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.
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: An individual may return his/her unused or unwanted controlled substance prescription medication to any retail pharmacy that is authorized by the DEA to collect unwanted pharmaceutical controlled substances. Search for an Authorized Collector Location. Alternately, if a pharmacy maintains mail-back packages, individuals may place unused or unwanted medications inside a mail-back package. Individuals may not give these unwanted medications to pharmacy employees, but must directly deposit the medications inside a collection receptacle at the pharmacy or inside a mail-back package provided by the pharmacy.
A provision in the Code of Federal Regulations allows for an individual to return his/her unused controlled substance medication directly to a pharmacy in the event of a 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 and that is consistent with applicable Federal, State, tribal, and local laws and regulations. In situations where an individual is deceased, any person lawfully entitled to dispose of the decedent’s property may dispose of controlled substances which were lawfully obtained by the deceased individual.