tl;dr Utah Law Flashcards
(201 cards)
1
Q
Who are the DOPL Board Members?
A
five members, four of whom shall be licensed or certified practitioners in good standing of the occupation or profession the board represents, and one of whom shall be a member of the general public
2
Q
The general public pharmacy board member shall be a UT resident who:
A
- is 21 years or older
- has never been licensed to engage in the practice of pharmacy
- has never been the spouse of a person licensed to engage in the practice of pharmacy
- has never held any material financial interest in pharmacy practice
- has never engaged in any activity directly related to the practice of pharmacy
3
Q
The licensed pharmacist and licensed pharmacy technician members of the board shall:
A
- have been Utah residents continuously for at least three years;
- have at least five years experience in the practice of pharmacy in good standing with the division in Utah after licensure; and
- maintain licensure in good standing to engage in the practice of pharmacy or practice as a pharmacy technician in Utah for the duration of the appointment.
4
Q
Who elects the Chair of the Board?
How long is the term for the Chair of the Board
A
Elected by board members
1 year
5
Q
Who Selects Board Members?
A
Appointed by the Executive Director.
6
Q
How long do Board members serve?
A
4 years
7
Q
How many consecutive terms can each board member serve
A
2 terms in their lifetime
8
Q
How much is the pharmacist application fee
How much is the pharmacy intern application fee
A
$240
$140
9
Q
How many CE hours are required for pharmacist licensure renewal
A
30 biennially
10
Q
What are the special CE requirements for pharmacists
A
- 12 hours must be live or a webinar with live participation
- 15 hours of disease state management/drug therapy/HIV/AIDS therapy or patient safety
- 1 hour of pharmacy law or ethics
- If providing immunization administration: 2 hours in topics related to immunizations or vaccines
- If providing administration of long-acting injectables: 2 hours in topics related to long-acting injectables
- If dispensing a self-administered hormonal contraceptive per Family Planning Access Act: 2 hours in topics related to hormonal contraceptive therapy
11
Q
How many live or webinar CE hours must a pharmacist complete every 2 years
A
12
12
Q
How many CE hours of disease state management/drug therapy/HIV/AIDS therapy or patient safety must a pharmacist complete every 2 years
A
15
13
Q
How many CE hours of pharmacy law or ethics must a pharmacist complete every 2 years
A
1
14
Q
If administering immunizations, how many CE hours in topics related to vaccines must a pharmacist complete every 2 years
A
2
15
Q
If administering long-acting injectables, how many CE hours in topics related to LAI must a pharmacist complete every 2 years
A
2
16
Q
If dispensing a self-administered hormonal contraceptive per Family Planning Access Act, how many CE hours in topics related to hormonal contraceptive therapy must a pharmacist complete every 2 years
A
2
17
Q
What are the minimum intern hours for a new, transfer/reciprocated, or foreign graduate pharmacist
How many intern hours are required for a foreign grad
A
1740
1440
18
Q
Documents (Transcript/Drug Test/Background Check) for a new pharmacist
A
Official transcript
Background check
2 fingerprint clearance cards
19
Q
Documents (Transcript/Drug Test/Background Check) for a transfer/reciprocated pharmacist
A
- Official Transcript
- Background Check
- Proof of having lawfully practiced as a licensed pharmacist a minimum of 2,000 hours in the 4 years immediately preceding the date of application
- 2 fingerprint clearance cards
20
Q
Documents (Transcript/Drug Test/Background Check) for a foreign pharmacist
A
FPGEC copy
Official transcripts
Background check
2 fingerprint clearance cards
21
Q
When is the renewal period for pharmacist & tech license
A
September 30th of odd-numbered years
22
Q
How many hours of CE must a pharmacy tech complete and how often & includes:
A
20 hours biennially
- 8 hours of live or technology-enabled participation at lectures, seminars or workshops
- 1 hour of pharmacy law or ethics
23
Q
How many live hours of CE must a pharmacy tech complete
A
8
24
Q
How many hours of law/ethics CE must a pharmacy tech complete
A
1
25
Application fee for a tech and tech trainee
$90
| $50
26
How many hours of directly supervised practical training in a licensed pharmacy must a pharmacy tech complete
180
27
T/F: Pharmacies must have a designated counseling area
true
28
What is the requirement for pharmacy closures
notice shall include the date of the closing and the name, address and telephone number of the pharmacy acquiring the prescription drug orders, including refill information and patient medication records of pharmacy.
29
How many days in advance should a pharmacy notify a change in ownership & what must be reported
10 days before
• Change of name or ownership
• Location of pharmacy facility
• Closure of pharmacy facility
• Sale or transfer of controlled substances as a result of permanent closing or change of ownership
A reporting pharmacy shall maintain a copy of any notification required by this section for two years and make a copy available for inspection.
30
Time to Notify Board of Changes to PIC?
30 days
31
Time to Notify Board of Changes to Address?
10 days
32
Time to Notify Board of Changes to Email Address?
Must notify the Division within 7 calendar days of change of email address
33
What Are the Fees for A Pharmacy License?
• $200 non-refundable application fee made payable to “DOPL”
• $30 non-refundable fingerprint processing fee for PIC
• $30 non-refundable fingerprint processing fee the PIC’s Direct Supervisor
• Note: if the PIC is the sole owner and has no direct supervisor, please only include $30 and for the
fingerprint processing fee and a copy of the company’s organizational chart
34
T/F: to own a pharmacy in UT, you do not need to be a pharmacist
False
35
If your practice will include dispensing controlled substances to any person other than an inpatient in a licensed health care facility, you must apply for a Utah Controlled Substance License by submitting the following:
• $100 non-refundable application processing fee made payable to “DOPL”
• Complete the “Utah Controlled Substance Law and Rule Affidavit”
• Complete the “Controlled Substance Database Questionnaire”
• Note: In addition to the Utah Controlled Substance License, you must hold a valid Federal Drug Enforcement
Administration (DEA) registration
36
RPh to intern ratio
No more than two pharmacy interns during a working shift except as below:
(ii) up to five pharmacy interns at public-health outreach programs such as informational health fairs, chronic
disease state screening and education programs, and immunization clinics, provided:
a. the totality of the circumstances are safe and appropriate according to generally recognized industry
standards of practice; and
b. the preceptor has obtained written approval from the pharmacy interns' schools of pharmacy for the
intern's participation
37
Is Facility Licensure Required for General Compounding? Sterile Compounding?
