Federal
Register Notices > Rules -
2007 > Issuance of
Multiple Prescriptions for Schedule II Controlled Substances
FR Doc E7-22558[Federal Register: November 19, 2007 (Volume 72, Number
222)] [Rules and Regulations] [Page 64921-64930] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr19no07-2]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA-287F] RIN 1117-AB01
Issuance of Multiple Prescriptions for Schedule II Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice
ACTION: Final rule.
SUMMARY: The Drug Enforcement Administration (DEA) is finalizing a
Notice of Proposed Rulemaking published on September 6, 2006 (71 FR 52724). In
that document, DEA proposed to amend its regulations to allow practitioners to
provide individual patients with multiple prescriptions, to be filled
sequentially, for the same schedule II controlled substance, with such
multiple prescriptions having the combined effect of allowing a patient to
receive over time up to a 90- day supply of that controlled substance.
DATES: Effective Date: This rule is effective December 19, 2007.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Background
On September 6, 2006, the Drug Enforcement Administration (DEA) published
in the Federal Register a Notice of Proposed Rulemaking (NPRM) (71 FR 52724)
proposing to amend its regulations to allow practitioners to provide
individual patients with multiple prescriptions, to be filled sequentially,
for the same schedule II controlled substance, with such multiple
prescriptions having the combined effect of allowing a patient to receive over
time up to a 90- day supply of that controlled substance.
Comments Received
DEA received 264 comments regarding the NPRM. Two hundred thirty- one
commenters supported the NPRM, 33 commenters opposed the rulemaking.
Commenters supporting the NPRM included six physician associations, including
those representing anesthesiologists, pediatricians, and psychiatrists, and
three state level licensing organizations;
[[Page 64922]]
five nursing associations, including several nursing specialty
associations; 3 pharmacy associations and 6 state boards of pharmacy; 17
organizations focusing on the treatment of pain and end of life issues; 8
other organizations; and individual commenters including 73 pain patients, 65
physicians or physicians' offices, 31 parents of children with attention
deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD), 30
individual citizens, 16 pharmacists, 5 nurses, and 2 physician's assistants.
Commenters opposing the NPRM included 1 organization focusing on the treatment
of pain; 17 individual citizens; 8 physicians; 3 pharmacists or pharmacy
workers; 2 parents of pain patients; 1 nurse; and 1 physician's assistant.
The vast majority of commenters supported the rulemaking as proposed,
although some commenters suggested various changes or requested clarification
of certain issues. DEA has carefully considered all comments received. An
in-depth discussion of the issues raised by commenters and DEA's responses to
those comments follows.
Discussion of Comments
Of the 264 comments DEA received, 166 expressed approval of the proposed
rule without change. The remainder of the comments either objected to the
proposed rule or suggested modifications thereto. The major issues raised by
the commenters are addressed below.
Comments expressing approval of the proposed rule without change:
Commenters who expressed support for this rule represented a broad variety of
interest groups, medical professionals, pharmacists, and patients. General
comments regarding the support for this rule and the benefits commenters
believed it will have appear below.
Patients being treated for pain: Commenters who described themselves
as patients who receive controlled substances for the treatment of pain were
very supportive of implementation of the rule as proposed. These commenters
noted that the allowance for multiple prescriptions would reduce the number of
visits they would need to make to practitioners, which would be beneficial
financially. Many of these patients indicated they are unemployed or
underemployed due to their medical conditions, and each additional visit to
practitioners for the purpose of receiving another prescription takes a
financial toll on them.
Among the patients who commented in support of the rule were those who
indicated that they live in rural areas. These commenters explained that,
currently, they must either drive to their practitioners, which is difficult
for them, or must find someone to drive them because they cannot drive
themselves due to their condition. They noted that arranging rides is often
difficult and that the drive to a practitioner may be several hours each way.
Some also stated that the trip is expensive and that the length of the trip
exacerbates their conditions. According to these commenters, implementation of
the proposed rule would enable them to visit their prescribing practitioners
less frequently, thereby lessening the foregoing difficulties.
Parents of children receiving controlled substances: Commenters who
described themselves as parents of children with ADD or ADHD welcomed the
proposed rule. In their view, if the proposed rule is implemented, they no
longer will have to take their children to their prescribing practitioners
every month. As a result, they indicated they will be able to take less time
off from work and their children will have fewer absences from school. Many of
these commenters also noted that having to make monthly visits to
practitioners is especially burdensome to single parents. These commenters
also identified reduced costs as a reason for their support of the proposed
rule.
Prescribing practitioners: Commenters who identified themselves as
practitioners who prescribe controlled substances were, for the most part,
strongly supportive of the proposed rule. Many of these commenters expressed
the view that allowing the issuance of multiple sequential prescriptions for
schedule II controlled substances will drastically reduce the work of the
practitioners' offices and free up valuable practitioner-patient time. Many
also expressed the view that for some of their patients whom they
characterized as "stable'' (including certain patients with chronic pain and
ADD or ADHD), they believe there is no medical need to see such patients every
month. In such cases, some of these commenters added they believe having to
make monthly visits to the practitioner is a hardship to patients who are
already suffering. It should be noted that some commenters who identified
themselves as practitioners expressed a sharply contrasting view, asserting
that patients who receive schedule II controlled substances should be seen in
person at least once a month to ensure proper medical supervision and to
lessen the likelihood of drug addiction and abuse. This latter perspective of
some commenting practitioners is addressed further below.
Pharmacists: Commenters who identified themselves as pharmacists
were, for the most part, supportive of the proposed rule. These commenters
stated that issuing multiple prescriptions for sequential filling for schedule
II controlled substances would reduce the quantity of those controlled
substances dispensed to a patient at any one time. They argued that this
reduced quantity could reduce the potential for abuse or diversion of these
controlled substances. Some pharmacists indicated they would be more
comfortable dispensing these prescriptions because of the more limited
quantities dispensed.
90-day supply at one time: Sixteen commenters who supported the NPRM,
and six commenters who disagreed with the NPRM, believed that the entire
90-day supply of controlled substances was available at one time instead of in
sequential prescriptions. Commenters who supported the rule but believed that
DEA is advocating the dispensing of a 90-day supply of controlled substances
at one time cited the ease of filling prescriptions and obtaining
reimbursement as reasons for their support. Those who objected to the rule on
this ground believed it would be more difficult to monitor patients.
