Exam Two Flashcards
(190 cards)
1
Q
What did the Harrison Narcotics Act required?
A
importers, manufacturers, and distributors of cocaine and opiates to:
- register with the U.S. Treasury
- Pay a special tax on these drugs
- keep records of each transaction
2
Q
What was the first federal law involved in the regulation and control of certain drugs?
A
The Harrison Narcotics Act
3
Q
What did the Harrison Narcotics Act allow practitioners to do?
A
to prescribe opiates and cocaine in the course of their professional practice only
4
Q
What was the Marihuana Tax Act?
A
- federal government banned marijuana under this act by requiring a high-cost transfer tax stamp for every sale of marijuana
- all states made the possession of marijuana illegal for awhile
5
Q
The Federal Bureau of Narcotics combined with the Bureau of Drug Abuse to form what?
A
Bureau of Narcotics and Dangerous Drugs (now the DEA)
6
Q
What did Title II of the Comprehensive Drug Abuse Prevention and Control Act establish?
A
- Established 5 separate schedules of controlled substances
- regulated the manufacture, distribution, and dispensation of controlled substances
7
Q
What is Title II of the Comprehensive Drug Abuse Prevention and Control Act most commonly referred to as?
A
Control Substances Act
8
Q
What is the DEA’s primary domain and primary function?
A
- The Controlled Substances Act
- Enforcing the Controlled Substances Act
9
Q
What is a controlled substance?
A
a drug with dependence liability and/or abuse potential
10
Q
What are factors that determine scheduling of controlled substances?
A
- actual or relative potential for abuse
- scientific evidence of its pharmacologic effect, if known
- state of current knowledge regarding the drug or other substance
- history and current pattern of abuse
- scope duration, and significance of abuse
- risk to public health
- psychic or psychological dependence liability
- whether the substance is an immediate precursor of a substance already controlled under this subchapter
11
Q
The eight factors for determining controlled substance scheduling allow for?
A
- scheduling a drug that was previously not scheduled
- changing a drug from one schedule to another
- removing a drug from the schedules entirely
- keeping a drug in it current position (controlled/uncontrolled)
12
Q
Schedule 1 is the only schedule with what?
A
no acceptable medical use?
13
Q
Does schedule 2 have the same abuse potential as schedule 1?
A
Yes
14
Q
How are schedules 3,4,5 stratified?
A
by abuse potential and/or addiction potential
15
Q
Do different dosage forms have different schedules?
A
maybe
16
Q
Do different drug combinations have different schedules?
A
Yes (codeine)
17
Q
What if a controlled substance is classified as a nonprescription drug?
A
- it can be sold without a prescription
- codeine/guaifenesin
18
Q
How old does a patient have to be for a pharmacist to sell an OTC controlled substance?
A
18 years old or older
19
Q
OTC Controlled Substances sales are limited to what?
A
- 240 mL (8 oz) or 48 dosage units (tabs, caps) of any controlled substance containing opium
- 120 mL (4 oz) or 24 dosage units of any other controlled substance in a 48 hour period
20
Q
What must a pharmacist verify before selling an OTC controlled substance product
A
- review valid form of ID and record information
- name of purchaser
- name and quantity of controlled substance purchased
- date of each purchase
- name or initials of pharmacist
21
Q
OTC Controlled Substance Sales must be documented in what?
A
- bound book
- not electronically or on loose papers
22
Q
What three products under the CSA are limited to sell due to their ability to produce methamphetamine
A
- pseudoephedrine
- ephedrine
- phenylpropanolamine
23
Q
Federal law limits the sales of listed chemicals to what?
A
- 3.6 grams/day
- 9 grams in 30 days
24
Q
OTC sales of pseudoephedrine, ephedrine, and phenylopropanolamine requires what?
