The Controlled Substances Act: Regulatory Requirements
The Controlled Substances Act:
Updated October 28, 2008
James E. Nichols
American Law Division
Brian T. Yeh
American Law Division
The Controlled Substances Act:
This report highlights certain non-criminal regulatory requirements of the
Controlled Substances Act (CSA). The CSA and its implementing regulations
establish a framework through which the federal government regulates the use of
controlled substances for legitimate medical, scientific, research, and industrial
purposes, and prevents these substances from being diverted for illegal purposes.
The CSA assigns various plants, drugs, and chemicals (such as narcotics, stimulants,
depressants, hallucinogens, and anabolic steroids) to one of five schedules based on
the substance’s medical use, potential for abuse, and safety or dependence liability.
Schedule I contains substances that have no currently accepted medical use and
cannot safely be made available to the public under a prescription, while Schedules
II, III, IV, and V include substances that have recognized medical uses and may be
manufactured, distributed, and used in accordance with the CSA. The order of the
schedules reflect substances that are progressively less dangerous and addictive —
and progressively more beneficial. To restrict access to chemicals used in the illicit
manufacture of certain controlled substances, the CSA also regulates 40 “listed
chemicals.” Furthermore, the CSA regulates controlled substance “analogues,”
which are substances that are not controlled but are structurally or pharmacologically
similar to substances found in Schedule I or II and have no accepted medical use.
Unless specifically exempted by the CSA, any person who handles controlled
substances or listed chemicals (such as drug manufacturers, wholesale distributors,
doctors, hospitals, pharmacies, and scientific researchers) must register with the Drug
Enforcement Administration (DEA) in the U.S. Department of Justice, which
administers and enforces the CSA. Registrants must keep accurate and complete
records of all transactions involving controlled substances, maintain detailed
inventories of the substances in their possession, and periodically file reports with the
DEA, as well as ensure that controlled substances are securely stored and safeguarded
in accordance with DEA regulations.
Between 10%-11% of all drug prescriptions written in the United States are for
pharmaceutical controlled substances. Only licensed medical practitioners (who are
registered with the DEA) are authorized to prescribe controlled substances listed in
Schedules II-V to patients; such prescriptions may only be issued by a practitioner
who is “acting in the usual course of his professional practice,” and for a “legitimate
medical purpose.” The CSA authorizes the DEA Administrator to suspend or revoke
a physician’s prescription privileges upon a finding that he has “committed such acts
as would render his registration ... inconsistent with the public interest.”
While the CSA provides criminal sanctions for illicit possession, manufacture,
or distribution of controlled substances, the statute also contains a few noteworthy
penalty provisions that are specifically applicable to persons who are authorized by
the DEA to handle controlled substances lawfully. The CSA sets forth certain
offenses involving listed chemicals and DEA registration and other prohibited acts
relating to registrants who manufacture, distribute, and dispense controlled
Emergency or Temporary Scheduling..........................3
Controlled Substances Analogues.............................4
International Treaty Obligations..............................4
Dispensing to Patients.....................................10
Exceptions to the Regulatory Requirements Under the CSA...........14
Appendix. Classification of Controlled Substances......................16
The Controlled Substances Act:
The Controlled Substances Act (CSA or the act)1 is the statutory framework
through which the federal government regulates the lawful production, possession,
and distribution of controlled substances. The CSA places various plants, drugs, and
chemicals (such as narcotics, stimulants, depressants, hallucinogens, and anabolic
steroids) into one of five schedules based on the substance’s medical use, potential
for abuse, and safety or dependence liability. Further, the act requires persons who
handle controlled substances or listed chemicals (such as drug manufacturers,
wholesale distributors, doctors, hospitals, pharmacies, and scientific researchers) to
register with the Drug Enforcement Administration (DEA) in the U.S. Department
of Justice, which administers and enforces the CSA. Registrants must maintain
detailed records of their respective controlled substance inventories as well as
establish adequate security controls to minimize theft and diversion.2 Although the
CSA sets forth criminal provisions3 for the unlawful manufacture, possession, and
distribution of controlled substances, this report will instead focus on the act’s non-
criminal regulatory requirements4 for those who legitimately produce, distribute, and
dispense controlled substances.
The placement of drugs or other substances into schedules under the CSA is
based upon the substance’s medical use, potential for abuse, and safety or5
dependence liability. The act further provides a mechanism for substances to be
1 21 U.S.C. §§ 801 et seq.
2 See 21 C.F.R. § 1304.11(a) (“Each inventory shall contain a complete and accurate record
of all controlled substances on hand ...”); see also 21 C.F.R. § 1301.74(a) (“All applicants
and registrants shall provide effective controls to guard against theft and diversion of
controlled substances ...”).
3 For a detailed summary of the CSA’s criminal provisions, see CRS Report RL30722, Drug
Offenses: Maximum Fines and Terms of Imprisonment for Violation of the Federal
Controlled Substances Act and Related Laws, by Charles Doyle and Brian T. Yeh.
4 This report does not cover all the requirements under the CSA, nor does it address state
controlled substances regulations. Although federal and state governments both regulate
controlled substances, federal law preempts state law when state law conflicts with the CSA.
