Notices - 2010
FR Doc 2010-15757[Federal Register: June 29, 2010 (Volume 75, Number 124)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-337N]
Dispensing of Controlled Substances to Residents at Long Term
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice; solicitation of information.
SUMMARY: To analyze ongoing issues related to the dispensing of
controlled substances to residents residing at long term care
facilities (LTCFs), DEA is soliciting information on this subject from
practitioners, pharmacists, LTCFs, nurses, residents and family of
residents in long term care facilities, State regulatory agencies, and
other interested members of the public. Specifically, DEA is exploring
whether--while adhering to the framework of the Controlled Substances
Act--any further revisions to the DEA regulations are feasible and
warranted toward the goal of making it easier for residents of LTCFs to
receive controlled substance medications. This notice recites the
pertinent statutory considerations and contains a series of questions
designed to elicit public comment that will assist DEA in making this
DATES: Written comments must be postmarked and electronic comments must
be submitted on or before August 30, 2010. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after midnight Eastern Time on the last day of the comment
ADDRESSES: To ensure proper handling of comments, please reference
"Docket No. DEA-337'' on all written and electronic correspondence.
Written comments being sent via regular or express mail should be sent
to the Drug Enforcement Administration, Attention: DEA Federal Register
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.
Comments may be sent to DEA by sending an electronic message to
firstname.lastname@example.org. DEA will accept attachments to
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel
file formats only. DEA will not accept any file formats other than
those specifically listed here.
Please note that DEA is requesting that electronic comments be
submitted before midnight Eastern Time on the day the comment period
closes because http://www.regulations.gov terminates the public's
ability to submit comments at midnight Eastern Time on the day the
comment period closes. Commenters in time zones other than Eastern Time
may want to consider this so that their electronic comments are
received. All comments sent via regular or express mail will be
considered timely if postmarked on the day the comment period closes.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152;
telephone: (202) 307-7297.
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at http://www.regulations.gov and in the Drug
Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase "PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase "CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. Please note
that the Freedom of Information Act applies to all comments received.
If you wish to inspect the agency's public docket file in person by
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.
In enacting the Controlled Substances Act (CSA) in 1970, Congress
recognized at the outset of the Act that while "[m]any of the drugs
included with [the Act] have a useful and legitimate medical purpose
and are necessary to maintain the health and general welfare of the
American people, * * * [t]he illegal * * * distribution, and possession
and improper use of controlled substances have a substantial and
detrimental impact on the health and general welfare of the American
people.'' 21 U.S.C. 801. To minimize the likelihood that pharmaceutical
controlled substances would be diverted into illicit channels, Congress
established under the CSA a "closed system of drug distribution'' for
legitimate handlers of controlled substances. This system is comprised
of a series of statutory provisions designed to ensure that all persons
in the legitimate distribution chain are registered and keep records
with respect to all transfers of controlled substances. Another key
element of the CSA regulatory scheme is the requirement (first
established under Federal law in 1914) that controlled substances only
be dispensed for a legitimate medical purpose by DEA-registered
practitioners acting in the usual course of their professional
As the agency responsible for enforcing the CSA and administering
the regulatory provisions of the Act, DEA has continually sought to
reevaluate the regulations within the statutory framework. That is, any
DEA regulation must maintain the statutory requirements of the CSA.
Also, whenever DEA is evaluating whether to revise the regulations, the
agency must take into account the dual aims of facilitating the
delivery of controlled substance medications to patients for legitimate
medical purposes and safeguarding against the diversion of these drugs
into illicit channels.
DEA regulates controlled substances which account for between 10
percent and 11 percent of all prescriptions written in the United
States. Controlled substances are drugs and other substances that have
a potential for abuse and psychological and physical dependence; these
include opioids, stimulants, depressants, hallucinogens, anabolic
steroids, and drugs that are immediate precursors of these classes of
substances. The CSA and implementing regulations at 21 CFR 1308 list
controlled substances and place them in five schedules based on whether
they have an accepted medical use in the United States and their
relative abuse potential and likelihood of causing dependence when
abused. The degree of restriction under the CSA depends upon the
schedule of a given controlled substance. The intent of the statute and
regulations is to protect the public health and safety by ensuring that
there is a sufficient supply of controlled
substances for medical, scientific, and other legitimate purposes while
preventing and deterring the diversion of controlled substances to
Schedule I substances have a high potential for abuse and have no
accepted medical use in treatment in the United States. 21 U.S.C.