DEA response: In view of these comments, DEA wishes to make clear
that the NPRM did not advocate that physicians prescribe a 90-day supply of
controlled substances with a single prescription. Rather, the NPRM stated that
if a physician determines it is medically appropriate to issue multiple
schedule II prescriptions, the physician may provide for up to a 90-day supply
through the use of multiple schedule II prescriptions under the conditions
specified in the proposed rule.
As to the comment that DEA should allow multiple schedule II prescriptions
for unlimited days' worth of schedule II controlled substances, as DEA
explained in the NPRM, for the proposed rule to be legally permissible, it
must be consistent with the text, structure, and purposes of the Controlled
Substances Act (CSA). In this regard, 21
U.S.C. 829(a) states: "No prescription for a controlled substance in
schedule II may be refilled.'' By comparison, subsection 829(b) states that,
for a schedule III or IV controlled substance, a prescription may be refilled
up to five times within six months after the date the prescription was issued.
Thus, Congress clearly mandated greater prescription controls for schedule II
substances than for schedule III and IV substances. For example, a physician
may--consistent with the statute--issue a prescription for a schedule III or
IV controlled
[[Page 64923]]
substance and indicate on the prescription a certain number of refills. In
this manner, a physician may provide a patient with up to a six- month supply
of a schedule III or IV controlled substance with a single prescription
indicating five refills. The same cannot be done with a schedule II controlled
substance since section 829(a) prohibits refills. The statute requires a
separate prescription if the physician wishes to authorize a continuation of
the patient's use of a schedule II drug beyond the amount specified on the
first prescription. Thus, if DEA were to allow multiple prescriptions for an
unlimited days' worth of schedule II controlled substances, the controls for
prescribing schedule II controlled substances would be less stringent than for
schedule III and IV controlled substances--a result that would conflict with
the purpose and structure of the CSA. DEA believes that the 90-day limit,
under the terms specified in the proposed rule, strikes a fair balance that
takes into account the limitation imposed by Congress under section 829 as
well as the general structure of the statute, which imposes greater controls
for schedule II substances than those in lower schedules.
Sequential filling of prescriptions, "refills'': One commenter
opposed the NPRM because the commenter believed that sequential prescriptions
were "refills'' which are not permitted by law. Two commenters suggested
writing all sequential prescriptions, which the commenters referred to as "refills,''
on one prescription. They believed this would prevent the patient from
changing the dates or using multiple pharmacies to fill the prescriptions.
Commenters also believed this would eliminate the possibility of the patient
claiming that the original prescription had been lost and requesting
replacement prescriptions. Two commenters recommended allowing 90-day
sequential prescriptions on one prescription blank, but allowing the
practitioner to prescribe the intervals at which it would be filled, rather
than only permitting 30-day interval sequential fillings.
One commenter suggested writing a single prescription with two "refills''
with the annotation "Do not fill more frequently than once a month.'' One
commenter suggested permitting not more than two "refills'' of a schedule II
prescription, but requiring the use of triplicate prescription blanks with one
copy being sent to the state and the second copy being sent to DEA. The
commenter then suggested that if a practitioner chose not to agree to this
system, then the practitioner would not be permitted to sequentially prescribe
any schedule II prescription. The commenter believed that this system would
prevent theft and loss.
DEA response: As discussed above, DEA believes that the proposed
rule takes into account the CSA prohibition on refilling prescriptions for
schedule II controlled substances in a manner consistent with the overall
framework of the Act. The use of multiple prescriptions for the dispensing of
schedule II controlled substances, under the conditions set forth in this
Final Rule, ensures that the prescriptions are treated as separate dispensing
documents, not refills of an original prescription. As this Final Rule
indicates, each separate prescription must be written for a legitimate medical
purpose by a practitioner acting in the usual course of professional practice,
and the practitioner must provide written instructions on each separate
prescription regarding the filling of that prescription.
Regarding the comment that suggested allowing the writing of a single
prescription with two "refills'' with the annotation "Do not fill more
frequently than once a month,'' this would conflict with the CSA, which, as
explained above, disallows the refilling of schedule II prescriptions. As
indicated in this Final Rule, when issuing multiple prescriptions for a
schedule II controlled substance, each of the prescriptions to be filled
sequentially must be written on a separate prescription blank and must contain
the information specified in this Final Rule.
As for the suggestion that DEA require the use of triplicate prescription
blanks, DEA has never required triplicate prescription blanks for
prescriptions and believes, at this time, that the requirements contained in
this Final Rule provide adequate safeguards against diversion, which render
unnecessary the use of triplicate prescription blanks. However, as with all
newly promulgated regulations, DEA will continue to monitor the situation to
determine whether additional modifications are needed to safeguard against
diversion. DEA recognizes that some states require the use of triplicate
prescriptions for some or all controlled substances. DEA supports the efforts
of states to take the specific action they deem necessary to prevent the
diversion of controlled substances within their jurisdictions. This Final Rule
expressly requires practitioners to comply with all applicable provisions of
state law when issuing multiple schedule II prescriptions.
Federal law and schedule II controlled substances: Five commenters
requested written clarification that this rule is not intended to change
existing Federal law which does not limit the length of time for which an
individual prescription may be written or the total quantity, including the
number of dosage units, that may be prescribed at one time. Further, two
commenters suggested that DEA state, in the Final Rule, that federal law does
not address how frequently a practitioner must see his patient, and that it
remains within the practitioner's reasonable medical judgment as to how
frequently the practitioner sees a patient.
Commenters requested that DEA clarify that the practitioner is not required
to see the patient every 30 days or at the end of 90 days. One commenter
requested that DEA clarify whether a practitioner is required to see a patient
after 90 days. Alternatively, the commenter inquired as to whether the
practitioner is permitted to write a new prescription with "Do not fill
until'' and mail it to the patient or have the patient pick it up if, in the
prescribing practitioner's medical judgment, the patient does not need to see
the practitioner. One commenter recommended DEA clarify whether it is DEA's
intent to limit any schedule II controlled substance prescription to only a
90-day supply or, alternatively, to limit sequential schedule II prescriptions
written on the same day to a 90-day supply. One commenter requested
clarification as to whether the regulation limits the supply to 90 days when
only a single schedule II controlled substance prescription is issued.
