subjected to prosecution therefore by the Secretary and the substances themselves shall be impounded by a hazardous material handler under the authority of the Secretary at (f & g). (3) Type I poisons that are experimental in nature are subject to the same treatment as (h, 1 & 2) above, and those properly packaged and sealed poisons with legitimate use shall be accounted for under the procedure in (f & g) of this section. (4) Complaints and suspicions regarding type I, II, and III substances shall be given due process by the Secretary regarding revocation, suspension of their license(s) and bio-security.
6. Attorney General is changed to “Secretary of Public Health” at 21USC(13)§825 (a) and to “Secretary at (b & d) and it is inserted (d) Type I, II, or III controlled substances. Attorney General is changed to “Secretary of Public Health” at 21USC(13)§826 (a) and to “Secretary” at (b-f). There shall be appended (h) Quotas for Type I, II and III Substances: The Secretary shall determine the total quantity and establish production quotas for estimated legitimate registered research, veterinary and lethal injection needs to be manufactured each year. Production quotas shall be exactly sufficient to meet legitimate demand of the prior year. For good reason the Secretary may increase or reduce the production for a specific substances or eliminate the legitimate production of a substance completely. Attorney General is changed to “Secretary of Public Health” at 21USC(13)§827(b) and thereafter to “Secretary” at (b, c, 3, d, e, f, g & h) at (f) after consultation with the Attorney General, is repealed. Attorney General is changed to “Secretary of Public Health” at 21USC(13)§828(a) and to “Secretary” at (c, 1, 2, d, 1 & 2) and at (a) it is inserted “Type I, II, III or IV” before controlled substance and after is inserted “or”. At the end of (b, 1), “it is forbidden to export Type II or III controlled substances. Attorney General is changed to “Secretary of Public Health” at 21USC(13)§829(a) and to “Secretary” at (b & d). Attorney General is changed to “Secretary” at 21USC(13)§830 (a, 2, 3, b, 1, B, 2, 3, B, D, v, E, c, 3, e, 1, A, iii, v, vii, B, i, ii, iii, iv, C, F, 2, A, 3)
7. The hypocrisy regarding the up to five years sentence for poisoning and mandatory sentences for popular illicit drugs is resolved pursuant to Blakely v. Washington No. 02-1632 (2004). Attorney General is changed to “Secretary” at 21USC(13)§841(g, 2 & 3). The sentences at (b) are changed to, “up to 10 years or up to 20 years where corruption of a minor, bodily injury, involuntary manslaughter occurred through the negligence of the dealer, or up to life where there were many preventable deaths”, at least is changed to “up to” twice and the last two sentences are repealed At (b,1 B) sentencing is changed to up to five years and up to 20 years where corruption of a minor, serious bodily injury or involuntary manslaughter occurs as the result of the negligence of the dealer or up to life where there were many preventable deaths, at least is changed to “up to” twice, and the last two sentences are repealed. At (b, 1, C) sentencing is changed to up to 20 years and where death resulted, up to life. At (b, 6) “on Federal lands” is repealed, so that the sentence for hazardous poisoning is increased to a fine under Title 18 to cover the cost of cleanup, damages and the courts and up to 5 years if causing only minor accidental bodily injury to a human or death to a few animals, or up to 10 if involuntary manslaughter occurred or if a participant in organized torture caused serious bodily injury and up to 20 for the mastermind of an organized torture operation that didn’t kill but seriously injured many people and up to life imprisonment if death was the result of an intentional act of criminal mischief. After 21USC(13)§841(a, 14 & 4, A) Attorney General is changed to “Secretary”. At 21USC(13)§848 (a) the penalty for continuing criminal enterprise shall be up to 20 years, at (b) insert “up to” to at (d) “under this section, imposition or execution of such sentence shall not be suspended, probation shall not be granted, and…not” are repealed (e) is repealed (s) is repealed. At 21USC(13)§859 (a, 2) “a term of imprisonment under this subsection shall be not less than one year. The mandatory minimum” is repealed” and at (b, 2) except and the two sentences following are repealed. At 21USC(13)§860 “(b)(6)” is added after (a)(1) and at (a, 2) “ . Except to the extent a greater minimum sentence is otherwise provided by section 841 (b) of this title, a person shall be sentenced under this subsection to a term of imprisonment of not less than one year. The mandatory minimum” is repealed and at (b, 2) ‘Except to the extent a greater minimum sentence is otherwise provided by section 841 (b) of this title, a person shall be sentenced under this subsection to a term of imprisonment of not less than three years.” is repealed, subpart (d) is repealed and (e) is relettered (d). At 21USC(13)§861(b) the second sentence and the second sentence at (c) shall be repealed and (e) is repealed and (f) relettered (e). Secretary of Health and Human Services is changed to Secretary at 21USC(13)§862 (a, 2 & b, 2). At 21USC(13)§862a (a) after eligible shall be inserted “while in prison”.
(a)Torture or conspiracy to intentionally torture people using Type II or III controlled substances or a medically unnecessary combination of prescription drugs, whose labels warn of serious adverse reaction or to without informed consent dose a person with a schedule I hallucinogen to induce mental illness, is a felony for which a perpetrator faces fines and up to life in prison, if death or mass murder results from their abuse of a Type I, II or III controlled substance.