Yes, must register as a “Class A” or “Class B” pharmacy
38
Restrictions on Compounding Without Prescription?
Facilities may compound in anticipation of receiving prescriptions in limited amounts.
39
A nuclear pharmacy shall have the following:
(a) have applied for or possess a current Utah Radioactive Materials License; and
(b) adequate space and equipment commensurate with the scope of services required and provided.
A licensed Utah pharmacist shall be immediately available on the premises at all times when the facility is open or available to engage in the practice of pharmacy
40
Prescription files, including refill information, shall be maintained for a minimum of ___ years
five
41
Act of omission vs act of commission
Omission - failing to do something a reasonable person would do
Commission - doing something a reasonable person would not do
42
Pure Food and Drugs Act 1906
Prohibited adulterated or misbranded drugs from interstate commerce
No longer active law; replaced by the Food, Drug & Cosmetic Act (FDCA) of 1938
43
Harrison Narcotic Act (1914)
Required a license to import/export opium and to track handling
Refined or prepared opium (ready-to-smoke) was banned for export/import
Manufacturing limits for morphine and cocaine
Use limited to medical and legitimate use only
Brought raw opium trade under the watch of government
Required containers of narcotic drugs to bear tax stamps which were used to seal containers.
44
Food Drug and Cosmetic Act (FDCA) 1938
- Prompted by the 1937 “Elixir of Sulfanilamide” tragedy
- Act required drugs to be tested for safety prior to approval
- Expanded the definitions of adulteration & misbranding
labels had to include adequate directions for use
- labels for certain narcotics had to include: “Warning: may be habit forming”
- placed drug advertising under the control of the FTC and later changed to FDA for rx drugs and FTC for OTC drugs
45
Durham Humphrey Amendment 1951
- Exempted certain drugs from the labeling requirement, “Adequate directions for use” by creating “prescription drug exemption"
- "Caution: Federal Law prohibits dispensing without a prescription"
- Provided provisions for oral rx and refills
- Distinguishes between "Adequate Directions for Use" and "Adequate Information for use"
46
Kefauver-Harris Amendments 1962
- Required drugs to be tested for efficacy prior to approval
- Created standard for manufacturer registration with the federal government
- Allow for inspections of manufacturing facilities
- Created standards for Good Manufacturing Practices (GMP)
- Created procedures for New Drug approval process
- Manufacturers now have to prove safety and effectiveness prior to marketing approval
- Created the Drug Efficacy Study Implementation (DESI) program to review clinical efficacy of drugs approved for marketing between 1938-1962
47
Controlled Substances Act 1970
- Created the Drug Enforcement Administration (DEA)
| - Scheduling of drugs and other substances
48
Poison Prevention Packaging Act 1970
- Requires that all controlled substances and all rx drugs are subject to special packaging requirements
- must be placed in child-resistant containers. child-resistant = no more than 20% of children under 5 years of age can gain entry into the container within a ten (10) minute testing period. Exceptions = sublingual nitroglycerin and isosorbide dinitrate, etc.
49
Medical Device Act 1976
- broadened the definition of medical devices
| - established a panel of experts to review devices and to set standards for the review of devices
50
Three types of medical devices
- Class I - relatively low potential for causing harm; pre-market testing is not considered necessary
e. g., scissors, forceps, hemostats, needles
- Class II - safety and effectiveness must be evaluated by specific standards set by a panel of experts
e. g., hearing aids, sunlamps, tampons, thermometers and catheters
- Class III - devices that are usually life-supporting systems; failure of these devices may lead to death or serious injury. Must undergo pre-market evaluation to review for safety and effectiveness of construction, testing, labeling or directions for safe use.
e. g., indwelling catheters, neuromuscular stimulators, pacemakers
51
Orphan Drug Act (1983)
- provided special incentives, in the form of tax relief and special exclusive licensing for manufacturers of drugs intended for rare diseases
- rare disease - affects less than 200,000 individuals in the US
52
Drug Price Competition Act (Hatch-Waxman Amendment) (1984)
- provided a mechanism for accelerated drug approval process for generic versions of approved drugs that were approved after 1962 and whose patents are about to expire
- Created the "Abbreviated New Drug Application" (ANDA)
53
Prescription Drug Marketing Act (PDMA) 1987
- provides federal standards for storage, distribution and recordkeeping of prescription drugs.
- Established "drug pedigrees"
- referred to as the “Drug Diversion Act”
- bans the re-importation of drugs manufactured in the US
54
Prescription Drug User Fee Act (PDUFA) 1992
Provides for annual fees on manufacturers and their products
fees are appropriated to the FDA for improving the regulatory process and speeding drug approvals.
