U.S. Drug Abuse Regulation and Control Act of 1970
An Introduction
Originally published Mar 23, 1993, minor edits by Erowid Mar 31 2007
alt.drugs and Hyperreal Drug Archives
Citation: Klausmeier C. "U.S. Drug Abuse Regulation and Control Act of 1970 : An Introduction". Hyperreal Archive of alt.drugs. Mar 23 1993. /psychoactives/law/law_fed_info1.shtml
__________________________________________________ U.S. Drug Abuse Regulation and Control Act of 1970 __________________________________________________ (Controlled Substances Act and other supply control mechanisms) 1. Purpose and scope: The "Controlled Substances Act," as it is referred to, is designed to limit and control access to drugs that can make you "high" or intoxicated in a pleasant way, and also is now used to control certain other drugs of abuse such as anabolic steroids used by athletes to increase muscle mass. It is a law over and above the "Food, Drug, and Cosmetic Act" and the "Durham- Humphrey" laws that designate drugs as prescription only or over the counter and freely available to the public. Thus, a prescription drug may or may not also be a "controlled substance". The FDA decides which drugs are prescription, while the DEA (Drug Enforcement Administration) decides which drugs are controlled substances. The Controlled Substances Act replaced, in 1970, the "Harrison Narcotic Act" which preceded it. The newer act allows for finer control of drugs of abuse, since it uses 5 categories instead of 3. Along with the Controlled Substances Act were harsher prison sentences, new DEA registra- tion numbers for all prescribers or drug handlers, and other additions that are beyond the scope of this file. Most states have passed laws that mirror the Controlled Substances Act, although from state to state there are differences and peculiarities. As a rule, a state can add restrictions to the federal Act, but almost never reverses or reduces them. Pharmacies and doctors must conform to all applicable laws within their jurisdiction. 2. Controlled Substances labelling symbols: Federal law provides for all legally manufactured drug containers (such as pharmacist stock bottles, not individual prescription vials) to contain one of two symbols if the product is regulated under the Controlled Substances Act. This symbol must be placed either in the upper right corner of the label, or in half-tone over the face of the label. It consists of either the symbol C-II (roman numerals II through V) or a large letter "C" with the roman numeral inscribed inside it, such as: _____ / / --- which is the symbol for a | | | Schedule II substance. The | | | roman numeral II could be \ --- replaced by a III, IV, or V \ ____ / for other drugs. Almost all Controlled Substances are also prescription drugs; they are a subset of prescription drugs. The labelling of prescription drugs differs from the Controlled Substances. Assigned by the FDA, they are officially referred to as "legend drugs" because the law requires every prescription drug label to bear the legend, or message: Caution: Federal law prohibits dispensing without prescription. Veterinary prescription drugs bear the different legend: Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. If a veterinary drug is a Controlled Substance, it uses the same symbols as do drugs for humans. In addition to the above, an old U.S. law requires narcotic analgesics and some barbiturates to carry the legend: Warning: May be habit forming. On individual patient prescription vials, none of the above legends are necessary. In their place, the following message must be inserted: Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. Some pharmacy labels are lazy and put this legend on all their labels, even though its use is limited to Controlled Substances. In other countries other schemes are used. For instance, in Canada all prescription drugs must have a "Pr" in a square to the immediate left of the brand or generic name on the label. Some U.S. prescription drugs bear the legend in hard-to-find places, such as on the side of the label. Unlike this, the Controlled Substances symbols are always easy-to-find. ____________________________________________________________________________ 3. Key to Controlled Substances Categories [Schedules I - V] Products listed with the symbols shown below are subject to the Controlled Substances Act of 1970. These drugs are categorized according to the potential for abuse as perceived by the government and tradition. The greater the perceived potential for abuse, the more severe the