QUIZ #2 Flashcards
1
Q
The Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 is more commonly known as what?
A
The Controlled Substances Act (CSA)
2
Q
What are controlled substances?
A
A category of drugs that society has determined require more severe restrictions and controls due to their potential for abuse and addiction.
3
Q
How many titles is the CSA composed of?
A
3
4
Q
What is Title I of the CSA?
A
provisions for rehabilitation programs for abusers
5
Q
What is Title II of the CSA?
A
provisions for registration and distribution of controlled substances
6
Q
What is Title III of the CSA?
A
provisions for importation and exportation of controlled substances
7
Q
What does Title II of the CSA create?
A
it creates a closed system for the manufacturing, distributing, and dispensing of controlled substances
8
Q
Why is it considered a closed system?
A
because individuals must be registered with the DEA before they can legally engage in the move activities with controlled substances
9
Q
Who regulates controlled substance?
A
DEA
10
Q
Where is the DEA in the government?
A
It is under the executive branch within the department of justice (DOJ)
11
Q
What other agency is under the DOJ?
A
FBI (federal bureau of investigation) and ATP (bureau of alcohol, tobacco, firearms, and explosives)
12
Q
Who is the head official of the DOJ?
A
attorney general
13
Q
what is the DEA’s mission?
A
- enforce controlled substances laws and regulations
- bring to the criminal and civil justice system those involved in the illegal growing, manufacture, or distribution of controlled substances part of, or destined for illicit drug markets
- recommend and support non-enforcement programs to reduce the availability of illicit controlled substance on domestic and international markets
14
Q
DEA’s main responsibilities
A
1) to prevent diversion and abuse of CS and 2) ensuring an adequate and uninterrupted supply is available to meet the country’s legitimate medical, scientific, and research needs
15
Q
DEA has how many divisions and how many domestic offices?
A
23 divisions across the US
239 domestic offices
16
Q
What is Florida’s division called?
A
Miami Division
17
Q
how many district and resident offices does the Miami division have?
A
4 district offices
7 resident offices
18
Q
Does DEA have any foreign offices?
A
yes, 93 foreign office in 69 countries
19
Q
what is the DEA pharmacist manual good for?
A
important guidance for pharmacists for practice and the MPJE
20
Q
What does the Federal Register have?
A
it contains information on new rules and regulations or proposed changes
21
Q
What does the daily journal of the United States government do/have?
A
it documents the actions of federal agencies
22
Q
4 types of entries in the Register
A
- presidential documents, including executive orders and proclamations
- rules and regulations, including policy statements and interpretations of rules
- proposed rules, including petitions for rule making and other advance proposals
- notices, including scheduled hearings and meetings open to the public, grant applications, administrative order, and other announcements of government actions
23
Q
What is the CFR?
A
Code of Federal Regulations which is the collection of the rules made by agencies
24
Q
How does the FDCA play into controlled medications?
A
FDCA is the main federal food and drug law and since controlled substances are drugs, they are subject to the FDCA as well so DEA works with the FDA sometimes
25
When can the state regulate controlled substances under their police powers?
AS LONG AS state law does not conflict with federal law
26
T/F
DEA generally leaves routine investigations of pharmacies to the state boards
true
27
What happens if the board finds a controlled substance violation?
They may inform the DEA who may then choose to investigate or will allow the state board to proceed with investigation and enforcement
28
Who has authority to regulate drugs through the interstate commerce clause in the US Constitution?
The federal government
- can regulate CSs in inTERstate commerce and inTRAstate commerce
29
what is inTERstate?
across state or several states
30
What is inTRAstate?
within a state
31
Which law is more strict? and what happens id state is less strict that federal?
state is generally more strict that federal
if state law if less strict than federal law, federal law trumps it through the preemption doctrine
32
What happens if the state and federal laws are conflicting and PharmD follows state law which then violates federal law?
the PharmD is then, technically, at risk for prosecution by the DEA
33
What is the anti-commandeering doctrine
it was established but the Supreme Court and says that the federal government can make laws but it can't order state governments to carry them out. States can choose to cooperate, but they can't be forced to use their resources (like police of officials) to enforce federal rules (Comes from the 10th Amendment)
34
T/F
A major portion of controlled substances flow through inTRAstate and foreign commerce and has a substantial and direct effect upon inTRAstate commerce.
