Below is a question I frequently receive from both students and professionals inquiring about the changes to federal law when it comes to Schedule II prescriptions. Please see my response below and feel free to comment.
Question: How has the federal law changed regarding partial filling of CII prescriptions? Our state is silent on partial fills, and our pharmacy still follows the 72-hour DEA rule, but other pharmacies are partial filling for longer time periods.
Answer: This is a great question and a confusing topic for pharmacists! One of the important restrictions on prescribing and dispensing schedule II - controlled substances is that no refills are permitted; however, there are situations where partial fills of CII medications are permitted. In 2016, the Comprehensive Addiction and Recovery Act (CARA)(Public Law 114-198) was passed, which included comprehensive strategies to address the opioid epidemic. One strategy, Section 702 of CARA, amended the federal Controlled Substances Act (CSA) (21 U.S.C. 829(f)) to allow pharmacies to provide partial fills of a CII medication up to 30 days from the date of the prescription. For pharmacists to partially fill a CII prescription, it must be requested by the patient or the prescriber, and the total quantity dispensed in all partial fills cannot exceed the total quantity prescribed. If state law prohibits or places stricter limits on partial fills, then the pharmacist must follow state law. Partial fills of schedule II-controlled substances may also be provided when a pharmacist receives a verbal prescription in an emergency situation. The remainder of the prescription must be provided to the patient within 72 hours. After 72 hours, no further dispensing of the emergency prescription is allowed. It is important to keep in mind that CARA was passed in response to the opioid epidemic. Since diversion often occurs from medications stored at home, partial fills could reduce the amount of schedule II-controlled substances dispensed as well as the amount remaining unused in homes.
The partial filling of CII medications under CARA has caused confusion in pharmacy practice. This is because there has been a long-standing DEA rule that allowed for a partial fill of a schedule II controlled substance within 72 hours when the pharmacy was “unable to supply” the full quantity of the medication (21 C.F.R. § 1306.13(a)). Since the DEA has not updated its regulations to reflect the partial filling of CII medications under CARA, pharmacists and prescribers may be reluctant to comply with the amended federal controlled substances ace (CSA). In December 2017, Congress sent a letter to the DEA urging the agency to update the regulations and guidance related to partial filling of CII medications.
Under the long-standing DEA Rule that requires updating, when a pharmacist was unable to supply the full quantity and provided a partial fill, the pharmacist was required to note the quantity supplied on the face of the prescription and provide the balance of the prescription amount within 72 hours after the partial filling. If the pharmacist was unable to supply the remaining quantity within 72 hours, the pharmacist had to notify the prescriber and no further quantity was to be supplied beyond 72 hours without a new prescription. Historically, “unable to supply” under the DEA rule meant the pharmacy did not have enough of the medication in stock to supply at the time of dispensing. Subsequently, however, the DEA decided that other situations would also be appropriate, including when the drug was in stock, but the pharmacy was waiting for verification of the legitimacy of the prescription; when the patient could not afford to pay for the entire amount; or when the patient did not want the entire amount for some other reason. Now, under CARA, interpreting “unable to supply” should not be a concern for the pharmacist; however, the DEA should update the regulations to reflect this. From a practical standpoint and based on the intent of CARA, providing partial fills may offer a benefit in a variety of situations, including preventing abuse and diversion. Thus, the pharmacist should be willing to participate when the circumstances are appropriate. Until the DEA provides updated rules or guidance, reluctant pharmacists could contact their DEA field division for clarification.
Keep in mind there is another other long-standing rule where a pharmacist may partially fill schedule II controlled substances for patients in LTCFs or for patients with a medical diagnosis documenting a terminal illness. For these patients, schedule II prescriptions may be partially filled to allow for the dispensing of individual dosage units but for no longer than 60 days from the date of issuance (21 C.F.R. § 1306.13(b)). The total quantity of drug dispensed in all partial fillings must not exceed the quantity prescribed. If there is any question regarding whether a patient may be classified as having a terminal illness, the pharmacist must contact the prescriber before partially filling the prescription. Both the pharmacist and the prescriber have a corresponding responsibility to ensure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription whether the patient is “terminally ill” or an “LTCF patient.” A prescription that is partially filled and does not contain the notation “terminally ill” or “LTCF patient” is deemed to have been filled in violation of the CSA.
To read more on this topic, please refer to Chapter 5 of my text, Pharmacy Practice and the Law, Ninth Edition.
I hoped this helps clarify! Please feel free to leave a comment if you have additional questions.
- Kimberly A. Burns, RPh, JD
About the text:
The Ninth Edition of the best-selling text, Pharmacy Practice and the Law goes beyond preparation for the board exam, helping students understand and critically analyze the law that governs both the profession and the products they distribute. The Ninth Edition continues to include the most up-to-date federal, legal, regulatory, and policy developments, as well as new developments to various medical/pharmaceutical programs. Challenging, open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Critical issues are discussed in non-legal, easy-to-understand language. Pharmacy Practice and the Law, Ninth Edition is the most comprehensive and engaging resource for teaching the facts of federal pharmacy law, and for encouraging critical thinking and analysis on relevant issues.