(1)Registrants convicted of torturing people generally shall be disbarred for up to ten years. Employees, particularly those caring for vulnerable people, are usually dismissed. Law enforcement officers are routinely dismissed from the evidence and employment. A judge or lawyer negligently acquitting a torturer shall face malpractice proceedings for negligence and those found conspiring to torture and issuing orders to torture people shall be disbarred and punished as if they had committed the offense themselves.
(2) Although civil and criminal penalties for torture are required of statute under Arts. 2 & 4 of the Convention against Torture, Cruel, Inhuman and Degrading Punishment or Treatment of 1986 as the result of the frequency with which the crime of torture occurs, it is far more important, than torturing the perpetrator with legal sanctions in revenge, for the victim, or the family of the deceased, to be compensated and provided for as complete a recovery as possible under Art. 14. No criminal investigation is justified without having paid the victim/witness/researcher compensation, purchased rights.
(3) Properly performed, in writing, the civil tort should be sufficient to correct the offender, the ailment of the victim and any systemic abuse. Proceedings are confidential. The civil conviction must be sent to the professional license board, DEA, employer and any research grants the registrant is participating in, for the registrant’s record, keeping the victim’s identifying information confidential, and outlining the particulars of the offense.
9.The Administrative and Enforcement Provisions transfer significant authority to Secretary of Public but retain the cooperation of the Attorney General for the regulation of arresting law enforcement officers with firearms employed by the Secretary and court proceedings involving the District Attorney. The Attorney General essentially has power of attorney for the Secretary in whose name proceedings are undertaken and who is informed of case proceedings and statistics. Attorney General is changed to “Secretary of Public Health” at 21USC(13)§871 and to “Secretary” at (a, b, and c); Department of Justice is changed to “Drug Evaluation Agency” at (a) and “or she” is inserted after he at (b & c). Attorney General is changed to “Secretary” at 21USC(13)§871a, at (a, 1) Drug Enforcement Administration is changed to “Drug Evaluation Agency” and the phrase “involving methamphetamine” is repealed. At (a, 2, A) “of methamphetamine or scheduled listed chemicals (as defined pursuant to the amendment made by section 711 (a)(1)” is repealed and “controlled substances” inserted and at (a, 2, A, 1) methamphetamine is changed to “controlled substances”. Attorney General is changed to “Secretary of Public Health” at 21USC(13)§872 and to “Secretary at (a, b, c, e & f), 21USC(13)§872a.(a & b). At 21USC(13)§873 after agencies is inserted “Secretary of Public Health”. Attorney General is changed to “Secretary” at 21USC(13)§874, §875(a), §876(a & c), §877, Drug Enforcement Administration is changed to “Drug Evaluation Agency” and after Attorney General is inserted “to be employed by the Secretary of Public Health” at 21USC(13)878(a) and after designate at (a, 5) is inserted “within the discretion of Secretary”. Attorney General is changed to “Secretary” at 21USC(13)§880(a, 2, b, 1, 2) At 21USC(13)§881(f, 1 & 2) before schedule I and II is inserted “Type I, II or III or” and at (g, 1) after schedule I or II is inserted “or type I, II, or III” and Attorney General is changed to “Secretary” at (b, c, d, e, 1, D, 2, A, B, 3, 4, A, B, f, 2, g, 2, 3 and l). The Drug Enforcement Administration is changed to Drug Evaluation Agency at 21USC(13)§883 and §886(a & b) where. Attorney General is changed to “Secretary” at (a & c). Drug Enforcement Administration is changed to “Drug Evaluation Agency” at 21USC(13)§886a (1, a, b & c) and Attorney General to “Secretary” at (1, D). Attorney General is changed to “Secretary” at 21USC(13)§887. Drug Enforcement Administration is changed to Drug Evaluation Agency at 21USC(13)§890. Attorney General is changed to “Secretary” and Department of Justice to “Drug Evaluation Agency” at 21USC(13)§904.
VI. Import and Export
10.Attorney General is changed to “Secretary of Public Health” at 21USC(13)§952(a, 1) and to “Secretary” at( 2, A, B, C, b, 2, c, d, 1, 2, B, C). A new paragraph “(f) Importation of Type II and III Pathogens are Prohibited”, is added that states, “Type I poisons and Type II and III pathogens may not be imported into the United States. The Secretary of Public Health may apply to the Secretary of State for an exception, that will be made available to the public. (1) In the annual application for Type I poisons he or she must explain the legitimate commercial applications of the poison, market analysis, quota and safety measures thereto. (2) In the special application for Type II or III pathogens he or she must name the pathogen, explain the disease caused by the pathogen, the public health threat posed by the pathogen, where the disease is endemic, why US scientists want to study the pathogen, why US scientists don’t go to where the disease is endemic and could quarantine and prohibit the pathogen scientifically, what laboratories have approved applications to study the pathogen, what safety and containment methods they have in place, exactly how much of the pathogen they expect to need for their chemical analysis and what detection, anti-toxin, safety or regulatory technology of legitimate, prophylactic or medicinal merit they hope to develop.”