DEA response: As the NPRM made clear, the proposed rule in no way
changes longstanding federal law governing the issuance of prescriptions for
controlled substances. As stated in the NPRM: "What is required, in each
instance where a physician issues a prescription for any controlled substance,
is that the physician properly determine there is a legitimate medical purpose
for the patient to be prescribed that controlled substance and that the
physician be acting in the usual course of professional practice.'' (71 FR
52725, September 6, 2006). Further, this Final Rule itself contains the
following statement:
Nothing in this subsection shall be construed as mandating
or encouraging individual practitioners to issue multiple prescriptions or
to see their patients only once every 90 days when prescribing Schedule II
controlled substances. Rather, individual practitioners must determine on
their own, based on sound medical judgment, and in accordance with
established medical standards, whether it is appropriate to issue
[[Page 64924]]
multiple prescriptions and how often to see their patients
when doing so.
In addition, in the August 26, 2005, "Clarification of Existing
Requirements Under the Controlled Substances Act for Prescribing Controlled
Substances'' (70 FR 50408), DEA stated the following:
The CSA and DEA regulations contain no specific limit on
the number of days worth of a schedule II controlled substance that a
physician may authorize per prescription. Some states, however, do impose
specific limits on the amount of a schedule II controlled substance that may
be prescribed. Any limitations imposed by state law apply in addition to the
corresponding requirements under Federal law, so long as the state
requirements do not conflict with or contravene the Federal requirements. 21
U.S.C. 903. Again, the essential requirement under Federal law is that the
prescription for a controlled substance be issued for a legitimate medical
purpose in the usual course of professional practice. In addition,
physicians and pharmacies have a duty as DEA registrants to ensure that
their prescribing and dispensing of controlled substances occur in a manner
consistent with effective controls against diversion and misuse, taking into
account the nature of the drug being prescribed. 21
U.S.C. 823(f).
This Final Rule does not change any of the foregoing principles of the CSA
and DEA regulations.
Effective date of prescription: Two commenters requested that DEA
clarify the effective date of a sequential prescription for a schedule II
controlled substance. Some commenters pointed out that some states stipulate "effective
dates'' for prescriptions, noting that these states have laws which require
that, to be valid, prescriptions must be filled within a certain time after
they are written, and that these time limits differ by state. Some commenters
noted that if the time limit starts on the date all the sequential
prescriptions are written, then it cannot be used in some states. If the
effective date starts on the "Do not fill until'' date on the second and third
prescriptions, then it will be valid in many more states.
Three commenters requested clarification as to whether it is legally
permissible for a practitioner to issue a single prescription with "Do not
fill before [date],'' in which the "Do not fill'' date is, for example, 7-10
days in the future.
DEA response: Neither the CSA nor the DEA regulations use the term "effective
date'' for a prescription. The DEA regulations require that all prescriptions
for controlled substances "be dated as of, and signed on, the day when
issued.'' 21
CFR 1306.05(a). This Final Rule does not amend the regulations regarding
the date of issuance of a prescription.
Under longstanding federal law and DEA regulations, there is no express
requirement that a prescription be filled within a certain time after it was
issued. The proposed rule likewise contained no such express requirement, as
DEA believes that the requirements contained in the proposed rule provided
adequate safeguards against diversion. At the same time, the proposed rule
made clear that the issuance of multiple prescriptions is permissible only if "the
individual practitioner complies fully with all other applicable requirements
under the [CSA] and [DEA] regulations as well as any additional requirements
under state law.'' (71 FR 52726). To make this point unambiguous, the NPRM
also stated that "nothing in this proposed rule changes the requirement that
physicians must also abide by the laws of the states in which they practice
and any additional requirements imposed by their state medical boards with
respect to proper prescribing practices and what constitutes a bona fide
physician- patient relationship.'' (71 FR 52725).
The proposed rule did not address whether a single prescription with "Do
not fill before [date]'' instructions is permissible. Nor does any existing
provision of the CSA or DEA regulations address this type of prescribing.
Accordingly, there is no prohibition on doing so under the CSA or DEA
regulations, provided the practitioner otherwise complies fully with all
applicable requirements of federal and state law.
Insurance reimbursement considerations: Four commenters requested
further relaxation of the regulations to allow a 90-day supply of schedule II
controlled substances to be dispensed at one time because, these commenters
asserted, this would significantly decrease the cost of the medications to the
patients through their health insurance. One commenter also recommended
permitting the pharmacy to dispense a 90-day supply on one prescription,
making it available in 30-day intervals, but allowing the patient to pay for
the entire supply at one time to save on the cost of the medication.
DEA response: It is beyond the scope of DEA's authority under the
CSA to take regulatory action for the specific purpose of affecting the manner
in which patients pay for the medications or the manner in which insurance
providers reimburse patients for such costs. As mentioned previously, the CSA
and DEA regulations contain no specific limit on the number of days' worth of
a schedule II controlled substance that a practitioner may authorize per
prescription.
Limitations regarding certain medications: Three commenters
supported the use of sequential prescriptions specifically for schedule II
controlled substances used to treat ADD or ADHD, but disagreed with the use of
sequential prescriptions for schedule II controlled substances used in the
treatment of pain. Commenters believed pain patients should be seen and
evaluated every 30 days and have medications prescribed at that time. One
commenter requested that DEA include explicit language indicating that this
regulation is applicable to all patients being treated for ADHD with stimulant
medications.
Conversely, one commenter supported the use of sequential prescriptions
only for narcotic schedule II controlled substances, or pain medications.
Another commenter suggested rescheduling methylphenidate and amphetamines,
except methamphetamine, to separate them from pain medications because the two
populations for ADHD medications and pain medications are different.
DEA response: This rule pertains to all schedule II controlled
substances, not just those substances intended or approved to treat certain
conditions. As DEA stated in the September 6, 2006, Policy Statement published
in conjunction with the Notice of Proposed Rulemaking (71 FR 52716), it is
certainly appropriate for prescribing practitioners and medical oversight
boards to explore questions regarding appropriate treatment regimens for
particular categories of controlled substances. Moreover, it might indeed be
beneficial toward preventing diversion and abuse of controlled substances for
prescribing practitioners to see patients at regular intervals when
prescribing certain controlled substances for certain medical conditions.