5 21 U.S.C. §§ 811-812.
controlled,6 or added to a schedule; decontrolled, or removed from the scheduling
framework altogether; and rescheduled or transferred from one schedule to another.7
The proceedings to add, delete, or change the schedule of a drug or substance
may be initiated by the DEA, the U.S. Department of Health and Human Services
(HHS), or by petition by any interested person.8 When a petition is received by the
DEA, the agency initiates its own investigation of the drug or substance. The DEA
may also initiate an investigation at any time in response to information received
from law enforcement laboratories, state and local law enforcement and regulatory
agencies, or other sources of information.
After the DEA’s initial investigation, the DEA Administrator (Administrator)9
requests from the Assistant Secretary of Health of HHS (Assistant Secretary of
Health) a scientific and medical evaluation and recommendation as to whether the
drug or substance should be controlled or removed from control.10 The Assistant
Secretary of Health in turn solicits information from the Commissioner of the Food
and Drug Administration, and obtains evaluations and recommendations from the
National Institute on Drug Abuse. The Assistant Secretary of Health then
consolidates the requested information and transmits back to the DEA a medical and
scientific evaluation regarding the drug or substance, along with a recommendation
as to whether the drug or substance should be controlled and into which schedule it
should be placed.11
The Administrator then evaluates all of the relevant data and makes a final
determination as to whether the drug or substance should be controlled or removed
entirely from control.12 In making a determination regarding the control of a drug or
substance, the Administrator must consider factors such as the drug’s actual or
relative potential for abuse; scientific evidence of its pharmacological effect; the
current state of scientific knowledge regarding the drug or substance; the risk to the
public health; and whether the substance is an immediate precursor of a substance
6 For the purposes of the CSA, the term “control” as defined by 21 U.S.C. § 802(5) means
“to add a drug or other substance, or immediate precursor, to a schedule under [§ 812 of the
act], whether by transfer from another schedule or otherwise.”
7 The procedures for these actions are found at 21 U.S.C § 811.
8 21 U.S.C. § 811(a).
9 Although the CSA grants to the Attorney General the authority to enforce its provisions,
21 U.S.C. §§ 801 et seq., the Attorney General has delegated this authority to the DEA
Administrator at 21 C.F.R. § 0.100. Accordingly, the term “Administrator” will be used
instead of the term “Attorney General” for the remainder of this report.
10 21 U.S.C. § 811(b).
11 The medical and scientific evaluations are binding on the DEA with respect to such
matters and form a part of the scheduling decision. The recommendation on the initial
scheduling of a substance is binding only to the extent that if HHS recommends that the drug
or substance not be controlled, the DEA may not add it to its schedules. Id.
already controlled under the act.13 After the Administrator makes such a
determination, he must make specific findings concerning the drug or substance that
dictate the schedule in which the drug or substance will be placed.14
Congress may also add a substance to a schedule through legislation.
Emergency or Temporary Scheduling. The CSA was amended by the
Comprehensive Crime Control Act of 198415 to include a provision allowing the
Administrator to place a drug or substance, on a temporary basis, into Schedule I
when necessary to avoid an “imminent hazard to public safety.”16 The Administrator,
however, may not issue a temporary scheduling order until thirty days after he
notifies both the public and the HHS Secretary of his intent to issue the temporary17
scheduling order and of his justification for issuing the order. Further, the
Administrator must consider any of the HHS Secretary’s comments regarding the18
When issuing a temporary scheduling order, the Administrator must consider,
with respect to the finding of an imminent hazard to public safety (i) the history of
the drug or substance and its current pattern of abuse; (ii) the scope, duration, and
significance of the drug or substance’s abuse; (iii) the risk to public health; (iv)
diversion of the drug or substance from legitimate channels; and (v) the drug or
substance’s “clandestine importation, manufacture, or distribution.”19 A drug or
substance may be temporarily scheduled for one year and possibly longer — up to an
additional six months — if formal scheduling procedures have been initiated.20 This
emergency scheduling applies only to substances with no accepted medical use in the
Listed Chemicals. In an effort to restrict access to chemicals used in the
illicit manufacture of certain controlled substances in violation of the CSA, Congress
passed the Chemical Diversion and Trafficking Act (CDTA) in 1988.21 The CDTA
and its subsequent amendments22 allow the DEA to control 40 chemicals23 and
13 See 21 U.S.C. § 811(c)(1)-(8) (complete listing of factors Administrator must consider
when determining control or removal of substances from schedules).
14 See 21 U.S.C. § 812(b) (“[A] drug or other substance may not be placed in any schedule
unless the findings required for such schedule are made with respect to such drug or other
substance”). For a summary of the findings necessary for Schedules I-V, see Appendix.
15 P.L. 98-473.
16 21 U.S.C. § 811(h)(1).
18 21 U.S.C. § 811(4).
19 21 U.S.C. § 811(h)(3).
20 21 U.S.C. § 811(h)(2).