11. Attorney General is changed to “Secretary of Public Health” at 21USC(13)§953 (a, 2) and “Secretary” at (1, 4, b, c, 1, 3, 4, e, 1, 2, 3, f, 2, 4, 6, 7). A new paragraph “(g) Exports of Type II and III Pathogens Prohibited” is added that states, “The export of Type I poisons without legitimate commercial applications and Type II and III pathogens from the United States is prohibited. The Secretary of Public Health may apply to the President of the United States for an exception, that will be made available to the public. (1) In the case of Type I poisons the Secretary shall annually report on those poisons legitimately manufactured in the United States for export, the purchasing nations, the purchasing corporations, whether the purchasers have adequate safeguards in place, set quotas. (A) Individuals, who have not been licensed in both the sending and receiving country for possession and legitimate use of a poison are not be permitted to cross the border in possession of poison or to use the Postal Service for the shipping of poisons. (2) In the case of Type II and III Pathogens the Secretary shall make a special application when he or she approves of a plan to export pathogens to foreign scientists, other than the World Health Organization, for analysis. In the application the Secretary shall name the pathogen, explain the disease caused by the pathogen, why foreign scientists want to study the pathogen, why the foreign scientists don’t come to the United States to study the pathogen where it is quarantined and prohibited against export and malevolent distribution, what nations and laboratories have approved applications to receive the pathogen, what safety and containment methods they have in place, exactly how much of the pathogen they want for the chemical analysis and what detection, anti-toxin, safety or regulatory technology of legitimate, prophylactic or medicinal merit they hope to develop. (A) In regards to the export of pathogens to the World Health Organization, or other approved receivers, the Secretary shall annually, or when suspicions pertaining to the export of pathogens exist but are not sufficiently substantiated to justify individual prohibitive action on the part of the Secretary, report to the Secretary of State.”
12. Controlled is changed “psychotropic” and Attorney General is changed to “Secretary of Public Health” at 21USC(13)§954(1&2). “Type I, II or III or” is inserted before schedule at 21USC(13)§955. Attorney General is changed to “Secretary” in 21USC(13)§956 (a & b) and controlled is changed to “psychotropic” at (a, 1 & 2). Attorney General is changed to “Secretary” at 21USC(13)§975 (a & b, 2), §958 (a, c, 1, 2, A, B, d, 1-6, e, f, g & i). “Type I, II, or III or” is inserted at §959 (a). At 21USC(13)§960 (b, 1 & 2) not less than is changed to “up to” thrice and at least to “up to” twice and the last two sentences are repealed in both; at (3) at least changed to “up to” twice and the last two sentences are repealed, at (4, A & B) not less than is changed to “up to” in both; at (d, 5) Attorney General is changed to “Secretary”. At §960a(a) not less than twice the minimum is changed to “up to twice the” and at least to “up to”. Attorney General is changed to “Secretary” at 21USC(13)§961. “Secretary and” is twice inserted before Attorney General at §965. Attorney General is changed to “Secretary” at 21USC(13)§971(a, b, 1, 2, c, 1, 2, d, 1, B, C, D, 2, A, i, B, f, 1, 2, 3, g, h, 2, 3).
VII. Change of Address
13. The Drug Enforcement Administration and references to the Department of Justice shall be repealed in the indexing of Title 21 of the Code of Federal Regulations to read Drug Evaluation Agency.
In both 21CFR§1300.01 and §1300.02 (b)(2) the term Drug Enforcement Administration is changed to Drug Evaluation Agency (DEA) and at (b)(3) the term Administrator means Administrator of
the Drug Evaluation Agency and the second sentence pertaining to the delegation of authority is repealed. §1301.03 requests for information on rules and §1301.13 (2) requests for forms §1301.14
applications §1301.18(c) research protocol increase requests §1301.51 modification of registration §1301.52(c) termination of registration §1309.32 application should be sent to Registration Unit,
strike - Drug Enforcement Administration, Department of Justice, Post Office – insert - Drug Evaluation Agency - Box 28083, Central Station, Washington, DC 20005. Department of Justice repealed
from the mailing addresses at §1301.52(b), §1301.71(d ), §1303.12(b&d), §1303.22. Drug Enforcement Administration repealed from mailing address in §1304.31(a) and §1304.32(a) . Administrator,
Drug Enforcement Administration, Department of Justice changed to Administrator, Drug Evaluation Agency §1301.17, §1307.03, §1307.22, §1308.25. §1308.24 (d), §1308.32, §1308.34, §1308.43
repeal Drug Enforcement Administration, Department of Justice and insert Drug Evaluation Agency. Drug Enforcement Administration changed to Drug Evaluation Agency at 28 CFR 0.100, §1306.03(d),
§1309.12(b), §1309.33(a), §1309.61, §130971(c), §1310.05 (e,2), §1310.06(d & g), §1310.21(b), §1311.08(c), §1312.13, §1312.18(b), §1312.19(b), §1312.22(a & d, 8), §1312.27(a & b, 5, iv),
§1312.28(d), §1312.30, §1312.31(b), §1312.32(a), §1313.12(b, d & e), §1313.14(b), §1313.21 (b, d & e), §1313.22(e), §1313.23(b), §1313.24 conclusion, §1313.31(b), §1313.32(b), §1313.34(b),
§1314.110(a, 1 & 2), §1316.02(b), §1316.21(a & b), §1316.22(b), §1316.23(a & b), §1316.24(a, b), §1316.31, §1316.45, §1316.46(a), §1316.47(a), §1316.48, §1316.72, §1316.77(a).