812(b)(1). These substances may only be used for research, chemical
analysis, or manufacture of other drugs. Schedule II controlled
substances have accepted medical use in treatment in the United States
while having a high potential for abuse and having the greatest
potential for physical and psychological dependence of the FDA-approved
pharmaceutical controlled substances. 21 U.S.C. 812(b)(2). For this
reason, Schedule II controlled substances are subject to the highest
levels of controls among FDA-approved controlled substances. Examples
of schedule II narcotics include morphine, codeine, and opium. Some
common brand names include hydromorphone (Dilaudid[supreg]), methadone
(Dolophine[supreg]), meperidine (Demerol[supreg]), oxycodone
(OxyContin[supreg]), and fentanyl (Sublimaze[supreg] or
Duragesic[supreg]). Schedule II narcotics are commonly prescribed for
the treatment of moderate to severe pain.
Controlled substances in Schedules III-V have an accepted medical
use in the United States and have a lower dependence and abuse
potential than Schedule II substances. 21 U.S.C. 812(b)(3), (4), (5).
Thus, the statutory and regulatory restrictions on Schedule III-V
substances, while significant, are not as extensive as those for
Schedule II substances. Examples of schedule III narcotics include
combination products containing less than 15 milligrams of hydrocodone
per dosage unit (Vicodin[supreg], Lorcet[supreg], and Lortab[supreg])
and products containing not more than 90 milligrams of codeine per
dosage unit (i.e., Tylenol with codeine[supreg]). Schedule III
narcotics are commonly prescribed for moderate pain. Substances in this
schedule have a lower potential for abuse relative to substances in
Examples of Schedule IV substances include propoxyphene
(Darvon[supreg] and Darvocet-N 100[supreg]), alprazolam
(Xanax[supreg]), clonazepam (Klonopin[supreg]), and triazolam
(Halcion[supreg]). Examples of Schedule V substances are cough
preparations containing not more than 200 milligrams of codeine per 100
milliliters or per 100 grams (Robitussin AC[supreg], and Phenergan with
Long Term Care Facilities
With specific regard to nursing homes and other Long Term Care
Facilities (LTCFs), DEA has made a number of revisions to the
regulations over the years to make it easier for residents of these
facilities to receive controlled substance medications, including the
For schedule II controlled substances, a practitioner or a
practitioner's agent may fax to a pharmacy a prescription written by
the practitioner for a LTCF resident. 21 CFR 1306.11(f). This
accommodation obviates the need to physically deliver a hard copy of
the original written prescription to the pharmacy. It should be noted
that allowance for faxing prescriptions for schedule II controlled
substances is not permissible as a general rule in non-LTCF settings.
Pharmacies may install at a LTCF (but in no other setting)
an automated dispensing system (ADS). 21 CFR 1301.27. As with all
dispensing of controlled substances by pharmacies, such dispensing must
still be pursuant to valid prescription, but these machines can
alleviate certain burdens in the LTCF setting by placing the supply of
controlled substances directly on site for convenient dispensing to a
resident. Once a pharmacy receives a valid prescription issued by the
practitioner, the pharmacy initiates the release of the prescribed
drugs from the automated dispensing system at the LTCF by remotely
entering a code. Thereafter, a practitioner or authorized nurse at the
LTCF enters another code that completes release of the drugs from the
machine. In this manner, pharmacies may, in their discretion, dispense
small amounts of the drugs (e.g., daily doses) rather than the entire
amount indicated on the prescription at one time. The automated
dispensing systems may be used in both emergency and nonemergency
situations. The automated dispensing systems thereby provide at least
two benefits: (1) They allow for immediate dispensing of controlled
substances in emergency situations and (2) they help to prevent
accumulation of unused medications at the LTCF.
The regulations make a special allowance in the LTCF
setting for partial filling by pharmacists of prescriptions for
schedule II controlled substances. 21 CFR 1306.13(b). Under this
provision, where the patient is a resident of a LTCF (or is terminally
ill), such partial filling may occur as long as the amount dispensed
does not exceed the total prescribed and occurs within 60 days of the
date that the prescription was written. This lessens the extent to
which LTCFs accumulate unused controlled substances.
Although the CSA prohibits the refilling of prescriptions
for schedule II controlled substances (21 U.S.C. 829(a)), DEA has
issued a regulation that allows practitioners to issue multiple
sequential prescriptions authorizing a patient to receive up to a 90-
day supply for these substances. 21 CFR 1306.12. This accommodation
applies to all practitioners, not just those with patients in LTCFs,
but it can be particularly useful in the LTCF setting where physicians
sometimes visit the residents only once every 30 or 60 days.
To facilitate the dispensing of controlled substances in
emergencies, DEA has allowed pharmacies to place in LTCFs "emergency
kits'' that are routinely stocked with commonly dispensed controlled
substances (45 FR 24128, April 9, 1980). These kits are considered
extensions of the pharmacy and are controlled under the pharmacy's DEA
registration. Again, the same requirement of a valid prescription
delivered to the pharmacy prior to dispensing applies with respect to
these kits; however, they provide an immediate supply of the drugs in
emergencies and eliminate the need to wait for a delivery from the
pharmacy in such circumstances.
