Issuance of Multiple Prescriptions for Schedule II Controlled Substances --> RE: DEA question

[Guest guest]

No time to clean up the formatting but here is the ruling.

Read the attachment for the full meal deal.

Locke, MD

http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual090506.pdf

Issuance of Multiple Prescriptions for Schedule II Substances

On September 6, 2006, the DEA published in the Federal Register a Notice of Proposed Rulemaking, which proposes to permit an individual practitioner to issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance, provided that certain conditions are met. If and when this proposed rule becomes final, DEA will update this manual accordingly.

http://www.asipp.org/11192007Newsupdate.html

November 19, 2007

Important ASIPP Update

Final Rule on Issuance of Multiple Prescriptions for Schedule II Controlled Substances

ASIPP has received notification and is pleased to announce that as per DEA Administrator Tandy's promise, the notice regarding the Multiple Schedule II Rule, has now been prepared and will be published in the Federal Register on Nov. 19, 2007. The rule entitled, "Issuance of Multiple prescriptions for Schedule II Controlled Substance," will take effect on Dec. 9, 2007. The final rule amends DEA's previous regulation to allow practitioners to provide individual patients with multiple prescriptions for a specific schedule II controlled substance, written on the same date, to be filled sequentially. The new rule allows physicians to write three separate prescriptions with staggered fill dates. Patients can still be given the equivalent of a 90-day prescription for schedule II controlled substances when medically appropriate. Federal Register Notice

http://www.asipp.org/documents/72FR64921finalruleonissuanceofScheduleII.pdf

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.

snip-snip

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

============================

§ 1306.12 Refilling prescriptions; issuance of multiple prescriptions.

(a) The refilling of a prescription for

a controlled substance listed in

Schedule II is prohibited.

((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 ( 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:

§ 1306.14 Labeling of substances and

filling of prescriptions.

* * * * *

(e) Where a prescription that has been

prepared in accordance with section

1306.12( 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

From: [mailto: ] On Behalf Of Annie SkaggsSent: Wednesday, January 02, 2008 5:10 PMTo: Subject: DEA question

Lovely young lady in today, new patient, but daughter of established patients. She is 20, self pay and home on vacation from England. She just graduated with an MA from some school in London, and took a job there.

Did her undergrad at Xavier in Cincinnati, and while there, got started on Adderall. Once she went to the UK, she says they don’t have Adderall available, so her parents have been buying it here and mailing it to her. They have been getting the prescriptions from the same doc who prescribed it in Cinci. She did not bring records, but brought the most recent Rx, which Kentucky pharmacies have started refusing to fill because they are not written on the special controlled substance Rx paper required in KY.

I don’t doubt her story, or that she finds it beneficial. Her mom would probably do well on something for ADD too. My question is about the legal implications. The DEA says no refills on Adderall, we’re supposed to follow her monthly. We can no longer write “do not fill before___” on the Rx because the DEA says no. Obviously she can’t come in monthly. How much trouble can I get into by handing her folks a year’s worth of post-dated scripts? I recommended she speak to a UK pharmacy when she goes back about what IS available there, but if there is no option, what can I do to help her and not get myself into trouble?

Thanks,

Annie