False
it't inTERstate
35
What are the different sources of diversion? (There are 6)
- patient
- physician
- nurse/assistant
- pharmacist
- internet pharmacies
- theft
36
Schedule II narcotics
morphine, codeine, and opium, combination products containing hydrocodone, hydromorphone, methadone, oxycodone, and fentanyl
37
Schedule 11N non-narcotics (stimulants)
amphetamine, methamphetamine, and lisdexamphetamine; other schedule II substances include: cocaine, amobarbital, and glutethimide
38
schedule III narcotics
products containing not more then 90 mg of codeine per dosage unit (Tylenol #3) and buprenorphine
39
Schedule IIIN non-narcotics
benzphetamine (Didrex), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin)
40
Process at the DEA for the scheduling of controlled substances
- attorney general/DEA requests a scientific & medical evaluation of the drug and recommendation for scheduling from the secretary of the department of health and human services
41
The attorney general/DEA is bound by particular recommendations from HHS/FDA such as:
- recommendations based on scientific and medical matters
- recommendation that a drug not be controlled
- Attorney general may place a drug into schedule I w/o consulting the secretary of HHS/FDA to prevent an "imminent hazard to the public safety"
42
How or why would the attorney general/DEA deny, suspend, or revoke a DEA registration?
(there are 5)
falsity, felony, license problem, excluded from medicaid/medicare, act inconsistent w/ public interest
43
8 factors analysis considered by the attorney general or DEA when scheduling a substance
1. actual or relative potential for abuse
2. evidence of drug's pharmacological effect
3. current scientific knowledge about the drug
4. history and current pattern of abuse
5. scope, duration, and significance of abuse
6. public health risk
7. psychic or physiological dependence liability
8. if the drug in question is an immediate precursor of a controlled substance
44
Schedule I definition:
- drug or other substance that has a high potential for abuse
- drug or other substance has NO currently accepted medical use in treatment in the US
- lack of accepted safety for use of the drug or other substance even under medical supervision
45
most common examples of schedule I drugs:
heroin, lysergic acid diethyl amide (LSD), marijuana, synthetic cathodes (bath salts), 3,4-methylenedioxymethamphetamine (ecstasy), gamma-hydroxybutyric acid (GHB)
46
Where are drugs "placed" for emergency scheduling?
temporarily listed under schedule 1
47
Schedule II definition
- drug or other substance that has high potential for abuse
- drug or other substance has currently accepted medical use in treatment in the US or a currently accepted medical use with severe restrictions
- abuse of the drug or other substances may lead to severe psychological or physical dependence
48
Schedule III definition:
- drug or other substance has potentials for abuse less than the drugs or other substances in schedules I and II
- the drug or other substance has a currently accepted medical use in treatment in the US
- abuse of the drug or other substance may lead to moderate or low physical or psychological dependence
49
Schedule IV definition:
- drug or other substance has low potential for abuse relative to the drugs or other substances in schedule III
- drug to other substance has a currently accepted medical use in treatment in the US
- abuse of the drug or other substance may lead to limited physical dependence to psychological dependence relative to the drugs or other substance in schedule III
50
Examples of schedule IV meds
xanax, diazepam, Ativan, midazolam. triazolam, phenobarbital, chlordiazepoxide, zaleplon, tramadol, modafinil
51
schedule IV definition:
- drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV
- drug or other substance has currently accepted medical use in treatment in the US
- abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substance in schedule IV
52
manufacturer/commercial containers of CSs must be labeled with...
drug schedule symbol
- C-I, C-II, C-III, C-IV, C-V
53
Exempt from the label if...
commercial container is too small, otherwise unable to accommodate a label, or container use in clinical research.
