VALID PRESCRIPTION REQUIREMENTS

Question 1

To dispense controlled substances, a pharmacist must know:

Answer 1

a pharmacist must know the requirements for a

valid prescription

Question 2

A prescription is an

Answer 2

order for medication which is dispensed to or for an ultimate user.

Question 3

A prescription is not an order

Answer 3

for medication which is dispensed for immediate administration to the ultimate user (i.e., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription).

Question 4

A prescription for a controlled substance must be dated and signed on

Answer 4

the date when issued.

Question 5

The prescription must include

Answer 5

the patient’s full name and address, and the practitioner’s full name, address, and DEA registration number.

Question 6

Besides the patient’s full name and address, and the

practitioner’s full name, address, and DEA registration number the prescription must also include

Answer 6

1. Drug name
2. Drug strength
3. Dosage form
4. Quantity prescribed
5. Directions for use
6. Number of refills authorized (if any)

Question 7

A paper prescription must be written in

Answer 7

ink or indelible pencil or typewritten, or printed on

a computer printer, and must be manually signed by the practitioner on the date when issued.

Question 8

An individual (i.e., secretary or nurse) may or may not prepare prescriptions for the practitioner’s signature.

Answer 8

may

Question 9

The practitioner is responsible for

Answer 9

for ensuring the prescription conforms to all requirements of the law and regulations, both federal and state.

Question 10

A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills

Answer 10

who fills a prescription not prepared in the form prescribed by DEA regulations.

Question 11

A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is:

Answer 11

1. Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice, and
2. Registered with DEA or exempted from registration (e.g., Public Health Service, Federal Bureau of Prisons, military practitioners), or
3. An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered, provided that additional requirements as set forth are met.

Question 12

To be valid, a prescription for a controlled substance must be issued for

Answer 12

a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

Question 13

The practitioner is responsible for the proper prescribing and dispensing of controlled substances, but

Answer 13

but a corresponding responsibility rests with the pharmacist who fills the prescription.

Question 14

An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in legitimate and authorized research is not

Answer 14

a prescription within the meaning and intent of 21 U.S.C. 829.

Question 15

The person knowingly filling a prescription that is not legally valid, as well as the person issuing it, shall be:

Answer 15

shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

Question 16

A prescription may or may not not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients?

Answer 16

may not

Question 17

An individual practitioner may or may not authorize an agent to perform a limited role in communicating such prescriptions to a pharmacy in order to make the prescription process more efficient?

Answer 17

may

Question 18

Even though the CSA established a closed system in which all persons in the distribution chain are required to be registered and are held accountable for every controlled substance transaction, Congress recognized

Answer 18

a role for agents under the Act

Question 19

Does the CSA exempt agents of registrants, including practitioners, from the requirement of registration.

Answer 19

yes

Question 20

The CSA statute defines an “agent” as

Answer 20

“an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser.”

Question 21

The CSA does not permit a prescribing practitioner, however, to delegate to an agent or any other person

Answer 21

the practitioner’s authority to issue a prescription for a

controlled substance.

Question 22

A practitioner acting in the usual course of his or her professional practice must determine that there is a legitimate medical purpose for a controlled substance prescription; an agent

Answer 22

may not make this determination.

Question 23

The common means to communicate a prescription to a pharmacy include

Answer 23

hand delivery, facsimile, phone call, or an electronic transmission

Question 24

The proper role of an agent is fact specific and depends upon the

Answer 24

schedule of the controlled substance prescribed, the circumstances of the ultimate user, and the method of communication, among other things.

Question 25

Summary of the acts that an agent may execute in connection with controlled substance prescriptions:

Answer 25

1. An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner, provided that the practitioner, in the usual course of professional practice, has determined that there is a legitimate medical purpose for the prescription and has specified to the agent the required elements of the prescription. 2. Where a DEA registered individual practitioner has made a valid oral prescription for a controlled substance in schedules III-V by conveying all the required prescription information to the practitioner’s authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist. 3. In those situations in which an individual practitioner has issued a valid written prescription for a controlled substance, and the regulations permit the prescription to be transmitted by facsimile to a pharmacy, the practitioner’s agent may transmit the practitioner-signed prescription by facsimile.

Question 26

DEA believes it is in the best interest of the practitioner, the agent, and the dispensing pharmacist that the

Answer 26

designation of those persons authorized to act on behalf of the practitioner and the scope of any such authorization be reduced to writing.

Question 27

A signed copy authorization should also be provided to

Answer 27

the practitioner’s designated agent, the agent’s employer (if other than the practitioner), and any pharmacies that regularly receive communications from the agent pursuant to the agreement.

Question 28

Providing a copy of agent authorization to pharmacies likely to receive prescriptions from the agent on the practitioner’s behalf may assist those pharmacists with their...

Answer 28

corresponding responsibility regarding the dispensing of controlled substances.

Question 29

However, even where the pharmacist has a copy | of an agency agreement, the pharmacist may also have a duty to inquire further depending on

Answer 29

depending upon the particular circumstances.

Question 30

Does a pharmacist has a corresponding responsibility for the proper dispensing of controlled substances .

Answer 30

yes

Question 31

An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in legitimate and authorized research is

Answer 31

an invalid prescription within the meaning and intent of the CSA.

Question 32

The person knowingly filling such an invalid prescription, as well as the person issuing it, shall be subject to

Answer 32

the penalties provided for violations of the provisions of law relating to controlled substances.

Question 33

A pharmacist is required to exercise sound professional judgment, and to adhere to

Answer 33

professional standards, when making a determination about the legitimacy of a controlled substance prescription

Question 34

A determination about the legitimacy of a controlled substance prescription is made before

Answer 34

the prescription is dispensed.

Question 35

The law does not require a pharmacist to dispense a prescription of

Answer 35

doubtful, questionable, or suspicious medical legitimacy.

Question 36

The pharmacist who deliberately ignores the high probability that a prescription was not issued for a legitimate medical purpose and fills the prescription, may be

Answer 36

prosecuted along with the issuing practitioner, for knowingly and intentionally distributing controlled substances

Question 37

Deliberately ignoring the high probability that a prescription was not issued for a legitimate medical purpose and filling the prescription is a

Answer 37

felony offense, which upon conviction, may result in a term of imprisonment and a fine

Question 38

Unlawful dispensing of controlled substances by a pharmacist may also be subject to criminal actions against the

Answer 38

pharmacy or pharmacist, and to civil enforcement actions against the pharmacy or pharmacist for money penalties or injunctions.

Question 39

The DEA may revoke a pharmacy’s registration based on a finding that its pharmacists have violated the corresponding responsibility rule and

Answer 39

both the pharmacy and pharmacists may be the subject of proceedings against their state licenses.

Question 40

Electronic Prescriptions

Answer 40

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