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The Moore decision also makes clear that, under the CSA, the requirement of a legitimate medical purpose in the usual course of professional practice is tied to the concept of registration. The Supreme Court stated, with respect to the prescribing and dispensing of controlled substances, "only the lawful acts of registrants are exempted" from the CSA's general prohibition on dispensing controlled substances. The foregoing aspects of the CSA, viewed collectively, can be reiterated as setting forth the following principles: To lawfully dispense a controlled substance to a patient, the dispenser must Post dating cii prescriptions in ltc in one of the following two categories: For either of the foregoing two categories of dispensers, the dispenser must be licensed or otherwise authorized prescripttions State law to engage in such activity and also have a Presriptions registration authorizing such activity.

Because controlled substances may only be dispensed for a legitimate medical purpose by a practitioner acting in the usual course lhc professional prescriltions, and only a Prescriphions practitioner may make the determination there is such a legitimate medical purpose for a given instance of dispensing, a DEA registrant may not delegate to a subordinate the medical decision making that must underlie each instance of dispensing. Accordingly, to be consistent with the CSA, any type of arrangement under which controlled substances would be dispensed to patients who reside in LTCFs must adhere to the foregoing principles.

Note Regarding Electronic Prescribing of Controlled Substances DEA revised its regulations effective June 1, to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations also permit pharmacies to receive, dispense, and archive these electronic prescriptions. This rule provides another tool for practitioners to use when prescribing a controlled substance for their patients, including those who reside in a LTCF. This rule allows a practitioner to use a computer, laptop or personal digital assistant PDA to send a prescription to a pharmacy from a remote location instantaneously. The basic framework of the CSA outlined above remains in effect with respect to the issuance of electronic prescriptions.

Note Regarding Authority of Agents of Individual Practitioners While a prescription for a controlled substance must always be issued by a DEA-registered practitioner rather than the agent of a practitioneran agent may, under certain circumstances, be involved in the transmission of the prescription to the pharmacy. The general statutory requirements, as implemented through regulations, are described below. The CSA provides that--except in emergency situations--a controlled substance in schedule II may only be dispensed by a pharmacy pursuant to a written prescription signed by a practitioner. The written prescription generally must be directly, physically provided to the pharmacist.

Where a practitioner issues an electronic prescription in accordance with these regulations, such a prescription constitutes a written prescription within the meaning of the CSA. When such an electronic prescription is used, the prescription information is conveyed electronically from the practitioner to the pharmacy, rather than through the delivery to the pharmacy of a hard copy of the prescription that was signed by the practitioner.

Prescriptions in ltc cii Post dating

In this context, Congress assigned to the Secretary of HHS, in consultation with the Attorney General, responsibility for defining the term "emergency" by regulation. The Secretary delegated this responsibility to the Food and Drug Administration, which set forth the definition of "emergency" in 21 CFR Assuming the lt constitutes a bona fide emergency within the meaning of the Ltv regulation, and a practitioner determines that such emergency warrants the dispensing of a schedule II controlled substance, a pharmacy may dispense the medication upon receiving oral authorization from the practitioner in accordance with 21 Prescriptipns That regulation requires, among other things, that the quantity prescribed and dispensed be limited to the amount adequate to treat the patient during the emergency period, and that the practitioner follow up within 7 days with a written prescription to the dispensing pharmacy.

The regulation further requires the pharmacy to make a reasonable effort to determine that the oral authorization came from the practitioner, which may include a callback to the practitioner using his phone number as listed in the telephone directory. For controlled substances in schedules III-V, the CSA provides that a pharmacy may dispense pursuant to a "written or oral prescription. Where an oral prescription is permitted by the CSA, the DEA regulations also provide that a practitioner may transmit to the pharmacy a facsimile of a written, manually signed prescription in lieu of an oral prescription. As a result, a prescription issued by a practitioner for substance in schedules III-V may be transmitted to a pharmacy in the following ways: As previously discussed, the CSA does not permit the prescribing practitioner to delegate to an agent or any other person the practitioner's authority to issue a prescription for a controlled substance.

Thus, the determination of a legitimate medical purpose must be made by the practitioner acting in the usual course of their professional practice; the determination may not be made by the agent.

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Likewise, the required elements of the prescription set forth in 21 CFR Part must be specified by the prescribing practitioner--not the agent. The pharmacist who fills a prescription for a controlled substance has a corresponding responsibility to ensure that these requirements have been met. Other Considerations Regarding State Licensure As indicated, to be eligible for a DEA registration, a dxting must be licensed or otherwise authorized by the State in which he practices to carry out the specific activity for which he seeks a registration. This typically entails a determination by the applicable State regulatory body that the practitioner meets certain qualifications.

For example, presfriptions practice medicine, States generally require that a prescgiptions obtain a medical license issued by the State medical board, which typically requires the physician dqting demonstrate the completion of certain education and training, to pass an examination demonstrating competency to practice medicine, and to undergo a background check to verify professional competence, ethics, and character. To operate a hospital, States generally require, at a minimum, that the facility obtain a license from the State public health department, which typically requires the facility to demonstrate that it has appropriate levels of qualified healthcare professional staff physicians, nurses, etc.

As part of the licensure process, States may also require that the hospital demonstrate specific qualifications to provide particular types of services. To operate a pharmacy, States generally require the pharmacy to obtain a license from the State board of pharmacy, which also typically requires a showing of properly qualified staff and facilities. Thus, by requiring practitioners to obtain a State license or other State authorization as a prerequisite to obtaining a DEA registration, the CSA ensures that controlled substances are only dispensed by those persons who have appropriate professional qualifications and who follow professional standards.

