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Changes to Regulations Governing Prescribing of Schedule II Controlled Substances - Frequently Asked Questions
March 18, 2008
The Drug Enforcement Administration (DEA) recently finalized a rule change for prescribing schedule II controlled substances. Effective December 19, 2007, prescribers may write up to three 30-day prescriptions for the same schedule II controlled substance on the same day, as described below and as allowed by laws in their individual state.
The Drug Information Service has extensively researched the ruling and its effects on clinical practice. We have had several conversations with officials at the local DEA office, the Utah State Board of Pharmacy, and the Utah Division of Occupational and Professional Licensing (DOPL). Based on our research, we have prepared this document to assist Utah prescribers and pharmacists who may be affected by the ruling. Because regulations differ between states, clinicians licensed in other states should consult the licensing authority and Controlled Substances Act of their individual state .
What is post-dating?
Post-dating is the act of specifying a future date as the date of prescribing, rather than the actual date the prescription is written. A post-dated prescription does not indicate the actual date of prescribing. Post-dating prescriptions had been a common practice among prescribers caring for patients requiring long-term therapy with schedule II controlled substances (ie, patients with chronic pain or attention deficit hyperactivity disorder). Prescribers would prepare multiple prescriptions for the patient on the same day but would write different prescribing dates on the individual prescriptions. Federal regulations do not allow post-dating. The new rule allows prescribers to write for up to a 90-day supply by specifying the earliest fill date on the prescriptions.
For example, Patient X visits Prescriber Y on March 1, 2008 for evaluation of their attention deficit hyperactivity disorder. The patient requires ongoing therapy with methylphenidate and has been on a stable therapeutic regimen for several years. Patient X visits Prescriber Y every 3 months; the next visit is planned for late May 2008. During the March 1st visit, Prescriber Y writes three prescriptions for methylphenidate, as follows:
- Prescription 1: dated March 1, 2008 (the actual date, legal prescription). The intent is that Patient X fill this prescription to obtain medication for the month of March 2008.
- Prescription 2: dated March 1, 2008 with instructions stating "earliest fill date April 1, 2008." The intent is that Patient X fill the prescription to obtain medication for the month of April 2008.
- Prescription 3: dated March 1, 2008 with instructions stating "earliest fill date May 1, 2008." The intent is that Patient X fill the prescription to obtain medication for the month of May 2008.
Why was there a controversy about post-dating?
In 2004, the Federal Register retracted a DEA statement implying that it was legal to write multiple post-dated prescriptions for a schedule II controlled substance for one patient on the same day. Federal law explicitly states that post-dating prescriptions is not legal. The 2004 Federal Register ruling created a conflict between federal law and Utah law (Utah Controlled Substances Act and Rules) and had many implications for clinicians who provide patient care.
While federal law explicitly states that post-dating prescriptions for schedule II substances is not legal, DEA statements and the Federal Register have issued statements implying that post-dating was an accepted practice. In 2004, controversy arose when the Federal Register stated that post-dating has never been legal despite earlier DEA statements implying as much.
Has the DEA reconsidered the 2004 statement?
Yes. In August 2006, the DEA announced a proposed rule change reversing the earlier decision. This change was recently finalized and took effect December 19, 2007. The change allows prescribers to write multiple prescriptions (up to a 90 day supply) at one time as long as the "fill by" dates are specified. Prescribers may write up to three 30-day prescriptions for the same schedule II controlled substance on the same day, provided that two of the prescriptions indicate a date in the future when the prescription may be filled (ie, with the intent that the prescriptions are to be filled 30 days apart). This change is being made in response to numerous comments the agency had received from healthcare providers and patients about the 2004 decision. Additional information about the new changes is available at http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm
Can I just post-date schedule II prescriptions under the current regulations?
No. Post-dating is not allowed (2CFR 1306.05a). Prescribers may write multiple prescriptions (up to a 90-day supply) on the same date, noting the earliest fill date on each prescription. The 2004 Federal Register ruling supersedes any state regulations that allow post-dating. The 2004 Federal Register ruling considers post-dating prescriptions the same as prescribing refills. Under federal law, it is illegal to refill prescriptions for schedule II controlled substances (21CFR1306.12).