However, as the Policy Statement made clear, DEA does not regulate the general
practice of medicine and the agency lacks the authority to issue guidelines
that constitute advice on the general practice of medicine. DEA wishes to
reiterate the general principle that the prescribing practitioner must
properly determine there is a legitimate medical purpose for the patient to be
prescribed the controlled substance and must be acting in the usual course of
professional practice. Similarly, a pharmacy has a corresponding
responsibility in this regard.
Regarding the comment suggesting the rescheduling of certain schedule II
[[Page 64925]]
controlled substances based on the conditions and populations which they
are intended to treat, DEA notes that scheduling of controlled substances is
based on scientific determinations regarding the substance's potential for
abuse, its potential for psychological and physical dependence, and whether
the substance has a currently accepted medical use in treatment in the United
States (21 U.S.C. 812(b)).
DEA may not reschedule a substance merely based on the population it is
intended or approved to treat.
Language on sequential prescriptions: Two commenters suggested not
limiting the language on the prescription to "Do not fill before [date].''
These commenters suggested other alternatives including "Do not fill until xx/xx/xxxx,''
and "Fill on xx/xx/xxxx.'' Five commenters requested that DEA provide examples
of acceptable language in the Final Rule. One commenter suggested requiring a
standardized method for dating prescriptions, and considering prescriptions
void if that standard is not adhered to. Another commenter recommended that
specific indication should be provided regarding sequential prescriptions by
including "1 of 3,'' "2 of 3,'' and "3 of 3'' on the prescriptions.
DEA response: The Final Rule states that the individual practitioner
must "[provide] written instructions on each prescription (other than the
first prescription, if the prescribing practitioner intends for that
prescription to be filled immediately) indicating the earliest date on which a
pharmacy may fill each prescription.'' The commenters have correctly observed
that this provision does not mandate that the practitioner use any particular
language in the instructions on the sequential prescriptions, so long as such
instructions make clear what is the earliest date on which the pharmacy may
fill each prescription. DEA believes this is a sufficiently clear rule that
practitioners will be able to understand and carry it out and, therefore, it
is unnecessary to insist on a particular scripted approach. Likewise, under
this Final Rule, a practitioner may--but is not required to--do as the
commenter suggested and write on the sequential prescriptions, "1 of 3,'' "2
of 3,'' and "3 of 3'', so long as each prescription complies fully with all
the requirements of this Final Rule, including that it contains specific
instructions regarding the earliest date on which the sequential prescription
may be filled.
One commenter recommended that the practitioner write in his/her own
handwriting in blue ink "Do not fill until [date].''
DEA response: DEA appreciates that the underlying intent of this
comment is to ensure that the "Do not fill until [date]'' instructions were
actually written by the practitioner, as opposed to being the result of
forgery. While DEA supports all efforts of practitioners to take steps to
prevent forgery in the context of prescriptions, the agency believes it is
unnecessary to adopt the particular added requirement suggested by this
commenter.
One commenter recommended that certain diagnostic codes, known as ICD-9
codes, should be written by the practitioner in their own handwriting on the
face of the prescription.
DEA response: DEA has not previously required that prescriptions
contain such diagnostic information, and the agency does not believe that such
requirement is necessary to prevent diversion and abuse of controlled
substances when issuing multiple prescriptions in accordance with the rule
being issued today.
Post-dating of prescriptions: One commenter recommended allowing
post-dated prescriptions so the practitioner does not have to use space on the
prescription blank for the phrase "Do not fill before [date].''
DEA response: The DEA regulations have always required that all
prescriptions for controlled substances "be dated as of, and signed on, the
day when issued.'' 21
CFR 1306.05(a). This requirement is essential to monitor compliance with
all provisions of the CSA and DEA regulations relating to the prescribing and
dispensing of controlled substances, including (but not limited to) the
requirement that a controlled substance be dispensed, including prescribed,
only for a legitimate medical purpose by a practitioner acting in the usual
course of professional practice. Accordingly, it would be inappropriate to
allow post-dating of prescriptions under any circumstance, including when
issuing multiple prescriptions under the Final Rule being issued today.
Return of unfilled prescriptions: One commenter suggested that a
patient return to the practitioner unfilled prescriptions (if issued for
sequential dispensing) if the practitioner changes the medication and before
the patient can receive a new prescription, as compared with simply destroying
the previous prescriptions. The commenter asserted this would help to ensure
that the previously-issued prescriptions will not be filled and diverted.
DEA response: Neither the CSA nor the DEA regulations address what a
patient should do with an unfilled prescription for a controlled substance.
Thus, regardless of whether the practitioner writes a single prescription or
issues multiple prescriptions at the same time under the Final Rule being
issued today, there is no mandatory procedure for handling unfilled
prescriptions. In all situations, however, practitioners should use common
sense in determining what steps are appropriate to prevent diversion in view
of the particular patient's circumstances. While not required under the CSA or
DEA regulations, it would be acceptable--and may even be the preferred
practice--for a practitioner to ask the patient to return unfilled
prescriptions for controlled substances, or for a patient to voluntarily do
so.
Pharmacies and dispensing of sequential prescriptions: One commenter
recommended that DEA clarify what a pharmacy is permitted to do if a
prescription is written for 30 days and the month has 31 days (e.g., a
prescription for 30 days with "Do not fill'' before dates of 10/18/yy, 11/18/yy,
12/18/yy, but October has 31 days). The commenter also asked whether a
pharmacist who fills a sequential prescription a day before the date stated
because the pharmacy will be closed on the date the sequential prescription
may be filled (e.g., Sunday) would be violating the regulation. Other
commenters asked similar questions as to whether a pharmacist may fill
sequential prescriptions earlier than the date specified by the prescribing
practitioner. One commenter requested that DEA allow some language for a
pharmacist's "good judgment'' rather than having as an absolute that
sequential prescriptions cannot be filled before the "Do not fill'' date. At
the very least, the commenter recommended that DEA include a statement of its
intent to use enforcement discretion in these cases. Two commenters
recommended that DEA clarify whether pharmacists can fill a sequential
prescription before the "Do not fill'' date (1) if the practitioner has not
been contacted and (2) if the practitioner has been contacted. Three
commenters requested that DEA clarify whether pharmacies are held accountable
for filling the sequential prescriptions before the indicated date. Two
commenters suggested that the Final Rule clarify any implications or
responsibilities for the dispensing pharmacy.