DEA is continuing to evaluate whether further regulatory changes
are warranted for the LTCF setting and is seeking public comment on
this topic. As indicated, the dispensing of controlled substances to
residents of LTCFs--as with the dispensing of controlled substances to
patients in any other setting--must take place in accordance with the
CSA. Thus, in order to consider what types of controlled substance
dispensing practices might be permissible in a LTCF setting, and
whether any revisions to the DEA regulations might be warranted to
accommodate such practices, the provisions of the CSA governing the
dispensing of controlled substances must be considered. The following
is a brief summary of these provisions, which have remained consistent
since the enactment of the CSA in 1970.
The registration requirement--As set forth in 21 U.S.C. 822(a),
every person who dispenses any controlled substance must obtain a DEA
registration issued in accordance with the agency regulations. The
regulations governing registration are set forth in 21 CFR Part 1301.
Persons registered with DEA are authorized to dispense controlled
substances only to the extent authorized by their registration and in
conformity with the CSA. 21 U.S.C. 822(b). In addition, to be eligible
under the CSA to obtain a registration to dispense controlled
substances, a practitioner--which could be an individual (such as
a physician), an institution (such as a hospital), or a pharmacy--must
be licensed or otherwise authorized to dispense controlled substances
under the laws of the State in which the practitioner practices. 21
U.S.C. 802(21), 823(f), 824(a)(3).
The recordkeeping requirement--As set forth in 21 U.S.C. 827(a),
every registrant authorized to dispense controlled substances must
maintain, on a current basis, a complete and accurate record of each
such substance dispensed.
The prescription requirement--The requirement of a prescription is
set forth in 21 U.S.C. 829. For schedule II controlled substances, this
provision states, in pertinent part:
Except when dispensed directly by a practitioner, other than a
pharmacist, to an ultimate user, no controlled substance in schedule
II, which is a prescription drug * * *, may be dispensed without the
written prescription of a practitioner, except that in emergency
situations * * *, such drug may be dispensed upon oral prescription
in accordance with [21 U.S.C. 353(b)].
21 U.S.C. 829(a).
For schedule III and IV controlled substances, the pertinent part
of the statute states:
Except when dispensed directly by a practitioner, other than a
pharmacist, to an ultimate user, no controlled substance in schedule
III or IV, which is a prescription drug * * * may be dispensed
without a written or oral prescription in conformity with [21 U.S.C.
21 U.S.C. 829(b).
Prescriptions are required to contain specific information
including: patient name and address; drug name, strength, dosage form,
quantity prescribed, directions for use; and name, address, and DEA
number of the issuing practitioner. 21 CFR 1306.05(a). All
prescriptions for controlled substances must be dated as of, and signed
on, the day when issued.
Two aspects of these statutory provisions bear emphasis here.
First, in those situations in which a controlled substance is not
dispensed directly by a practitioner (e.g., it is dispensed by a
pharmacy), the dispensing must be pursuant to a prescription issued by
a practitioner. Second, the prescription must be issued in writing by
the practitioner if the drug is a schedule II controlled substance
(except in an emergency, in which an oral prescription issued by the
practitioner is permitted); whereas the prescription may be issued in
writing or orally by the practitioner if the drug is a schedule III or
IV controlled substance.
The requirement of a legitimate medical purpose in the usual course
of professional practice--As the United States Supreme Court explained
in United States v. Moore, 423 U.S. 122, 136-138 (1975), implicit in
the CSA is the requirement that every 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. As the Supreme Court stated in Moore, id., this implicit
requirement of the CSA is made explicit in a provision of the DEA
regulations, 21 CFR 1306.04(a), which states:
A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice. The responsibility for the proper prescribing and
dispensing of controlled substances is upon the prescribing
practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription. An order purporting to be a
prescription issued not in the usual course of professional
treatment or in legitimate and authorized research is not a
prescription within the meaning and intent of [21 U.S.C. 829] and
the person knowingly filling such a purported prescription, as well
as the person issuing it, shall be subject to the penalties provided
for violations of the provisions of law relating to controlled
The Moore decision also makes clear that, under the CSA, the
requirement of a legitimate medical purpose in the usual course of
professional practice is tied to the concept of registration. The
Supreme Court stated, with respect to the prescribing and dispensing of
controlled substances, "only the lawful acts of registrants are
exempted'' from the CSA's general prohibition on dispensing controlled
substances. Id. at 131 (emphasis added). Further, the Court stated that
the CSA was intended "to limit a registered physician's dispensing
authority to the course of his `professional practice' '' and that the
registration of a practitioner "is limited to the dispensing and use
of drugs `in the course of professional practice * * *.' '' Id. at 140-
The foregoing aspects of the CSA, viewed collectively, can be
reiterated as setting forth the following principles:
To lawfully dispense a controlled substance to a patient,
the dispenser must be in one of the following two categories: (1) A
practitioner authorized to dispense controlled substances directly to
patients (such as a physician or a hospital) or (2) a pharmacy or other
entity authorized to dispense controlled substances pursuant to a
prescription issued by a practitioner.