21 P.L. 100-690.
22 Domestic Chemical Diversion Control Act of 1993, P.L. 103-200; Comprehensive
restrict their diversion. These 40 chemicals are referred to by the CSA as “listed
chemicals.”24 Listed chemicals are divided into two categories: List I25 and List II.26
While both categories of chemicals can be used to illicitly manufacture controlled
substances, List I chemicals are more strenuously regulated than List II chemicals
because List I chemicals are “important to the manufacture of a controlled
Controlled Substances Analogues. Controlled substance analogues are
substances that are not controlled but are structurally or pharmacologically similar
to substances found in Schedule I or II and have no accepted medical use.28 A
substance that meets the definition of the term “controlled substance analogue” and
is intended for human consumption is treated as if it were a controlled substance in29
Schedule I. Controlled substance analogues are different from listed chemicals
because such analogues are typically intended for human consumption as a substitute
for a controlled substance, whereas listed chemicals are not intended for human
consumption but are instead used as “ingredients” in the manufacture of certain
International Treaty Obligations. The United States is a party to the Single
Convention on Narcotic Drugs of 1961, which was designed to establish effective
control over international and domestic traffic in narcotics, coca leaf, cocaine, and
marijuana. The United States is also party to the Convention on Psychotropic
Substances of 1971, which was designed to establish similar control over stimulants,
depressants, and hallucinogens. Treaty obligations may require the Attorney General
Methamphetamine Control Act of 1996, P.L. 104-237; Methamphetamine Anti-Proliferation
Act of 2000, P.L. 106-310; Combat Methamphetamine Epidemic Act of 2005, P.L. 109-177.
23 The 40 listed chemicals are set forth at 21 C.F.R. § 1310.02(a) and (b).
24 See 21 U.S.C. §§ 802(33) — (35) and 21 C.F.R. §§ 1300.02(b)(17) — (19) (defining listed
25 21 C.F.R. § 1300.02(b)(18) defines the term “List I chemical” as “a chemical specifically
designated by the Administrator in [21 C.F.R.] § 1310.02(a) ... that, in addition to legitimate
uses, is used in manufacturing a controlled substance in violation of the [CSA] and is
important to the manufacture of a controlled substance.”
26 21 C.F.R. § 1300.02(b)(19) defines the term “List II chemical” as “a chemical, other than
a List I chemical, specifically designated by the Administrator in [21 C.F.R.] § 1310.02(b)
... that, in addition to legitimate uses, is used in manufacturing a controlled substance in
violation of the [CSA].”
27 21 C.F.R. § 1300.02(b)(18).
28 21 U.S.C. §§ 802(32)(A) and (B).
29 See 21 U.S.C. § 813 (“A controlled substance analogue shall, to the extent intended for
human consumption, be treated, for the purposes of any Federal law as a controlled
substance in schedule I”).
to control or reschedule a substance if existing controls are less stringent than those
required by a treaty.30
The CSA creates a “closed system” of distribution31 in which distribution may
lawfully occur among registered handlers of controlled substances, referred to as
“registrants.”32 Central to this closed system of distribution is the registration of all
persons or entities authorized by the DEA to handle controlled substances. All
registrants are required by the act to maintain complete and accurate inventories and
records of all regulated transactions involving controlled substances and listed
chemicals, as well as provide adequate security controls to prevent their diversion.
Registration. The CSA defines who must register with the DEA in order to
handle controlled substances.33 Every person who manufactures, distributes,
dispenses, imports, or exports any controlled substance, or who proposes to engage
in the manufacture, distribution, dispensing, importation, or exportation of any34
controlled substance, must register with the DEA, unless they are exempt.
Generally, all manufacturers, distributors, and practitioners who deal with controlled
substances must register.
Manufacturers and distributors of controlled substances must register with the
DEA annually, and those who dispense controlled substances must obtain35
registrations that may not be issued for less than one year or more than three years.
Any person who is required to register in order to manufacture, distribute, or dispense
controlled substances, but has not yet registered, may apply for registration at any
time.36 Those who already are registered can apply for re-registration not more than37
60 days before the expiration date of their current registration. Registrations specify
the extent to which registrants are authorized to manufacture, possess, distribute, or
dispense controlled substances. The Administrator is authorized to charge reasonable
fees relating to the registration and control of the manufacturing, distribution, and
30 The procedures for these scheduling actions are found at 21 U.S.C. § 811(d).
31 Drug Enforcement Administration, Electronic Prescriptions for Controlled Substances,
32 According to 21 C.F.R. § 1300.02(b)(24), the term “registrant” means “any person who
is registered [with the DEA] pursuant to [21 U.S.C. §§ 823 or 957].”
33 21 U.S.C. § 822; 21 C.F.R. Part 1301.
34 21 C.F.R. §§ 1301.22-1301.24 (exempting agents of registrants, certain military personnel,
and law enforcement officials from DEA registration requirements).
35 21 C.F.R. § 822(a).
36 21 C.F.R. § 1301.13.
dispensing of controlled substances under the act.38 In addition, the Administrator
can inspect the establishments of registrants or applicants for registration.39
Registration is granted to applicants only if it would be consistent with the
“public interest” to do so.40 The Administrator uses several criteria to assess whether
registering an applicant is consistent with the “public interest.” The criteria differ
depending on the substance involved and whether the applicant is a manufacturer,
distributor, or practitioner, but generally include factors such as those relating to
public health and safety and compliance with state and local laws.41
The Administrator also has the authority to deny, revoke, or suspend
registrations under certain circumstances but must provide adequate grounds for
doing so.42 Before the DEA can deny an application, the agency must provide the
applicant with an opportunity to demonstrate why the registration should not be
denied.43 However, the Administrator can suspend without notice any registration
in order to avoid imminent danger to public health and safety.44 A revocation or
suspension of a registration may be applicable to a particular controlled substance or
class of controlled substances. For example, a manufacturer who has been found to
have violated the registration provisions regarding a Schedule II substance will still
be able to manufacture controlled substances in Schedules III-V because the
revocation or suspension relates only to one class of controlled substances.45
38 21 U.S.C. § 821; see also 21 C.F.R. § 1301.13(e)(1) (chart detailing specific types of
registrations and respective fees).