54
characteristics of the label
must be prominently located on the label or labeling of the container and must be large enough ti easily identify w/o removing itself from the shelf
- must be clear and large enough to allow prompt identification upon inspection
55
What is an SLCP?
scheduled listed chemical product defined as a product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be markets or distributed lawfully in the US under the FDCA as a nonprescription drug.
56
Chemicals controlled under the CSA that were detailed in the chemical diversion and trafficking act of 1988 are placed in what?
list I chemical and list II chemical
57
what is a List I Chemical?
a chemical specifically identified in the CSA that in addition to the legitimate uses, is used in manufacturing a controlled substance in violation of the CSA and is important to the manufacture of a CS
-Ex: ephedrine, pseudoephedrine, methylamine, red phosphorous
58
What is a List II Chemical?
a chemical other than a List I Chemical that in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the ACT
-mostly solvents and reagents including acetone, hydrochloric acid, permanganate, toluene, sulfuric acid, etc.
59
who has to register with the DEA?
every person who distributes, imports, or exports must register
60
exception to ppl who have to register with the DEA
pharmacies (retail distributors) if the amount they carry is below "threshold quantities"
61
How do you become a part of the "closed system"?
entities must register with the DEA
62
the "closed system" was created by whom/what?
CSA
63
Pharmacies that dispense controlled substances have to register with DEA and have...
a state license, as well as prescribers who prescribe controlled substances
64
Which activities require separate registration for each?
- manufacturing registration
- distributing registration
- reverse distribution of controlled substances
- dispensing registration
- research with schedule I
research with schedules II-V
- conducting narcotic treatment program registration
- conducting chemical analysis of CSs registration
- importing and exporting CSs registration
- registration of individual practitioners to prescribe CSs
65
Prescriber Registration
prescribers who prescribe CSs must register with the DEA
66
Form 223
(sent from DEA to registrant who has submitted successful application form)
REGISTRATION CERTIFICATE
-must be maintained at the registered location and kept available for official inspection
67
Form 224
NEW APPLICATION FORM for pharmacies, hospital/clinics, practitioners, teaching institutions, or mid-level practitioners
68
Form 224a
renewal form
69
Form 224b
retail pharmacy registration affidavit for CHAIN RENEWAL
-covers rental of chain pharmacy registrant in lieu of a separate DA application form for each
70
Form 224c
Online pharmacy
71
Form 225
NEW APPLICATION FORM for manufacturer, distributor, researcher, analytical laboratory, importer, exporter, reverse distributor
72
Form 363
new application for Narcotic Treatment Programs
73
Form 510
new application for Chemical Registrants
74
DEA (registration) Number validation
- First letter A, B, F, or G
--- M for midlevel practitioners
--- P or R for distributors
- second letter is USUALLY the first letter of their last name
- first 6 digits represent the assigned n umber
- 7th digit is the "check digit" to aid verification of authenticity
75
Who are considered midlevel practitioners?
nurse practitioners, nurse anesthetists, nursing midwives, physician assistants, optometrists
76
Who is exempt from obtaining a DEA number if they handle CSs on a day-to-day basis?
- pharmacists
- delivery ppl who deliver the drugs from the warehouse
- a patient who gets a prescription for a CS
- medical offices
- law enforcement officials
77
What must mfgs and distributors do under CSA?
report CS transactions to the DEA
- how ARCOS was created
78
What is ARCOS?
Automation of Reports and Consolidation Orders Systems
- an automated, comprehensive drug reporting system which monitors the flow of DEA CSs from their point of mfg through commercial distribution channels to point of sale or distribution at the dispensing/retail level - hospitals, retail pharmacies, practitioners, mid-level practitioners, and teaching institutions
79
What CSs does ARCOS track?
