All controlled substance prescriptions issued by an individual practitioner must be dated as of the date of issuance; in other words, a prescriber may not predate or postdate prescriptions. In addition to the date of issuance, all controlled substance prescriptions must contain at least the following information (21 C.F.R. § 1306.05(a)):
The full name and address of the patient
The name, address, and registration number of the practitioner
The drug name, strength, dosage form
The quantity prescribed
Directions for use
Recall that a prescription issued for MAT pursuant to the Drug Addiction Treatment Act (DATA) and related CSA amendments previously required the prescriber's DEA UIN (or "X" number) or a written notice that the prescriber is acting in "good faith" while waiting for the identification number to be issued. However, as of December 2022, the Mainstreaming Addiction Treatment Act (the MAT Act) eliminated the DEA "X" number requirement for practitioners to prescribe buprenorphine products to treat opioid-use disorder (See Chapter 4 Treatment of Addicts Outside of OTPs). Additionally, a prescription written for gamma-hydroxybutyric acid must include the medical need of the patient written on the prescription. The regulation establishes a "corresponding liability" on the pharmacist to ensure that the prescription is prepared properly.
The prescriber must sign written controlled substance prescriptions on the day of issuance. When oral orders are not permitted, the prescription must be written in ink or indelible pencil or typewritten and manually signed by the prescriber. A computer-generated prescription that is printed out or faxed by the prescriber must be manually signed. If the pharmacist receives the prescription orally, the pharmacist may write in the name of the prescriber. Electronic controlled substance prescriptions must comply with DEA regulations (summarized later in this chapter).
Although the prescriber's agent may prepare the prescriptions for the prescriber's signature, it is the responsibility of both the individual practitioner and the pharmacist to ensure that the prescriptions conform to all essential aspects of the law and regulations.
Individual practitioners exempt from registration must include on the prescriptions the registration number of the hospital or other institution at which they practice and the special internal code number assigned to them by the hospital or institution (21 C.F.R. § 1306.05(g)). Each written prescription must have the name of the physician stamped, typed, or hand printed on it as well as the signature of the physician. Those exempt from registration because they are members of the armed services or public health service must include on each prescription their service identification number in lieu of the registration number (21 C.F.R. § 1306.05(h)).
Before filing the prescription in the pharmacy, regulations also require the prescription to contain the written or typewritten name or initials of the pharmacist dispensing the drug, the date dispensed, and the number of units or volume dispensed (21 C.F.R. § 1304.22(c)). Pharmacists should keep in mind that state laws and/or company policies may also require additional information on filed prescriptions.
Occasionally, pharmacies receive controlled substance prescriptions that are incomplete or that contain errors and the question becomes whether the pharmacist can legally correct the prescription. Regarding schedule III, IV, or V prescriptions, for many years, the DEA had provided a clear answer at its website; however, this information has been removed from the DEA FAQs. Nevertheless, various states have adopted this past DEA guidance and many individual pharmacists still use it. The previously published DEA policy stated:
If the prescription does not contain the patient's address or contains an incorrect address, the pharmacist may add or correct the address upon verification. The pharmacist may also add or change the dosage form, drug strength, drug quantity, directions for use, or issue date after consultation with and agreement of the prescriber and after documentation on the prescription. The pharmacist is never permitted to make changes to the patient's name, controlled substance prescribed (except for generic substitution), or the prescriber's signature.
Of course, in most states, a pharmacist is permitted to contact the prescriber and simply convert the written prescription to an oral one if any of this information does need to be changed or added. It is also important for pharmacists to keep up to date on state law or guidance on this matter and follow state requirements if they are stricter.
Whether a pharmacist can correct a schedule II prescription has involved conflicting opinions from the DEA and has created considerable controversy. Prior to 2009, the DEA's website had provided that a pharmacist could essentially correct a schedule II prescription in the same manner just described for a schedule III, IV, or V prescription. However, in the preamble to a regulation enacted in November 2007 titled, "Multiple Prescriptions for Schedule II Controlled Substances" (discussed under "Multiple Schedule II Prescriptions for the Same Drug and Patient Written on the Same Day"), the DEA stated that the "essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed) ... may not be modified orally."
In October of 2008, the DEA issued a policy statement that it recognized the conflict and instructed pharmacists to follow state regulations or policy until the DEA could resolve this issue by regulation. Subsequently, sometime in 2009 and without notice, the DEA withdrew its original policy statement (that permitted correcting schedule II prescriptions) from the website and replaced it with the statement from the preamble to the regulation stating that schedule II prescriptions may not be corrected. The healthcare community complained vigorously and the DEA appeared to have listened. A few months later, in 2010, the DEA again reversed its position and changed its website, instructing pharmacists to follow state law or policy regarding whether they can correct a schedule II prescription. However, the DEA then proceeded to further confuse the matter by issuing a letter in late 2010 to a pharmacy audit firm stating that the pharmacist is not an agent of the prescriber for the purposes of adding the prescriber's DEA registration number on the written prescription. (Letter from Mark Caverly, Chief Liaison and Policy Section, Office of Diversion Control, to Rena Bielinski, Chief Pharmacy Officer, National Audit (Nov. 1, 2010)).
This letter raised the question of whether the DEA had again changed its mind, believing that a pharmacist is not an agent and thus cannot make any changes. The National Association of Boards of Pharmacy (NABP) then requested a clarification on the DEA's policy in July of 2011. In August of 2011, the DEA issued a letter to NABP stating that whether it is appropriate for pharmacists to make changes in a schedule II prescription varies on a case-by-case basis, and that a pharmacist should exercise professional judgment and knowledge of state and federal laws to make a decision. (Letter from Joseph Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, to Carmen Catizone, NABP (Aug. 24, 2011)). Therefore, it was interpreted by many that pharmacists could make corrections if state law or policy allows. A few years after this letter, the DEA removed all questions and answers from its website regarding this topic.
To add to the confusion years later, during a telephone discussion between the DEA and the National Association of Chain Drug Stores (NACDS) in May of 2022, the DEA verbally stated that schedule II controlled substance prescriptions must arrive at the pharmacy with all required elements. When the NACDS requested DEA to confirm this stated position in writing, it did not respond. This prompted the NACDS to issue a letter to its stakeholders to inform them of this concern, as well as suggesting that they contact the DEA for additional information (Letter from Steven Anderson, President and CEO of NACDS, to Patient Care Stakeholders, NACDS (June 17, 2022)). In the months following the NACDS letter, and after receiving requests to clarify the matter, the DEA informally clarified its policy on Schedule II prescription changes. In August of 2022, the DEA released the following statement: "In the past few months, DEA has received an increasing number of questions concerning pharmacists' ability to add or modify information - like a patient's missing address - on paper prescriptions. To address these questions, DEA has been reviewing the relevant regulations and working to draft new regulations to address this issue. As an interim measure, pharmacists are permitted to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with a prescriber." Therefore, until the DEA writes new regulations on this topic, pharmacists should adhere to state regulations or policy, if available, regarding this topic. For those states that have not provided any guidance, pharmacists are left without a clear answer on how to handle the situation and must exercise professional judgment in deciding whether to make corrections. As the DEA is expected to address this concern in the future, one should verify the most current position of the DEA and their state. In the 2022 DEA Pharmacist's Manual, there is a heading under Section VII Valid Prescription Requirements titled, "Acceptable Changes to a Prescription" that has been reserved for the DEA to provide future information on the topic.