DEA response: As explained in the NPRM, the requirements contained
in the proposed rule were included to ensure that the rule can be reconciled
with the text, purpose, and structure of the CSA. This includes, but is not
limited to, adherence to the principles of requiring a written prescription
for a schedule II controlled substance,
[[Page 64926]]
maintaining clear accountability by practitioners when prescribing
controlled substances, and ensuring adequate safeguards to prevent diversion
and abuse. The Final Rule being issued today states expressly that, where a
practitioner has issued multiple prescriptions in accordance with the rule, no
pharmacist may fill any prescription before the date specified by the
practitioner. The rule contains no exceptions to this requirement. In
addition, because the CSA states that prescriptions for schedule II controlled
substances must be written (21
U.S.C. 829(a)), the essential elements of the prescription written by the
practitioner (such as the name of the controlled substance, strength, dosage
form, and quantity prescribed, and--in the case of multiple prescriptions
under this Final Rule--the earliest date on which the prescription may be
filled) may not be modified orally.
Changes to Regulatory Text
Section
1306.12: Some commenters suggested revising the proposed rule to state
that multiple prescriptions do not constitute refills.
DEA response: DEA believes such a revision is unnecessary as it is
clear from the text of the rule that it is permissible to issue multiple
prescriptions in the manner specified in the rule.
Use of the term "properly'': Section 1306.12(b)(1)(i) of the
proposed rule read: "The individual practitioner properly determines there is
a legitimate medical purpose for the patient to be prescribed that controlled
substance and the individual practitioner is acting in the usual course of
professional practice.'' Several commenters suggested removing the word "properly''
here, asserting that the use of the word "properly'' in this context is
unclear or modifies the meaning of the longstanding requirement that a
controlled substance be dispensed for a legitimate medical purpose by a
practitioner acting in the usual course of professional practice.
DEA response: Although the language of the proposed rule was meant
simply to reiterate (and not modify) the meaning of the longstanding
requirement that a controlled substance be dispensed for a legitimate medical
purpose by a practitioner acting in the usual course of professional practice,
DEA has decided to revise section 1306.12(b)(1)(i) in view of the comments.
Specifically, DEA has revised this paragraph to more closely track the
pertinent language contained in the longstanding regulation 21
CFR 1306.04(a). The paragraph being finalized today reads: "Each separate
prescription is issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of professional practice.''
Section 1306.12(b)(1)(iii): Section 1306.12(b)(1)(iii) of the proposed
rule stated: "The individual practitioner concludes that providing the
patient with multiple prescriptions in this manner does not create an undue
risk of diversion or abuse.'' Several commenters objected to this provision,
asserting that its meaning is unclear or that it imposes an undue burden on
practitioners to prevent diversion and abuse. One commenter requested that DEA
state whether this imposes a new standard on practitioners.
Eleven commenters recommended deleting the paragraph in its entirety.
Commenters believed that the practitioner cannot account for all possible
scenarios in making this conclusion. Commenters stated that the potential
liability problem for practitioners is that their conclusions and prescribing
actions could come into question any time a patient was implicated in abuse or
diversion. Commenters believed that practitioners will waste valuable patient
time documenting why issuing sequential prescriptions does not cause undue
risk. Commenters believed it could also cause the unintended consequences of
practitioners avoiding prescribing a medication the patient needs for fear of
liability in court. Commenters argued that sequential prescriptions, in
limiting the quantity of controlled substances prescribed at one time,
supposedly decrease the potential for abuse/diversion.
DEA response: Since the inception of the CSA, it has always been a
requirement that all DEA registrants (manufacturers, distributors,
practitioners, pharmacies, researchers, importers and exporters) take
reasonable steps to prevent their DEA registrations from being used in a
manner that results in an undue risk of diversion. This requirement is
inherent in the CSA registration provisions (21
U.S.C. 823) as well as the DEA regulations. For example, 21
CFR 1301.71 states: "All * * * registrants shall provide effective
controls to guard against theft and diversion of controlled substances.'' It
bears emphasis that the Final Rule being issued today in no way changes this
requirement. Under this Final Rule, practitioners who prescribe controlled
substances are subject to the same standard in preventing diversion as they
always have been under the CSA and DEA regulations. Section 1306.12(b)(1)(iii)
of this Final Rule is intended to make clear that a practitioner may not
simply comply with the other requirements of this Final Rule while turning a
blind eye to circumstances that might be indicative of diversion. Thus, section
1306.12(b)(1)(iii) merely underscores that the longstanding requirement of
providing effective controls against diversion remains in effect when issuing
multiple schedule II prescriptions in accordance with this Final Rule.
Further, as DEA stated in the Policy Statement (71 FR 52716), published
alongside the NPRM, "one cannot provide an exhaustive and foolproof list of
`dos and don'ts' when it comes to prescribing controlled substances for pain
or any other medical purpose.'' Just as DEA cannot provide an exhaustive list
of "dos and don'ts'' to elaborate on the phrase "legitimate medical purpose in
the usual course of professional practice,'' the agency cannot expand upon the
general requirement that practitioners take reasonable steps to prevent
diversion by setting forth a list of every hypothetical scenario a
practitioner might encounter along with specific instructions on how the
practitioner should handle the situation. DEA has an obligation to carry out
all regulatory requirements in a reasonable manner, consistent with the
governing statutes enacted by Congress, and to take into account all
circumstances of the particular case at issue. The agency will do so with
regard to all aspects of this Final Rule, including section
1306.12(b)(1)(iii).
Section 1306.12(b)(2): Section
1306.12(b)(2) of the proposed rule contained the statement:
Nothing in this paragraph (b) shall be construed as
mandating or encouraging individual practitioners to issue multiple
prescriptions or to see their patients only once every 90 days when
prescribing Schedule II controlled substances. Rather, individual
practitioners must determine on their own, based on sound medical judgment,
and in accordance with established medical standards, whether it is
appropriate to issue multiple prescriptions and how often to see their
patients when doing so.
In this context, two commenters suggested deleting the words "in accordance
with established medical standards.'' The commenters indicated they were not
aware of any standards that a practitioner could use to determine whether it
is appropriate to issue multiple prescriptions.