A
- seller must maintain a written or electronic sales record which contain:
- name, address, and signature of purchaser
- date and time of sale
- name and amount of product purchased
25
Purchaser of pseudoephedrine, ephedrine, and phenylopropanolamine must present what?
valid form of ID which contains a photograph, is nonexpired , and issued by a state or federal government
26
Controlled Substance Labeling
- symbol prominently displayed on the label of the commercial container
- large enough to easily identify the product's schedule on a pharmacy or warehouse shelf
27
What are the ten business activities for which a DEA registration may be obtained?
- manufacturing
- distributing
- reverse distributing
- dispensing or instructing
- research (C-1)
- research (C2-5)
- narcotic treatment program (including compounder)
- importing
- exporting
- chemical analysis
28
Before engaging in an activity requring DEA registration, you must first obtain what?
- a separate registration for each place of business/practice location where controlled substances are held
29
DEA Form 224
application for dispensing or instructing registration
30
DEA Form 225
application for manufacturer, distributor, reverse distributor, researcher, analytical laboratory, importer, or exporter registration
31
How long are dispensing or instructing registrations valid for?
3 years
32
Most registrations are renewed when?
annually
33
A typical pharmacy would be registered for which drug schedules?
2, 2N, 3, 3N, 4, 5
34
A dispensing or instructing registration is limited to which schedules?
II-V
35
What are coincident activities?
- extra activities that a DEA registrant may engage in without obtaining a different registration
- often required to allow registrant to complete their primary registered function
36
Which registration types do not permit coincident activities?
- reverse distributing
- exporting
37
What are the dispensing or instructing registration coincident activities?
- May conduct research and instructional activities with substances for which
registration was granted (mid-level practitioners may only conduct research to
the extent authorized in state statute)
- A pharmacist may manufacture a product containing a narcotic controlled substance in schedule II-V in a proportion not exceeding 20% of the complete
solution, compound or mixture
- A retail pharmacy may perform central fill pharmacy activities
- A pharmacy may distribute a controlled substance to another practitioner for the
purpose of general dispensing, so long as that distribution does not exceed 5%
of the total dosage units distributed and dispensed within the same year
38
How are DEA numbers structured?
- nine characters
- two letters
- seven numbers
39
What does the first letter of the registrant represent?
type of registrant
40
dispensing or instructing registration types have DEA numbers that start with
A, B, F, G
41
Mid level practitioners have DEA numbers that start with
M
42
Big four prescribers have DEA nubmers that start with
A, B, F, or G
43
What does the second letter represent of the DEA nubmer
name of the business that initially registered or registrants last name
44
Is an agent or employee of a person who is registered to engage in a particular activity required to obtain an individual registration?
NO
45
Are common or contract carriers and warehousemen who possess a controlled substance in the usual course of business reuqired to obtain a DEA number?
no
46
is the ultimate user who possesses a controlled substance required to have a DEA number
NO
47
Institutional DEA Numbers
reserved for individual practitioners who are agents or employees of a hospital/health system and do not have their own DEA number
48
What are the requirements a practitioner must meet when using an instiutional DEA number
- activity is done in the usual course of the individual's professional practice
- the jurisdiction in which the individual is practicing allows the action
- the institution has verified the individual may perform the action
- acts within scope of their employment
- applies internal code to DEA nubmer
- keeps current list of internal codes for verification processes
49
What does the CSA state about CS Security
registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances
50
What does the DEA consider in terms of controlled substance security
- activities conducted
- type and form of controlled substances handled
- quantity of controlled substances handled
- storage system of controlled substances
51
Where must C1s be stored?
securely locked, substantially constructed cabinet
52
How must a practitioner store controlled substance if in office or clinic?
in a locked cabinet
53
C2-5 Storage
“Controlled substances shall be stored in a securely locked,
substantially constructed cabinet. However, pharmacies and institutional practitioners can disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.”
54
Employment Screenings for Controlled Substance Registrants
- shall not employ an person convicted of a felony offense relating to controlled substances
- who had an application for registration with the DEA denied
- had DEA registration revoked
- has surrendered a DEA registration for cause
55
What is an employment waiver?
if a registrant wants to employ an individual who does not qualify for employment, they may apply for a waiver
56
When will the DEA consider an employment waiver?
unless diversion is unlikely to occur
57
The CSA requires all records and reports involving controlled substances to be kept for at least...
two years from their origin date
58
If the DEA catches a registrant not properly record keeping, what is the consequence?