55
Nutritional Labeling Education Act (NLEA) (1990)
- amended the FDCA to prohibit disease-prevention claims in food labeling unless it conforms to FDA drug regulations
- NLEA was strongly opposed by dietary supplement (herbal) manufacturers who feared FDA scrutiny
56
Dietary Supplement & Health Education Act (DSHEA) 1994
- Removed dietary supplements from the NLEA, i.e., they are not longer classified as foods
- dietary supplement are now defined as a product intended to supplement the diet and may contain a vitamin, mineral, herb or other botanical, amino acid, dietary supplement
- labeling of dietary supplements cannot make specific therapeutic claims, e.g., “treats arthritis” but, in-store literature not produced by the manufacturer or the store can make therapeutic claims
57
Food and Drug Administration Modernization Act (I, II, III) (1997)
- Intended to promote efficiency in regulatory procedures
- many provisions directed to several different areas, including: encourage pediatric clinical studies, when appropriate, in return for additional exclusivity in the market for manufacturers, pharmacy compounding (exempts compounding from NDA requirements), labeling requirements liberalized ("Rx only" could replace the federal legend warning)
58
Best Pharmaceuticals for Children Act (2002)
Designed to stimulate additional research into pediatric data for pharmaceuticals
Develop databases to chart ADRs in children
Voluntary incentive to industry to sponsor pediatric studies
59
Pediatric Research Equity Act (2003)
Allows FDA to require research on certain pharmaceuticals before licensing
Any NDA or supplemental NDA submitted to FDA must have pediatric assessment
60
FDA Amendments Act (FDAAA) (2007)
Overall design is to provide additional funding for FDA and also to provide additional authority for drug safety & surveillance
61
Patient Protection and Affordable Care Act (PPACA) (2010)
Healthcare reform law, sometimes referred to in the pejorative as, “Obamacare”
Includes an “individual mandate” to carry/purchase health insurance coverage
Intent is to extend healthcare coverage to all individuals in the US
62
Drug Quality and Security Act (DQSA) (2013)
Amends FFDCA with respect to the regulation of compounding drugs. Establishes 503A (traditional compounding pharmacy) and 503B (outsourcing compounding pharmacy)
Establishes annual registration requirement for any outsourcing facility (503 B)
63
NDC has __ digits
First section has __ digits and represents ___
Second section has __ digits and represents ___
Third section has __ digits and represents ___
11
First section: 4-5 characters representing the manufacturer or distributor (aka “Labeler”)
Second section: 3-4 characters representing the “product”
Third Section: 1-2 characters representing the “packaging”
Conversion to 11 digit will always follow 5-4-2 format (add a zero where needed)
64
Class I vs II vs III recall
- Class I Recall: Reasonable probability use will cause serious adverse health consequences or death
- Class II Recall: Use may cause temporary or medically reversible adverse health consequences. Probability of serious adverse health consequences is remote
- Class III Recall: Use is not likely to cause serious adverse health consequences
65
Phase I-IV for investigational new drug (IND)
Phase I
– Safety testing; small sample of normal patients; initial studies on toxicity and pharmaceutics (ADME); determine preferred administration route and safe dosage
Phase II
– Larger sample; efficacy testing in patients with only the indication for which drug is being tested;
additional pharmacology studies on animals
Phase III
– Larger studies; often multi-center, safety and efficacy in patients meeting strict criteria; risk-to- benefit analysis
Post-marketing surveillance/Phase IV
– On-going evaluation of safety and efficacy
Can also have formal study during post-approval period (Phase IV)
66
ANDA for generic equivalents testing
Only limited bioavailability testing required
67
BUD for non-aqueous formulations
BUD is not later than the time remaining until the earliest expiration date of any API, or 6 months, whichever is earlier
68
BUD for water containing oral formulations
Not later than 14 days when stored at controlled cold temperatures
69
BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations
not later than 30 days
70
ISO Class 5 means there are ___ particles (0.5 micron or larger) per cubic foot (ft3) of airflow.
ISO Class 7 & 8?
100
10,000
100,000
71
Low risk level CSPs utilize aseptic manipulations within an ISO Class 5 environment using ____ sterile products and entries into any container.
three or less
72
a low-risk level CSP may not be stored for more than __ hours at controlled room temperature, __ days under cold temperature, & __ days under frozen state
48 hours
14 days
45 days
73
Medium-risk level CSPs utilize aseptic manipulations within an ISO Class 5 environment using prolonged and complex mixing and transfer, more than ___ sterile products and entries into any container, and pooling ingredients from multiple sterile products to prepare multiple CSPs (e.g., batch processing).
three
74
a medium-risk level CSP may not be stored more than __ hours at controlled room temperature, __ days under cold temperature, & __ days under frozen state
30 hours
9 days
45 days
75
High-risk level CSPs utilize one or more ____ ingredients or confirmed or suspected exposure of sterile ingredients for more than ___ hour(s) to air quality inferior to ISO Class 5 before final sterilization of the CSP. High-risk level CSPs require a sterilization method or process before the product can be dispensed.
nonsterile
| one
76
high-risk level CSP may not be stored more than __ hours at controlled room temperature, __ days under cold temperature, & __ days under frozen state
24 hours
3 days
45 days
77
Personnel who perform CSP activities with High-risk level and Hazardous substances need to be re-evaluated on a ____ basis.
semiannual
78
In most instances in hospital/institutional pharmacy, sterilization is accomplished with ____.
filters
79
Who has the authority to place an unscheduled drug into a schedule, place a scheduled drug into a different schedule, or remove a drug from scheduling
The US attorney general
80
To obtain a DEA registration, a pharmacy can request a DEA form ___
224
| 224a for renewal
81
Pharmacy DEA registrations must be renewed how often
every 3 years
82
T/F: if a person owns and operates multiple pharmacies, they only need to register one pharmacy with the DEA
false
83
To obtain a DEA Chemical Distributor registration, a pharmacy can request DEA form ___ (for wholesale distribution of List I chemicals)
510
84
Pharmacies seeking to become registered for the first time must request DEA form ___
224
85
Any time a pharmacy moves to a new physical location or the postal address changes at the same location, what must be obtained
a new DEA certificate reflecting the new address
86
Corporations that own or operate a chain of pharmacies may submit a single DEA form ___ for registration renewal
224-b
87
Who has the authority to suspend or revoke a DEA registration upon a finding that the registrant has falsified any application field, been convicted of a felony related to a controlled substance or a list I chemical, has his/her state license or registration suspended, revoked or denied, committed an act which would render his registration inconsistent with the public interest, been excluded from participation in a Medicaid/Medicare program
US Attorney General
88
Any registrant who discontinues his/her business or transfers it to another person must
notify the nearest DEA registration field office in writing before terminating the pharmacy's registration
89
A registrant transferring a pharmacy business to another registrant shall notify the nearest DEA registration field office at least _____ before the date of the proposed transfer and provide the following information:
1. The name, address, registration number of the registrant discontinuing business;
2. The name, address, registration number of the registrant acquiring the pharmacy;
3. Whether the business activities will be continued at the location registered by the current business owner or
moved to another location. If the latter, give the address of the new location.
4. The date on which the controlled substances will be transferred to the person acquiring the pharmacy
14 days
90
If a pharmacy goes out of business or is acquired by a new pharmacy, it may transfer the controlled substances to another pharmacy, supplier, manufacturer or distributor registered to dispose of controlled substances. To transfer schedule II substances, the receiving registrant must issue an official DEA form ___ to the registrant transferring the drugs
222
91
On the day controlled substances are transferred to another pharmacy, what must be completed?
a complete inventory which documents the drug name, dosage form, strength, quantity, and date transferred
92
When must a DEA registered pharmacy register as a distributor with the DEA
If the pharmacy transfers to DEA registrants an amount of controlled substances that is >/= 5% of all controlled substances dispensed during a one-year period
93
DEA recommends that any pharmacy seeking to dispose of controlled substances first contact who for disposal instructions
the nearest DEA Diversion Field Office
94
Practitioner inventory seeking to dispose of controlled substances can request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located. The request shall be made by submitting one copy of the DEA Form ___ to the Special Agent in Charge in the practitioner's area. The form shall list the controlled substance or substances which the registrant desires to dispose.
