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43 Cards in this Set

  • Front
  • Back
Controlled substances can only be prescribed by individual practitioner who is both:
-authorized in the state in which licensed to practice (state law)
-either registered or exempt from registration under the CSA (fed law)
Controlled substances can only be dispensed by a pharmacist who is both:
-licensed by a state in which practicing of controlled substances
-registered individually or employed by registered pharmacy or registered institutional practitioner
Corresponding responsibility doctrine can be violated by the:
-issuer
-person knowingly (pharmacist had to know that there was a problem) filling improper prescription are both subject to penalty
Corresponding responsibility doctrine:
-verification is not enough; consider other factors
-treatment of pain
-treatment of addiction
Dispensing sched II controlled substances
-must have written prescription signed by an individual practitioner
Types of per se violations
-Price fixing
-Boycotting
-Tying Arrangements
An unnecessary drug is any drug when used:
-in excessive dose (inc duplicative therapy)
-for excessive duration
-W/o adequate monitoring
-W/o adequate indications
-In the presence of adverse consequences that indicate the dose should be reduced or d/c
-Any combination of these reasons
Schedule I:
-High potential for abuse
-No currently accepted medical use in treatment
-Lack of accepted info on safety of use
-The medical marijuana dilemma (illegal fed treatment preempts legal state treatment)
Schedule II:
-High potential for abuse
-Currently accepted med use in treatment or currently accepted med use with severe restrictions
-Abuse may lead to severe physical or psychological dependence
Schedule III:
-Potential for abuse is less than I or II
-Currently accepted medical use in treatment
-Abuse may result in moderate or low physical dependence or high psychological dependence
Schedule IV:
-Low potential for abuse relative to III
-Currently accepted medical use in treatment
-Abuse may lead to limited physical or psychological dependence relative to III
Schedule V:
-Low potential for abuse relative to IV drugs
-Currently accepted medical use in treatment
-Abuse may lead to limited physical or psychological dependence relative to IV
The Controlled Substances Act consists of three titles:
I- establishes rehabilitation programs for drug abusers
II-provides for the registration and distribution of controlled substances (applies to pharm practice)
III- addresses the importation and exportation of controlled substances
The secretary and attorney general must base the ultimate decision on these factors:
-Actual or relative potential for abuse
-Scientific evidence of its pharm effect, if known
-The state of current scientific knowledge regarding the drug or other substance
-Hx and current pattern of abuse
-Scope, duration, and significance of abuse
-Risk to the public health
-Physiological or psychic dependence liability
-Whether the substance is an immediate precursor of a substance already controlled
Registration for manufacturers and dispensers:
-1 year
-3 years
The CSA specifically allows the following persons to possess controlled substances without registration:
-An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance if such agent or employee is acting in the usual course of business or employment
-A common or contract carrier or warehouseman, or an employee thereof, whose possession of the controlled substance is in the usual course of his business or employment
-An ultimate user who possesses such substance for a lawful purpose
Activities that require registration:
-Manufacturing sched I-V
-Distributing sched I-V
Reverse distributing of controlled substances
-Dispensing sched II-V controls or instructing
-Conducting research with sched I-V
-Conducting a narcotic treatment program (inc a compounder) using any narcotic drug listed in sched II-V
-Conducting chemical analyses with controlled substances
-Importing or exporting controls
Dispense means:
to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, inc the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for such delivery
Practitioner means:
A physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed...
Registration for chain stores:
Need a separate registration for each store even though they are part of a chain.
Dispensers need to fill out:
DEA form 224
Manufacturers, distributors, and narcotic treatment programs must fill out:
DEA form 225
The following info must be included if the registrant wants to D/C the business by transferring it to another person:
-The name, address, registration number, and authorized business activity of the registrant D/C business and that of the person acquiring the business
-Whether the business activities currently registered will be continued at the present address or at another specified address
-Whether the transferor has a quota to manufacture or procure any controlled substance in sched I or II
-The date on which the transfer of controlled substances will occur
The attorney general may deny a practitioner-applicant a registration to dispense controlled substances if it is determined that the registration would not be in the public interest. Attorney general must consider:
-The recommendation of the appropriate state licensing board
-The applicant's experience
-The applicant's conviction record with respect to controlled substances
-The applicant's compliance with applicable state, fed, or local laws
-Any other conduct by the applicant that may threaten the public health and safety
A registration to manufacture, distribute, or dispense controlled substances may be suspended or revoked by the attorney general on the finding that the applicant:
-Has materially falsified any application
-Has been convicted of a felony relative to controlled substances
-Has had a state license or registration suspended, revoked, or denied
When evaluating whether the overall security system of a registrant or applicant is adequate, the DEA may consider any of the following:
-They type of activity conducted
-They type and form of controlled substances handled
-The qty of CS handled
-The location of the premises
-The type of building construction and its general characteristics
-They type of vault, safe, and secure enclosures or other storage system
-The type of closures on vaults, safes, and secure enclosures
-The adequacy of key control systems or combo lock control systems
-The adequacy of electronic detection and alarm systems
Security system evaluation by the DEA (con'd)
-The extent of unsupervised public access to the facility, inc the presence and characteristics of perimeter fencing, if any
-The adequacy of supervision over employees having access to manufacturing and storage areas
-The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel
-The availability of local police protection or security personnel
-The adequacy of the system used for monitoring the receipt, manufacture, distribution, and disposition of CS.