limitations on their prescription (by being in a numerically lower Schedule). BASICALLY, THE LOWER THE NUMBER (OF THE DRUG SCHEDULE), THE HEAVIER ARE THE CONTROLS FOR IT. Category Interpretation C-I The PDR does not list any schedule I drugs so they do not describe this schedule. Basically, this schedule contains drugs with the highest abuse potential that have no accepted medicinal value. No one is allowed to possess or prescribe these drugs, except in the performance of licensed research. Legal source of Schedule I substances is via NIH licensure and then by ordering from Sigma or certain other chemical supply companies. Marijuana cigarettes (joints) are produced solely on a high- security farm in Mississippi (Univ. of Miss.). The problem with Schedule I is that drugs of VARYING abuse potential are all lumped together because of the prohibition of legitimate medical use in the U.S. C-II High potential for abuse. Use may lead to severe physical or psychological dependence. Prescription must be written in ink, or typewritten and signed by the practioner. Verbal prescriptions must be confirmed in writing within 72 hours, and may be given only in a genuine emergency. NO REFILLS are permitted, and many states require a special narcotic prescription form, to curtail prescription forgery and fraud. In addition to the above, the DEA places QUOTAS on the absolute quantity of Schedule II drugs that can be manufactured or imported in each given year. The quotas, more than anything else, make it hard to illegally obtain Schedule II drugs, since there is little around at any point in time. It also means that physicians have trouble prescribing Schedule II drugs, since if too many doctors prescribed them, the current supply would be depleted. This takes the judgement on the use of these drugs out of the hands of doctors and put into the control of the U.S. government. Often Schedule II drugs are underprescribed, leading to unjustified suffering by patients. C-III Some potential for abuse. Use may lead to low-to-moderate physical dependence or high psychological dependence. Prescriptions may be oral or written. Up to 5 renewals are permitted within 6 months, if permitted in the prescription. Usually, however, Schedule III prescriptions carry no refills. C-IV Low potential for abuse. Use may lead to limited physical or psychological dependence. Prescriptions may be oral or written. Up to 5 renewals are permitted within 6 months, if permitted in the prescription. Note that Schedule III and IV drugs are generally of the same level of control and abuse liability. C-V Subject to state and local regulation. Abuse potential is low; a prescription may not be required. IF permitted by state and local law, certain Schedule V products may be sold as "exempt narcotics" without a physician's order. Persons must be over 18 years of age, and must provide their name, address, and signature for permanent record in a book designated for this purpose. Sale is at the pharmacist's discretion, and cannot be more frequent than once per 48 hours. ___________________________________________________________________________ 4. EXAMPLES OF DRUGS IN DEA SCHEDULES I - V (List is not inclusive of all agents): C-I diamorphine (heroin), lysergide (d-LSD), cannabis (marijuana), psilocybin, mescaline, DOM, methaqualone (Quaalude), MDMA (Ecstasy), ibogaine, dimethyltryptamine (DMT), cathinone, metcathinone, nicomorphine, amphetamine injections. Summary: includes hallucino- gens, narcotic analgesics including many foreign narcotics not sold in the U.S., sedatives, cannabis, and amphetamine or tryptamine derivatives. C-II pentobarbital (Nembutal), phenmetrazine (Preludin), methylphenidate (Ritalin), methamphetamine, amphetamine, morphine, levorphanol, oxymorphone, oxycodone (Percodan/Percocet), alfentanil, sufentanil, fentanyl, methadone, meperidine (Demerol), cocaine, secobarbital (Seconal), amobarbital (Amytal), codeine (pure), hydromorphone (Dil- audid), tincture of opium (laudanum), hydrocodone (pure), dextroam- phetamine (Dexedrine), phencyclidine (Sernylan). Recently dronabinol (Marinol, THC) was added to Schedule II. Summary: includes narcotic analgesics, stimulants, sedatives, and dronabinol. C-III codeine/aspirin, codeine/acetominophen, phendimetrazine (Bontril, etc) hydrocodone/acetominophen, methyprylon, benzphetamine, butabarbital, butalbital/aspirin (Fiorinal), camphorated tincture of opium (pare- goric), thiopental (Pentothal), pentobarbital SYRUP (Nembutal), glu- tethimide (Doriden), methohexital (Brevital), hydrocodone/acetomino- phen (Vicodin), tiletamine/zolazepam (Telazol), some opium/compound tablets, hydrocodone cough syrups (Hycodan, etc., that contain 1-5 mg/5cc). Recently stanozolol (Winstrol) and potentially other ana- bolic steroids were added to Schedule III. Summary: includes narcotic analgesics, stimulants, sedatives, and anabolic steroids. C-IV pemoline (Cylert), ethchlorvynol, midazolam, defenoxin (Motofen), mazindol (Sanorex), prazepam (Centrax), phentermine, propoxyphene (Darvon), flurazepam (Dalmane), clonazepam, chlordiazepoxide (Librium), diazepam (Valium), meprobamate (Miltown), alprazolam (Xanax), penta- zocine (Talwin), phenobarbital, barbital, lorazepam (Ativan), cloraze- pate (Tranxene), quazepam (Doral), temazepam (Restoril). Summary: includes weaker stimulants, benzodiazepine antianxiety drugs, some barbiturate and older sedatives, and one narcotic antidiarrheal. C-V codeine cough syrups (containing 10 mg/5cc, such as Robitussin A-C, terpin hydrate and codeine elixir, Novahistine DH, Novahistine Expectorant, Cheracol), opium antidiarrheal preparations (such as Donnagel PG, Parepectolin), diphenoxylate/atropine (Lomotil, Rx only) buprenorphine (Buprenex, Rx only). Loperamide (Immodium) USED TO be in Schedule V, but was appropriately removed since there are no psychological effects from it. Summary: includes opium/codeine liquid narcotic cough or diarrhea drugs, and one potent narcotic analgesic. NO Although they may be prescription drugs, the following drugs of abuse CONTROL are not in the above DEA Schedules: butalbital/acetominophen (Fiori- BUT Rx cet, although its exact equivalent Fiorinal IS in C-III!), carisopro- dol (Soma, similar to meprobamate), nalbuphine (Nubain), butorphanol (Stadol), dezocine (Dalgan), phenytoin/phenobarbital (Dilantin with phenobarbital), ketamine (Ketalar or Ketaset). Summary: includes mixed agonist/antagonist narcotic analgesics, sedatives, and a dissociative anesthetic. It should be noted that many psychoactive drugs are neither con- trolled substances NOR SHOULD BE. Neuroleptics such as chlorproma- zine (Thorazine), haloperidol (Haldol), and thioridazine (Mellaril) do not produce a "high" and can be downright unpleasant. Lithium can be toxic and has no perceivable psychological effect. Anti- depressants such as amitryptaline (Elavil) and fluoxetine (Prozac) DO produce psychological effects, but they are not particularly pleasant. The OLDER antidepressants, the MAO inhibitors such as tranyl- cypromine (Parnate), can be argued for inclusion since they, after about 2-4 weeks, produce an amphetamine-like high. However, they are not controlled substances. The new antianxiety drug buspirone (Buspar) is effective but does not produce any kind of soothing sedation as does diazepam (Valium). Phenytoin (Dilantin) and other anticonvulsants do not produce outward sedation except in the case of toxic overdosage. Nicotine Rx preparations such as Nicorette gum and Habitrol or Nicoderm transdermal patches can be argued for inclusion as Controlled Substances due to nicotine's extremely high abuse liability. It can also be put the other way: since cigarettes are OTC, why have the other nicotine preparations prescription drugs? NO A strong argument can be made for putting ethanol (alcoholic CONTROL beverages) and nicotine (in cigarettes, cigars, and chewing AND OTC tobacco) into the Controlled Substances Act. Alcohol is bad as the only legal sedative since it often leads to crimes against others, in contrast to something like Valium that just makes one peaceful. Also, UNLIKE many actual controlled substances, alcohol affects coordination and driving to a serious extent. Nicotine is the most addictive commonly known drug there is. As little as 2 cigarettes can produce physical dependence of a most insidious kind. In addition, it causes lung cancer, emphysema, heart disease, and stroke. It is responsible for more actively traceable deaths than ALL OTHER CONTROLLED SUBSTANCES COMBINED. Yet, due to TRADITION and SOCIETAL HISTORY, these drugs are freely available to the public, while the Controlled Substances are not. This is hypocrisy in its most malevolent form. It is a prime illus- tration that there is little SCIENTIFIC basis for why some drugs are controlled but others less so. ____________________________________________________________________________ 5. RELATED U.S. DRUG REGULATIONS AND CONTROLS In the United States, the federal Drug Enforcement Administration (DEA) is the main regulatory agency for the Controlled Substances Act. The DEA, part of the Department of