- all schedule I and II materials (mags and distributors)
- schedule III narcotic and gamma-hydroxybutyric acid (GHB) materials (mfgs and distributors)
- select schedule III and IV psychotropic drugs (mfgs only)
80
Who must submit to ARCOS?
ONLY manufacturers and distributors
81
How frequent is ARCOS submitted?
submitted quarterly
82
83
How long are DEA registrations valid for, for individual prescribers and pharmacies?
36 months (3 years)
84
How long are DEA registrations valid for, for manufacturers and distributors?
12 months (1 year)
85
How far in advance do renewal forms (forms 224a, 224b, 224c) need to be submitted?
submitted online up to 60 days before expiration
86
How many 224 forms does a retail chain pharmacy need to submit to the DEA?
ONE!
A chain pharmacy must have a separate registration for each store, but submit a SINGLE form 224b to renew the registration for all stores within the chain
87
What happens if DEA reinstatement isn't done within one calendar month after the expiration date?
An application for a new DEA registration would then be required
88
If renewal application was submitted in a timely manner prior to expiration and has not received word back from DEA, what is the practitioner allowed to do?
The practitioner may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application
89
What request has the DEA made for corporations with 50 or more retail pharmacy registrations?
for them to enroll through the chain renewal program
- corporation would need to send a spreadsheet with their DEA registration information. The DEA will then create the chain indicator number and send them back with the renewal letter and an affadavit
90
Every registrant shall be required to report any changes of professional or business address in accordance with DEA regulations is called what?
what is a "modification"?
91
When should a modification be handled?
Before moving to a new physical location
92
How are modifications handled?
in the same manner as applications and must be approved by the DEA
93
How can modification registrations be requested?
online via www.DEAdiversion.usdoj.gov or in writing to the local DEA Registration Program Specialist responsible for the area in which the pharmacy is or will be located
94
requirements for the modification
must contain:
- registrant's name
- registrant's address
- registration number as printed on the Certificate of Registration
- new name or address
- signature
95
What should the registrant keep with the new certificate?
the old one until expiration
96
If transferring a business to another registrant, what needs to happen?
proposal must be submitted in person or by registered or certified mail to local DEA special agent AT LEAST 14 days prior to the transfer unless the special agent waives this requirement
97
What must be included on the proposal to transfer businesses to another registrant?
- name
- address
- registration number
- authorized business activity of the registrant discontinuing business and that. of the person acquiring the business
98
What must be done in order to transfer businesses to another registrant?
- complete inventory of all CSs taken on date of xfer
- all records xferred on date of xfer
- xfer of schedule ii drugs must be done with DEA Form 222 or electronic or electronic equivalent
- xfer of schedule iii-v CSs must be documented in writing
99
What must be included documented on the form to xfer the CSs Ciii-V?
- drug name
- dosage form
- strength
- quantity
- date transferred
--document must include the names, addresses, and DEA registration number to the parties involved in the xfer of the CSs
100
When would a person be able to register for a DEA number prior to the completion of a xfer of a pharmacy?
if the registrant acquiring the pharmacy owns at least one other pharmacy licensed in the same state as the pharmacy being transferred.
101
Under what circumstances does a registration need to be terminated?
if a practitioner dies, retires, or pharmacy goes out of business
102
What needs to happen if a pharmacy goes out of business w/ no xfer?
- registration must be returned to local DEA Registration Program Specialist along with unexecuted 222 forms
- unwanted CSs in pharmacy possession must be disposed of in accordance w/ DEA regulations
- Must keep all pharmacy records for at LEAST 2 years after termination of business
103
What happens to records if a pharmacy goes out of business and there is no xfer?