Storing of Sched I CS
Must be securely locked in a cabinet
Storing of Sched II-V CS
-Individual practitioners must handle in the same manner as I
-Pharmacies and institutional practitioners may disperse throughout stock in manner that will obstruct theft and diversion
-Persons whose registration has been denied or revoked may not be employed in position that allows access to CS
Nonpractitioners must store CS:
-Sched I and II in safe
-Sched III, IV, V in stingently secured area
Theft or loss of CS:
Must be reported to the DEA
Penalties from Distributing or dispensing in violation of CSA:
- If with knowledge or intent, criminal penalty of up to 1 year in prison, up to $25,000 fine, or both
-If negligent, civil penalty of up to $10,000
Order form 222 violation:
-For Sched I and II
-If with knowledge and intent, criminal penalty of up to 4 years in prison, up to $30,000 fine, or both
Drug trafficking offenses:
-Practitioners are not immune from being prosecuted as drug traffickers.
-It shall be unlawful for any person knowingly or intentionally-
1. To manufacture, distribute or dispense, or possess with intent to manufacture, distribute or dispense a CS
2. To create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance
Criminal vs Civil penalty
Criminal- knowing or intentional
Civil- negligent
Illegal possession:
Section 844. Applies to everyone while the others apply to RPhs. Prohibits any person form knowingly or intentionally possessing a CS, except persuant to a valid Rx. Penalty for first time violators: 1 year in prison and/or a fine up to $1000. Possession of cocaine carries a much higher risk.
State Board Discipline:
RPhs prosecuted under the CSA are also subject to disciplinary proceedings by the state board of pharmacy. Licenses could be revoked or suspended, but also could be subject to a fine, depending on state law.
4th amendment protects individuals from unreasonable search and seizure and thus requires a warrant:
-Requires a probable cause
-Failure to obtain a warrant can result in exclusionary rule, barring evidence from being used in court against defendant
DEA inspections under CSA:
-DEA may enter and inspect places where persons are registered under CSA or where controlled substances records are kept
-Inspector is first req to state purpose of inspection ans present credentials and written notice of inspection to owner or PIC
-Informed consent in writing from owner or PIC
Consent requirement. Inspector must obtain and owner or PIC must sign. The statement must include:
-There is a constitutional right to refuse the inspection until an admin inspection warrant has been obtained
-Any incriminating evidence found may be seized and used against the owner or PIC in a criminal prosecution
-A notice of inspection has been presented
-The consent is voluntary and not coerced
-The consent may be w/drawn at any time during the course of inspection
An administrative inspection warrant (AIW) must contain:
-The name and address of the premises to be inspected
-A statement of the statutory authority for the warrant
-A statement as to the nature and extent of the inspection inc, when necessary, a request to seize specific items
-A statement that the premises either have not been previously inspected or were last inspected on a particular date
Exceptions to an Administrative Inspection Warrant:
-The inspection is an initial inspection of a new pharmacy for licensure purposes
-The records are ordered pursuant to an administrative subpoena
-The owner has given informed consent
-The situation presents an imminent danger to the public health and safety
-It is an exceptional or emergency situation where obtaining a warrant would be impractical bc of lack of time or opportunity to obtain one
-It is a situation where a warrant is not constitutionally required
It is a situation where a warrant is not constitutionally required. Examples include:
-When the search is made incident to a lawful arrest
-When the inspection is limited to areas of the commercial premises open to the public
-When the evidence is in plain view- providing that the officer is legally in a place the officer should be and inadvertently sees the evidence