Background Schedule II opioids (e.g. morphine, oxycodone, methadone, hydromorphone, fentanyl) play a major role in the management of symptoms at the end of life. Because of possible abuse, trafficking, and diversion of opioids, federal statutes mandate that appropriate safeguards be adhered to by prescribing clinicians and dispensing pharmacists. There are regulations that are important to understand for patients in hospice and long-term care settings, or who may have rapidly changing symptoms at home. This Fast Fact will review US federal regulations regarding prescribing Schedule II drugs for adult and pediatric patients. Note: a) some states may impose additional restrictions – check with your state licensing boards for specifics, and b) individual pharmacists may enforce these regulations with variable stringency.
Prescription information Prescriptions for Schedule II opioids must be written (or typed), dated, and signed on the day issued, and include the full name and address of the patient, the drug name, strength, quantity prescribed, and directions for use. The name, address, and Drug Enforcement Agency (DEA) registration number of the practitioner must also be included. Most schedule II opioids are not hand-written anymore, but rather electronically ordered directly to a pharmacy.
Refills and prescription series Refills are not allowed on Schedule II opioid prescriptions. However, there are no federal regulations limiting the number of days a prescription can cover (many state or local professional standards have limited this to a 30- or 90-day supply). It is permissible to write a prescription series for up to a 90-day supply of medication. For example, at a single office visit a patient can be given 3 prescriptions, each for 30 days worth of the same drug, with two of the prescriptions noting: “Do not fill until [1 or 2 months, respectively, from the issue date].”
Emergency prescriptions Prescriptions can be phoned into a pharmacist but only for an emergency. The pharmacist must make a reasonable effort to determine that the verbal authorization came from a registered practitioner and that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. If an emergency prescription is called into a pharmacy, the prescriber must provide a written and signed prescription to the pharmacy within 7 days. The prescription must have “Authorization for emergency dispensing” written on it as well as the date of the verbal order.
Partial dispensing Partial dispensing is allowed if the pharmacist is unable to supply the full quantity at one time. The remaining portion of the prescription must be filled within 72 hours. For patients in a LTCF or with a terminal illness, partial quantities up to 60 days from the issue date may be dispensed. The script must designate the patient is ‘terminally ill’ or in a LTCF.
Pharmacist changes to prescriptions Pharmacists may independently add or change the patient’s address. Depending upon the state of practice, they may also be able to forward the electronic prescription on to another pharmacy if they are not able to fill the prescription. After consultation with the prescriber, pharmacists may also add or change the dosage form, drug strength, drug quantity, directions for use, and issue date. While the aforementioned changes are permissible, many pharmacists will request a rewritten prescription. In general, pharmacists are expected to utilize due diligence and ensure that prescriptions are valid before dispensing the medication.
Patients with opioid use disorder or in a drug treatment program Opioid use disorder and pain can co-exist at the end of life. Clinicians approved for Schedule II prescribing by their DEA license can prescribe any Schedule II drug in the inpatient and outpatient settings (including buprenorphine and methadone) for pain and symptom relief, even if the patient is enrolled in an opioid maintenance program. Clinicians are strongly advised to seek specialist help in these situations (from both pain and addiction specialists) as well as to work collaboratively with the patient’s treatment program. To better identify cases of risky opioid use, it is recommended that clinicians access their state prescription drug monitoring program (PDMP) to make sure the requested opioid prescription is appropriate. Standardized protocols on how to approach cases of risky opioid behaviors are also recommended for hospice organizations.
Which opioids are not Schedule II medications? Buprenorphine is a schedule III medication; tramadol is a schedule IV medication; codeine is a schedule II medication when prescribed alone, however when prescribed at 90 mg or less as a combination product or cough preparation, it is a scheduled III or IV medication. The bottom line is that for these medications, best opioid monitoring practices should still be followed, however, it is legal to provide refills in the prescription.
References
- US Department of Justice; Drug Enforcement Administration; Diversion Control Division. Lists of scheduling actions controlled substances regulated chemicals. December 2024. Available at: Orange Book – List of Controlled Substances and Regulated Chemicals.
- US Department of Justice; Drug Enforcement Administration; Diversion Control Division. Practitioner’s Manual. An Informational Outline of the Controlled Substances Act. 2023. Available at: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-071)(EO-DEA226)_Practitioner%27s_Manual_(final).pdf.
- US Department of Justice; Drug Enforcement Administration; Diversion Control Division. Phamacist’s Manual. An informational outline of the controlled substances act. 2022. Available at: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist%27s_Manual_DEA.pdf.
- Horn DB, Vu L, Porter BR, et al. Responsible controlled substance and opioid prescribing. Stat Pearls [Internet]; Treasure Island (FL): StatPearls Publishing; 2025 Jan-.
- Preuss CV, Kalava A, King KC. Prescription of controlled substances: benefits and risks. Stat Pearls [Interet] Treasure Island (FL): StatPearls Publishing; 2025 Jan-.
Version History: Originally published February 2008. 2nd Edition in June 2009; 3rd Edition in November 2015 by Lynn McPherson PharmD; 4th Edition in June 2025.
Conflicts of Interest: None to report.