Federal Laws on Prescribing Controlled Substances

Carolyn Buppert, CRNP, JD

Disclosures

Journal for Nurse Practitioners. 2009;5(1):15-17. 

Jack Heneisen, a primary care physician in Georgia, pre-signed blank prescription sheets so that, on his day off, the nurse practitioners (NPs) he worked with could refill prescriptions for chronic pain patients. On April 18, 2003, state and federal drug agents raided the clinic where he worked. He was criminally prosecuted and served 7 months in federal prison. He lost his medical license and was ordered to pay a $30,000 fine. The prosecutors said he made it way too easy for patients to get Oxycontin. In October 2006, Heneisen returned to practice in Georgia and was welcomed back to the community, according to the Savannah Morning News.

Federal law prohibits prescribers from pre-signing prescriptions. Here is the legal language: "Manner of issuance of prescriptions. (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address, and registration number of the practitioner" (21 CFR, Section 1306.05).

Heneisen's story was covered in an article by Don Lowery in Savannah Now on July 30, 2005. NPs circulated the Savannah Now article via e-mail, and many expressed indignation that the physician was prosecuted. Some NPs thought the prosecution was a slap at physicians who work with NPs, or a ridiculous application of the law. This response indicates that some NPs are not aware of the legalities of prescribing controlled dangerous substances (CDS). The legal issue that got the physician in trouble involved NPs, but the prosecution was not about them. The problem was that he pre-signed prescriptions.

Three years later, I still hear about NPs who either pre-sign prescriptions themselves or work in a physician practice where the physician pre-signs prescriptions and NPs write in the medication, route, dosage, and amount. Don't do either of these things and don't post-date a prescription. If you need to provide a prescription for November's dose of CDS in October, date the prescription for the day you write the prescription and write "Dispense after November 1, 2008."

According to federal law, a prescription for a controlled substance must include the following information (21 CFR 1306.05[a]):

  • 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

  • Manual signature of prescriber

A prescription must be written in ink or indelible pencil or typewritten and must be signed manually by the practitioner. Signature stamps are not legal. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature, except that prescriptions for Schedule II controlled substances must be written and signed by the practitioner. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.

Here is the federal regulation on how to write a prescription: "Manner of issuance of prescriptions: (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner. Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (eg, J. H. Smith or John H. Smith)."

"Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescriptions may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations" (21 CFR 1306.05).

Here are some additional federal requirements of clinician prescribing of CDS:

Limits on Amounts Prescribed

While states may have more restrictive rules, the federal law does not limit the amount prescribed. So, a patient could get all of a 6-month supply of a Schedule II substance at one time if the clinician writes the prescription in that way.

Limits on the Time a Prescription is Valid

Under federal law, there is no expiration of a prescription for Schedule II substances. So, a clinician could write a prescription for a Schedule II substance in April 2007 and the patient could fill it in September 2008. However, a state could establish rules tighter than the federal rules.

Prescriptions for Schedule III substances expire 6 months after the date written. There may be 5 refills within the 6-month period. Refill authorization can be transferred from one pharmacy to another once within the 6-month period. A practitioner may issue a new prescription for the Schedule III substance within a 6-month period if necessary.

Partial Filling of Prescriptions

A pharmacist may partially fill a prescription for controlled substances. If the remainder is not dispensed to the patient within the following 72 hours, the prescription is void and must be rewritten in order for the patient to get the remainder. Partial refills of Schedule III, IV, and V controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (ie, 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 6 months past the date of issue" (21 CFR Section 1306.13).

Refilling Prescriptions for Controlled Substances

Prescriptions for Schedule II controlled substances cannot be refilled. A new prescription must be issued. However, an authorized prescriber may prepare multiple prescriptions on the same day with instructions to fill on different dates. Prescriptions for Schedule III through V controlled substances may be refilled up to 5 times in 6 months. The prescription may be telephoned or transmitted via facsimile to the pharmacy. Office staff may communicate the information to the pharmacy when acting as an agent of the registered physician (21 CFR 1306.12).

Emergency Situations

Emergency is defined by the Secretary of Health and Human Services as "situations in which the prescribing practitioner determines that: (1) immediate administration of a controlled substance is necessary, for proper treatment of the intended ultimate user; (2) that no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and (3) it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to dispensing" (21 CFR 290.10).

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 sent to the pharmacy within 7 days. (States may require that the prescription be sent to the pharmacist in a shorter time frame.) Prescriptions for Schedule III through V controlled substances may by written or transmitted orally or by fax.

Here are some additional requirements to heed when orally transmitting prescriptions in emergency situations: "In an emergency, the prescriber may give an oral prescription for a Schedule II drug if the pharmacist makes a reasonable effort to identify the prescriber and the amount is limited to what is necessary to treat the patient during the emergency. The prescriber must cause to be delivered an original prescription to the dispensing pharmacist within 7 days. The prescriber must write 'Authorization for Emergency Dispensing' on the prescription. The prescriber must document how the situation met the criteria for emergency treatment" (21 CFR 290.10).

Faxing Prescriptions for Controlled Substances

Prescriptions may be faxed under certain conditions. Here are the conditions, as stated in federal regulations: "A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with Sec. 1304.04(h) of this chapter.

"(e) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained in accordance with Sec. 1304.04(h) of this chapter" (21 CFR Section 1306.11).

Therefore, Schedule II prescriptions can be faxed to a pharmacist, but the copy is just an alert to the pharmacist that the patient is en route with an original prescription.

Schedule III and IV prescriptions may be telephoned in or faxed to the pharmacist, or the practitioner could go to the pharmacy counter and request that a drug be dispensed to a patient. In the latter case, the pharmacist would have the responsibility of reducing the verbal order to writing. Here is the legal language: "A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only 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 containing all information required in Sec. 1306.05, except for the signature of the practitioner" (21 CFR Section 1306.21[a]).

Finally, and most important, don't write prescriptions for controlled substances unless you have an active DEA number and any registration required by your state. Nurse practitioners have done this and suffered visits from drug enforcement agents. Even if you do this and are able to talk your way out of criminal prosecution, expect to lose your job.

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