For either of the foregoing two categories of dispensers,
the dispenser must be licensed or otherwise authorized under State law
to engage in such activity and also have a DEA registration authorizing
Because controlled substances may only be dispensed for a
legitimate medical purpose by a practitioner acting in the usual course
of professional practice, and only a DEA-registered practitioner may
make the determination there is such a legitimate medical purpose for a
given instance of dispensing, a DEA registrant may not delegate to a
subordinate the medical decision making that must underlie each
instance of dispensing.
Accordingly, to be consistent with the CSA, any type of arrangement
under which controlled substances would be dispensed to patients who
reside in LTCFs must adhere to the foregoing principles.
Note Regarding Electronic Prescribing of Controlled Substances
DEA revised its regulations effective June 1, 2010 to provide
practitioners with the option of writing prescriptions for controlled
substances electronically. 75 FR 16236, March 31, 2010. The regulations
also permit pharmacies to receive, dispense, and archive these
electronic prescriptions. This rule provides another tool for
practitioners to use when prescribing a controlled substance for their
patients, including those who reside in a LTCF. This rule allows a
practitioner to use a computer, laptop or personal digital assistant
(PDA) to send a prescription to a pharmacy from a remote location
instantaneously. The basic framework of the CSA outlined above remains
in effect with respect to the issuance of electronic prescriptions.
Note Regarding Authority of Agents of Individual Practitioners
While a prescription for a controlled substance must always be
issued by a DEA-registered practitioner (rather than the agent of a
practitioner), an agent may, under certain circumstances, be involved
in the transmission of the prescription to the pharmacy. The general
statutory requirements, as implemented through regulations, are
The CSA provides that--except in emergency situations--a controlled
substance in schedule II may only be dispensed by a pharmacy pursuant
to a written prescription signed by a practitioner. 21 U.S.C. 829(a).
The written prescription generally must be directly, physically
provided to the pharmacist.\1\ Where the patient is a
resident of a LTCF, and the drug being dispensed is a schedule II
controlled substance, the DEA regulations permit an individual
practitioner, or his agent where a valid agency relationship exists, to
transmit by facsimile to the pharmacy a written prescription that has
been issued and signed by the practitioner. 21 CFR 1306.11(f).
\1\ As stated above, DEA has recently issued regulations
allowing for the electronic prescribing of controlled substances.
Where a practitioner issues an electronic prescription in accordance
with these regulations, such a prescription constitutes a written
prescription within the meaning of the CSA. When such an electronic
prescription is used, the prescription information is conveyed
electronically from the practitioner to the pharmacy, rather than
through the delivery to the pharmacy of a hard copy of the
prescription that was signed by the practitioner.
As indicated, the CSA contains an exception that allows
practitioners to issue oral prescriptions for schedule II controlled
substances in an emergency. 21 U.S.C. 829(a). In this context, Congress
assigned to the Secretary of HHS, in consultation with the Attorney
General, responsibility for defining the term "emergency'' by
regulation. The Secretary delegated this responsibility to the Food and
Drug Administration, which set forth the definition of "emergency'' in
21 CFR 290.10. Assuming the situation constitutes a bona fide emergency
within the meaning of the FDA regulation, and a practitioner determines
that such emergency warrants the dispensing of a schedule II controlled
substance, a pharmacy may dispense the medication upon receiving oral
authorization from the practitioner in accordance with 21 CFR
1306.11(d). That regulation requires, among other things, that the
quantity prescribed and dispensed be limited to the amount adequate to
treat the patient during the emergency period, and that the
practitioner follow up within 7 days with a written prescription to the
dispensing pharmacy. 21 CFR 1306.11(d). The regulation further requires
the pharmacy to make a reasonable effort to determine that the oral
authorization came from the practitioner, which may include a callback
to the practitioner using his phone number as listed in the telephone
For controlled substances in schedules III-V, the CSA provides that
a pharmacy may dispense pursuant to a "written or oral prescription.''
21 U.S.C. 829(b). Where an oral prescription is permitted by the CSA,
the DEA regulations also provide that a practitioner may transmit to
the pharmacy a facsimile of a written, manually signed prescription in
lieu of an oral prescription. 21 CFR 1306.21(a). As a result, a
prescription issued by a practitioner for substance in schedules III-V
may be transmitted to a pharmacy in the following ways: (1) By delivery
to the pharmacy of the original, written prescription signed by the
practitioner; (2) by the practitioner or his agent (where a valid
agency relationship exists) faxing the written prescription signed by
the practitioner; or (3) by the practitioner or his agent (where a
valid agency relationship exists) orally transmitting the prescription
to a pharmacy, where it is promptly reduced to writing by the
pharmacist prior to dispensing. 21 CFR 1306.21(a) and 1306.03(b).