39 21 U.S.C. § 822(f); 21 C.F.R. § 1301.31.
40 21 U.S.C. § 823.
41 21 U.S.C. §§ 823(a)-(f).
42 21 U.S.C. § 824(a) states in pertinent part: “A registration pursuant to section 823 of this
title to manufacture, distribute, or dispense a controlled substance or a list I chemical may
be suspended or revoked by the [Administrator] upon a finding that the registrant —
(1) has materially falsified any application filed pursuant to or required by this subchapter
or subchapter II of this chapter;
(2) has been convicted of a felony under this subchapter or subchapter II of this chapter or
any other law of the United States, or of any State, relating to any substance defined in this
subchapter as a controlled substance or a list I chemical; (3) has had his State license or
registration suspended, revoked, or denied by competent State authority and is no longer
authorized by State law to engage in the manufacturing, distribution, or dispensing of
controlled substances or list I chemicals or has had the suspension, revocation, or denial
recommended by competent State authority;
(4) has committed such acts as would render his registration under section 823 of this title
inconsistent with the public interest as determined under such section; or
(5) has been excluded (or directed to be excluded) from participation in a program pursuant
to section 1320a — 7(a) of [the Social Security Act, which excludes certain individuals and
entities from participation in Medicare and State healthcare programs] . . .”
43 21 U.S.C. § 824(c).
44 21 U.S.C. § 824(d); 21 C.F.R. § 1301.36(e).
45 THOMAS C. FOX, CAROL COLBORN LOEPERE & JOSEPH W. METRO, HEALTH CARE
The registration of an individual terminates when the person dies, ceases legal
existence, or discontinues business or professional practice.46 A registrant who
ceases legal existence or discontinues business or professional practice must notify
the DEA promptly of this occurrence. A registration cannot be transferred to
someone else unless the Administrator provides his express, written consent for such
a transfer to occur.47
In some instances, applicants must apply for several separate registrations in
order to comply with the CSA. Separate registrations are required for each principal
place of business or professional practice where controlled substances are
manufactured, distributed, imported, exported, or dispensed.48 For example, a
physician who is regularly engaged in dispensing controlled substances at one
location must register to dispense controlled substances at other locations if he
chooses to dispense controlled substances at these other locations.49 However, with
the enactment of the Ryan Haight Online Pharmacy Consumer Protection Act of
2008, the DEA Administrator must modify existing registrations of pharmacies to
authorize them to dispense controlled substances by means of the Internet, unless the
Administrator determines that such modification would be inconsistent with the
Recordkeeping Requirements. In addition to registration requirements,
the CSA contains several recordkeeping provisions.51 A registrant authorized to
handle controlled substances must keep accurate records and maintain detailed
inventories in compliance with applicable federal and state law. For example, a
registrant must maintain a complete and accurate record of each substance
manufactured, received, sold, delivered, or otherwise disposed of by the registrant.5253
Furthermore, inventories must be available for inspection for at least two years.
These records are generally open for inspection by federal authorities and state54
officers tasked with enforcing state narcotics laws.
FINANCIAL TRANSACTIONS MANUAL § 20:62 (2005).
46 21 C.F.R. § 1301.52.
47 21 C.F.R. § 1301.52(b).
48 21 C.F.R. § 1301.12.
49 See United States v. Clinical Leasing Service, Inc., 925 F.2d 120 (5th Cir. 1991).
50 Section 3(b) of P.L. 110-425, with an effective date of April 13, 2009, amending 21
U.S.C. § 823(f).
51 21 U.S.C. § 827; 21 C.F.R. Part 1304.
52 21 U.S.C. § 827(a)(3); 21 C.F.R. § 1304.21(a).
53 21 U.S.C. § 827(b)(3); 21 C.F.R. § 1304.04(a).
Certain DEA regulations implementing the CSA also apply to listed chemicals.55
For example, all registrants authorized to handle listed chemicals (List I and List II)
must maintain records of regulated transactions and submit various reports to the
DEA.56 However, the Administrator has the authority to exempt specified
concentrations of listed chemical mixtures from the recordkeeping requirements set
forth in section 830 of the act that require registrants to maintain detailed records of
every regulated transaction.57
Distribution. As a means to ensure that only authorized registrants obtain
Schedule I and II drugs from manufacturers and distributors, the CSA requires58
registrants who legitimately distribute controlled substances or listed chemicals to
keep records of shipments to purchasers.59 Manufacturers and distributors must
receive a special order form from a purchaser prior to shipping Schedule I and II
drugs.60 The form is preprinted by the DEA with the name and address of the
purchaser and the drugs must be shipped by the supplier filling the order to the
purchaser’s registered location.61 All manufacturers must forward copies of
completed order forms to the DEA by the close of the month in which the shipment
is made.62 The CSA also provides for electronic orders of Schedule I and II drugs.63
Manufacturers must also forward copies of filled electronic orders to the DEA within
The DEA further monitors the distribution of controlled substances by requiring65
manufacturers and distributors of Schedule I and II drugs to file reports through the
Automated Reports and Consolidated Orders System (ARCOS).66 Certain narcotics
listed in Schedules III and IV are also covered by the ARCOS reporting
Registered pharmacies that are authorized to dispense controlled substances by
means of the Internet must report to the DEA Administrator the total quantity of each
