The Federal Government via the Department of Justice’s Drug Enforcement Administration (DEA), has
changed its regulations with regards to the Prescription Laws. This was
announced via the Federal Registry Notices FR Doc 04-25469 [Federal Register: November
16, 2004 (Volume 69, Number 220)] [Notices] [Page 67170-67172] From the Federal
Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr16no04-82]. This
change went into effect immediately on November 16th, 2004. New
regulations will now make it unlawful to continue the practice of providing
patients with multiple schedule II narcotic prescriptions.
Refills of
schedule II prescriptions--The August 2004 FAQ stated: "Schedule
II prescriptions may not be refilled;
however, a physician may prepare multiple prescriptions on the same day with
instructions to fill on different dates.'' (Italics added.) The first part
of this sentence is correct, as the CSA expressly states: "No prescription
for a controlled substance in schedule II may be refilled.'' 21 U.S.C. 829(a). However,
the second part of the sentence (italicized above) is incorrect. For a
physician to prepare multiple prescriptions on the same day with instructions
to fill on different dates is tantamount to writing a prescription authorizing
refills of a schedule II controlled substance. To do so conflicts with one of
the fundamental purposes of
section 829(a).
Schedule
II substances
(a) 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 as determined under the
Federal Food, Drug, and Cosmetic Act, may be dispensed without the written
prescription of a practitioner, except that in emergency situations, as
prescribed by the Secretary by regulation after consultation with the Attorney
General, such drug may be dispensed upon oral prescription in accordance with
section 503(b) of that Act. Prescriptions shall be retained in conformity with
the requirements of section 827 of this title. No prescription for a controlled
substance in schedule II may be refilled.
Schedule II Substances: The drugs in this schedule have a high potential for abuse, a currently accepted medical use in the United States, and their use may lead to severe psychological or physical dependence. Most of Schedule II Substances have been known in the past as Class A Narcotic Drugs; some examples are: opium, morphine, codeine, dihydromorphinone, methadone (Dolophine), meperidine (Demerol), cocaine, oxycodone, Percodan, etc. Also included in this Schedule is any compound which contains in any form the substance of methamphetamines as an injectable liquid.
In order to comply with new federal laws and
regulations, patients requiring schedule II medications will need to be seen
for evaluation by the medical staff, on monthly bases. On each evaluation
visit, a specific medication questionnaire will need to be answered by
patients. Drug testing will be undertaken as per each practice’s guidelines or
protocols. Once this process is completed, the patient may then receive a one
month prescription of their pain medication, assuming that the process
indicates that it is still warranted.