DEA response: The requirement that a prescription for a controlled
substance be issued in accordance with established medical standards has been
an integral part of federal law for decades and has been upheld by the
[[Page 64927]]
United States Supreme Court.\1\ This requirement applies to all controlled
substances and applies regardless of whether a practitioner issues a single
prescription or multiple prescriptions in accordance with this Final Rule.
---------------------------------------------------------------------------
\1\ United States v. Moore, 423 U.S. 122, 139-142 (1975).
---------------------------------------------------------------------------
Pharmacies and dispensing of sequential prescriptions: In section
1306.14, Labeling of substances and filling of prescriptions, DEA proposed
the following new paragraph (e): "Where a prescription that has been prepared
in accordance with section 1306.12(b) contains instructions from the
prescribing practitioner indicating that the prescription shall not be filled
until a certain date, no pharmacist may fill the prescription before that
date.''
One commenter suggested the following additional language to section
1306.14(e): "No pharmacist or pharmacy including mail order operations may
auto-fill any additional prescriptions for schedule II drugs before verifying
that the patient is still in need of each prescription refill.''
DEA response: It has always been the case under the CSA and DEA
regulations that a pharmacist who fills a prescription for a controlled
substance has a corresponding responsibility to ensure that the prescription
was issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of professional practice. This requirement, which
is set forth in 21
CFR 1306.04(a), is one of the primary legal bases upon which pharmacists
are held accountable under the CSA. DEA believes it is not necessary to modify
or expand upon this longstanding requirement in the context of multiple
schedule II prescriptions, so long as the prescribing and filling of such
prescriptions takes place in accordance with all the provisions of this Final
Rule.
Other Issues
Electronically transmitted prescriptions: Four commenters
recommended DEA allow electronically transmitted prescriptions for controlled
substances.
DEA response: DEA notes that the electronic prescribing of
controlled substances is outside the scope of this rulemaking. DEA intends to
address electronic prescribing of controlled substances in a separate future
rulemaking.
Authorization to use sequential prescriptions prior to publication of
Final Rule: Two commenters requested that DEA allow practitioners to begin
issuing multiple schedule II prescriptions based on the issuance of the NPRM
(without waiting for a Final Rule to be published and to take effect).
DEA response: Under the Administrative Procedure Act (APA), when an
agency seeks to impose a new substantive rule that modifies legal obligations
of members of the public, the agency must first engage in notice-and-comment
rulemaking (5 U.S.C. 553(b)). The APA further provides that substantive rules
may not take effect until at least 30 days after publication of the final rule
(5 U.S.C. 553(d)). Exceptions to these procedural requirements can be made
only "when the agency for good cause finds (and incorporates the finding and a
brief statement of reasons therefor in the rules issued) that notice and
public procedure thereon are impracticable, unnecessary, or contrary to the
public interest'' (5 U.S.C. 553(b)(B)). DEA has not found that there is such a
legal justification to exempt this Final Rule from the basic procedural
requirements of the APA. Accordingly, this Final Rule does not take effect
until the effective date indicated herein (December 19, 2007).
Long Term Care Facilities: One commenter asked if this rule will
apply to patients in long term care facilities.
DEA response: The DEA regulations contain a variety of provisions
relating to the dispensing of controlled substances at long term care
facilities. These provisions are unaltered by this Final Rule. This Final Rule
may be utilized in the context of a long term care facility, provided such
activity complies with any other applicable provisions of the DEA regulations.
Miscellaneous: One commenter recommended that DEA make one federal
rule regarding prescriptions to supersede the many different state laws.
DEA response: Under the CSA, Congress envisioned that the Federal
and State Governments would work in tandem to regulate activities relating to
controlled substances. This is reflected in 21
U.S.C. 903, which indicates that Congress did not intend to preempt state
controlled substance laws, so long as such state laws do not conflict with
federal law. Thus, each state may enact controlled substance laws that go
beyond the requirements of the CSA, provided such laws do not conflict with
the CSA. Given this aspect of the CSA, it would not be appropriate for DEA to
seek to preempt or supersede state laws relating to the prescribing of
controlled substances, provided such laws do not conflict with the CSA or DEA
regulations.
One commenter suggested DEA work with other federal agencies and national
professional medical societies to be certain doctors are screening for
alcoholism and drug addiction in their private medical practices as they are
prescribing schedule II controlled substances in the treatment of legitimate
medical illnesses.
DEA response: DEA firmly supports all efforts of practitioners to
screen for factors that might be indicative of whether the patient may be
likely to seek controlled substances for purposes of abuse or to satisfy an
addiction. However, such a consideration is beyond the scope of this Final
Rule. Persons interested in such considerations might wish to review the
Policy Statement, which was published in the Federal Register alongside the
NPRM (71 FR 52716).
Three commenters recommended that DEA explain existing law and the impact
of the new rule to health care professionals, state attorneys general, drug
control officials, and professional licensing and regulatory boards.
DEA response: DEA works cooperatively with a wide variety of
organizations who have an interest in the CSA and DEA regulations and
policies, including, but not limited to: State Boards of Medicine and Boards
of Pharmacy; law enforcement; regulatory and professional licensing
authorities and agencies; the pharmaceutical industry; and professional
organizations representing prescribing and dispensing practitioners. DEA meets
regularly with these organizations to discuss matters of mutual concern.
Included in these meetings are discussions of DEA legal and regulatory
activities.
One commenter suggested allowing partial filling of schedule II
prescriptions so as not to constitute a refill.
DEA response: The DEA regulations delineate the circumstances under
which the partial filling of a prescription for a controlled substance in
schedule II is permissible (21
CFR 1306.13). Adherence to this aspect of the DEA regulations serves a
critical function in preventing diversion of schedule II controlled
substances. Accordingly, this Final Rule does not modify the requirements of
the DEA regulations relating to the partial filling of prescriptions.
Objections to Notice of Proposed Rulemaking
Treatment of Pain Patients: Nineteen commenters opposed the NPRM
because they believed that, for a patient who is receiving controlled
substances for the treatment of pain, the practitioner should see the patient
more than once every 90 days to properly monitor the
[[Page 64928]]
patient's condition and whether that patient is responding well to the
medication. These commenters asserted that such a patient should see the
practitioner every 30 days because treatment for pain does not consist of
medication alone.