55 See generally 21 C.F.R. Part 1310 (records and reports of listed chemicals).
56 21 U.S.C. § 830(a) and (b); 21 C.F.R. §§ 1310.03-06.
57 See chart at 21 C.F.R. § 1310.12(c).
58 For the purposes of the CSA, the term “distribute,” as defined by 21 U.S.C. § 802(11),
means “to deliver (other than by administering or dispensing [to an ultimate user or research
subject]) a controlled substance or listed chemical.”
59 21 C.F.R. Part 1305.
60 DEA Form 222 is only issued to customers who are properly registered with the DEA.
61 21 C.F.R. § 1305.13(c).
62 21 C.F.R. § 1305.13(d).
63 21 C.F.R. § 1305 Subpart C.
64 21 C.F.R. § 1305.29.
65 21 C.F.R. §§ 1304.31 and 1304.32.
66 21 C.F.R. § 1304.33.
67 21 C.F.R. § 1304.33(d).
controlled substance that the pharmacy has dispensed each month.68 In addition,
online pharmacies69 must clearly display on their website homepage a statement that
they comply with federal and state law concerning the delivery or sale of controlled
substances, as well as post certain disclosure information such as
!the name and address of the pharmacy as it appears on the
pharmacy’s DEA registration certificate,
!the pharmacy’s telephone number and email address,
!a list of states in which the pharmacy is licensed to dispense
!the identification and contact information of the pharmacist-in-
!the following statement: “This online pharmacy will only dispense
a controlled substance to a person who has a valid prescription
issued for a legitimate medical purpose based upon a medical
relationship with a prescribing practitioner. This includes at least
one prior in-person medical evaluation or medical evaluation via
telemedicine in accordance with applicable requirements of section
An online pharmacy must notify the DEA Administrator, and the state boards of
pharmacy in any states in which the online pharmacies operate, thirty days before
offering a controlled substance for sale, delivery, distribution, or dispensing; such
notification must include pharmacy’s Internet site address, the information that is
required to be posted on the pharmacy’s website, and the DEA registration numbers
of the pharmacy and practitioners who work for it.71 Online pharmacies that are
already operational as of April 13, 2009, must submit this notification to the DEA
Administrator and any applicable state boards of pharmacy no later than May 12,
68 Section 3(c) of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, P.L.
However, pharmacies are exempt from such reporting requirement if they do not exceed in
a given month either of two thresholds: (1) 100 or more prescriptions dispensed, or (2) 5,000
or more dosage units of all controlled substances combined. Id.
69 An “online pharmacy” means a person, entity, or Internet site, whether in the United
States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers
or attempts to deliver, distribute, or dispense, a controlled substance by means of the
Internet, but does not include, among other things, (1) manufacturers and distributors who
do not dispense controlled substances to an unregistered individual or entity, (2)
advertisements that do not attempt to facilitate an actual transaction involving a controlled
substance, or (3) a registered pharmacy whose dispensing of controlled substances via the
Internet consists solely of refilling or filling new prescriptions for controlled substances in
schedule III, IV, or V. 21 U.S.C. § 802(52), as added by section 3(a) of P.L. 110-425, with
an effective date of April 13, 2009.
70 Section 3(d) of P.L. 110-425, with an effective date of April 13, 2009, adding new § 311
to the Controlled Substances Act.
Dispensing to Patients. The CSA further provides special control
mechanisms for licensed practitioners and pharmacists who dispense72 controlled
substances in Schedules II-V to patients for legitimate medical purposes. Because
controlled substances classified as Schedule I drugs are deemed to have no accepted
medical purpose in the United States, they may only be used for research, and
practitioners may not prescribe them to patients. Under the CSA, only licensed73
medical practitioners are authorized to prescribe controlled substances listed in
Schedules II-V to patients.74 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.”75 Accordingly, practitioners have a
responsibility to ensure that the controlled substance is properly prescribed and
No controlled substance in Schedules II may be dispensed to a patient by a77
pharmacist without a written prescription from a practitioner, except in certain
cases where the practitioner administers the controlled substance directly to the78
patient. However, in the case of an emergency situation, a practitioner may orally
authorize a pharmacist to fill a prescription for a Schedule II controlled substance.79
Controlled substances in Schedules III-V may be dispensed by a pharmacy pursuant
to either a written or oral prescription, including a facsimile of a written
72 According to 21 U.S.C. § 802(10), the term “dispense” means “to deliver a controlled
substance to an ultimate user or research subject by, or pursuant to the lawful order of, a
practitioner, including the prescribing and administering of a controlled substance and the
packaging, labeling or compounding necessary to prepare the substance for such delivery.”