41
95
T/F: a person who has been convicted of a felony related to controlled substances or who has had an application for DEA registration denied, revoked or surrendered for cause cannot be employed in a position which allows access to CS
true, unless requesting an exception from the DEA
96
If CS theft or significant loss is discovered, the pharmacy must contact the nearest DEA Diversion Field Office by phone, fax, or written message within what period of time
also should notify local police
1 business day
97
Which DEA form must be completed for CS theft or significant loss & what should it include
form 106
1. Name and address of firm (pharmacy)
2. DEA registration number
3. Date of theft
4. Name and telephone number of local PD notified
5. Type of theft (night break in, armed robbery, etc.)
6. Listing of symbols or cost code used by pharmacy in marking containers (if any)
7. Listing of controlled substances missing from theft or significant loss
If after an investigation of the circumstances surrounding the theft or significant loss it is determined that no such theft or significant loss occurred, no DEA Form-106 need be filed.
However, the registrant should notify DEA in writing of this fact in order to resolve the initial report and explain why no DEA Form-106 was filed regarding the incident.
98
If it’s discovered after a pharmacist has signed for or taken custody of a CS shipment that an in-transit loss or theft has occurred, the pharmacist must
submit DEA form 106
When all or part of a shipment disappears, or never reaches its intended destination, the supplier is responsible for reporting the in-transit loss of CS to the DEA
99
T/F: the breakage or spillage of CS constitutes a "loss" of controlled substance and must be reported to the DEA
false
When there is breakage, damage or spillage or some other form of destruction, any recoverable controlled substances must be disposed of according to DEA requirements. Damaged goods may be disposed of through shipment to a “reverse distributor” or by a DEA approved process as defined in (Destruction of Controlled Substances). When this disposal occurs, it must be reported using DEA form 41
100
Controlled Substance Registrant Protection Act (CSRPA) provides for the federal investigation of pharmaceutical thefts and robberies if any of the following conditions are met:
1. Replacement cost of the controlled substances taken is $500 or more.
2. A registrant or other person is killed or suffers “significant” bodily injury during the commission of the robbery or theft of a controlled substance.
3. Interstate or foreign commerce is involved in planning or executing the crime.
101
A registrant desiring to maintain shipping and financial records at a central location other than the registered location must notify the nearest DEA Diversion Field Office & may begin maintaining central records __ days after notifying DEA
14 days
102
The Code of Federal Regulations (CFR) requires that the inventory for controlled substances includes:
1. Inventory date
2. Time the inventory is taken
3. Drug name
4. Finished form of the substance (e.g. 10 mg tablet)
5. Number of dosage units of each finished form in the commercial container (e.g., 100 tablet bottle)
6. Number of commercial containers of each finished form (e.g., four 100 tablet bottles)
7. Count of the substance (CII need an exact count and CIII-V needs an estimate unless the stock bottle holds more than 1000 units and has been opened, then an exact count is required)
103
How can you request official DEA Order Form 222
Official Order Forms can be initially requested by checking “block 3” on the application for new registration (DEA Form-224). There is no charge.
Additional forms may be ordered online at DEAdiversion.usdoj.gov or by calling
104
Each book of DEA Official order forms consists of how many sets of forms & each pharmacy is provided a maximum of how many books at one time
7
| 6
105
On DEA form 222, which copy is the purchaser's copy, the supplier's copy, and the DEA copy
Purchaser - copy 3
Purchaser sends copies 1 and 2 to supplier
Supplier keeps copy 1 and forwards copy 2 to the DEA
106
When C2s are received by the pharmacist, the pharmacist must document on their copy of form 222:
the actual number of packages received and the date receieved
107
What should be done if a pharmacist does not receive their shipment of C2s
he/she should first contact the supplier to determine whether the original DEA Form-222 was received. If the original order form has been lost or stolen, the pharmacist must complete a second order form so the supplier can fill the original order. The pharmacist must also prepare a statement which includes the first order form's serial number and date and verify that the drugs ordered were never received. Attach a copy of the statement to the second order form that is sent to the supplier. The pharmacist must keep a copy of the statement with copy 3 from the first and second order forms
108
When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of nonacceptance to the original order. The original statement must be retained for how long
2 years
Neither a purchaser nor a supplier may correct a defective order. The purchaser must issue a new order for the order to be filled.
109
If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the purchaser must provide to the supplier:
a signed statement including the unique tracking number and date of the lost order and state that the goods covered by the first order were not received through loss of that order
110
A prescription for a controlled substance must include:
1. Dated and signed on the date issued
2. Patient's full name and address
3. Practitioner's name, address, and registration number
4. Drug name, strength & dosage form
5. Qty prescribed
6. Directions for use
7. Number of refills authorized (if any)
111
Prescribers can fax a C2 prescription, but the patient must provide a hard copy to the pharmacy. The fax may serve as the original prescription if:
1. the rx is for a patient undergoing home infusion/IV pain therapy
2. rx is for patient in a long term care facility
3. the rx is for a patient in hospice care
112
The label for a controlled substance must include
1. date of filling
2. pharmacy name and address
3. rx number
4. name of patient
5. name of prescriber
6. directions for use and cautionary statements
FDA regulations require that the label of any CS must contain the warning: "CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
113
In a bona fide emergency, a practitioner may telephone a Schedule II prescription to the pharmacy or transmit the prescription by facsimile to the pharmacy, and the pharmacist may dispense the prescription provided that:
1. The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period
2. The prescription order must be immediately reduced to writing by the pharmacist and must contain all info, except for the prescriber's signature
3. If the prescriber is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the phone authorization came from a valid practitioner, by verifying the phone number with that listed in the directory and by making other good faith efforts to ensure proper identity.