As previously discussed, the CSA does not permit the prescribing
practitioner to delegate to an agent or any other person the
practitioner's authority to issue a prescription for a controlled
substance. Thus, the determination of a legitimate medical purpose must
be made by the practitioner acting in the usual course of their
professional practice; the determination may not be made by the agent.
Likewise, the required elements of the prescription (set forth in 21
CFR Part 1306) must be specified by the prescribing practitioner--not
the agent. The pharmacist who fills a prescription for a controlled
substance has a corresponding responsibility to ensure that these
requirements have been met. 21 CFR 1306.04(a), 1306.05(a).
Other Considerations Regarding State Licensure
As indicated, to be eligible for a DEA registration, a practitioner
must be licensed or otherwise authorized by the State in which he
practices to carry out the specific activity for which he seeks a
registration. This typically entails a determination by the applicable
State regulatory body that the practitioner meets certain
qualifications. For example, to practice medicine, States generally
require that a physician obtain a medical license issued by the State
medical board, which typically requires the physician to demonstrate
the completion of certain education and training, to pass an
examination demonstrating competency to practice medicine, and to
undergo a background check to verify professional competence, ethics,
and character. To operate a hospital, States generally require, at a
minimum, that the facility obtain a license from the State public
health department, which typically requires the facility to demonstrate
that it has appropriate levels of qualified healthcare professional
staff (physicians, nurses, etc.) and facilities to provide a proper
standard of hospital service to the community. As part of the licensure
process, States may also require that the hospital demonstrate specific
qualifications to provide particular types of services. In addition,
some States may require hospitals to obtain accreditation and/or
certification from public and private agencies. To operate a pharmacy,
States generally require the pharmacy to obtain a license from the
State board of pharmacy, which also typically requires a showing of
properly qualified staff and facilities.
Thus, by requiring practitioners to obtain a State license or other
State authorization as a prerequisite to obtaining a DEA registration,
the CSA ensures that controlled substances are only dispensed by those
persons who have appropriate professional qualifications and who follow
Accordingly, to remain consistent with the CSA, if a LTCF were to
be eligible to obtain a DEA registration, it would need to have the
requisite State license or other State authorization that is
commensurate with the extent of the qualifications of its staff and
with its ability to adhere to applicable professional standards for
dispensing controlled substances to patients.
Distinctions Between LTCFs and Hospitals
An important distinction between LTCFs and hospitals is that States
authorize hospitals to have independent controlled substances authority
and accordingly hospitals may register with DEA. This means, among
other things, that hospitals are authorized to maintain common stocks
of controlled substances for immediate dispensing or administration
pursuant to a practitioner's medication order and are subject to DEA
regulatory oversight and inspection. LTCFs, on the other hand,
typically have no independent State controlled substances authority and
accordingly are not eligible to become DEA registrants, as explained
above. This means they may not maintain common stocks of controlled
substances. Therefore, any prescribed controlled substance medication
in a LTCF is deemed, for CSA purposes, to be possessed by the resident
and not the facility. A further consequence of their lack of DEA
registration is that LTCFs are not subject to direct DEA regulatory
oversight and inspection, security and recordkeeping requirements, or
administrative action (suspension or revocation of registration).
There are a variety of reasons that States may currently treat
LTCFs differently than hospitals. For example, although LTCFs provide
care for residents, the nature of their practice is not the same as
that of a hospital. LTCF
residents typically reside in these facilities for long periods of time
and have health issues and disorders that require long-term medical
attention. Generally, they do not receive daily care from an on-site
physician; and, indeed, many facilities do not employ a physician as
part of their staff 24 hours a day. Likewise, the extent to which
registered nurses (rather than licensed practical nurses or nursing
assistants) are involved in resident care is generally less in LTCFs
than in hospitals. Also, in contrast to the length of stays of
residents of LTCFs, patients in hospitals are typically there for short
periods of time and are regularly monitored by their attending
physician or hospital staff physicians.
Note Regarding Chart Orders
As explained above, because a DEA-registered hospital is a
"practitioner'' within the meaning of the CSA, it is permissible under
the Act for such a hospital to dispense controlled substances directly
to patients without a prescription. 21 U.S.C. 829(a), (b). Because of
this, in a hospital setting, a hospital may dispense a controlled
substance, for immediate administration to a patient, pursuant to an
order for medication made by a physician (or other individual
practitioner) who is an employee or agent of the hospital. 21 CFR
1306.11(c). This may occur, for example, through the issuance of a
"chart order'' by a hospital physician. In this context, the term
"chart order'' should be distinguished from the term "prescription.''