One commenter stated that he had a family member who became addicted to
schedule II controlled substances that were prescribed for pain and whose
quality of life diminished significantly as a result. This commenter therefore
objected to "slackening the restrictions on these highly addictive and
destructive drugs.''
DEA response: DEA recognizes, as these comments reflect, that some
practitioners believe that seeing a patient who is receiving controlled
substances only once every 90 days is inadequate. However, the CSA does not
expressly address how frequently a practitioner must see a patient when
prescribing controlled substances. At the same time, practitioners who
prescribe controlled substances must see their patients in an appropriate time
and manner so as to meet their obligation to prescribe only for a legitimate
medical purpose in the usual course of professional practice and to thereby
minimize the likelihood that patients will abuse, or become addicted to, the
controlled substances. In this regard, section 1306.12(b)(2)
of this Final Rule states:
Nothing in this section shall be construed as mandating or
encouraging individual practitioners to issue multiple prescriptions or to
see their patients only once every 90 days when prescribing Schedule II
controlled substances. Rather, individual practitioners must determine on
their own, based on sound medical judgment, and in accordance with
established medical standards, whether it is appropriate to issue multiple
prescriptions and how often to see their patients when doing so.
Diversion: One commenter opposed the NPRM, asserting that a
practitioner cannot always tell whether he or she is "getting scammed'' by a
patient seeking drugs for abuse. This commenter suggested that, if a
practitioner is being deceived by such a patient, the harm will be less if the
prescription is only for a 30-day supply of a controlled substance (rather
than a 90-day supply). Another commenter opposed the NPRM because the
commenter believed that drug abusers will change the dates on the multiple
prescriptions and have all the multiple prescriptions filled at once by
different pharmacies. Another commenter, who indicated she worked in a
pharmacy, expressed the view that drug addicts will see multiple practitioners
in a 90-day period to obtain overlapping 90-day supplies of schedule II
controlled substances.
DEA response: It is true that, other factors being equal, the
diversion of a 90-day supply of controlled substances causes greater harm than
the diversion of a 30-day supply. Likewise, the adverse effects of any
improper conduct on the part of a drug-seeking patient (such as "doctor
shopping'' or seeing multiple prescribing practitioners) will be magnified if
the patient is receiving a 90-day supply of a schedule II controlled substance
as opposed to a 30-day supply. However, for the reasons provided in responding
to the preceding comments, DEA believes it is appropriate to allow for up to a
90-day supply of schedule II controlled substances under the conditions set
forth in this Final Rule--with the understanding that 90 days is the upper
limit and by no means mandatory. To the contrary, as this Final Rule
indicates, the practitioner must determine on his/her own, on a case-by-case
basis, based on sound medical judgment, and in accordance with established
medical standards, the appropriate amounts of schedule II controlled
substances to prescribe.
Possibility of increased pressure on prescribing practitioners: Some
commenters expressed the view that implementation of the proposed rule will
result in practitioners receiving an increased number of "demands'' by
patients to receive a 90-day supply of controlled substances. As a result,
these commenters asserted practitioners might feel undue pressure to prescribe
a 90-day supply of controlled substances at each office visit.
DEA response: Given this important concern, DEA repeats for emphasis
the following statement in this Final Rule:
Nothing in this [Final Rule] shall be construed as mandating or encouraging
individual practitioners to issue multiple prescriptions or to see their
patients only once every 90 days when prescribing Schedule II controlled
substances. Rather, individual practitioners must determine on their own,
based on sound medical judgment, and in accordance with established medical
standards, whether it is appropriate to issue multiple prescriptions and how
often to see their patients when doing so.
It is indeed essential that practitioners adhere to the above- quoted
provision and not simply--based on pressure from patients or any other
improper reason--feel obligated to provide multiple prescriptions totaling a
90-day supply of schedule II controlled substances. Toward this end,
practitioners may wish to refer their patients to the above- quoted provision
if they believe doing so will be beneficial.
Appropriateness of this rule in view of the extent of prescription
controlled substance abuse in the United States: Among those commenters
who objected to the proposed rule, many pointed to the alarming increase in
prescription controlled substance abuse in the United States and resulting
deaths and harm to the public welfare. Such commenters expressed the view that
the proposed rule--or any other lessening of drug controls--will exacerbate
the problem.
DEA response: DEA shares the concerns of those who are deeply
troubled by the increasing levels of prescription controlled substance abuse
in the United States and the resulting detriment to the public health and
welfare of the American people. DEA addressed these concerns in depth in the
September 6, 2006, Policy Statement that was published in conjunction with the
proposed rule, and the agency encourages those interested in this topic to
review that document. To minimize the likelihood that this Final Rule will
exacerbate the extensive problem of prescription controlled substance abuse in
the United States, DEA has reiterated in the text of the regulation several
important and longstanding legal principles. Among these are the requirements
that "Each separate prescription is issued for a legitimate medical purpose by
an individual practitioner acting in the usual course of professional
practice'' and that "The individual practitioner concludes that providing the
patient with multiple prescriptions in this manner does not create an undue
risk of diversion or abuse.'' In addition, as stated repeatedly above, nothing
in this Final Rule shall be construed as mandating or encouraging individual
practitioners to issue multiple prescriptions or to see their patients only
once every 90 days when prescribing schedule II controlled substances; rather,
individual practitioners must determine on their own, based on sound medical
judgment, and in accordance with established medical standards, whether it is
appropriate to issue multiple prescriptions and how often to see their
patients when doing so. It is with the understanding that adherence to all of
these principles is essential that DEA has concluded that implementation of
this Final Rule is consistent with the overall structure of the CSA and DEA's
mission.
Methadone: Among the commenters who objected to the proposed rule,
several mentioned the prescribing of methadone in particular and the
significant number of deaths that have resulted from methadone abuse. These
[[Page 64929]]
commenters expressed concern that the proposed rule would lead to even more
deaths from methadone abuse.