VIII. Probable Cause of PTSD
14. In Title 21 of the Code of Federal Regulations §1305.13(f) Procedure for filling DEA Forms 222 for Schedule I controlled substances states, “(f) DEA Forms 222 submitted by registered
procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than
the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting
the order.” It goes on in §1305.22 Procedure for Filling Electronic Order so that at (f) A supplier must ship the controlled substances to the registered location associated with the digital certificate
used to sign the order, except as specified in paragraph (h) of this section. (h) Registered procurement officers of the Defense Supply Center of the Defense Logistics Agency may order controlled
substances for delivery to armed services establishments within the United States. These orders may be shipped to locations other than the registered location, and in partial shipments at different
times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.” Schedule I substances include a number of hallucinogens, not popular
on the street, that could be responsible for the spike in suicide rates among deployed troops, as well as the mental illness aspects of Post Traumatic Stress Disorder. Also of concern to Gulf War
Illness sufferers are substances causing sciatica and neuromuscular pain and dysfunction as well deadly Lou Gehrig’s disease and also lock picks. §1305.13(f) and the exception clause ending
§1305.22(f) that states, “Except as specified in paragraph (h) of this section” and (h) need to be repealed. All contracts there-under need to be terminated under 41USC(2)§101(f) to prevent
improper payments and to detect and prosecute fraud and under 21CFR§1308.43.
15.There shall be inserted (8) Afghanistan and (9) Myanmar at 21CFR§1312.13(f) pertaining to nations from whence the approved importation of narcotic raw material (opium, poppy straw, and
concentrate of poppy straw) may have its source. At §1312.13(g) the import requirement that at least 80% of the narcotic raw material in the United States shall have as its original source
Indian and Turkey and, except in times of shortage, not more than 20% of raw material from Spain, France, Poland, Hungary and Australia shall be amended so that, “at least 80% of the
narcotic raw material imported into the United States shall have as its original source in Afghanistan. Except under conditions of insufficient supplies of narcotic raw materials, not more
than 20% of narcotic raw materials imported into the United States annually shall have as its source, Turkey, India, Spain, France, Poland, Hungary, Australia and Myanmar.” 96% of the
world’s illicit opium supply is produced in Afghanistan, three times the world’s licit demand. Whereas the United States and the international community have invested so heavily in
Afghanistan they must arrange with the Afghan government to purchase a quota of opium legitimately from the Afghan Opium Agency. To consume the rest of the Afghan opium
production without much trouble with the law scholars in the field of Asian opium trade recommend turning Afghanistan into something of a red light district for tourists the population,
8% of whom are involved in the opium trade, would support, to arrest the manufacturers of heroin and smugglers, like they do in the Netherlands, more than in the rest of Europe.
To extend the registration and prohibition of controlled substances by the DEA to all pathogens causing diagnosable disease used in laboratories, so that the criminal malevolence of the
DEA would be directed against society’s real organized criminals from whence the high levels of vehemence against substance abuse have been diverted to the slavery of relatively harmless
narcotic addicts, a new Part of DEA statute in the CFR and Type setting of substances controlled by drug regulation are drafted for both the CFR and CSA to set forth a rational regime for
the registration of the possession, transfer and use of named pathogens to facilitate the control, inspection, prohibition and destruction of poisons and disease pathogens. The new Part 1317
is as follows:
(a)Procedure for the registration, inspection and prosecution of all laboratories possessing, using, transferring, distributing and manufacturing Type II and III pathogens and for their
destruction, pursuant the definitions in §1317.12 & 13 and 21USC(13)(I)(B)§815 (as amended by this Act) and the Prohibitions with Respect to Biological Weapons under
18USC(10)§175 and their Destruction under §176 of Title 18 .
(b) To put drug and disease control in perspective Typesetting extends farther than the responsibility of the DEA to cover all substances with medicinal or toxic qualities for the benefit
of pharmacology and the understudy of toxicology, but the new authority of the DEA extends only to Type II and III pathogens, without further statutory authorization.
(a)To better protect the population against being involuntarily subjected to biomedical research pathogens diverted from their intended for use in animal toxicology studies, or adapted
for use there from, or other laboratory pathogen, the American Association and regional Poison Control Centers shall be informed by the DEA of all manufacture, distribution,
possession and use of investigational pathogens in laboratories in their respective jurisdictions.
(1)The Poison Control Centers shall have observational access to the registration database and shall receive a 33% share of all license fees under §1317.05(d)
(2) The Poison Control Centers shall personally inspect the documentation and security of all laboratories manufacturing, distributing, possessing and using pathogens registered with
the DEA pursuant to 21USC(13)IE§880.
(3) The Poison Control Center shall send one copy of their inspection report to the Institutional Ethics Committee of the laboratory, if any, and one copy of their inspection report to the
office of the DEA that registered the manufacture, possession or use of the controlled substance(s).
(4)If consent to inspect the laboratory is denied, the Poison Control Center shall inform the Institutional Ethics Committee, if any, and the DEA of probable cause for an inspection
warrant under 21ISC(13)IE§880(d).
(b) Institutional Ethics Committees authorized under Title 45 of the Code of Federal Regulations Part 46 shall not be subjected to any regulation by the DEA whereas their independent
judgment pertaining to the ethics of human research projects undertaken by the institution or institutions that employs them, must be protected. Under this section however Institutional
Ethics Committees shall take responsibility for the mockery of the IRB in their authorizing statute and shall inventory all pathogens in their institutions in cooperation with the regional
Poison Control Centers in accordance with (a)(3) above. This section shall help Institutional Ethics Committees to prevent grave breaches of human research protection involving leaks
of hazardous pathogens from laboratories in their institution, where there is no informed consent.
(1)In reward for materially complying with their Institutional Ethics Committee and Poison Control Centers in regards to their inventories of pathogens institutional laboratories will be
annually entitled to a highly reduced “institutional” license fee. For the purpose of granting an institutional discount the DEA shall verify that the Institutional Ethics Committee is
authorized by the Office of Human Research Protection (OHRP).