Federal regulations allow states to be more restrictive in their controlled substance policies. However, if the federal regulations are stricter than the individual state’s, clinicians must comply with the federal standards rather than the less restrictive state regulations. Since the Federal Register has revoked the practice of post-dating, State Boards of Pharmacy may not override this ruling.
Can an individual pharmacy or pharmacy department change their policy and still accept post-dated schedule II prescriptions?
No. It is not currently legal for pharmacies to accept or fill post-dated prescriptions for schedule II controlled substances. This is a federal regulation, not a departmental, institutional, or local policy.
What are the quantity limits for prescribing or dispensing schedule II controlled substances in Utah?
The Utah Controlled Substances Act and Rules specify a 30-day supply as the maximum quantity that may be prescribed or dispensed for schedule II controlled substances at any one time.
Federal law does not currently mandate a specific quantity limit. Prescribers and pharmacists licensed in other states should consult the Controlled Substances Act of their individual state. In general, practitioners should avoid routinely prescribing or dispensing excessive quantities of controlled substances (usually greater than a 34-day supply or 120 doses).
How long do patients have to fill prescriptions for schedule II controlled substances once the prescription is written?
Federal regulations do not specify how much time may lapse between writing and dispensing the prescription. In Utah, prescriptions for Schedule II controlled substances must be presented to the pharmacy within 30 days of when the prescription is written. Because requirements may differ in other states, prescribers and pharmacists should consult the Controlled Substances Act of the individual state.
Can prescribers still specify a "future fill" date on schedule II prescriptions if the prescription is properly dated?
This situation might arise when a prescriber writes the actual date of prescribing on the prescription, but then specifies in the instructions to the patient (and the pharmacy) a date within the next 30 days when the prescription may be filled. The patient receives only a single prescription for the controlled substance and the quantity prescribed is no more than a 30-day supply. Because this "future fill" date is within 30 days of prescribing and the prescription is not post-dated, this practice is still allowed in Utah, assuming the prescription meets all other legal requirements.
For example, Patient A initially visits Prescriber B on March 2 for evaluation of their chronic pain. The prescriber writes a prescription for a 30-day supply of Oxycontin (dated 3/2/08), which the pharmacy fills the same day. During a follow-up visit on March 25, Prescriber B decides to continue therapy with Oxycontin since it is working well. The prescriber writes a prescription for a second 30-day supply of Oxycontin (dated 3/25/08) with the following additional instructions written on the prescription “do not fill until 3/30/08.” Both prescriptions are considered legal prescriptions, as summarized below:
- Prescription 1, written on March 2, 2008: dated March 2, 2008 (the actual date, legal prescription). The intent is that Patient A fill the prescription to obtain medication for the month of March 2008.
- Prescription 2, written on March 25, 2008: dated March 25, 2008 (the actual date, legal prescription) with the additional written instructions to the patient and the pharmacy “do not fill until 3/30/08.” The intent is that Patient A fill the prescription to obtain medication for the month of April 2008.
The current law does allow prescribers to write a second prescription for a schedule II controlled substance a few days before the patient’s initial 30-day supply runs out, so that the patient may continue therapy uninterrupted. Similarly, pharmacies are allowed to fill a second prescription for a schedule II controlled substance a few days before the initial 30-day supply runs out.
Can mail order pharmacies in other states fill prescriptions for greater quantities of schedule II controlled substances (compared with pharmacies located in Utah)?
No. The Utah Pharmacy Practice Act Rules and the Utah Controlled Substances Act Rules require that mail order pharmacies be licensed with the state of Utah, in order to fill prescriptions for patients living in Utah. As such, mail order pharmacies must comply with Utah's regulations for filling prescriptions, including prescriptions for controlled substances. This means that out-of-state mail order pharmacies must abide by the same quantity limits and fill limits as pharmacies located within Utah. Clinicians practicing in other states should consult their specific state's Controlled Substances Act.
What is the best way for specialty prescribers to manage patients on stable, long-term therapy with schedule II controlled substances (such as long-term therapy for ADHD)? What if the patient lives hundreds of miles away and is only seen in the specialty clinic twice a year?