- $10,000 fine for each unintentional violation
- more severe penaltiesor jail time for intentionally committed violations
59
What do registrants need to maintain copies of for recordkeeping purposes?
a complete and accurate record of each substance
- manufactured
- imported
- received
- sold
- delivered
- exported
- or disposed of
60
How must controlled substance records be stored
- CII records separate from other records
- CIII-CV may be kept separately or with other records as long as they are retrievable
61
What does readily retrievable mean?
- have a red C no less than 1 inch high stamped in the lower right corner of the prescription face
- must identify prescriptions by prescription number in computer system
62
How must you be able to search CIII-CVs in an electronic system?
- prescriber name
- patient name
- drug dispensed
- date filled
63
What is central recordkeeping?
records are transferred to a central location other than the registration location
64
When does a registrant need to notify the DEA of its intent to initiate central recordkeeping?
in writing 14 days in advance and the note must include
- records to be kept centrally
- the exact location of the records
- name, address, DEA registration number, and type of DEA registration of the registrant storing records centrally
- whether control records will be maintained manually or by computer
65
When must records be transferred to central location if central recordkeeping is allowed?
two business days
66
What things cannot be stored centrally?
- executed order forms (DEA Form 222)
- inventories
- prescriptions
- POA
67
How can you order CIII-CVs
- can utilize standard invoice for record of receipt so long as it contains
- date
- must be able to easily identify controlled substances from non-controlled medications
68
How can CIIs (and CIs) be ordered
using a DEA 222 form
69
What must a DEA Form 222 include?
- purchases
- transfers
- sales
70
What is the other way to deliver CIIs other than through a DEA 222
via a prescriptions
71
Who can fill out a 222 order form?
DEA registrant or POA
72
Does a separate POA need to be filled out for each person individually?
Yes
73
Stipulations with POAs
- POAs may be revoked at any time, and must be available for inspections alongside other records (kept at registered locations)
- POA agents should sign "Registrant by Agent, Attorney in Fact"
74
To order DEA Form 222s, the registrants must first submit what?
DEA Form 222a
75
DEA Form 222as must have what?
- name
- address
- registration number
- number of books desired
- must be signed by registrant or POA
76
Can DEA Form 222s be altered ?
NO
77
What do the DEA Form 222s have on them that cannot be altered ?
- name
- address
- registration number
- authorized activities
- schedules registrants can handle
78
If there are errors with the 222, what must happen
must send the forms back to the DEA who will correct the information and issue new forms
79
What does the current 222 form have on it
- supplier information
- purchaser name
- purchaser signature
- date
- number of packages
- package size
- drug name
- last line completed
- supplier completes part 3 and 4
- purchaser completes part 5 upon receipt
80
How can 222 forms be completed
- typewriter
- computer printer
- pen
- indelible pencil
81
what may be filled on a 222 form that may cause delays if not on the order
NDC
82
When do you need to fill out multiple 222 forms
when ordering 20 products
83
Once completed a ___ of the executed 222 must be made because the ___ will be sent back to the supplier
copy, original
84
If an error occurs when filling out a DEA 222, what must be done?