(c) Once inspection has confirmed the control of DEA registered laboratories, and the American Association is statistically prepared, the regional Poison Control Centers shall take
calls from the public in regards to their suspected exposure to laboratory pathogens and investigate those reports.
(1)Registrants shall respect the order of the Poison Control Center or Institutional Ethics Committees, to destroy their stockpiles of any pathogen and document their compliance to
(2) If the laboratory wishes to contest the order to destroy a pathogen the
§1317.05 New Registration and Annual Renewal
(a)Every laboratory who manufactures, distributes, possesses or uses any Type II or III controlled substance or who proposes to engage in the manufacture, distribute, possess or use
of any controlled substance shall obtain a registration from the DEA. If an institution or corporation has more than one laboratory each laboratory must register, but they shall be filed
together under the name of the institution or corporation, and provided they have an Institutional Ethics Committee approved by the Office of Human Research Protection (OHRP)
shall be entitled to a discount institutional rate.
(b) To protect DEA staff against exposure all registration and orders shall be done electronically, over a secure Internet connection. Digital signatures shall be required. After a form
is filled out the computer shall generate an easily printable receipt of all the information in the form. Payment will also be taken online. An application will not be processed without
payment. The registrant is required to print out at least one copy for their records. Not to burden the proof with tampered evidence DEA records should be particularly secure. The
DEA is liable to ensure that all their law enforcement activities are lawful and that the premises and people and computers of the laboratory and central DEA computer program are
free of malevolent searches and tampering under 21USC(13)§885(d).
(c) The initial application for DEA registration account must include:
(i)Name, address of laboratory, and DEA registration number; if any.
(ii) Email address, telephone number
(iii) Institutional affiliation.
(iv) Qualifications, including a curriculum vitae and an appropriate bibliography (list of publications).
(2) Research project:
(i) Title of project.
(ii) Statement of the purpose.
(iii) Name of the controlled substance or substances involved, whether they manufacture it on site, and the amount of each needed.
(iv) Disease, disorder or condition caused by the pathogen.
(v) Description of the research to be conducted, including the number and species of research subjects, the dosage to be administered, the route and method of administration, and
the duration of the project.
(vi) Location where the research will be conducted.
(vii) Statement of the security provisions for storing the controlled substances (in accordance with §1301.75) and for dispensing the controlled substances in order to prevent diversion.
(ii) Applicable federal, state and local laws and licenses.
(ii) Approval of a Human Research Committee for human studies and certification in research not intended for humans.
(iii) Indication of an approved active Notice of Claimed Investigational Exemption for a New Drug (number).
(iv) Indication of an approved funded grant (number), if any.
(v) If the investigator desires to manufacture, export or import any Type II or III controlled substance for distribution a statement of the quantity to be manufactured or imported and the sources of
the chemicals to be used or the substance to be imported the investigator may pay for the registration but must be approved by both the Secretary of Public Health and Secretary of State
before beginning to engage in the activity.
(d) Prohibitive Cost
(1) Each registration for authorization to acquire, manufacture or purchase to possess and use a justified quantity of one Type III pathogen, for one year, costs $5,000
(2) Each registration for authorization to acquire, manufacture or purchase to possess and use a justified quantity of one Type II pathogen, for one year, costs $10,000
(3) Each registration for authorization to distribute a justified quantity of one Type III pathogen, for one year, costs $25,000
(4) Each registration for authorization to distribute a justified quantity of one Type II pathogen, for one year, costs $50,000
(5) Each registration for authorization to manufacture and distribute a justified quantity of one Type III pathogen, for one year, costs $50,000
(6) Each registration for authorization to manufacture and distribute a justified quantity of one Type II pathogen, for one year, costs $100,000
(7) Each registration for an institution with an OHRP approved Human Research Board, other than for manufacture and distribution, shall be half the price.
(i) 33% of filing fees go to the regional Poison Control Center who shall also inspect the facility.
(ii) 33% of filing fees shall be put in a victim/witness/independent prohibition authors and hazardous material destruction fund.
(iii) 33% of filing fees shall go to finance the diversion control operations of DEA.
(e) Applications submitted for filing are dated upon receipt. Applications failing to comply with the requirements will not generally be accepted for filing. In the case of minor defects as
to completeness, the Administrator may accept the application for filing with a request to the applicant for additional information. A defective application will be returned to the applicant
within 10 days following its receipt with a statement of the reason for not accepting the application for filing. If found to be complete, the application will be filed with ATSDR for
toxicological and epidemiologic analysis. Provided these are not novel substances, when the DEA possesses official government toxicological and epidemiologic information regarding
all the pathogens in question an inspector shall be dispatched. If they are novel substances the laboratory will also be required to pay for a patent pursuant to §1317.08 and the DEA shall
issue the substance a DEA Controlled Substance Number when the substance is sufficiently understood. Once background information is found to be complete and filed the DEA inspector
shall call upon the laboratory to conduct an inspection. Registration will not be granted unless the DEA inspector feels the documentation and security of the laboratory are sufficient to
contain the pathogen and the proposed research is morally justified. The DEA inspector will not accept any bribes or gifts.