Accordingly, to remain consistent with the CSA, if a LTCF were to be eligible to obtain a DEA registration, it would need to have the requisite State license or other State authorization that is commensurate with the extent of the qualifications of its staff and with its ability to adhere to applicable professional standards for dispensing controlled substances to patients. This means, among other things, that hospitals are authorized to maintain common stocks of controlled substances for immediate dispensing or administration pursuant to a practitioner's medication order and are subject to DEA regulatory oversight and inspection. LTCFs, on the other hand, typically have no independent State controlled substances authority and accordingly are not eligible to become DEA registrants, as explained above.

This means they may not maintain common stocks of controlled substances. Therefore, any prescribed controlled substance medication in a LTCF is deemed, for CSA purposes, to be possessed by the resident and not the facility. A further consequence of their lack of DEA registration is that LTCFs are not subject to direct DEA regulatory oversight and inspection, security and recordkeeping requirements, or administrative action suspension or revocation of registration. For example, although LTCFs provide care for residents, the nature of their practice is not the same as that of a hospital. LTCF [[Page ]] residents typically reside in these facilities Post dating cii prescriptions in ltc long periods of time and have health issues and disorders that require long-term medical attention.

Generally, they do not receive daily care from an on-site physician; and, indeed, many facilities do not employ a physician as part of their staff 24 hours a day. Likewise, the extent to which registered nurses rather than licensed practical nurses or nursing assistants are involved in resident care is generally less in LTCFs than in hospitals. Also, in contrast to the length of stays of residents of LTCFs, patients in hospitals are typically there for short periods of time and are regularly monitored by their attending physician or hospital staff physicians. Note Regarding Chart Orders As explained above, because a DEA-registered hospital is a "practitioner" within the meaning of the CSA, it is permissible under the Act for such a hospital to dispense controlled substances directly to patients without a prescription.

Because of this, in a hospital setting, a hospital may dispense a controlled substance, for immediate administration to a patient, pursuant to an order for medication made by a physician or other individual practitioner who is an employee or agent of the hospital. This may occur, for example, through the issuance of a "chart order" by a hospital physician. In this context, the term "chart order" should be distinguished from the term "prescription. The CSA ensures this condition is satisfied by allowing only those practitioners who have obtained the requisite State licensure and DEA registration to make such medical determination and issue the corresponding prescription or chart order.

Another point worth noting is that, in the hospital setting, where a physician issues a chart order for a controlled substance, the physician, as well as the nursing staff and hospital pharmacy staff who take certain steps in carrying out the order, are all acting as employees or agents of the DEA-registered hospital and thus are collectively viewed as the "practitioner" within the meaning of the CSA.

The PPost who issues the chart order is prescriptionx so under the hospital's DEA registration number in accordance with the requirements of 21 CFR The hospital is, therefore, responsible for ensuring that all such persons are acting in accordance with the CSA and DEA regulations, and any failure to do so may result in criminal or civil liability on the part ib the hospital or loss of the hospital's DEA registration. These legal consequences are part of the fabric of the CSA that promotes compliance with the Act. As indicated, most LTCFs are cik licensed prescruptions the State as hospitals or other practitioners authorized to dispense controlled substances directly to patients, and thus they are not eligible under the CSA for registration as practitioners.

HHS establishes requirements deemed necessary for the health and safety of individuals to whom services are furnished in nursing facilities participating in Medicare and Medicaid. For example, basic resident rights and jn are outlined along with certain basic responsibilities of the facility. Some of these responsibilities include facility organization such as requiring a medical director 42 CFR The facility must operate and provide services in compliance with all applicable Federal, State and local laws and professional standards. A pharmacist cannot add or change to a CII prescription: A pharmacist may partially fill a CII prescription for the following scenarios: In either case the pharmacist must: There is no limit to the number of times a prescription can be partially filled within the 30 days so long as the total quantity in all partial fillings does not exceed the total quantity that was prescribed.

Can a pharmacist accept a faxed CII prescription? Generally no. The pharmacy will consider the facsimile prescription a "written prescription" and no further prescription verification is required. All normal requirements of a legal prescription must be followed. The facsimile prescription serves as the original written prescription for the pharmacy. The practitioner or agent will note on the prescription that it is for a hospice patient. The facsimile serves as the original written prescription. Schedule III-V Substances A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.

However, the prescription may only be refilled up to five times within six months after the date on which the prescription was issued. After five refills or after six months, whichever occurs first, a new prescription is required. Facsimile Prescriptions for Schedule III-V Substances Prescriptions for Schedules III-V controlled substances may be transmitted by facsimile from the practitioner or an employee or agent of the individual practitioner to the dispensing pharmacy. The facsimile is considered to be equivalent to an original prescription. Is there a limit on the number of separate prescriptions per schedule II controlled substance that may be issued for the day supply?

The rule does not stipulate how many separate prescriptions per schedule II controlled substance may be issued for the day supply. It is up to the practitioner to determine how many separate prescriptions to be filled sequentially are needed to provide adequate medical care. How is the issuance of multiple schedule II prescriptions different than issuing a refill of a schedule II prescription? The issuance of refills for a schedule II controlled substance is prohibited by law. The use of multiple prescriptions for the dispensing of schedule II controlled substances, under the conditions set forth in the Final Rule, ensures that the prescriptions are treated as separate dispensing documents, not refills of an original prescription.


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