DEA response: DEA shares the concerns of those commenters who
pointed to the unique and significant problems associated with methadone
abuse. In view of these concerns, DEA repeats the following statement from the
September 6, 2006, Policy Statement that was published in conjunction with the
proposed rule:
Methadone, a schedule II controlled substance, has been approved by the
[Food and Drug Administration (FDA)] as an analgesic. While a physician must
have a separate DEA registration to dispense methadone for maintenance or
detoxification, no separate registration is required to prescribe methadone
for pain. However, in a document entitled "Methadone-Associated Mortality:
Report of a National Assessment,'' [The Department of Health and Human
Services, Substance Abuse and Mental Health Services Administration] recently
recommended that "physicians need to understand methadone's pharmacology and
appropriate use, as well as specific indications and cautions to consider when
deciding whether to use this medication in the treatment of pain.'' \2\ This
recommendation was made in light of mortality rates associated with methadone.
---------------------------------------------------------------------------
\2\ CSAT Publication No. 28-03. Available at http://
dpt.samhsa.gov/medications/methreports.aspx.
---------------------------------------------------------------------------
Since 2003, the FDA has issued revised labeling for methadone analgesic
products, and physician education and training curricula have been developed
for methadone treatment.\3\ In 2007, SAMHSA convened an expert panel to
consider the implications of methadone mortality.
---------------------------------------------------------------------------
\3\ The FDA health advisory can be found at http://www.fda.gov/
cder/drug/advisory/methadone.htm and the package insert can be found at
http://www.fda.gov/cder/foi/label/2006/006134s028lbl.pdf.
---------------------------------------------------------------------------
Conclusion
As DEA discussed at the beginning of this document, the vast majority of
comments received regarding this rulemaking were supportive of its adoption.
Two hundred thirty-one of the 264 comments received supported this action. As
DEA noted previously, this rulemaking was supported by a wide variety of
individuals and organizations--medical professionals, patient advocacy
organizations, and patients themselves. To reiterate, the majority of
commenters believed this Final Rule would be beneficial from both physical and
financial perspectives, citing the time and money saved due to less frequent
visits to prescribing practitioners, and the reduced physical toll resulting
from the reduced visits. While many commenters sought clarification regarding
various aspects of this rulemaking, it is important to reiterate the
overwhelmingly positive reaction this rule generated.
DEA, state authorities, practitioners, and pharmacists all share a common
interest in ensuring that controlled substances are prescribed for legitimate
medical purposes by prescribing practitioners acting in the usual course of
professional practice. As discussed throughout this document, DEA, through its
enforcement of the CSA and its implementing regulations, must prevent the
diversion and abuse of controlled substances while ensuring that there is an
adequate supply for legitimate medical purposes. DEA supports the intent of
this Final Rule to address patients' needs for schedule II controlled
substances while preventing the diversion of those substances. DEA believes
that this Final Rule provides an option for practitioners to treat their
patients, which is legally permissible and consistent with the text,
structure, and purposes of the CSA.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has been
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612),
has reviewed this regulation, and by approving it certifies that this
regulation will not have a significant economic impact on a substantial number
of small entities. This rule provides an additional option that practitioners
may utilize when prescribing schedule II controlled substances under certain
circumstances. The rule will not mandate any new procedures. Therefore, a
regulatory flexibility analysis is not required for this rule.
Executive Order 12866
The Deputy Administrator further certifies that this rulemaking has been
drafted in accordance with the principles in Executive Order 12866, Regulatory
Planning and Review, Section 1(b). This rule has been deemed a "significant
regulatory action.'' Accordingly, this rule has been reviewed by the Office of
Management and Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in Sections 3(a)
and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Executive Order 13132
This rule does not preempt or modify any provision of state law; nor does
it impose enforcement responsibilities on any state; nor does it diminish the
power of any state to enforce its own laws. Accordingly, this rulemaking does
not have federalism implications warranting the application of Executive Order
13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and tribal
governments, in the aggregate, or by the private sector, of $120,000,000 or
more (adjusted for inflation) in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed necessary
under the provisions of the Unfunded Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the Small
Business Regulatory Enforcement Fairness Act (Congressional Review Act). This
rule will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices; or significant adverse effects on
competition, employment, investment, productivity, innovation, or on the
ability of United States-based companies to compete with foreign-based
companies in domestic and export markets.
List of Subjects in 21 CFR Part 1306
Drug traffic control, Prescription drugs.
- Pursuant to the authority vested in the Attorney General under sections
201, 202, and 501(b) of the CSA (21
U.S.C. 811, 812,
and 871(b)),
delegated to the Deputy Administrator pursuant to section 501(a) (21 U.S.C.
871(a)) and as specified in 28 CFR 0.100 and 0.104, Appendix to Subpart R,
the Deputy Administrator hereby orders that Title 21 of the Code of
Federal Regulations, Part 1306, be amended as follows:
PART 1306--PRESCRIPTIONS
- 1. The authority citation for part 1306 continues to read as follows:
Authority: 21
U.S.C. 821, 829,
871(b), unless otherwise noted.
Sec. 1306.12 Refilling prescriptions; issuance of multiple
prescriptions.
(a) The refilling of a prescription for a controlled substance listed in
Schedule II is prohibited.
[[Page 64930]]
(b)(1) An individual practitioner may issue multiple prescriptions
authorizing the patient to receive a total of up to a 90-day supply of a
Schedule II controlled substance provided the following conditions are met:
(i) Each separate prescription is issued for a legitimate medical purpose
by an individual practitioner acting in the usual course of professional
practice;
(ii) The individual practitioner provides written instructions on each
prescription (other than the first prescription, if the prescribing
practitioner intends for that prescription to be filled immediately)
indicating the earliest date on which a pharmacy may fill each prescription;
(iii) The individual practitioner concludes that providing the patient
with multiple prescriptions in this manner does not create an undue risk of
diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section
is permissible under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable
requirements under the Act and these regulations as well as any additional
requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or
encouraging individual practitioners to issue multiple prescriptions or to see
their patients only once every 90 days when prescribing Schedule II controlled
substances. Rather, individual practitioners must determine on their own,
based on sound medical judgment, and in accordance with established medical
standards, whether it is appropriate to issue multiple prescriptions and how
often to see their patients when doing so.
- 3. Section
1306.14 is amended by adding a new paragraph (e) to read as follows:
Sec. 1306.14 Labeling of substances and filling of prescriptions.
* * * * *
(e) Where a prescription that has been prepared in accordance with section
1306.12(b) contains instructions from the prescribing practitioner indicating
that the prescription shall not be filled until a certain date, no pharmacist
may fill the prescription before that date.
Dated: November 7, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-22558 Filed 11-16-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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