tl;dr Utah Law Flashcards
Who are the DOPL Board Members?
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
The general public pharmacy board member shall be a UT resident who:
- 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
The licensed pharmacist and licensed pharmacy technician members of the board shall:
- 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.
Who elects the Chair of the Board?
How long is the term for the Chair of the Board
Elected by board members
1 year
Who Selects Board Members?
Appointed by the Executive Director.
How long do Board members serve?
4 years
How many consecutive terms can each board member serve
2 terms in their lifetime
How much is the pharmacist application fee
How much is the pharmacy intern application fee
$240
$140
How many CE hours are required for pharmacist licensure renewal
30 biennially
What are the special CE requirements for pharmacists
- 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
How many live or webinar CE hours must a pharmacist complete every 2 years
12
How many CE hours of disease state management/drug therapy/HIV/AIDS therapy or patient safety must a pharmacist complete every 2 years
15
How many CE hours of pharmacy law or ethics must a pharmacist complete every 2 years
1
If administering immunizations, how many CE hours in topics related to vaccines must a pharmacist complete every 2 years
2
If administering long-acting injectables, how many CE hours in topics related to LAI must a pharmacist complete every 2 years
2
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
2
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
1740
1440
Documents (Transcript/Drug Test/Background Check) for a new pharmacist
Official transcript
Background check
2 fingerprint clearance cards
Documents (Transcript/Drug Test/Background Check) for a transfer/reciprocated pharmacist
- 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
Documents (Transcript/Drug Test/Background Check) for a foreign pharmacist
FPGEC copy
Official transcripts
Background check
2 fingerprint clearance cards
When is the renewal period for pharmacist & tech license
September 30th of odd-numbered years
How many hours of CE must a pharmacy tech complete and how often & includes:
20 hours biennially
- 8 hours of live or technology-enabled participation at lectures, seminars or workshops
- 1 hour of pharmacy law or ethics
How many live hours of CE must a pharmacy tech complete
8
How many hours of law/ethics CE must a pharmacy tech complete
1
Application fee for a tech and tech trainee
$90
$50
How many hours of directly supervised practical training in a licensed pharmacy must a pharmacy tech complete
180
T/F: Pharmacies must have a designated counseling area
true
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.
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.
Time to Notify Board of Changes to PIC?
30 days
Time to Notify Board of Changes to Address?
10 days
Time to Notify Board of Changes to Email Address?
Must notify the Division within 7 calendar days of change of email address
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
T/F: to own a pharmacy in UT, you do not need to be a pharmacist
False
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
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
Is Facility Licensure Required for General Compounding? Sterile Compounding?
Yes, must register as a “Class A” or “Class B” pharmacy
Restrictions on Compounding Without Prescription?
Facilities may compound in anticipation of receiving prescriptions in limited amounts.
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
Prescription files, including refill information, shall be maintained for a minimum of ___ years
five
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
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
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.
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
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”
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
Controlled Substances Act 1970
- Created the Drug Enforcement Administration (DEA)
- Scheduling of drugs and other substances
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.
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
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
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
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)
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
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.
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
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
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)
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
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
FDA Amendments Act (FDAAA) (2007)
Overall design is to provide additional funding for FDA and also to provide additional authority for drug safety & surveillance
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
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)
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)
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
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)
ANDA for generic equivalents testing
Only limited bioavailability testing required
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
BUD for water containing oral formulations
Not later than 14 days when stored at controlled cold temperatures
BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations
not later than 30 days
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
Low risk level CSPs utilize aseptic manipulations within an ISO Class 5 environment using ____ sterile products and entries into any container.
three or less
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
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
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
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
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
Personnel who perform CSP activities with High-risk level and Hazardous substances need to be re-evaluated on a ____ basis.
semiannual
In most instances in hospital/institutional pharmacy, sterilization is accomplished with ____.
filters
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
To obtain a DEA registration, a pharmacy can request a DEA form ___
224
224a for renewal