A prescription--unlike a chart order--must contain all the information
specified in 21 CFR 1306.05 (including, among other things, the
signature of the physician).\2\
\2\ If a physician wrote all the elements of a prescription
specified in 21 CFR 1306.05(a) on a patient's chart, including the
signature on the date when issued, this would be considered a valid
"prescription'' within the meaning of the CSA and DEA regulations,
and such document containing all the required elements could be
delivered to a pharmacy for dispensing in accordance with 21 U.S.C.
It bears emphasis that regardless of whether the controlled
substance is dispensed by a pharmacy pursuant to a prescription or
hospital pursuant to a chart order, the person who issues the
prescription or order must be authorized under the CSA to make the
medical determination, while acting in the usual course of professional
practice, that there is a legitimate medical purpose for the drugs to
be dispensed to the patient. The CSA ensures this condition is
satisfied by allowing only those practitioners who have obtained the
requisite State licensure and DEA registration to make such medical
determination and issue the corresponding prescription or chart order.
Another point worth noting is that, in the hospital setting, where a
physician issues a chart order for a controlled substance, the
physician, as well as the nursing staff and hospital pharmacy staff who
take certain steps in carrying out the order, are all acting as
employees or agents of the DEA-registered hospital and thus are
collectively viewed as the "practitioner'' within the meaning of the
CSA. The physician who issues the chart order is doing so under the
hospital's DEA registration number in accordance with the requirements
of 21 CFR 1301.22(c). The hospital is, therefore, responsible for
ensuring that all such persons are acting in accordance with the CSA
and DEA regulations, and any failure to do so may result in criminal or
civil liability on the part of the hospital or loss of the hospital's
DEA registration. These legal consequences are part of the fabric of
the CSA that promotes compliance with the Act.
As indicated, most LTCFs are not licensed by the State as hospitals
or other practitioners authorized to dispense controlled substances
directly to patients, and thus they are not eligible under the CSA for
registration as practitioners.
Other Federal Regulations Governing Long Term Care Facilities
For purposes of the CSA, DEA defines the term "long term care
facility'' (LTCF) as "a nursing home, retirement care, mental care, or
other facility or institution which provides extended health care to
resident patients.'' 21 CFR 1300.01(b)(25). The Secretary of Health and
Human Services (HHS) applies more specific definitions for purposes of
defining facilities eligible to participate in Medicare and Medicaid.
42 CFR 483.5.
HHS establishes requirements deemed necessary for the health and
safety of individuals to whom services are furnished in nursing
facilities participating in Medicare and Medicaid. 42 CFR 483.1. For
example, basic resident rights and obligations are outlined along with
certain basic responsibilities of the facility. Some of these
responsibilities include facility organization such as requiring a
medical director (42 CFR 483.5(b)(2)(iii)) and maintaining a quality
assessment and assurance committee consisting of a physician, the
director of nursing services and three others. 42 CFR 483.75(o). The
facility must operate and provide services in compliance with all
applicable Federal, State and local laws and professional standards. 42
Other HHS requirements for LTCFs establish a level of care. For
example, the facility must perform periodic assessments of a resident's
needs (42 CFR 483.20(b), (c)) and must establish and follow nursing
services standards. 42 CFR 483.30. Among requirements for physician
The facility must have physician orders for the resident's
immediate care at the time each resident is admitted. 42 CFR 483.20(a).
Each resident must remain under the care of a physician
and there must be physician supervision when their attending physician
is unavailable. 42 CFR 483.40(a).
The facility must provide or arrange for the provision of
physician services 24 hours a day, in case of an emergency. 42 CFR
The facility must provide or obtain laboratory services
only when ordered by the attending physician. 42 CFR 483.75(j)(2)(i).
A physician may not delegate a task when the regulations
specify that the physician must perform it personally, or when the
delegation is prohibited under State law or by the facility's own
policies. 42 CFR 483.40(e)(2).
A few of the requirements with respect to medications are that:
The facility must employ or obtain the services of a
licensed pharmacist to establish a system of records of receipt and
disposition of all controlled drugs and, among other responsibilities,
to review the drug regimen of each resident at least monthly. 42 CFR
The facility must establish minimal requirements for
quality of care, including that a resident's drug regimen must be free
from unnecessary drugs as defined in 42 CFR 483.25(l).
The facility must also provide separately locked,
permanently affixed compartments for storage of controlled drugs listed
in Schedule II and other drugs subject to abuse unless the facility
uses single unit package drug distribution systems in which the
quantity stored is minimal and a missing dose can be readily detected.