(a)The inspector shall be a salaried employee of the DEA. The inspector shall have a post-graduate degree in toxicology, pharmacy, chemistry, public health, or medicine and laboratory
experience sufficient to verify the veracity of normal scientific inventory claims. The inspector shall be versed in medical ethics, human rights, federal, state and local law pertaining
bio-medical research laboratories and bio-hazardous material in his or her jurisdiction. The inspector shall be trained and certified by the Attorney General to make arrests and to bear
firearms. During the course of a normal inspection the inspector shall not bear firearms or handcuffs. Authority to inspect controlled premises of laboratories comes from the Secretary
of Public Health (formerly the Secretary of Health and Human Services) under 21USC(13)IE§880
(1)It is forbidden to give a DEA inspector any bribes or gifts or to intimidate them or their family or commit acts of violence against them.
(2) The inspector shall be in perfect health, entitled to up to 20 sick days a year, eligible for transfer to another position or disability or retirement benefits.
(3) Should the inspector fall ill the laboratories inspected over the past two or three days will be re-inspected.
(4)The inspector shall be clean and polite.
(b) The inspector must be permitted, upon furnishing appropriate credentials and a written notice of inspection to enter the controlled premises of the laboratory for the purposes of:
(1)Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept.
(2) Inspecting, within reasonable limits and in a reasonable manner prescribed by guided tour of the principal investigator or knowledgeable staff, the controlled premises and all
pertinent equipment, finished and unfinished pathogens, finished or unfinished drugs, listed chemicals, and other substances or materials, containers, and labeling found therein and
the wellbeing and treatment of any animal laboratory animals.
(3) Questioning knowledgeable staff regarding the operations of the laboratory, the records, equipment, treatment and inventory.
(4)In most circumstances the inspector will call to schedule an appointment. Usually the inspector wishes to interview the principal investigator or staff or for their guided tour, in
which case he or she shall call before he comes. Inspections are however at the leisure of the inspector, on the receipt of a confidential complaint, or on a semi-annual basis.
(c) Within a reasonable time after the inspection has been complete, not to exceed one week, the inspector shall prepare an inspection report. If the inspector finds the stockpile of
pathogens is too large or all or part of the experiment is unethical or otherwise unjustified or makes any other finding with which the laboratory must materially comply, the laboratory
shall have to comply with the directives to limit their use of pathogens, for the continuing approval of their registration. The inspector shall return after a reasonable time to verify
compliance with the order. If the inspector decides to deny or revoke an authorization for the possession of pathogens the laboratory must request hearing within 20 days under
§1316.47. If the registrant decides to withdraw their application and is verified to have destroyed their pathogens, the initial filing fee or remainder of the year’s registration shall
be returned. If the registrant decides to appeal they shall be responsible for the cost of the entire of the year if they must be ordered to destroy their stockpiles. If the registrant
wishes to contest a negative decision of the DEA in Court the pathogens shall be seized by a licensed a hazardous materials handler employed at the expense of the DEA, for the
duration of Court proceedings. If the Court decides against the Registrant they shall be liable for $25,000 court costs.
(d) If the inspector determines that the laboratory is involved in grave violations of the Controlled Substances Act, the Registrants shall be tried for felony upon conviction of which
will warrant their suspension under 21USC(13)IC§824 and prosecution under Prohibitions with Respect to Biological Weapons under 18USC(10)§175 and their Destruction
under §176 of Title 18.
§1317.07 Initial Inventory
(a)The initial inventory filings to the DEA will be voluminous. Within three months from the passage of this Act all licensed bio-medical research laboratories possessing pathogens
capable of causing deadly or disabling disease shall either destroy their pathogens or be required to file for and pay the registration fees for their entire inventories. Failure to either
destroy their pathogens or pay the filing fee for pathogens within their possession or control, after three months will result in a reasonable fine not to exceed $250,000 for simple
possession under Prohibitions with Respect to Biological Weapons under 18USC(10)§175 to pay for their Destruction under §176 of Title 18.
(b) To process the applications the first thing that must be developed in cooperation with ATSDR and the FDA is a computer program to accept applications and payment under
§1317.05 and to monitor all subsequent transfers of pathogens between Registrants.
(c) The initial workload will be divided geographically and into months. Application fees will provide money to hire new toxicologists and will provide technical and Within one
year all Registrants should be inspected and those Registrants who are approved authorized. Stockpiles of deadly and disabling pathogens in the United States should be dramatically
depleted. The DEA Diversion Control website should have a fairly comprehensive list of pathogens with DEA Controlled Substance Numbers indexed to the disease they cause and
Registrants manufacturing, distributing and possessing those pathogens searchable by pathogen, geographic area, name of Registrant and .
(c) The DEA will be required to report on their operations and prosecutions lowering national and regional levels of laboratory pathogens and corresponding impact on epidemiology,
as available, under this Part one year after the implementation of this program and every year thereafter, when it should be possible to gauge epidemiologic progress under the existing
two year delay on mortality statistics.
§1317.08 Patent Cooperation
(a)The DEA shall cooperate with the US Patent and Trademark Office (USPTO) to inform the scientific community and public of the names, and chemical formulas or physical composition
of pathogens, to facilitate their control and the development of detection, anti-dote, prohibition and elimination technology.
(1)The application must include the name of the pathogen; the chemical formula or material composition of the pathogen; the disease or pathogenesis it causes; the threat it poses to public
health; method of manufacture, acquisition or purchase (mail order catalogues and formulary books of pathogens should be attached), method of control and containment, method of
destruction, neutralization or disposal; plan for the elimination, control or limitation on the legitimate medical research uses of the pathogen; and any confidentiality or security concerns
the scientists wishes the Patent Office to honor.