4. Within 7 days after authorizing an emergency telephone rx, the prescribing practitioner must supply the pharmacist with a written, signed rx for the CS prescribed & must have written on its face "Authorization for Emergency Dispensing." May be delivered in person or by mail. By law, the pharmacist must notify the DEA if the prescriber fails to provide a written rx within 7 days. If the pharmacist fails to do so, his/her authority to dispense without a written rx will be void
114
Pharmacist may partially fill a C2 if they are unable to supply the full qty in a written or emergency oral (telephone) rx provided:
1. pharmacist notes the qty supplied on the front of the written rx (or on a written record of the emergency oral rx
2. Remaining portion may be dispensed within 72 hours of the first partial dispensing
3. if the remaining portion is not or cannot be filled within 72 hours, the pharmacist must notify the prescriber & the patient would need a new rx
115
Exception for Schedule II Prescriptions at Long Term Care Facilities
- Partial filling documentation
- how long is rx valid for
Prescriptions may be filled in partial quantities, including single dosage units. For each partial filling, the pharmacist must note on the prescription (or other uniformly maintained, readily retrievable record) the date the prescription was partially filled, the quantity dispensed, the remaining quantity and the identification of the dispensing pharmacist
valid for a max of 60 days from the date of issue
116
Pharmacist may partially dispense a CIII-V if:
the pharmacist notes the qty dispensed and initials the back of the rx
117
Not more than ___ ml or not more than ___ solid dosage units of any substance containing opium, not more than ___ ml or not more than ___ solid dosage units of any other CS may be distributed at retail to the same purchaser in any given 48-hour period without a valid rx
```
240 ml (8 fl oz) or 48 solid dosage units
120 ml (4 fl oz) or 24 solid dosage units
```
118
Ryan Haight Online Pharmacy Consumer Protection Act of 2008
amends the CSA by adding a series of new regulatory requirements and criminal provisions designed to combat the proliferation of so-called “rogue Internet sites” that unlawfully dispense controlled substances by means of the Internet. Applies to all CS in all schedules.
it is illegal under federal law to deliver, distribute, or dispense a controlled substance by means of the Internet unless the online pharmacy holds a modification of DEA registration authorizing it to operate as an online pharmacy.
119
An online pharmacy shall notify DEA and the State Boards of Pharmacy in any states in which the online pharmacy offers to sell, distribute, or dispense controlled substances ___ days prior to offering a CS for sale, delivery, distribution, or dispensing by means of the internet
30 days
120
How to register as an online pharmacy
the online pharmacy must first be registered with DEA as a pharmacy then apply for a modification of registration to operate as an online pharmacy
121
An online pharmacy is required to post Internet Pharmacy Site Disclosure Info on the homepage of each Internet site it operates. It must be posted in a visible and clear manner and contain the following information:
1. Name and address of pharmacy as it appears on the pharmacy’s DEA Certificate of Registration.
2. Pharmacy phone # and email
3. name of PIC, professional degree, states of licensure , & phone #
4. list of state(s) in which the pharmacy is licensed to dispense CS
5. certification that the pharmacy is licensed to dispense, deliver, or distribute CS by means of the internet
6. name, address, phone number, professional degree & states of licensure of any practitioner who has a contractual relationship to provide medical evaluations or issue rxs for CS
7. The following statement must be visible on the website:
“This online pharmacy is obligated to comply fully with the Controlled Substances Act and DEA regulations. As part of this obligation, this online pharmacy has obtained a modified DEA registration authorizing it to operate as an online pharmacy. In addition, this online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation in accordance with section 309 of the Controlled Substances Act (21 U.S.C. § 829), or a medical evaluation via telemedicine in accordance with section 102(54) of the Controlled Substances Act (21 U.S.C. § 802(54)).”
122
What are the reporting requirements for an online pharmacy
- must submit a MONTHLY report to the DEA of the total qty of each controlled substance that the online pharmacy has dispensed the previous calendar month.
The report is required for every month in which the total amount of dispensing of controlled substances by the pharmacy is either (i) over 100 prescriptions filled or (ii) 5,000 or more dosage units dispensed of all controlled substances combined. Should an online pharmacy’s total quantity of dispensed controlled substances fall below both of the thresholds listed above, a report is still required that indicates a negative response for that
given month.
- Report the total number of dosage units dispensed for each NDC number.
- This report is due on or before the 15th day of the following month.
123
Rxs for CS listed in schedules II, III, IV, and V may be transmitted electronically from a retail pharmacy to a central fill pharmacy via fax. The retail pharmacy transmitting the rx must:
1. Write the word "CENTRAL FILL" on the face of the original rx and record the name, date, address, and DEA number of the central fill pharmacy to which the rx has been transmitted & the name of the retail pharmacist transmitting the rx, & the date of transmittal
2. maintain the original rx for 2 years from the date the rx was last refilled
3. Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common, or contract carrier) and the name of the retail pharmacy employee accepting delivery;
4. For schedules III-V prescriptions, indicate in the information transmitted the number of refills already dispensed and the number of refills remaining
124
Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances (i.e., methadone) for maintenance and detoxification treatment must obtain a separate DEA registration as a Narcotic Treatment Program via which DEA form
363
125
If a practitioner wishes to prescribe or dispense CIII-V CS approved by the FDA for addiction treatment (e.g., Suboxone) the practitioner must request a waiver from CSAT which will then notify the DEA of all waiver requests. These practitioners are referred to as:
DATA waived practitioners
126
USPS allows mailing of controlled substances if the following preparation and packaging standards are met:
1. the inner container of any parcel containing CS is marked and sealed as required by the provisions of the CSA and its implementing regulations, and is placed in a plain outer container or securely wrapped in plain paper
2. If the controlled substance consists of prescription medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner or other person dispensing the rx
3. the outside wrapper or container is free of makings that would indicate the nature of the contents
127
Regulated sellers are required to maintain a written (bound logbook) or electronic list of sales of List I Chemicals that identifies the transactions with the following information:
The logbook requirement does not apply to any purchase by an individual of a single sales package that contains not more than ___ mg of PSE.