Since records must be kept for at least 2 years after termination of business, the DEA may request the location of storage for inventories, prescriptions, and other required CS records during the required 2-yr retention period
104
T/F
Pharmacies do not need to provide effective controls and procedures to guard against theft and diversion of controlled substances
False. They "shall"
105
What form is used to report theft/loss of controlled substances to the DEA?
DEA form 106
106
T/F
You cannot perform research with Schedule I CS
False
it is possible, but it is also difficult
107
In order to get an approved research protocol...
- protocol must contain info on investigator, study design, and security measures
- must be approved by the DEA
- May also submit Notice of Claimed Investigational Exemption for a New Drug (IND)
108
What 2 things need to happen to do research on a schedule I CS?
1. must have an approved research protocol
2. DEA issues a certificate of registration
109
What form needs to used to order CI and CIIs?
DEA Form 222 or an electronic equivalent
110
How does a pharmacy obtain DEA Form 222?
the entity must be registered with the DEA
111
What for is needed to order CIII to CV?
There is no special form that is required, however, the invoices need to be kept
112
All orders and ordering receipts )DEA 222s and invoices for CIII to CV) must be...
"readily available". Maintained separately from other files
113
Where must order forms be held and for how long?
Must be retained for 2 years at the place of named registration
114
Definition of "Readily Retrievable"
- kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time
--------------------AND/OR-------------------------
- kept in such a manner that certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records
115
A DEA Form 222 is used to order...
Schedule I and schedule II CSs
116
The single-sheet form includes...
20 order lines (dbl the previous lines on old form) and fits on a standard 8.5 x 11 sheet
117
How are DEA Forms 222 issued?
via mailing envelopes containing a predetermined number of forms based on the business activity of the registrant (each consisting of one single-sheet)
118
Can additional forms be requested?
They can be specifically requested and a reasonable need for additional forms must be known
119
When a DEA Form 222 is utilized, who keeps the copy and who keeps the original?
the purchaser makes a copy of the original form for records and then the original is submitted to the supplier
120
In what format does the purchaser have to keep the form?
Either paper or electric form
121
Who can obtain DEA Forms 222?
- must have active DEA registration authorized to order Sched. I & II
- any person holding a registration authorizing the person to obtain a DEA Form 222
122
How is a new DEA Form 222 requested?
- any person holding a registration authorizing the person to obtain a DEA Form 222 may request the forms through a DEA secured network connection OR by contacting any Division Office or the Registration Section of the Administration customer service center
123
What must be on each request?
Each request must show the name, address, and registration number of the registrant and the number of DEA Form 222s desired
124
What will DEA Form 222s have?
an order form number and is issued with the name, address and registration number of the registrant, the authorized activity, and schedules of the registrant
125
Can information be altered on the form?
Information cannot be altered or changed by the registrant; the registrant must report any errors to the local Division Office or the Registration Section of the Administration to modify the registration
126
Who does the registrant report an errors to?
the local Division Office or the Registration Section of the Administration
127
What must be entered on the form?
name and address of the supplier from whom the CSs are being ordered
128
Who can enter the supplier's DEA registration number?
The number may be entered by the purchaser or the supplier
129
The purchaser has the option to retain the original
False
130
The copy retained by the purchaser may be in...
paper or electronic form
131
Who signs and dates the DEA Form 222?
Signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a Form 222
132
if name of the purchaser is different from the individual signing...
Their name must be inserted in the signature space as well
133
How is authorization revoked?
by executing a notice of revocation
134
Who can sign a DEA Form 222?
Any person registered by DEA may legally authorize one or more individual to sign on his/her behalf
135
Granting of power of attorney and revocation of power of attorney require...
2 witnesses
136
To grant power of attorney, you need...
- signature of registrant
- partner of the registrant OR
officer of the registrant
- signature of person being granted POA
- signature of the 2 witnesses
137
To revoke power of attorney, you need...
a signature of the person who signed the most recent DEA registration/reregistration and 2 witnesses
138
When is it necessary to grant a new POA?