VOID across the front and filed with other executed 222s
85
Upon receiving a 222, supplier will verify it can be filled and add the following information
- supplier DEA number
- NDC number for products sent
- number of bottles or containers sent
- date sent
86
What must suppliers do with the OG 222
keep the OG and forward a copy to the DEA by the end of month OR reports information on ARCOS
87
Partial filling a 222
60 days to supply balance of the order
88
endorsing a 222 order
supplier may send an order to another supplier within 60 days, second supplier fills full order (all or nothing)
89
defective 222 order
supplier must send the form back to purchaser with statement explaining the refusal to fill
90
order refusal 222
supplier may refuse to accept order and must send the form back to purchaser with a note that the order was not accepted
91
voiding part of a 222 order
if a supplier cannot fill a full order, they may draw a line through the voided items and print 'canceled' on the number of items shipped
92
Purchaser Order Receipt
when purchaser receives the order they must record
- date the order was received
- number of containers of each item received
93
Lost Executed 222
purchaser must execute a new DEA 222 identical to the first with accompanying note stating the original form number, date of lost form, and note stating substances not received
94
Lost Unexecuted 222
must report to the DEA immediately
95
Unused 222
return order forms to DEA
96
Electronic 222
- registrants must apply for digital certification from the DEA
- the digital certificate gives access to the CSOS
- CSOS orders may include drugs from any schedule
- electronic 222s cannot be endorsed
97
Controlled Substance Inventory
- every registrant must have a complete and accurate record of all controlled substances on hand on the date the inventory is taken
- if the drug is in the registrant's possession, it must be inventoried
98
Which Controlled Substance must be inventoried
- drugs stored in other areas of institution
- drugs returned by a patient
- in waiting bins ready to be picked up
99
Initial inventory
must be conducted on the day the registrant first engages in activties with controlled substances
100
Official inventory
must be conducted at least once every two years (biennially)
101
rescheduling inventory
must be conducted when previous noncontrolled medication becomes a controlled substance
102
final inventory
conducted when registrant goes out of business
103
Methods of inventory
- at opening of business on the inventory date
- at the close of business on the inventory date
(must note which method is used)
104
Which substances are inventoried as an exact count?
C1-CII
105
which substances can be estimated when inventoried
- CIII, CIV, CV
- unless bottle holds more than 1000 tablets
106
What is a prescription?
an order for a medication which is dispensed to or for an ultimate use but does not include an order for medication which is dispensed for immediate administration to the ultimate user
107
Who can issue a controlled substance prescription?
- practitioners authorized to prescribe
- controlled substance prescribers must have a DEA number or be exempt from registration
108
Who cannot communicate C-II emergency prescriptions?
- agents
- prescribers cannot give agency to anyone for this type of prescription
109
A prescriber must ensure prescriptions are what?
- issued for a legitimate medical purpose by a practitioner acting in the usual course of practice
110
Legitimate medical purpose
patient has a medical need for the medication
111
Usual course of practice
prescriber has a valid patient-provider relationship (at least one in person evaluation or telehealth)
112
Who is responsible for proper prescribing and dispensing of controlled substance
- prescribing practitioner
- pharmacist who fills prescription
113
Corresponding Responsibility
- pharmacists are accountable in making sure controlled substances are prescribed and dispensed appropriately
- pharmacist recognized the possibility of wrongdoing but refused to conduct a proper investigation
114
All concerns about controlled substance prescriptions should be handled in what way?
- should be resolved
- resolution does not have to be documented (to avoid legal issues, you should document to prove you have met corresponding responsibility)
115
When documenting issues about a controlled substance prescription, what is important?
