some info
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
1-5mg/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 10mg/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 hypocracy 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.
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