(b)The DEA shall receive pathogen patent applications under §1308.43 as they pertain to Typesetting decisions under §1317.10 and mostly to the granting of DEA Controlled Substance
Numbers to pathogens being put under control.
(1) The USPTO shall devise a special patent classification number for pathogens
(c) Designation as a weapon by the government under 35USCIII(27)§267 is insufficient whereas biological weapons are prohibited pursuant to 18USC(10)I§175. In regards to pathogens
it is not the substance that is useful but the patent, in eliminating the substance. The DEA Controlled Substances Number and registration system promises to give pathogens
the process of control and prohibition they are due. The patent system offers to promote the development of detection, containment and anti-toxin technology for a reasonable fee under
(c) When the DEA receives patent applications from Registrants or non registrants with novel pathogens the first thing the DEA shall do is request the Registrant to either destroy the
pathogen or pay a registration fee for its possession under §1317.05. Regardless of whether or not applicant pays the registration fee the DEA shall consult with the toxicologists of
the ATSDR and Secretary of Public Health (HHS) for corroborating toxicology and epidemiologic reports. Within three months, but not longer than three years, the DEA will
determine whether of not to grant the pathogen a DEA Controlled Substances Number. The applicant will be informed of the decision and consulted in regards to future control efforts,
if this is agreeable.
§1317.10 Type Setting
Also published at 21USC(13)IB§815
(a)When determining whether or not to grant a DEA Controlled Substances Number under §1308.43 the Administrator of the DEA, in consultation with the Secretary, shall primarily
decide whether the risk of abuse posed by a laboratory pathogen qualifies as a Type II deadly pathogen or III disabling pathogen. The Administrator shall also make decisions under
§1308.43 whether commonly prescribed drugs, such as chemotherapy, qualify as Type IV hard “drugs” and whether certain hallucinogens in Schedule I qualify as Type III for their
particularly high risk of mental illness and should be prohibited from circulation by Registrants under the Convention on Psychotropic Convention.
(b) When the Administrator receives an application for a novel controlled substance whether by patent application or Registrant the Administrator shall send the information with a
Request for Toxicology and Epidemiology Corroboration to the FDA who may consult with the Chemical Weapons Convention Implementation Assistance Program, ATSDR or
National Select Agent Registry of the Secretary of Public Health (HHS) and Secretary of State.
(1)The FDA shall respond to the DEA with either a Response Corroborating the Toxicity and Theoretical Epidemiology of a Pathogen and Directives on Typesetting and Control,
within one month, or a Request for Extension of Time.
(c) The FDA shall set the Type for a pathogen in accordance with the decision of the FDA and report the decision for publication in the Federal Register.
(1)All federal bio-medical research grantees shall be notified of the Type setting for a particular pathogen and within three months all manufacturers, distributors, possessors and
users shall be expected to either destroy the pathogens within their possession and control or file and pay for Registration.
Type I Poison
§1317.11 Type I Poisons
(a) All poisons and compounds deadly to human and animals shall be listed in Type I.
(b) Type I shall consist of those poisons, or deadly compounds, by whatever official name, common or usual name and brand name designated. The list shall be compiled by credible
science in cooperation with the Chemical Weapons Convention Implementation Program as follows:
Type II Deadly Pathogens
§1317.12 Type II Deadly Pathogens
(a)Each controlled substance is assigned the DEA Controlled Substances Code Number set forth opposite it. All toxins, bacteria, viruses and pathogens known to toxicology to cause a
diagnosable, deadly, disease, such as AIDS, atherosclerosis, Alzheimer’s, cancer, diabetes, etc., in humans or animals shall be listed in Type II.
(1)Permits for Type II pathogens shall be issued only to authorized chemical analysts for developing detection, anti-dote or safety technology and all applicable local, state and federal law.
(b) Type II shall consist of those toxins, bacteria, viruses and pathogens, known to toxicology to cause deadly disease in humans or animals, by whatever official name, common or usual
name or brand name designated and the disease or condition they cause. The list shall be compiled by credible science in cooperation with the Agency for Toxic Substances and Disease
Registry with particular attention to the pathogens used in academic animal toxicology studies, as follows:
(1)HIV Human Immunodeficiency Virus causes AIDS Acquired Immunodeficiency Syndrome.
(2)H(1-5)N(1-5) cause Influenza A
§1317.13 Type III Disabling Pathogens
(a)Each controlled substance is assigned the DEA Controlled Substances Code Number set forth opposite it. All toxins, bacteria, viruses and pathogens known to toxicology to cause a
diagnosable, painful and/or debilitating, disease or disability, other than deadly, such back pain, knee pain, irritable bowel syndrome, migraines, paranoid schizophrenia, depression,
arthritis, etc., shall be listed in Type III.
(1)Permits for Type III pathogens shall be issued only to authorized chemical analysts for developing detection, anti-dote or safety technology in accordance with all applicable local, state
and federal law.
(b) Type III shall consist of those toxins, bacteria, viruses and pathogens, known to toxicology to cause painful and/or debilitating disease or disability in humans or animals, by whatever
official name, common or usual name or brand name designated and the disease or condition they cause. The list shall be compiled by credible science in cooperation with the Agency for
Toxic Substances and Disease Registry, Secretary of HHS and Administrator of the UDSA, with particular attention to the pathogens used in academic animal and human toxicology
studies, as follows:
§1317.14 Type IV Chemotherapy and Hard Drugs
(a)Each controlled substance is assigned the DEA Controlled Substances Code Number and an FDA National Drug Code (NDC) set forth opposite it. All controlled substances
considered to be therapeutic “drugs” but known to pharmacology for their particularly high potential for abuse as the result of dangerous or debilitating side effects or addiction or
otherwise subjected to heightened regulation shall be listed in Schedule IV.
