4.2 Controlled Substance Prescribing (Federal + PA)

Schedule II Prescribing Rules

Under the federal Controlled Substances Act (CSA) and 21 CFR Part 1306, Schedule II prescriptions are the most restricted prescriptions that may be dispensed to a patient:

• No refills are permitted on any CII prescription (21 CFR § 1306.12). A new prescription is required for each dispensing.
• Emergency oral prescriptions are allowed under 21 CFR § 1306.11(d). The pharmacist must promptly reduce the order to writing, the quantity must be limited to what is needed for the emergency, and the prescriber must deliver a written prescription to the pharmacist within 7 days. If the written follow-up is not received, the pharmacist must notify the DEA of the prescriber's name, address, drug, and quantity.
• Exception for LTC/terminally ill: A practitioner may prescribe a CII for a patient in a long-term care facility or who is terminally ill for a compound to be directly administered to the patient; the prescription may be transmitted by fax and refilled under the federal compounding exception.

Federal Partial Fill of CII

A CII prescription may be partially filled under 21 CFR § 1306.13 if the pharmacist does not have sufficient quantity, or if the patient cannot tolerate the full quantity. The pharmacist must note on the face of the prescription the date, amount filled, and remaining quantity. The remaining quantity may be filled within 6 months of the original issue date. As of 2016 federal law (the Comprehensive Addiction and Recovery Act, CARA), a patient may also request a partial fill of a CII opioid prescription even when the pharmacy has the full quantity, with the same 6-month window.

CII vs CIII–CV Rules at a Glance

PA PDMP — ABC-MAP

The Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) is PA's PDMP, established by Act 191 of 2014 and effective August 2016. Query became mandatory January 1, 2017. It is operated by the PA Department of Health.

Dispenser submission duty: dispensers must submit dispensing data for Schedules II–V to ABC-MAP by the close of the next business day after dispensing.

Query triggers (when a dispenser or prescriber must query the PDMP):

1. The first time a controlled substance is dispensed to a new patient,
2. When there is a reasonable belief of abuse, misuse, or diversion, and
3. Each time an opioid or benzodiazepine is prescribed or dispensed.

Statutory exemptions to the query requirement include:

• A prescription of 7 or fewer days' supply,
• Patients receiving hospice or palliative care,
• Inpatients in a healthcare facility, and
• Other circumstances defined by DOH regulation.

Interstate data sharing with 30+ states via PMP InterConnect supports border-state prescribers.

Act 122 of 2016 — Safe Emergency Prescribing Act

Effective January 1, 2017, Act 122 of 2016 (Safe Emergency Prescribing Act) limited the supply of opioids prescribed in emergency departments, urgent care centers, and hospital observation units to no more than 7 days, with no refills.

Act 125 of 2016 — Prescribing Opioids to Minors

Act 125 of 2016 (effective February 4, 2017) requires prescribers to obtain written consent from a parent, guardian, or authorized adult before issuing an opioid prescription to a minor (under 18, emancipated minors excepted), and limits the supply to 7 days (or a single 72-hour supply with an authorized adult's consent). The prescriber must also assess whether the minor is taking medication for substance use disorder and discuss the risks with the parent/guardian/authorized adult.

Act 112 of 2019 — Opioid Treatment Agreements (Chronic Pain)

Act 112 of 2019 (effective November 27, 2019) requires prescribers to establish an opioid treatment agreement with a patient before issuing the first prescription in a single course of treatment for chronic pain with a controlled substance containing an opioid. The prescriber must educate the patient on abuse potential, addiction/overdose risk, and the dangers of combining opioids with benzodiazepines, alcohol, or other CNS depressants. This is a chronic-pain treatment-agreement rule, NOT an acute-pain 7-day cap. Exemptions: medical emergencies, cancer pain, and palliative/hospice care.

Minors and Opioid Prescribing

For patients under 18 (emancipated minors excepted):

• 7-day limit with written parent or guardian consent before issuing the prescription, or
• A single 72-hour supply with the consent of an adult authorized to consent to the minor's medical treatment.

Exceptions to Acute-Pain Limits

The 7-day and minor limits do NOT apply when the prescriber documents that the patient falls within an exception:

• Cancer treatment,
• Palliative or hospice care,
• Chronic pain, or
• Treatment following a major surgical procedure.

Practical MPJE Traps

• A 7-day emergency-room opioid prescription may not be refilled even though it is short — the no-refill rule for ED/urgent-care opioids is in addition to the CII no-refill rule.
• A CRNP or PA prescribing in an ED, urgent care, or observation setting is subject to the same Act 122 7-day limit.
• Pharmacists are not required to verify prescriber documentation in real time, but should not fill an ED/urgent-care/observation opioid prescription beyond 7 days, and should not fill a minor's opioid prescription beyond 7 days without written parent/guardian consent.
• The PDMP query is a clinical tool, not a substitute for the corresponding-responsibility analysis; a clean PDMP does not waive the duty to refuse a suspicious prescription.