42 CFR 483.60(e)(2).
Among the standards required for the provision of hospice-
related inpatient care in a participating Medicare/Medicaid facility is
the hospice's responsibility to provide "drugs necessary for the
palliation of pain and symptoms associated with the terminal illness
and related conditions.'' 42 CFR 418.112(c)(6).
As an element of certification and enforcement, HHS utilizes
"surveys'' of a given facility. These various surveys gather periodic,
resident-centered information about the quality of service furnished in
a facility to determine compliance with the requirements for
participation in Medicare and Medicaid. 42 CFR 488.301.
Solicitation of Information
Within the foregoing statutory framework, DEA is hereby seeking
input from interested members of the public regarding the types of
lawful controlled substance dispensing practices currently taking place
in the LTCF setting or which might take place if appropriate amendments
to the DEA regulations were issued that comported with the CSA. Along
similar lines, DEA is seeking comment on the types of controlled
substance licensing authorities that States currently provide to LTCFs,
or which States might be willing to provide in the future. To
facilitate the gathering of relevant information, DEA has specific
questions that appear below. These questions are separated into general
issues. Commenters are encouraged to reference the question number
enumerated below in their response.
The terminology used to describe and classify facilities that DEA
considers to be LTCFs varies between agencies and from State to State.
1. The definitions of facilities for Medicare reimbursement
purposes are different in many respects from the terms used in DEA
regulations. The DEA regulations define a LTCF as "a nursing home,
retirement care, mental care or other facility or institution which
provides extended health care to resident patients.'' How do State
regulators/licensing authorities define facilities that DEA would
2. Are all LTCFs Medicare/Medicaid facilities? If not, what
differentiates a facility that is not a Medicare/Medicaid facility from
one that is?
3. What does the term "prescription'' mean as used in a LTCF?
4. What does the term "chart order'' mean as used in a LTCF?
5. What does the term "standing order'' mean as used in a LTCF?
6. For how many residents does your LTCF provide care? Of those,
what percentage require controlled substance medications?
7. Approximately what percentage of those residents requiring
controlled substance medications receive such medications on a daily
basis? Further, of those who receive controlled substances on a daily
basis, what percentage receive Schedule II controlled substances?
8. When a person comes to a LTCF, does the person bring their own
9. What, if any, State requirements impact a person's ability to
bring medication into a LTCF?
10. If a person arrives at the facility without any medication
information, how does the facility obtain any needed medications?
11. If a person is moving from an acute care facility to a LTCF,
what factors impact the acute care practitioner's ability and
willingness to provide written prescriptions to the person?
12. If a person arrives at a facility without medication and
without prescriptions, what steps does the facility take to assess the
person's medication needs?
13. What are the current practices for obtaining controlled
substance prescriptions for residents at a LTCF? How do these practices
differ between Schedule II controlled substances and Schedule III-V
controlled substances? How do these practices differ between an
emergency situation and a non-emergency situation?
14. What types of emergency situations arise at a LTCF that would
necessitate the use of controlled substances?
15. What are the standard operating procedures to address
emergencies? What are the procedures in a LTCF for obtaining controlled
substance medications for residents in an emergency situation? Is the
process different for Schedule II as opposed to Schedule III-V
16. Has your facility experienced delays in obtaining controlled
substance medications for residents? If so, why have these delays
occurred? At what steps in the prescribing process have these delays
occurred? Please specify whether the delay was with a Schedule II
controlled substance or with a substance in Schedule III through V.
17. Have any residents at your facility experienced problems caused
by delays in obtaining prescriptions for controlled substances? If so,
what was the reason for the delay? How often have such problems
occurred? Did the delays occur with Schedule II controlled substances
or with substances in Schedule III through V?
18. Does your facility send residents to the hospital to receive
controlled substance medications because they were unable to receive
the medications at your facility in a timely manner? If so, how many
times did this occur in the last 12 months?
19. How often are practitioners contacted by LTCFs regarding
requests for changes in residents' medications generally? How often
does this occur for controlled substance prescriptions specifically?
20. How does communication currently occur among the practitioner,
the LTCF and the pharmacy, e.g. phone, fax, other? Do you expect the
new DEA regulations providing the option of electronic prescriptions
will be used by practitioners and pharmacies in your LTCF setting? If
so, do you anticipate that the use of electronic prescriptions will
alleviate delays you may have experienced in providing controlled
substances to residents?
21. Does the LTCF or practitioner communicate other information to
the pharmacy, such as changes in the resident's practitioner or the
change in status of a resident?
22. Would practitioners have any interest in designating certain
persons at LTCFs as their agents solely for the purpose of
communicating controlled substance prescription information to the
pharmacy, understanding that the agent would be working under the
prescriber's DEA registration and that the prescriber would be
responsible for the agent's actions, which must be consistent with the
D. Pharmacy Service
23. Would your LTCF be amenable to having a pharmacy on site as an
integral element of the LTCF? If so, would you seek to have the
pharmacy operate under a registration granted to the LTCF or operate
independently at the LTCF under its own pharmacy registration?