Justice, coordinates the legal licensing of drug handling personnel such as pharmacists and physicians. It also heads the interdiction efforts of the government to stem the domestic and international drug trafficking crimes. Undercover operations (as popularized on television) are but a small part of the DEA's agenda. All persons legally permitted to handle Controlled Substances must be licensed by the DEA. This includes pharmacists, physicians, nurse practi- tioners, biological researchers, drug manufacturers, regional distributors, and exporting/importing organizations. They are each individually assigned a "DEA Registration Number". Doctors must include this number on all prescriptions for controlled substances. The DEA Registration Number is of the form: AX1234567 The first character is always an "A" or a "B", followed by another letter, followed by seven digits. All authorized DEA numbers are indexed by computer and can be used to track the activities of a given individual. States that employ special "Regulated Drug prescription blanks" (usually in triplicate) can keep close track of a physician's prescribing tendencies. A copy of each Rx is sent to the state drug agency, which computerizes the transaction. There is a possibility that one of the characters in a DEA registration number serves as a CHECK DIGIT, i.e. a mathematical algorithm on the non-check digits can be performed to yield the proper value for the check digit, as a check on the validity of the registration number. If there is such a check digit, the greatest possibility is that the 2nd character, which is a letter from A-Z, is that check digit. In the above registration number example, that would be the "X". Needless to say, the existence of check digiting is a closely held secret. New York State has recently passed a law that is a special variation on triplicate prescription blanks. It was designed to both control Schedule II prescriptions, and to also cut down on nursing home and other institutional "oversedation" of inpatients. Therefore, a triplicate special prescription form, that is serialized, must be used for both Schedule II drugs and many if not all benzodiazepine drugs, including: diazepam, chlordiazepoxide, clorazepate, flurazepam, oxazepam, temazepam, alprazolam, prazepam, and a category marked "other" which presumably includes other newly developed benzodiazepines. All New York State triplicate prescriptions are treated like Schedule II drugs, i.e. no refills. Obviously from a pharmacological viewpoint this is highly illogical. Some benzodiazepines, such as chlordia- zepoxide (Librium) have virtually NO EFFECT or abuse potential, and cannot severely sedate a patient. Simularly, other Schedule III and IV older seda- tives have a potently potent depressant effect, such as glutethimide (Doriden) or even phenobarbital. In New York State, one copy is retained by the doctor, another is kept by the pharmacy, and the third is forwarded to the state Dept. of Health. There is a rumor that a prescriber must justify in writing why each and every tripicate prescription is necessary. This leads to tre- mendous underutilization of valuable analgesics and antianxiety drugs. Some other localities have passed additional controls. Such as the computer- ized central database for control of benzodiazepine prescriptions in Los Angeles. All prescriptions there are entered into the computer. It prevents a person from going from doctor to doctor to obtain multiple prescriptions for Valium or other similar agents. Data is checked for duplicity during any period of time. If the patient receives two or more prescriptions to cover the given time period, their name is printed out for follow-up investigation, and they can also be "blacklisted" from ever filling another prescription for benzodiazepines. Similar to the illogicality of the New York State system, one often finds that drugs are "mis-Scheduled," that is, placed in the wrong control category. An example is diazepam (Valium), that is highly addictive and should be a Sche- dule II drug (but is in Schedule IV), or diphenoxylate (Lomotil), which is barely controlled in Schedule V but nonetheless is a potent narcotic. There is often more a tendency to undercontrol drugs, as shown in the above examples, than to overcontrol them. But overcontrolling is also somewhat prevalent. For example, nalorphine (Nalline), the older narcotic antagonist, is in Schedule III but should probably not be in any Schedule. Also, codeine in its pure form, such as codeine sulfate injection or codeine phosphate tablets (without the Tylenol or aspirin), is in Schedule II but is no more or less addictive that other oral solid forms of codeine, such as Tylenol with codeine No. 3 that is commonly prescribed from Schedule III. Eradicating heroin and methaqualone from the therapeutic armamentarium, by placing them in Schedule I, is also highly illogical. They are no more addictive or dangerous than other equivalent Schedule II drugs. This brings to mind that, largely, the placement of drugs into Schedules is "tradition-based" and not often due to scientific fact. Some drugs just have unpopular connotations with society due to their history and some case examples. For instance, if a celebrity figure such as a famous athlete dies from an overdose of a parti- cular drug, it may lead to tighter controls or illogical Scheduling as a kind of reactionary response. For all states for Schedule II drugs, the information is then forwarded to the DEA ARCOS computer to record domestic narcotics orders. Various algorithms can be used on the data to spot irregularities or patients or prescribers worthy of detailed investigation. The DEA shares its data with the Customs Service TECS computer, the federal NCIC system of the FBI and its associated NLETS network, and state and local law enforcement bodies including the local police. Most states also have an equivalent to the DEA that overseas instate control of Scheduled substances. Various special regulations apply to the inventory, transportation, and disposition of controlled substances. For instance, hospital personnel must count floor supplies of controlled drugs once per shift. Usually one member of the old shift counts in the presence of a member of the new shift, under various schemes designed to prevent collusion among coworkers. Pharmacies must undergo licensed audits by bonded personnel several times per year, where every dose of drug is counted and accounted for. Errors or discrepancies must be documented on a specific DEA form that is then entered into ARCOS. Pharmacies may store Schedule III - V drugs among their normal stock, and usually do so. Schedule II drugs in pharmacies may be either: a. Stored in a locked cabinet/drawer or in a safe. b. Dispersed among the regular stock in such a way as to discourage pilferage. More pharmacies lock their Schedule II drugs rather than store them amongst their normal stock. The above two options apply only to retail pharmacies, not hos- pitals, which have more secure storage demands. Drugs that have reached their expiration date must be destroyed in the presence of legal witnesses or returned securely to the manufacturer. Various security systems must be in use to protect storage areas, depending on the quantity on site (distributors must use a vault). Drug companies themselves employ odor-sniffing dogs, constant surveillance, searches and urine testing, and background checks to regulate the very large quantities of drug on site. Hospitals, at the other end of the scale, employ "unit-dose" packaging almost exclusively. With this accounting scheme, each single dose, such as one tablet or prefilled syringe, is separately packaged and sequentially numbered in a tamper-proof container. This facilitates counting and makes it hard for an employee to substitute the drug in a capsule or syringe without breaking a seal. The packages themselves are then stored in a double-locked cabinet or floor medication cart that is left in an area under constant watch by nurses or other personnel. Nevertheless, large quantities of drugs still find their way from legal storage areas into illicit channels. Most of this is from the workers them- selves: at least one in ten drug-handling health professional is a heavy drug user. ____________________________________________________________________________ 6A. STATES WITH KNOWN TRIPLICATE PRESCRIPTION LAWS: California, Illinois, New York (syringes are also tightly regulated). 6B. STATES THAT STILL SELL SOME SCHEDULE-V DRUGS OVER THE COUNTER: Illinois, Ohio, North Carolina, Washington state, Masssachusetts (Donnagel-PG and Parepectolin antidiarrheals only). NOTE THAT PHARMACIES IN EVEN THESE STATES DO NOT HAVE TO SELL YOU SCHEDULE-V DRUGS, SINCE THEIR SALE IS A MATTER OF DISCRETION OF THE PHARMACIST. ____________________________________________________________________________
Revision History #
- Mar 31, 2007 : Erowid : Added title section and corrected typo (hypocracy=>hypocrisy)
- 1993 : Hyperreal : Archived in Hyperreal Drug Archives
- Mar 23, 1993 : Chris Klausmeier : Original Publication on alt.drugs