Sellers must maintain each entry in the logbook for not fewer than ___ years after the date on which the entry is made
1. The name of the purchaser
2. The address of the purchaser
3. The date and time of the sale
4. The amount of product sold
60 mg
2 years
128
As part of the requirements of Combat Methamphetamine Epidemic Act of 2005, how often must all regulated sellers of Scheduled List Chemical Products self-certify
annually
129
When a vacancy occurs in the board membership for any reason, the replacement shall be appointed for the unexpired term & After filling that term, the replacement member may be appointed for how many more terms
1 additional full term
130
An individual applying for initial licensure may apply for licensure without paying fees if the applicant provides evidence to the division that at the time of the application the applicant is:
1. on full-time active service with a branch of the armed forces of the US
2. receiving public assistance through one of the following programs administered by the Department of Workforce Services:
(a) the Family Employment Program
(b) General Assistance
131
The Division shall send a renewal notice to each licensee at least __ days prior to the expiration date shown on the licensee's license
60
132
A healthcare professional licensee may fulfill up to __% of the licensee's continuing education requirements by providing volunteer services at a qualified location earning one hour of CE credit for every __ documented hours of volunteer services
15%
| 4
133
If an application for reinstatement is received by the Division between 31 days & 2 years after the date of expiration of the license, the applicant shall:
submit a completed renewal form & pay the license renewal fee & REINSTATEMENT FEE (not a late fee)
134
if an application for reinstatement is received by the Division more than two years after the date the license expired and the applicant has not been active in the licensed occupation or profession while in the full-time employ of the United States government or under license to practice that occupation or profession in any other state or territory of the United States during the time the license was expired, the applicant shall:
(a) submit an application for licensure complete with all supporting documents as is required of an individual making an initial application for license
(b) provide information requested by the Division and board to clearly demonstrate the applicant is currently competent to engage in the occupation or profession for which reinstatement of licensure is requested; and
(c) pay the established license fee for a new applicant for licensure.
135
if an application for reinstatement is received by the Division more than two years after the date the license expired but the applicant has been active in the licensed occupation or profession while in the full-time employ of the United States government or under license to practice that occupation or profession in any other state or territory of the United States shall:
(a) provide documentation that the applicant has continuously, since the expiration of the applicant's license in Utah, been active in the licensed occupation or profession while in the full-time employ of the United States government or under license to practice that occupation or profession in any other state or territory of the United States;
(b) provide documentation that the applicant has completed or is in compliance with any renewal qualifications;
(c) provide documentation that the applicant's application was submitted within six months after reestablishing domicile within Utah or terminating full-time government service; and
(d) pay the established license renewal fee and the reinstatement fee.
136
The division may not take disciplinary action against a person for unprofessional or unlawful conduct unless the division enters into a stipulated agreement or initiates an adjudicative proceeding regarding the conduct within ___ years after the conduct is reported to the division.
The division may not take disciplinary action against a person for unprofessional or unlawful conduct more than ___ years after the occurrence of the conduct.
The division may refuse to issue a license due to unprofessional or unlawful conduct that occurred more than ___ years before a request or application for licensure is made
4
10
10
137
Any applicant who has been denied a license to practice or has been refused renewal or reinstatement may submit a request for agency to review the executive director within ___ days following notification of the denial of licensure or refusal to renew or reinstate a license
30
138
A special appeals board shall consist of three members appointed by the executive director as follows:
(a) one member from the occupation or profession in question who is not on the board of that occupation or profession;
(b) one member from the general public who is neither an attorney nor a practitioner in an occupation or profession regulated by the division; and
(c) one member who is a resident lawyer currently licensed to practice law in this state who shall serve as chair of the special appeals board.
139
Each diversion advisory committee shall consist of at least ___ licensees from the same or similar occupation or profession as the person whose conduct is the subject of the committee’s consideration.
3
140
A licensee may be eligible for a diversion program how many times for the same or similar offense, regardless of the jurisdiction.
The term of a diversion agreement shall be how long
Once
5 years or less
141
It is not unlawful conduct or unprofessional conduct and it does not violate the provisions of this chapter if a practitioner issues a prescription for a drug to treat a sexually transmitted disease to a partner by:
1. writing "partner of (patient's name)" on the rx order and
2. giving the partner's rx to the patient for subsequent use by the partner or
3. dispenses a drug sample to treat the STD to the patient for the subsequent use of the partner or
4. the pharmacist dispenses a drug for the treatment of STD to:
- a person who claims to be a partner & presents a prescription for the drug to the pharmacist which is written for the unnamed partner of a named patient
- the patient for the subsequent use by the unnamed partner
- an agent of the patient or partner
note: the partner does not have to be identified on the prescription & when dispensing a drug to treat STD directly to the partner the patient's identifying info may, but does not need to be, included on the partner's drug label
142
Class A Pharmacy
a pharmacy located in Utah that is authorized as a retail pharmacy to compound or dispense a drug or dispense a device to the public under a prescription order.
143
Class B Pharmacy
a pharmacy located in Utah:
- that is authorized to provide pharmaceutical care for patients in an institutional setting; and
- whose primary purpose is to provide a physical environment for patients to obtain health care services; and
- includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
- pharmaceutical administration and sterile product preparation facilities.
144
Class C Pharmacy
a pharmacy that engages in the manufacture, production, wholesale, or distribution of drugs or devices in Utah.
145
Class D Pharmacy
a nonresident pharmacy (mail-order)
146
Class E Pharmacy
(a) analytical laboratory pharmacies;
(b) animal control pharmacies;
(c) durable medical equipment provider pharmacies;
(d) human clinical investigational drug research facility pharmacies;
(e) medical gas provider pharmacies;
(f) animal narcotic detection training facility pharmacies
(g) third party logistics providers;
(h) non drug or device handling central prescription processing pharmacies; and
(i) veterinarian pharmaceutical facility pharmacies.
147
Closed-door pharmacy
a pharmacy that provides pharmaceutical care to a defined and exclusive group of patients who have access to the services of the pharmacy because they are treated by or have an affiliation with a specific entity, including a health maintenance organization or an infusion company, but not including a hospital pharmacy, a retailer of goods to the general public, or the office of a practitioner.
148
Which pharmacy class does not require a PIC
Class E pharmacy
(a) analytical laboratory pharmacies;
(b) animal control pharmacies;
(c) durable medical equipment provider pharmacies;
(d) human clinical investigational drug research facility pharmacies;
(e) medical gas provider pharmacies;
(f) animal narcotic detection training facility pharmacies
(g) third party logistics providers;
(h) non drug or device handling central prescription processing pharmacies; and
(i) veterinarian pharmaceutical facility pharmacies.
wholesaler, distributor
149
An applicant from another jurisdiction seeking licensure as a pharmacy technician in Utah is deemed to have met the qualifications for licensure if the applicant:
(a) has engaged in the practice of a pharmacy technician for a minimum of 1,000 hours in that jurisdiction within the past two years or has equivalent experience as approved by the Division in collaboration with the Board; and
(b) has passed and maintained current PTCB or ExCPT certification.