73 According to 21 U.S.C. § 802(21), the term “practitioner” means “a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered,
or otherwise permitted, by the United States or the jurisdiction in which he practices or does
research, to distribute, dispense, conduct research with respect to, administer, or use in
teaching or chemical analysis, a controlled substance in the course of professional practice
74 See 21 C.F.R. § 1306.03 (persons entitled to issue prescriptions).
75 21 C.F.R. § 1306.04.
76 Pharmacists share with practitioners the responsibility to ensure that controlled substances
are properly prescribed and dispensed. Both practitioners and pharmacists are subject to the
criminal and civil provisions of the CSA for knowingly prescribing and dispensing a
controlled substance in a manner inconsistent with the act. Id.
77 21 U.S.C. § 829(a); see also 21 C.F.R. § 1306.05 (manner of issuance of prescriptions
for Schedule II controlled substances).
78 21 U.S.C. § 829(a); see also 21 C.F.R. § 1306.11(b) (authorizing individual practitioners
to administer or dispense controlled substances directly to patients without prescription).
79 21 C.F.R. § 1306.11(d).
prescription;80 these substances may also be administered or dispensed directly by the
practitioner in the course of his professional practice without a prescription.81
Pharmacists may partially fill a prescription for Schedule II substances under
certain circumstances.82 Pharmacists are prohibited from refilling prescriptions for
Schedule II substances.83 Prescriptions for controlled substances in Schedules III and
IV, however, may be filled or refilled by pharmacists up to five times within six
months after the date on which the prescription was issued, unless the prescribing
practitioner authorizes a renewal of the prescription.84
A controlled substance that is a prescription drug may not be delivered,
distributed, or dispensed by means of the Internet without a “valid prescription.”85
Only with respect to this provision of the Controlled Substances Act, a “valid
prescription” means a prescription that is issued for a legitimate medical purpose in
the usual course of professional practice by a practitioner who has conducted at least
one medical evaluation of the patient in the physical presence of the practitioner.86
Quotas. The DEA limits the quantity of Schedule I and II controlled
substances which may be produced in a given calendar year. The CSA authorizes the
!establish aggregate production quotas for all manufacturers;
!establish individual production quotas for specific registered
!establish individual production quotas for registrants who have not
manufactured controlled substances during one or more proceeding
!implement quota increases for individual manufacturers where87
80 21 U.S.C. § 829(b). If the prescription is made orally, the pharmacist must promptly
reduce to writing all of the information required to be in a prescription under 21 C.F.R. §
81 21 U.S.C. § 829(b); 21 C.F.R. § 1306.21(b).
82 See 21 C.F.R. § 1306.13(a) (“The partial filling of a prescription for a substance listed in
Schedule II is permissible if the pharmacist is unable to supply the full quantity called for
in a written or emergency oral prescription.... The remaining portion of the prescription may
be filled within 72 hours of the first partial filling”).
83 21 U.S.C. § 829(a)(“No prescription for a controlled substance in schedule II may be
84 21 U.S.C. 829(b); 21 C.F.R. § 1306.22(a).
85 Section 2 of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, P.L.
87 See 21 U.S.C. §§ 826(a)-(e) (general provisions regarding the establishment of production
quotas for Schedule I and II controlled substances).
By regulation, the Administrator must consider the following factors in making
his quota determinations: (i) the total disposal of the controlled substance during the
current and two preceding years; (ii) trends in the national rate of new disposal of the
controlled substance; (iii) total inventories (actual or estimated) of “the class and all
substances manufactured from the class [of controlled substances listed in Schedule
I or II];” (iv) projected demand for a particular controlled substance; and (v) other
relevant factors affecting the use of controlled substances including, changes in the
currently accepted medical use of a controlled substance, the economic and physical
availability of the raw materials necessary to produce a controlled substance, and
recent unforeseen emergencies (i.e., natural disasters).88
Security. For the purposes of ensuring the secure storage and distribution of
controlled substances and listed chemicals, all applicants and registrants must
generally “provide effective controls and procedures to guard against theft and89
diversion of controlled substances.” DEA regulations further require all applicants
and registrants to substantially comply with specific security standards for storage of90
controlled substances and List I chemicals. Applicants and registrants must also be
prepared to make adjustments to their security systems in the event that a controlled
substance is transferred to another schedule or removed from control under the
DEA regulations also detail specific security requirements for the different types
of applicants and registrants. For example, non-practitioners (i.e., manufacturers,
distributors, and narcotic treatment programs) are required to store Schedule I and II
substances in electronically monitored safes, steel cabinets or vaults that meet or
exceed certain specifications.92 Licensed practitioners must store controlled93
substances in a “securely locked, substantially constructed cabinet” and must notify
the DEA of the theft or significant loss of any controlled substances within one94
business day of discovering such loss or theft. Furthermore, all practitioners are
prohibited from hiring employees who have been convicted of a drug-related felony
88 21 C.F.R. §§ 1303.11(b)(1)-(5).