Only if the renewal application is signed by a different person at the time the pharmacy goes to complete a renewal registration <-- RELOOK AT THIS QUESTION
139
T/F
POA HAS to be signed in-person by any or all persons required to sign
F - may be signed electronically
140
When would a new POA need to be granted for a renewal registration?
only if the renewal application is signed by a different person is it necessary to grant a new POA when the pharmacy completes a renewal registration
141
Where is the POA filed?
Should be filed with executed DEA Forms 222 if applicable and must be available for inspection
141
T/F
POA must be submitted to the DEA
F - the POA is not submitted to DEA
142
Which persons should be present and signatures required when granting a POA?
- person to be granted POA
- DEA registrant
- witness
- witness
143
Do the witnesses need to be the same as those who were witnesses for the POA?
You do NOT have to use the same witnesses as those who witnesses the POA
143
Which persons should be present and signatures required when revoking POA?
- person who signed the last registration (which could be the DEA registrant)
- witness
- witness
144
Does the purchaser keep the original or make a copy of original DEA Form 222?
Purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier.
145
The copy retained by the purchaser may be in what form?
paper or electronic
146
When the items ordered on the DEA form 222 are received, what needs to be done?
Once items are received, the purchaser must document on the purchaser's copy the actual number of commercial or bulk containers received as well as the date they were received
146
Which DEA Forms 222 does the purchaser have to keep?
all - even if you make a mistake on a form, you must keep it on file so that if DEA comes looking for it you can account for it. YOU CANNOT THROW IT AWAY
147
Can the supplier dispose of the original DEA Form 222?
No. the supplier must retain the original DEA Form 222 for their records
148
When can a DEA Form 222 not be filled?
- when the order is not complete, legible, or poorly prepared, executed, or endorsed
- when the order shows any alteration, erasure, or change of any description
149
What does the purchaser do with the DEA Form 222 when their order is unaccepted?
Purchaser must retain the original DEA Form 222 and the statement must be retained in the files
149
What happens when the supplier "rejects" the purchasers DEA Form 222?
If a DEA Form 222 cannot be filled for any reason under this section, the supplier must return the original DEA Form 222 to the purchaser with a statement as to the reason (e.g. illegible or altered)
150
Can DEA Form 222s be corrected?
NO! it must be replaced by a new DEA Form 222 for the order to be filled
151
What happens when the supplier refuses to fill electronically?
When purchaser receives an unaccepted electronic order from a supplier, the purchaser must electronically link the statement of non-acceptance to the original order, and retain the original order and statement
152
An electronic order for CSs may not be filled if:
- the required data fields haven't been completed
- the order isn't signed using a digital certificate issued by DEA
- the digital certificate used has expired or been revoked prior to signature
- purchaser's public key will not validate the digital certificate
- the validation of the order shows that the order is invalid for any reason
153
if an order cannot be filled, the supplier must...
notify the purchaser and provide a statement as to the reason (e.g improperly prepared or altered)
154
A supplier may, for any reason, refuse to accept any order. If a supplier refuses...
a statement that the order is not accepted is sufficient
155
When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must...
electronically link the statement of nonacceptance to the original order
156
The original unaccepted statement and all linked records for that order must be retained for _____ years
two
157
Who can correct a defective order?
No one. neither a purchaser nor a supplier may correct a defective order
158
If an order has been rejected, what must the purchaser do in order to get the order filled?
Purchaser must issue a new order for the order to be filled
159
T/F
A supplier can ONLY void an electronic order in its entirety
False - may void all or part
160
How does a supplier void an electronic order?
by notifying the purchaser of the voiding
161
If the entire order is voided, the supplier must ...
make an electronic copy of the order and indicate "void" on the copy and return it to the purchaser
162
T/F
Supplier is required to retain electronic copy of voided orders
False - purchaser must retain an electronic copy of the voided order
163
If a supplier PARTIALLY voids an order, the supplier must...
indicate in the linked record that nothing was shipped for each item voided
164
For each electronic order filled, a supplier must forward either...
a copy of the electronic order
OR
an electronic report of the order in a format that DEA specifies to DEA within TWO business days
165
In the event that a state board revokes the license of a pharmacy, DEA will request a voluntary surrender of the pharmacy's DEA registration.