150
If a pharmacy intern is suspended or dismissed from an approved College of Pharmacy, the intern shall notify the division within __ days of the suspension or dismissal
15
151
An individual who does not pass the NAPLEX or MPJE ___ times shall meet with the board to request additional authorization to test
2
152
What can count towards pharmacy law or ethics CE hours?
One live CE hour for attending a Utah Board of Pharmacy meeting, up to a max of 2 CE hours during each 2-year period
153
How many CE hours can you get for each hour of lecturing or instructing a CE course or teaching in the licensee's profession, & what is the max number of CE hours for this per each two-year cycle
2 CE hours per one hour of lecturing a CE course
max 10 CE hours (5 lecture hours) per cycle
154
A licensee shall maintain documentation for a period of ____ after the end of the renewal cycle for which the CE is due
4 years
155
Without specific authorization from a prescriber, a pharmacist or pharmacy intern may dispense:
(a) a prescription in a quantity different than the quantity prescribed if the prescribed quantity or package size is not commercially available; and
(b) a prescription in a dosage form different than the dosage form prescribed, if in the professional judgement of the pharmacist or pharmacy intern, dispensing a different dosage form is in the best interest of the patient.
This section does not apply if:
(a) the substitute would change the bioavailability of the medication;
(b) the substitute would change the treatment parameters; or
(c) the prescriber has written or clearly designated "dispense as written" on the prescription.
156
The pharmacy shall keep a daily written or electronic log of the temperature of the refrigerator or freezer on days of operation. The pharmacy shall retain each log entry for how long
at least 3 years
157
practitioner may not dispense more than a ___-day supply of a controlled substance in an emergency department for a patient's immediate need
two
3 day supply for non-CS
7 days for STI ppx
naloxone kit
158
a hospital pharmacy may dispense a limited supply of a prescription drug to an individual who is no longer a patient in the hospital setting if the hospital pharmacy dispenses a quantity of the prescription drug that is the lesser of:
a 72-hour supply; or
an adequate amount to treat the discharged patient through the first day on which the patient's Class A pharmacy is open after the patient's discharge from the hospital
159
If an audit is conducted on site at a pharmacy, the entity conducting the audit:
shall give the pharmacy 10 days advanced written notice of:
- the audit and the range of prescription numbers or a date range included in the audit; and
- may not audit a pharmacy during the first five business days of the month, unless the pharmacy agrees to the timing of the audit.
160
Charitable Prescription Drug Recycling Program
The division, in consultation with the board, shall implement the program, on a statewide basis, to permit:
- an individual or an eligible donor to transfer an eligible prescription drug to an eligible pharmacy for dispensing to a medically indigent (needy) individual; and
- an individual to transfer an eligible prescription drug to a physician's office:
(A) that is an eligible donor; and
(B) for transfer to an eligible pharmacy for dispensing to a medically indigent individual
161
"Legal dosage limit" of marijuana
means an amount that:
- is sufficient to provide 30 days of treatment based on the dosing guidelines that the relevant recommending medical provider or the state central patient portal or pharmacy medical provider recommends; and may not exceed:
- for unprocessed cannabis in a medicinal dosage form, 113 grams by weight; and for a cannabis product in a medicinal dosage form, a quantity that contains, in total, greater than 20 grams of active tetrahydrocannabinol.
162
a prescriber may not issue an initial opiate prescription without discussing with the patient, or the patient's parent or guardian if the patient is under 18 years of age and is not an emancipated minor. This does not apply to:
(a) a patient who is currently in active treatment for cancer;
(b) a patient who is receiving hospice care from a licensed hospice; or
(c) a medication that is being prescribed to a patient for the treatment of the patient's substance abuse or opiate dependence.
163
a prescription for a C2 or C3 that is an opiate issued for an acute condition shall be completely or partially filled in a quantity not to exceed what day-supply.
This does not apply to:
7
a prescription issued for surgery when the practitioner determined that a qty exceeding 7 days is needed, in which case the practitioner can prescribe up to a 30-day supply
or
complex or chronic conditions
164
No refill for a controlled substance may be issued until such time has passed since the date of the last dispensing that ___% of the medication in the previous dispensing should have been consumed if taken according to the prescriber's instruction
80
165
What is the Family Planning Access Act
Authorization for a pharmacist to dispense self-administered hormonal contraceptives
(1) to a patient who is 18 years old or older;
(2) pursuant to a standing prescription drug order
(3) without any other prescription drug order from a person licensed to prescribe a self-administered hormonal contraceptive;
and
(4) in accordance with the dispensing guidelines
A pharmacist or pharmacist intern who dispenses a self-administered hormonal contraceptive shall obtain a completed self-screening risk assessment questionnaire from the patient before dispensing the self-administered hormonal contraceptive
166
A pharmacist or pharmacist intern who dispenses a self-administered hormonal contraceptive may not continue to dispense a self-administered hormonal contraceptive to a patient for more than __ months after the date of the initial prescription without evidence that the patient has consulted with a primary care or women’s health care practitioner during the preceding __ months
24; 24
167
There is created the Online Prescribing, Dispensing, and Facilitation Licensing Board consisting of the following seven members:
(a) two members who are licensed under either Chapter 67, Utah Medical Practice Act, or Chapter 68, Utah Osteopathic Medical Practice Act, of which: one shall be engaged in the delivery of online pharmaceutical services and one may not be an online prescriber licensed under this chapter;
(b) two members who are licensed as a pharmacist of which: one shall be associated with an online contract pharmacy and one may not be associated with an online contract pharmacy;
(c) two members of the general public who are not associated with:
(i) an online prescriber;
(ii) an online contract pharmacy; or
(iii) an Internet facilitator; and
(d) one member who is licensed under this chapter as an Internet facilitator.
168
an optometrist may only prescribe oral antibiotics for eyelid related occular conditions or diseases & hydrocodone combo drugs or a schedule III drug if they are used for occular conditions, does not include refills, and does not exceed ___ supply
72 hour
169
What is the only CII substance that an optometrist may prescribe
hydrocodone combination products
170
In appointing the seven qualified medical providers of the Compassionate Use Board (for medical marijuana), the executive director shall ensure that at least two have a board certification in _____.
Of the members of the board that the executive director first appoints:
(i) three shall serve an initial term of __ years; and
(ii) the remaining members shall serve an initial term of ___ years.