89 See 21 C.F.R. § 1301.71 (general security requirements and standards for measuring
90 21 C.F.R. § 1301.71(b) states: “Substantial compliance with the standards set forth in
§§ 1301.72-1301.76 may be deemed sufficient by the Administrator after evaluation of the
overall security system and needs of the applicant or registrant.” Section 1301.71(b) also
sets forth a list of fifteen discretionary factors for Administrator to consider when evaluating
the overall security system of an applicant or registrant; see also 21 C.F.R. § 1309.71(a)-(c)
(general security requirements for List I chemicals).
91 21 C.F.R. § 1301.71(c).
92 See 21 C.F.R. §§ 1301.72(a)(1)(i)-(iii) (specifications required for safes and steel cabinets
storing Schedule I and II drugs or substances); see also 21 C.F.R. §§ 1301.72(a)(2) and
1301.72(a)(3)(i)-(vi) (specifications required for vaults storing Schedule I and II drugs or
93 See 21 C.F.R. § 1301.75 (physical security controls for practitioners).
94 21 C.F.R. § 1301.76(b).
or who have had a DEA registration denied or revoked.95 DEA regulations
recommend that non-practitioners carefully screen individuals before hiring them as
employees, to ensure that job applicants do not have convictions for crimes or have
engaged in unauthorized use of controlled substances.96
Penalties. While the criminal provisions of the CSA focus mainly on the97
illicit possession, manufacture, and distribution of controlled substances, there are
a few noteworthy penalty provisions applicable to persons registered with the DEA.9899
The CSA sets forth certain offenses involving listed chemicals, DEA registration,
and other prohibited acts related to registrants who manufacture, distribute and100
dispense controlled substances.
With respect to DEA registration generally, registrants authorized to distribute
or dispense any controlled substance are prohibited from distributing, dispensing, or
manufacturing controlled substances that are not authorized by a registrant’s
registration.101 Registrants must maintain accurate records and furnish them when102
required to do so by law enforcement officials. Registrants must also maintain a
degree of transparency by allowing law enforcement officials access to their premises103
for inspections authorized by the CSA. Failure to adhere to the registration
requirements of the CSA may subject a registrant to civil fines, imprisonment, or104
The CSA also proscribes certain acts related to the manufacture and distribution
of controlled substances and listed chemicals. Registrants who knowingly or105
intentionally (i) distribute Schedule I and II substances without a valid order form;
(ii) use an invalid registration number during the course of handling or acquiring106
controlled substances; (iii) furnish false or fraudulent material information in a
95 21 C.F.R. § 1301.76(a).
96 21 C.F.R. § 1301.90.
97 For a description of the criminal penalty provisions of the CSA, see CRS Report
RL30722, Drug Offenses: Maximum Fines and Terms of Imprisonment for Violation of the
Federal Controlled Substances Act and Related Laws, by Charles Doyle and Brian T. Yeh.
98 21 U.S.C. §§ 841(c); (e)-(f).
99 21 U.S.C. § 842.
100 21 U.S.C. § 843.
101 21 U.S.C. § 842(a)(2).
102 21 U.S.C. § 842(a)(5).
103 21 U.S.C. § 842(a)(6).
104 See generally 21 U.S.C. § 842(c) (penalties for committing prohibited acts set forth in
105 21 U.S.C. § 843(a)(1).
106 21 U.S.C. § 843(a)(2).
record or report required by the act;107 or (iv) present false or fraudulent identification
when receiving a listed chemical,108 are subject to criminal fines, imprisonment, or
both.109 Additionally, registrants who violate the aforementioned provisions may be
subject to injunctive or declarative actions filed by the Attorney General in federal
Finally, the CSA specifies several offenses regarding listed chemicals. For
example, criminal fines and/or imprisonment are available for any person who
knowingly or intentionally (i) possesses a listed chemical with the intent to
manufacture a controlled substance without proper registration; (ii) possesses or
distributes a listed chemical with knowledge or a reasonable belief that the listed
chemical will be used to manufacture a controlled substance; or (iii) evades the
CSA’s recordkeeping and reporting requirements by receiving or distributing listed
chemicals in small units.111 Also, any person who knowingly possesses or distributes
listed chemicals in violation of the CSA, or knowingly violates the CSA’s
recordkeeping requirements, is subject to criminal fines, imprisonment, or both.112
Furthermore, in addition to the other applicable penalties, violators of the
aforementioned provisions may also be enjoined for up to ten years from handling
Exceptions to the Regulatory Requirements Under the CSA
It is important to note that the CSA allows for exceptions and also exempts
certain individuals from some or all of its regulatory requirements. For example,
individuals exempted from registration requirements include, among others, officers
or employees of the DEA, officers of the U.S. Customs Service, offers or employees
of the U.S. Food and Drug Administration, and any other federal officers who are
authorized to possess, import, or export controlled substances in the course of their
official duties.114 Officers or employees of any state, or political subdivision of a
state, who are engaged in enforcement of state or local laws relating to controlled
substances, are also exempt from registering with the DEA.115 A person who has
107 21 U.S.C. § 843(a)(4)(A).
108 21 U.S.C. § 843(a)(4)(B).
109 See generally 21 U.S.C. § 843(d) (penalties for committing prohibited acts set forth in
110 21 U.S.C. § 843(f).
111 21 U.S.C. §§ 841(c)(1)- (3).
