Questions & Answers
Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a greater number of dispensations than the number of refills indicated on the prescription?
Answer: A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is notan order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription). To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a registered practitioner acting in the usual course of sound professional practice.
Answer: A prescription for a controlled substance must include the following information:
- Date of issue;
- Patient’s name and address;
- Practitioner’s name, address, and DEA registration number;
- Drug name;
- Drug strength;
- Dosage form;
- Quantity prescribed;
- Directions for use;
- Number of refills (if any) authorized; and
- Manual signature of prescriber.
A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.
Prescriptions for schedule II controlled substances must be written and be signed by the practitioner. In emergency situations, a prescription for a schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription being sent to the pharmacy within seven days. Prescriptions for schedules III through V controlled substances may by written, oral or transmitted by fax.
Answer: Prescriptions for schedule II controlled substances cannot be refilled. A new prescription must be issued. Prescriptions for schedules III and IV controlled substances may be refilled up to five times in six months. Prescriptions for schedule V controlled substances may be refilled as authorized by the practitioner.
Answer: A prescription written for a schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile.
A pharmacist may dispense directly a controlled substance listed in schedules III, IV, or V pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist.
Question: Is it appropriate to provide a DEA registration number on prescriptions written for medications other than controlled substances?
Answer: DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a practitioner’s DEA registration number.
The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR 3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend beyond May 23, 2008.
Question: Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a greater number of dispensations than the number of refills indicated on the prescription?
Answer: Yes. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue.
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?
Answer: On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, 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."
The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber. (Policy Letter)
Therefore, when information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V?
Answer: The pharmacist may add or change the patient’s address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions.
The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber’s signature.
Answer: Federal law and regulations do not restrict the prescribing, dispensing, or administering of any schedule II, III, IV, or V narcotic medication, including methadone, for the treatment of pain, if such treatment is deemed medically necessary by a registered practitioner acting in the usual course of professional practice.
Confusion often arises due to regulatory restrictions concerning the use of methadone for the maintenance or detoxification of opioid addicted individuals, in which case the practitioner is required to be registered with the DEA as a Narcotic Treatment Program (NTP).
Question: Can an individual return his/her controlled substance prescription medication to a pharmacy?
Answer: No. An individual patient may not return his/her unused controlled substance prescription medication to the pharmacy. Federal laws and regulations make no provisions for an individual to return the controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., individual patient).
The CFR does have a provision for an individual to return his/her unused controlled substance medication to the pharmacy in the event of the controlled substance being recalled or a dispensing error has occurred.
An individual may dispose of his/her own controlled substance medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.