(1)Quotas for Schedule IV drugs shall be set in accordance with the Controlled Substances Act and projected legitimate demand.
(2) A prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice under
§1306.04 or is specially registered to administer narcotic maintenance of detoxification treatment under §1306.07 or to administer chemo-therapy that should be subjected to extra
(b) Type IV shall consist of therapeutic “drugs” with a high potential for abuse as the result of harmful side-effects, mental illness, or addiction such as chemotherapy, heroin,
cocaine, crack cocaine, methamphetamine, LSD, gamma-hydroxybutyric acid etc. by whatever official name, common or usual name or brand name designated, that are for good
reason or government inability to remove, in circulation and consumed as drugs. The list shall be compiled by credible science in cooperation with the Food and Drugs Administration,
§1308.08 Type V Prescription Drugs
(a)Each controlled substance is assigned a DEA Controlled Substances Code Number and a FDA National Drug Code (NDC). All controlled substances considered to be prescription
drugs shall not have any special hazards, such as extraordinarily debilitating or dangerous side effects or a high risk of dependency, or otherwise not subjected to extra regulation or
prohibition shall be listed in Type V.
(1)A prescription for a controlled substance may be issued only by an individual practitioner authorized to dispense controlled substances in the jurisdiction in which they practice
(2) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional
practice under §1306.04.
(3) A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed
in a registered pharmacy, a registered central fill pharmacy, or registered institutional practitioner under §1306.06.
(b) Type V shall consist of all prescription drugs listed in the FDA National Drug Code (NCD) without a particularly high risk of abuse. There are too many to list herein. Due
process is for the patient, physician and pharmacist to evaluate them with particular concern for potential adverse drug reactions warned about in the warning label or in combination
with other drugs being taken or particular to that person.
(1)When drugs are found to be particularly dangerous the policy is to recall them, or if the therapeutic benefits cannot be found in other safer drugs or consumer demand is too strong,
to move them to Schedule IV for heightened regulation and when drugs are found to be particularly useful and harmless to move them to Schedule VI so they can be sold over the
(c) In 2003 there were 17 therapeutic classes of prescription drugs. These classes in order of sales are (1) Antidepressants (SSRIs, SNRIs) (2) Anti-hyperlipidemics (Statins) (3)
Anti-ulcerants (Proton-pump inhibitors) (4) Anti-hypertensives (ARBs, ACE inhibitors) (5) Antibiotics (Broad- and medium-spectrum) (6) Diabetes Therapies (Oral, injectible)
(8)Anti-arthritics (COX-2 inhibitors) (8) Antipsychotics (9) Antihistamines (Oral) (10) Neurological Drugs (For seizures or pain) (11) Other Vascular Drugs (Calcium- or beta-
blockers) (12) Anti-asthmatics (13) Aalgesics (Non-narcotic) (14) Bone Density Regulators (15) Oral Contraceptives (16) Anti-allergy Drugs (Nasal steroids) (17) Analeptics
§1308.09 Type VI Over-the-Counter Drugs
(a)Type VI shall consist of the over-the-counter drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated to be safe
for use without a prescription.
(1)Regulations on the format and content requirements for nonprescription drug product labeling are contained in 21 CFR 201.66.
(b) Type VI shall consist of all drugs and controlled substances approve for over-the-counter including those listed in §1308.15 that has contain trace amounts of drugs controlled
under the International Convention on Psychotropic Substances. There are too many for any but the FDA to list.
(a)Type VII is for popular recreational drugs sold to adults legally although they are highly addictive in the case of tobacco and impairing and sometimes addictive in the case of
alcohol, or are cultivated plants with mildly hallucinogenic or analgesic properties from whence a large number of pharmaceutical drugs are manufactured. They are all mildly
addictive and are sold illegally, although several states have passed medical marijuana laws. Marijuana, coca and opium have DEA Controlled Substances Code Numbers.
(1)Alcohol has been brewed for thousands of years and in the United States it is legally sold only to people over the age of 21 in most counties. Tobacco was smoked by native
Americans and today around 25% of the world population smokes, in the United States it is legally only to people over the age of 18.
(2)Although there are no known fatalities from marijuana and it is attributed with a number of medicinal qualities, for which reason many states have legalized medical marijuana a
nd have considered. In defiance of common sense marijuana is considered a Schedule I Substance for the purpose of import and export under the International Convention on
Psychotropic Substances at §1308.11
(3) Coca leaf and Opium are plant products listed as Schedule II Substance for the purpose of import and export under the International Convention on Psychotropic Substances at
§1308.12. Coca and opium grow primarily in the Andes and the so-called Golden Triangle and Golden Crescent in Asia, respectively. An extensive pharmacopeia of narcotic
analgesic and anesthetic drugs of varying strength are manufactured from coca leaves and opium poppy straw or opium gum, including several illicit hard drugs – heroin, cocaine
and crack. Coca leaf is a mild stimulant and opium a mild analgesic. The natural forms might be more therapeutic and cost effective than their derivatives, but are not traditional to
American culture, and are prohibited.
Type VIII Tea, Coffee and Stimulating Beverages (reserved)
Type IX Endangered Species, Toxic Plants and Animals (reserved)