- not to deface the prescription as that is the property of the patient
- small notes are ok as appropriate
- return to patient or destroy if indicated by doctor
- use professional judgement and document rational for filling or refusing to fill
116
Written prescription
wet signature required (signed by hand by prescriber)
117
fax prescription
wet signature required
118
electronic signature
electronic signature required (two factor authentication to verify identity in an electronic system)
119
telephone prescription
- transcribed by a pharmacist or intern when received at the pharmacy
- can be called in by prescriber or agent
120
CII prescriptions may be dispensed pursuant to each to of the following prescription types
- written, paper prescription signed by the prescriber
- electronic prescription transmitted by the prescriber
- a fax prescription if the patient presents the manually signed prescription to the pharmacist prior to dispensing
121
Acceptable CII Faxed Original Prescriptions
- CII narcotics administered by injection for direct administration
- CII for LTCF
- CII narcotic for patient enrolled in hospice program
122
CIII-CV prescriptions may be dispensed pursuant to each of the following prescription types
- written, paper prescription signed by the prescriber
- electronic prescription transmitted by the prescriber
- a fax prescription transmitted by the prescriber or the prescriber's agent
- a telephone prescription promptly reduced to writing by the pharmacist
123
Controlled Substance Prescription Quirks
- any CII-CV may be dispensed or administered without prescription by individual prescriber
- institutions may administer or dispense (not prescribe) CII-CV drugs based on a prescription or order from an individual practitioner if it is dispensed for immediate administration to the ultimate user
124
Required information for controlled substance prescription
- date of the prescription was issued
- full name and address of the patient
- drug name, strength, dosage form
- quantity prescribed
- directions for use
- name, address, and DEA number of prescriber
- signature of prescriber
125
What changes can a pharmacist make on a CII prescription
- adding or correcting patient's address
- adding or changing dosage form, strength, quantity, or directions for use after confirming with provider
126
What changes can't a pharmacist make on a CII prescription
- name of patient
- name of drug (except for generic sub)
- name of the prescriber, including signature
- a new prescription must be issued
127
What changes can a pharmacist make on CIII-CV prescriptions
- we can accept verbal orders so we can convert erroneous written prescriptions into new telephoned ones
- need authorization from prescriber to do this
- state specific electronic prescribing requirements may impact the ability to perform this change
128
Who is entitled to fill controlled substance prescriptions?
- only a pharmacist including those authorized to dispensed under supervision of pharmacist
129
Who is not entitled to fill controlled prescriptions?
- prescribers
- can dispense controls but not pursuant to a prescription
130
Refill
filling the prescription's face amount after the initial fill has been already dispensed
(prescription with 3 fills can be filled 4 times)
131
CII refills
not allowed
132
How long a CII prescriptions good for?
a year from written date
133
Is there a limit on the amount a CII can be prescribed for?
No
134
Multiple CII Prescriptions
prescribers may authorize multiple prescriptions for a patient to receive up to a 90 day supply of a controlled substance (cannot post date)
135
When prescribing multiple CII simultaneously (at once)
- written in accordance with controlled substance prescribing responsibilities
- date with the date issued and provide written instructions indicated earliest fill date
- does not create risk of diversion
- adhere to state statutes and regulations
- must meet all other CII prescription requirements
136
CIII and CIV Refils
- may have up to 5 refills (six total fills)
- may authorize additional refills if OG prescription has less than 5 refills
- cannot exceed 5 or extend beyond six months from original issue date
137
CV refills
no limit in federal law
138
How must a CIII-CIV refill be documented
- writing on the back of the prescription or another appropriate document
- documenting in an electronic prescription record
139
Documentation of CIII-CIV refill must include
- name and dosage form of controlled substance
- date filled or refilled
- quantity dispensed
- initials of dispensing pharmacist
- total number of refills for that prescription
140
CIII-CIV Electronic Refill Documentation
- may be used for storage and retrieval of refill information
- original prescription number
- date of issue
- name and address of patient
- name, address, and DEA of prescriber
- name, strength, dosage form, quantity prescribed of drug
- refills authorized
- refill history
141