If the pharmacy refuses to surrender...
DEA will seek administrative action to revoke it DEA registration based on lack of state authorization
166
In the event that a state board revokes the license of a pharmacy, DEA will request a voluntary surrender of the pharmacy's DEA registration.
additional administrative remedies that may be utilized to correct a lack of compliance include...
a letter of admonition or an administrative hearing.
167
In the event that a state board revokes the license of a pharmacy, DEA will request a voluntary surrender of the pharmacy's DEA registration.
DEA may also pursue civil or criminal sanctions if there is...
sufficient evidence to justify a prosecution
167
All action pertaining to the revocation of licensure are designed to...
protect the public health and safety
168
T/F
Pharmacies canNOT transfer electronic CII-CV prescriptions to another pharmacy upon patient request
False - as of August 28th, 2023, they are allowed to do so
169
What are the stipulations of being able to transfer electronic CII-CV prescriptions between pharmacies.
- scripts can only be transferred once between pharmacies and ONLY if allowed under existing state or other applicable law
170
Can an electronic prescription be altered?
NO - prescription must remain in its electronic form; may not be altered in any way; transfer must be communicated directly between two licensed pharmacists
171
If there are refills on the prescription, do they stay at the transferring pharmacy or transfer to the receiving pharmacy?
- any authorized refills transfer with the original prescription, which means any future refills will be filled at the same receiving pharmacy
172
Who does not need to be registered with the DEA?
hospitals interns and residents
173
Hospital and Institutional Employees
- must be licensed to prescribe by state
- can prescribe CS under the registration of the hospital or other institution
- Rxs may be filled outside of institution
174
Who assumes risk if anything happens?
hospital registration assumes risk
175
Hospital and Institutional employees must be...
- acting within the scope of employment
- authorized under hospital registration
- be assigned a specific internal code number by hospital
176
Electronic prescribing and transmitting of controlled substances is NOT mandatory for all CSs under Medicare Part D by Jan 1, 2021 pursuant to the every prescription conveyed securely act
False - it's mandatory
177
Pharmacy must utilize a software meeting...
stringent DEA requirements
178
How often does pharmacy have to back up electronic files and how long must records be kept?
pharmacy must back-up electronic files daily and records must be kept for TWO years
179
Must be approved by either a qualified third party audit or by an approved certification body
- import, display, and store prescription accurately and consistently
- limit access for annotation, alteration, or deletion of Rx
- Conduct internal audits to identify security problems
- Allow pharmacy to set access controls
180
What needs to be approved for each electronic prescription of CSs?
- date of issuance
- pt full name
- drug name
- dosage strength & form, qty, directions
- refills (if applicable)
- For CIIs written under the multiple CII prescription rule, the earliest date at which a pharmacy may fill each prescription must be present
- name, address, and DEA # or prescribing practitioner
-
181
DEA registration requirement is waived for whom?
- any official of the US Army, Navy, Marine Corps, Air Force, Space Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to administer, dispense, or prescribe, but not to procure or purchase CSs in the course of his or her official duties
182
Can military physician prescription's orders be filled off-base?
yes
183
For waived personnel, what must the Rx need?
- shall state branch of service on prescription order (e.g. "US Army" or "Public Health Service" or "Space Force")
- must provide svc ID number in lieu of DEA number
184
A Public Health Service employee;s service identification number is...
his or her social security identification number
185
If practitioners working for the government would like to obtain a DEA registration for private practice, they must...
be fully licensed to handle controlled substances in te=he state in which they are located
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