112 See 21 U.S.C. § 841(f)(1) and (2) (penalties for offenses involving listed chemicals).
113 21 U.S.C. § 841(e).
114 21 C.F.R. § 1301.24(a)(1).
115 21 C.F.R. § 1301.24(a)(2). For additional registration exceptions, see 21 C.F.R. §§
lawfully obtained, and who possesses, a controlled substance for his own use is also
not required to register.116
In addition, only those actually engaged in activities relating to manufacturing,
distributing, and dispensing controlled substances are required to obtain registration,
but related or affiliated persons who are not engaged in such activities are not
required to register. For example, a stockholder or parent corporation of a corporation
that manufactures controlled substances is not required to obtain registration, nor are
employees of a registered manufacturer, distributor, or dispenser.117
The DEA Administrator may, by regulation, waive the registration requirement
for certain manufacturers, distributors, or dispensers, if he finds it consistent with the
public health and safety.118
In certain circumstances, the CSA recordkeeping provisions do not apply. The
CSA recordkeeping provisions do not apply to the prescribing or administering of a
controlled substance in Schedules II-V by practitioners acting in the lawful course of
their professional practice unless such substance is prescribed or administered in the
course of maintenance or detoxification treatment of an individual.119 For example,
the prescribing or administering of methadone for the treatment of narcotic addiction
must be in conformity with the CSA’s recordkeeping provisions. The CSA also does
not apply to research conducted in conformity with the exemption granted under
certain provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) or to
preclinical research or teaching.120
116 21 U.S.C. § 822(c).
117 21 C.F.R. § 1301.11(a); 21 U.S.C. § 822(c).
118 21 U.S.C. § 822(d).
119 21 U.S.C. §§ 827(c)(1)(A), 827(c)(1)(B).
120 21 U.S.C. § 827(c)(2).
Appendix. Classification of Controlled Substances
ScheduleCSA Statutory ProvisionExamples of Scheduled Substances
Pursuant to 21 U.S.C. § 812(b)(1), a substance will be placed in Schedule I basedHeroin, lysergic acid diethylamide (LSD), marijuana,a
on specific findings made by the Administrator that “(A) The drug or otherMDMA (Ecstacy), methaqualone (Quaalude).
substance has a high potential for abuse. (B) The drug or other substance has no
currently accepted medical use in treatment in the United States. (C) There is a
lack of accepted safety for use of the drug or other substance under medical
iki/CRS-RL34635IPursuant to 21 U.S.C. § 812(b)(2), a substance will be placed in Schedule II basedMethadone, methamphetamine, methylphenidate
g/won specific findings made by the Administrator that “(A) The drug or substance(Ritalin®), morphine, oxycodone (OxyContin®),
s.orhas a high potential for abuse. (B) The drug or other substance has a currentlyphencylidine (PCP).b
leakaccepted medical use in treatment in the United States or a currently accepted
://wikimedical use with severe restrictions. (C) Abuse of the drug or other substancemay lead to severe psychological or physical dependence.”
IIPursuant to 21 U.S.C. § 812(b)(3), a substance will be placed in Schedule III basedAnabolic steroids, synthetic delta — 9
on specific findings made by the Administrator that “(A) The drug or other substancetetrahydrocannabinol (THC), codeine, hydrocodonec
has a potential for abuse less than the drugs or other substances in schedules I andwith aspirin or Tylenol®.
II. (B) The drug or other substance has a currently accepted medical use in treatment
in the United States. (C) Abuse of the drug may lead to moderate or low physical
dependence or high psychological dependence.”
IVPursuant to 21 U.S.C. § 812(b)(4), a substance will be placed in Schedule IV basedXanax®, Valium®, Equanil®, Talwin®, Darvon®.d
on specific findings made by the Administrator that “(A) The drug or other substance
has a low potential for abuse relative to the drugs or other substances in schedule III.
(B) The drug or other substance has a currently accepted medical use in treatment in
the United States. (C) Abuse of the drug or other substance may lead to limited
physical dependence or psychological dependence relative to the drugs or other
substances in schedule III.”
Pursuant to 21 U.S.C. § 812(b)(5), a substance will be placed in Schedule V basedCertain cough medicines with codeine, and certaine
on specific findings made by the Administrator that “(A) The drug or other substanceopium preparations.
iki/CRS-RL34635has a low potential for abuse relative to the drugs or other substances in schedule IV.
g/w(B) The drug or other substance has a currently accepted medical use in treatment in
s.orthe United States. (C) Abuse of the drug or other substance may lead to limited
leakphysical dependence or psychological dependence relative to the drugs or other
substances in schedule IV.”
http 21 C.F.R. § 1308.11(b)-(f) (complete listing of Schedule I drugs and substances); see also 21 C.F.R. § 1308.11(g) (temporary listing of substances subject to emergency scheduling
in Schedule I).
21 C.F.R. § 1308.12(b)-(g) (complete listing of Schedule II drugs and substances).
21 C.F.R. § 1308.13(b)-(g) (complete listing of Schedule III drugs and substances).
21 C.F.R. § 1308.14(b)-(f) (complete listing of Schedule IV drugs and substances).
21 C.F.R. § 1308.15(b)-(e) (complete listing of Schedule V drugs and substances).