If alternative record system for CIII-CIV refill documentation is utilized, the pharmacies must employ one of the following record keeping methods for refills
- print out all controlled substance refills with the information of the pharmacist who refilled the prescription. the printout must be reviewed and signed by the pharmacist, stored for 2 years
- maintain a bound logbook that each pharmacist involved in dispensing shall sign each day, attesting to the fact that the refill information entered has been reviewed and is correct
142
Partial filling CIIs circumstances
- at the request of the patient, patient rep, or prescribing practitioner
- if the pharmacy cannot provide full amount of prescription
- for a patient in a LTCF or who has medical diagnosis documenting terminal illness
143
Partial Filling Prescriptions Federal Criteria
- if not prohibited by state law
- patient, rep, or prescriber requested partial fill
- total quantity of all partial fillings does not exceed the total quantity prescribed
- remaining filled no later than 30 days from date prescription is written
- does not apply related to stock shortages or insurance limits
144
CII Partial FIll OOS
- remainder must be ready for pick up within 72 hours of the partial fill
- if remainder cannot be prepared within 72 hours, the remainder must be voided and prescriber must be notified with the quantity filled and reason for partial
145
CII Partial Fill LFTC/Terminal Illness
- may be partially filled for up to 60 days from the date issued
must document
- date of partial filling
- quantity dispensed
- remaining quantity to be dispensed
- identification of dispensing pharmacist
146
Parital filling CIII-CVs can happen as long as
- total quantity does not exceed total prescribed
- no amount is dispensed after the prescription expires
- must be recorded in the same manner as refills
- may partially fill a prescription more than 5 times
147
CII Emergency Prescriptions
- the immediate admin of a controlled substance is needed
- there is no appropriate alternative available, including non controls
- it is not possible for prescriber to provide a written prescription before dispensing
- should only be for the amount needed to cover the emergency period
- followed by covering prescription within 7 days of authorization
148
Cover prescription
- must have exact amount and directions authorized in the emergency prescription
- must meet standard CII prescription rules and have authorization for emergency dispensing written on the face of the prescription
- must be delivered to pharmacy in person or postmarked within the 7 day period
149
CII Emergency Prescription Documentation/Follow Up
- need to attach covering prescription to emergency prescription previously dispensed
150
CII Emergency Prescription Documentation/Follow Up for electronic covering prescription
pharmacist must annotate the prescription with the oral order's original authorization and date
151
CII Emergency Prescription Documentation/Follow Up for electronic covering prescription not received
- pharmacist must notify nearest DEA office
- after 7 days, notify the DEA immediately
152
Central Fill Community Pharmacy Documentation
- write the words "central fill" on the face of the original prescription
- record name, address, and DEA number of the central fill pharmacy
- record the name and the date of transmittal to central fill
153
Central Fill Community Pharmacy Documentation Records
- keep og prescription for at least two years
- record of receipt of the filled prescription
154
Central Fill Documentation
- a copy of the faxed prescription or electronic record with the name, address, and DEA number of the community pharmacy
- the date the prescription was received, pharmacist filling the prescription, and the date the prescription was filled
- the date the prescription was delivered to the community pharmacy and the delivery method
155
Central Fill Documentation Recordkeeping
- records maintained for two years
156
Controlled Substance Central Fill Refils
- CIII-CV
- community pharmacy must indicate in the information transmitted the number of refills already dispensed and the refills remaining
- central fill pharmacy must record the dates the prescription was filled and refilled
157
All Controlled Substance Prescription Labels
- date of filling
- dispensing pharmacy name and address
- prescription number
- name of patient
- name of prescriber
- directions for use
- cautionary statements if any (optional)
158
Prescription Labels additional requirement
- only CII-CV
- Caution: federal law prohibits the transfer of this drug to any person other than the patient whom it was prescribed for
159
What must be on the prescription label if dispensed by central fill
- unique identifier to indicate prescription was fill at central fill
160
When do labeling requirements do not apply to CIIs
administration in the institution so long as no more than 7 day supply of medication is dispensed at a time and the med is not in the possession of the ultimate user before admin
161
When do CIII-CV labeling requirements not apply?