24. Does your State allow pharmacies to install and operate
automated dispensing systems at LTCFs? If not, is your State
considering allowing them to do so?
E. Chart Orders
Additional information about the current use of chart orders for
other than controlled substances would be helpful.
25. In current practice, when must a practitioner acknowledge a
chart order by signing it? Do State laws/regulations, HHS regulations,
or other standards (e.g. Joint Commission) define the time period
within which the practitioner must sign the chart order for any care
setting (hospital, clinic, or LTCF)?
26. Currently, are chart orders (in hospitals or in LTCFs for non-
controlled substances) required to have an
"expiration'' date, at which time they must be either reauthorized or
closed? LTCFs differ from hospitals in that residents in LTCFs by
definition stay for a longer period. Because of this, should chart
orders in LTCFs "expire'' at some time after issuance? If so, what
time period would be appropriate?
27. If certain persons at the LTCF were designated to act as agents
of individual practitioners (to the extent authorized by the CSA) to
communicate controlled substance information from the individual
practitioner to the pharmacy, how would this change current practices
at your facility for obtaining controlled substance medications for
residents? What safeguards should be required?
F. State Regulatory Authorities
28. What authority does your State currently give LTCFs for
handling and managing controlled substances? Which agency is
responsible for such authority?
29. What controlled substance activities, if any, are authorized,
e.g. prescribing, administering, or dispensing? In what schedules? How
many LTCFs apply for any such authorization and how many receive such
30. What State requirements are there pertaining to the storage of
controlled substances at LTCFs?
31. Is your State considering giving/increasing LTCFs' authority to
handle/dispense controlled substances? If so, is your State considering
creating a new type of registration just for LTCFs or would your State
consider allowing LTCFs to register as institutional practitioners like
32. What changes in State pharmacy and LTCF laws/regulations would
be necessary for pharmacies to operate in LTCFs under a registration
granted to the LTCF or to operate independently at the LTCF under its
own pharmacy registration?
33. Do State laws or regulations specify or limit access to
emergency kits or to controlled substances in LTCFs?
34. Do State inspectors check the records and stock of emergency
kits? If so, how often?
To be eligible for Medicare or Medicaid reimbursement, nursing
facilities and skilled nursing facilities must be inspected by State
officials for compliance with HHS requirements. HHS regulations, for
instance, impose staffing requirements and requirements regarding the
safekeeping of drugs.
35. How often do State regulators inspect LTCFs? What is the legal
requirement in your State for frequency of inspection, and what is the
36. Has your LTCF sought accreditation by the Joint Commission or
other non-governmental accrediting organization? What do LTCFs see as
the advantages and disadvantages of seeking such accreditation?
37. Does the Medical Director of your facility also serve as
Medical Director for other locations or facilities? If so, for how
38. Is the Medical Director of your facility also an attending
39. Is your Medical Director registered with DEA as a practitioner?
40. If your LTCF is a Medicare or Medicaid approved facility, what
barriers, if any, has your facility faced in assuring the provision of
physician services 24 hours a day in case of an emergency?
41. As a LTCF, does your facility have a physician on site during
regular business hours?
42. How does your facility communicate with a resident's
43. How frequently is a physician on site at your facility? Do most
physicians treat multiple residents at a single facility?
44. Does your facility have a registered nurse on duty for more
than 8 hours a day, 7 days a week? Less?
45. When a registered nurse is not on duty at your facility, how
are procedures relating to medications different?
46. What are the State education and continuing education
requirements for licensed nurses other than registered nurses (LPNs,
etc)? Does the State require a criminal background check prior to
47. What role do nurses' aides have in helping residents get their
48. What are the State education and continuing education
requirements for nurses' aides? Does your State license nurses' aides?
49. What personnel/job descriptions have access to emergency kits
in your facility?
50. What personnel/job descriptions have access to controlled
substance storage in your facility? Are temporary employees or
volunteers given access?
51. What personnel/job descriptions have authority to contact the
pharmacy to relay a noncontrolled substance prescription/drug order for
I. Emergency Kits
52. Does your facility have an emergency kit that contains
controlled substances? If so, what controlled substances does your
emergency kit contain?
53. If your facility has an emergency kit that contains controlled
substances, how are those controlled substances procured and dispensed?
54. What are the current controlled substance inventory protocols
for any emergency kit and/or automated dispensing system at your LTCF?
55. What records document receipt and dispensing of controlled
substances to and from this kit?
56. How often in the last two years have controlled substances been
lost or stolen from an emergency kit at your facility?
Please submit written comments no later than August 30, 2010 using
the address information provided at the beginning of this document.
Dated: June 24, 2010
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2010-15757 Filed 6-28-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).