After an initial term expires each term is ___ years
pediatrics
two
four
four
171
Continuing education requirement for a qualified medical provider as a condition precedent to renewal (medical marijuana)
four hours every two years
172
A qualified medical provider registration card expires ___ years after the day on which the department issues the card.
2 years
173
An individual is eligible for a medical cannabis patient card if:
- the individual is at least 21 years old; or
- the individual is 18, 19, or 20 years old, the individual petitions the compassionate use board, and the compassionate use board recommends department approval of the petition;
- the individual is a Utah resident;
- the individual's recommending medical provider recommends treatment with medical cannabis
- the individual signs an acknowledgment stating that the individual received the information described in Subsection (8); and
- the individual pays to the department a fee
174
when does a medical cannabis card that the department issues in relation to a terminal illness expire
a medical cannabis card that the department issues under this section is valid for the lesser of:
never
-30 days initially then 6 months
175
a qualified medical provider may not recommend a medical cannabis treatment to more than ___ of the qualified medical provider's patients at the same time, as determined by the number of medical cannabis cards under the qualified medical provider's name in the state electronic verification system.
275
176
A qualified medical provider may recommend a medical cannabis treatment to up to ___ of the qualified medical provider's patients at any given time, as determined by the number of medical cannabis cards under the qualified medical provider's name in the state electronic verification system, if:
(i) the appropriate American medical board has certified the qualified medical provider in the specialty of anesthesiology, gastroenterology, neurology, oncology, pain, hospice and palliative medicine, physical medicine and rehabilitation, rheumatology, endocrinology, or psychiatry; or
(ii) a licensed business employs or contracts with the qualified medical provider for the specific purpose of providing hospice and palliative care.
600
177
The department shall issue a medical cannabis card to an individual who satisfies eligible criteria and submits an application within how many days
15
178
A conditional medical cannabis card is valid for the lesser of:
60 days; or
the day on which the department completes the department's review and issues a medical cannabis card, denies the patient's medical cannabis card application, or revokes the conditional medical cannabis card under Subsection (8).
The department may issue a conditional medical cannabis card to an individual applying for a medical cannabis patient card for which approval of the Compassionate Use Board is not required.
179
An individual is eligible for a medical cannabis guardian card if the individual:
- is at least 18 years old;
- is a Utah resident;
- is the parent or legal guardian of a minor for whom the minor's qualified medical provider recommends a medical cannabis treatment, the individual petitions the Compassionate Use Board and the Compassionate Use Board recommends department approval of the petition;
- the individual signs an acknowledgment stating that the individual received the information described in Subsection (9);
- pays to the department a fee, plus the cost of the criminal background check
- the individual has not been convicted of a misdemeanor or felony drug distribution offense under either state or federal law, unless the individual completed any imposed sentence six months or more before the day on which the individual applies for a medical cannabis guardian card.
180
On or before September 1, 2021, the department shall establish a process to allow an individual from another state to register with the department in order to purchase medical cannabis or a medical cannabis device from a medical cannabis pharmacy while the individual is visiting the state. The department may only provide the registration process to
a nonresident patient; and for no more than two visitation periods per calendar year of up to 21 calendar days per visitation period.
181
A person may not locate a medical cannabis pharmacy within ___ feet of of a community location; or in or within ___ feet of a district that the relevant municipality or county has zoned as primarily residential.
1000
| 600
182
A medical cannabis pharmacy license must be renewed by the board how often
every year
183
the department shall issue up to ___ medical cannabis pharmacy licenses
15
184
A pharmacy medical provider registration card expires ___ years after the day on which the department issues or renews the card.
two
185
A pharmacist or pharmacy intern may dispense a refill of a prescription for a liquid legend drug administered to the eye once an amount of time has passed after which a patient should have used __% of the dosage units of the drug according to a practitioner's instructions.
70
186
Can Interns Receive New Prescriptions Via Phone/Voicemail? Refills?
yes
| yes
187
Can Technicians Receive New Prescriptions Via Phone/Voicemail? Refills?
Refills: Yes
| New Prescriptions: No.
188
Can interns transfer prescriptions?
| Can technicians transfer prescriptions?
Interns - yes
| techs - no
189
A pharmacist may accept and redistribute an unused drug under Part 9, Charitable Prescription Drug Recycling Act; or accept back and redistribute any unused drug, or a part of it, after it has left the premises of the pharmacy if:
- the drug was prescribed to a patient in a nursing care facility, licensed intermediate care facility for people with an intellectual disability, or state prison facility, county jail, or state hospital;
- the drug was stored under the supervision of a licensed health care provider according to manufacturer recommendations;
- the drug is in a unit pack or in the manufacturer's sealed container;
- the drug was returned to the original dispensing pharmacy;
- the drug was initially dispensed by a licensed pharmacist or licensed pharmacy intern; and
- accepting back and redistributing of the drug complies with federal FDA & DEA regulations.
- is an injectable medication;
- is a cancer drug packaged in an unopened single-unit dose that has been removed from a multi-dose package;
190
Are out of state controlled substance prescriptions allowed in UT?
Yes
191
Members of UT State Board of Pharmacy
5 pharmacists
1 tech
1 public member
192
Which pharmacy classes require a PIC in Utah
Class A and B
193
To apply for license by endorsement, a licensed pharmacist must have worked a minimum of ____ hours in the 4 years immediately preceding application
2000
194
Pharmacy interns in UT must complete __ hours of IPPE in the first 3 years and at least ___ of those hours are between community and institutional pharmacy
300
| 150
195
Pharmacy interns in UT must complete __ hours of APPE in the last academic year & cannot work more than ___ hours/week
1440
| 50
196
Inventory records must be maintained for ___ years
5
197
Prescription transfer records must be maintained for how long
5 years
198
electronic prescriptions must be maintained for how long
5 years
199
Records and electronic data kept by automated pharmacy systems shall be maintained for
5 years
200
CS prescriptions and non-CS prescriptions, including refills, must be maintained for how long
5 years
201
controlled substance records must be maintained for
5 years
* DEA Registration
* Power of Attorney Forms
* CII Orders, transfer, or returns (DEA 222)
* CIII-V Orders, transfers, or returns (Invoices)
* CII-CV Destruction (DEA 41)
* CII-CV Loss or Theft (DEA 106)
* Inventories
* Dispensing Records (later in packet)