- administration in an institution so long as no more than 34 day supply of medication or no more than 100 dosage units is dispensed at a time
162
When are electronic controlled substance transfers to another pharmacy allowed
- applied to all schedules even if they have never been filed
- if allowed by state law
- the prescription was electronically prescribed
- if communicated between two licensed pharmacists
- the prescription is maintained in electronic formate
163
How many times can electronic prescriptions be transferred
one time but refills can be honored at the new pharmacy
164
Non electronic prescription transfers
- only CIII-CV
- must have been filled at least once before being eligible to be transferred
- may be only transferred one time unless real time online data base
- transfers must be communicated
165
Documentation of controlled substance transfer
- write VOID on the face of prescription or note it on electronic prescription
- need name, address, and DEA number of receiving pharmacy
- record date of transfer and the name of the transferring pharmacist
166
The receiving pharmacist for a controlled substance transfer must note
- the date of issue of OG prescription
- og number of refills authorized
- date of og dispensing
- number of refills remaining
- dates and locations of previous refills
- transferring pharmacy name, address, DEA number, and prescription number
- name of transferring pharmacist
- OG pharmacy name, address, DEA number and prescription number
167
SUD
problematic pattern of using a substance that results in impairment in daily life or noticeable distress
168
Detox
dispensing a narcotic drug in decreasing doses to bring patient to a drug-free state
169
short term detox
≤30 days
170
long term detox
30-180 days
171
maintenance of SUD
maintaining a patient on a stable dose of a narcotic drug for more than 180 days
172
SUD Treatment limitations: Prescriptions
may not be issued for detox treatment or maintenance treatment unless CIII-CV narcotic approved by FDA and the practitioner complies with requirements
173
SUD Prescription Exceptions
- practitioner registered with DEA as narcotic or opioid treatment program
- practitioner dispensing from their office supply
- hospitalized patient
- prescription for direct admin
174
SUD Registered Practitioner Scope
- NTP or OTP can administer or dispense a narcotic for maintenance or detox
- methadone clinics
175
Can you fill a prescription for methadone?
NO, not FDA approved for indication
176
Practitioner Dispensing SUD Drug Limitation
- initiating maintenance/detox treatment
- only 3 days supply to be dispensed
- no extensions on the thee days
177
SUD Hospitalized Patient treatment
- patient must be hospitalized due to an issue OUTSIDE of SUD
- goal is not to interrupt their treatment
178
SUD Prescription for Direct Admin
- injection or implantation
- must be administered within 14 days of receiving product from the pharmacy
- cannot be for office use
179
What two ways can pharmacies distribute controlled substances to registrants?
- distributing to another registrant that wants to dispense the medication to their patient
- reverse distributing
180
Dispensing Registrant may distribute a controlled substance to another registrant so long as...
- registrant appropriately registered with DEA (2, 2N, 3, 3N, 4, 5)
- pharmacy records distribution and receiving registrant as required
- if CI or CII, 222 is completed by both parties AND
- number of dosage units does not exceed 5% of total dosage units of all controlled substance distributed and dispensed in the same calendar year (not automatic dispensing systems in LTCF)
181
Distributing to a reverse distributor
- the pharmacy contacts the reverse distributor with a list of all drugs needing disposal
- the reverse distributor creates an invoice to the pharmacy with the exact quantities of substances destroyed (222 for CI-CII)
- pharmacy completes supplier's requirements and sends drugs to the reverse distributor for destruction
- reverse distributor fills out DEA 41
182
Four main methods of disposal
- on site destruction (wasting with 2 employees)
- delivery to reverse distributor
- send product back to distributor, warehouse, manufacturer (recall or return)
- request assistance directly from DEA field office
183
DEA Form 41Requirements
- must be filled for the destruction of controlled substances
- registrant number, name, address, telephone, contact name
- inventory information (name, strength, form, and quantity)
- method of destruction (date, location, method)
- witnesses if any
184
Where are DEA 41s maintained
with other CS records, does not need to be sent to the DEA
185
Theft or Signifcant Loss Reporting
- must be reported to the local DEA field office and Board of Pharmacy within one day
186
What form must be filled out for theft or significant loss
106 filled 45 days of discovery (electronic)
187
What must be reported in terms of theft/loss
- All theft
- only significant non theft losses
188
What does significant loss mean
- actual quantity lost in relation to the type of business
- specific controlled substance lost
- whether loss can be attributed to specific individuals or unique activities
- if patter of loss is present and there are efforts taken to resolve loss
- whether the substance is likely candidate for diversion
- local trends/indicators of diversion potential
189
Filling out DEA Form 106
- date of issue occurrence or discovery
- theft or significant loss indacted
- name, dosage form strength and quantity of a controlled substance lost or stolen
190
Where should 106 be forwarded to
DEA field office and BOP