In these cases, it may be desirable for the specialty prescriber to coordinate with the patient's local prescriber. The local prescriber could prescribe the schedule II controlled substances in between visits to the specialty clinic, as directed by the specialty prescriber.
Can I write controlled substance prescriptions ahead of time for my long-term patients if I lock the prescriptions in my office safe, and mail them to the patient after the date written on the prescription?
Yes, however, this practice would not be advised as it increases the risk of possible diversion of the prescriptions by office staff while the prescriptions are in the safe, or by other parties once the prescriptions are mailed. If prescriptions for controlled substances are sent to patients through the mail, it is advisable to send them via Federal Express or certified mail. This way, the prescriber has made every attempt possible to ensure that the prescription gets to the correct person and is not intercepted or diverted.
These situations can be handled in either of two ways, based on which works best for the specific patient:
How should we handle hospital discharge prescriptions for indigent patients? If the patient can only afford a small quantity (ie, 3-day supply) prior to arranging funding, can I write two prescriptions for the same schedule II controlled substance on the day of discharge, if the total quantity prescribed is only a 30-day supply and both prescriptions are properly dated?
- The discharging prescriber may prescribe a small supply (ie, 3-day supply) to be filled at discharge and then coordinate with the patient’s local prescriber to get the patient the remaining supply. The local prescriber could prescribe the remainder of the 30-day supply once the patient reaches home and arranges funding, as directed by the specialty prescriber.
- The discharging prescriber may write two prescriptions for the same schedule II controlled substance, so long as the total quantity prescribed is no more than a 30-day supply. The first prescription would be written for a small quantity (ie, 3-day supply) and would be filled at the time of discharge. The second prescription would be written for the remainder (ie, 27-day supply). The patient would get the second prescription filled upon arriving home and arranging funding, but within 30 days of the prescribing date.
Questions and Answers - Issuance of Multiple Prescriptions for Schedule II Controlled Substances.
New Rule (2007) - Effective December 19, 2007
- Code of Federal Regulations, Title 21 Food and Drugs, Part 1306, Prescriptions (21CFR1306). Volume 72. Available online at: http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-22558.pdf (accessed on November 20, 2007). Drug Enforcement Administration, US Department of Justice: November 19, 2007.
Proposed Rule Change (2006)
- Kaufman M. DEA revises rule on prescribing painkillers. Washington Post. 2006 Sept 7. http://www.washingtonpost.com/wp-dyn/content/article/2006/09/06/AR2006090601756.html. Accessed on September 8, 2006.
- Drug Enforcement Administration: Office of Diversion Control. Proposed Rule: Issuance of Multiple Prescriptions for Schedule II Controlled Substances. http://www.deadiversion.usdoj.gov/fed_regs/rules/2006/fr0906.htm. Accessed on September 8, 2006.
Current Rule (as of 2004)
- Code of Federal Regulations, Title 21 Food and Drugs, Part 1306, Prescriptions (21CFR1306). Volume 9. Available online at: http://frwebgate5.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=661253412949+7+1+0&WAISaction=retrieve (accessed on February 17, 2005). Drug Enforcement Administration, US Department of Justice: April 1, 2004.
- Controlled substances. In: Fink JL III, Vivian JS, Reid KK, eds. Pharmacy Law Digest. 35 th edition. St. Louis, MO: Facts and Comparisons; 2000:121-161.
- Drug Enforcement Administration: Diversion Control Program. Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel. www.deadiversion.usdoj.gov/faq/pain_med_faqs.htm. Accessed on January 19, 2005. NOTE: this document has been removed from the website and is no longer available online.
- Drug Enforcement Administration. Misstatements in the August 2004 FAQ. Federal Register. November 16, 2004;69(220):67171-2.
- Utah Controlled Substances Act http://www.dopl.utah.gov/licensing/statutes_and_rules/58-37.pdf
- Utah Controlled Substances Act Rules http://www.dopl.utah.gov/licensing/statutes_and_rules/R156-37.PDF
- DEA / Controlled Substances Pharmacist Manual - http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf
Updated March 18, 2008. Created February 17, 2005 by M. Christina Beckwith, PharmD, Drug Information Specialist.