Review PDF Flashcards
Where to find federal laws and regulations?
United States Code (USC)
Code of Federal Regulations (CFR)
***Most in title 21 in both places
Where to find Indiana laws and regulations?
Indiana Code (IC) - title 16, 25, and 35 Indiana Administrative Code (IAC) - title 856
What is adulteration and what are examples?
When something is wrong with the preparation, strength, or purity of a product
- Dirty drug, decomposing, expired
- Made or packaged in unsanitary conditions where it MAY have been contaminated
- Manufactured not according to good manufacturing practices
- Container is composed of poisonous or deleterious substance
- Doesn’t meet official standards
- Strength doesn’t match
- Incorrect substitution
What is misbranding and what are examples?
Something wrong with outside of product or with words associated with product
- False or misleading labeling
- Generic name must be half the size of brand name
- Adequate directions for use and warnings
- Imitation of another drug
- Directions are dangerous
- Not packaged in special packaging when required
Adulteration vs misbranding focus
Adulteration - drug product (strength, purity, quality, manufacturing process)
Misbranding - label and labeling of drug product
Current good manufacturing practice (CGMP or cGMP) definition
Set of regulations that establish the minimum requirements for manufacturing drug products for administration to humans OR ANIMALS
Who do cGMP regulations apply to?
Anyone manufacturing drug products IN the US or who are manufacturing drugs for USE IN the US (even if overseas)
Does not apply to pharmacies unless they engage in manufacturing
How often must manufacturers go through inspection to ensure cGMP?
Every 2 years
What criteria must a COMPOUND meet to be considered pharmacy compounding? Does cGMP apply to it?
- For an individual patient
- Based on the receipt of a valid prescription or drug order from a licensed practitioner
- Compounded by a licensed pharmacist or licensed physician
Is EXEMPT from cGMP, misbranding, and new drug requirements if compound meets all 3 criteria
Can pharmacists compound a medication before receiving a prescription?
Yes! They just can’t dispense it.
Does reconstitution count as compounding?
No! It is not considered compounding if the bottle contains directions on how to reconstitute or mix in approved labeling provided by the product’s manufacturer and other manufacturer directions
Pharmacies cannot compound and distribute more the ___% of total prescriptions dispensed or distributed unless there is an understanding between the pharmacy’s state and the FDA
5%
Outsourcing facility definition
if a location does not meet requirements for pharmacy compounding
Labeling requirements for compounded medications compounded by an outsourcing facility
“This is a compounded drug”
Info of outsourcing facility
Drug info including batch number, expiration date, storage and handling instructions, list of inactive ingredients
Class I medical device definition
Simplest device type
Not used for supporting, sustaining life or for preventing impairment of human health
Do not present a potential unreasonable risk of illness or injury
Class II medical device definition
Require promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidlines, recommendations, and other appropriate actions
Class III medical device definition
Require premarket approval
Used for supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of health or presents a potential unreasonable risk of illness or injury
Class I medical device examples
Stethoscopes, scissors, toothbrushes
Class II medical device examples
Syringes, tampons, condoms, and A1c immunoassays
Class III medical device examples
Pacemakers, replacement heart valves, soft contact lenses
Which class of medical devices do all new devices fall into?
Class III unless otherwise determined by the FDA to be I or II
Restricted devices definition
Devices that require a prescription due to potential for harm and need for collateral measures to ensure proper use
Restricted devices examples
Contact lenses and diaphragms
Custom devices definition
Ordered by HCP to fit the specific needs of a single patient
Ex: orthopedic footwear, certain braces, canes permanently modified for a patient’s height
Banned devices definition
Devices excluded from US market
Ex: prosthetic hair fibers
Does the FDA have the authority to require a manufacturer to recall a drug?
No - they do have the authority to take seizure or injunction (authoritative warning) action if manufacturer is unwilling
For what does the FDA have the authority to require a recall for?
Devices, biological products, and foods
NOT DRUGS
Class I, II, and II recalls severity
I - most serious; reasonable probability that if used or exposed to, the product will cause serious consequences or death
II - use or exposure to may cause temporary or medically reversible adverse health consequences or where probability of serious adverse health consequences is remote
III - Least serious; use of or exposure to is no likely to cause adverse health consequences
Who is responsible for notifying sellers of a recall? Who is responsible for nofitfying customers?
Sellers (pharmacies and wholesalers) - manufactueres
Customers - pharmacies
What is the poison prevention packaging act (PPPA)? What is the goal?
Gives consumer product safety comission (CPSC) the authority to require special packaging of “hazardous substances”
Prevent accidental poisonings of pts <5 years
What requirements must packaging meet to be considered child-resistant?
- 90% of adults must be able to open the container without significant difficulty
- 85% of children <5 years who have never seen the type of packaging undergoing testing should not be able to open the container in 5 minutes
- 80% of children under 5 cannot successfully open the package in 5 minutes after an adult shows them how to open the container
Drug exemptions for child-proof packaging
Non-oral medications (nasal spray, eye drops, ointments)
Pts and prescribers can waive child-resistant packaging
SL nitro
Birth control
Medrol dosepak
When waiving child-proof packaging, what can providers do? Patients?
Providers can grant a waiver on a prescription-by-prescription basis (covers refills for this rx)
Patients and pt representatives can make a blanket waiver for all prescriptions
If a pt brings their rx bottle, can you reuse it to refill their rx?
If plastic - no
If glass - yes but new cap is required
How are the years 2001 and 2006 important with regard to package inserts?
Before 2001 - new format not required
After 2006 - new format required
Between 2001 and 2006 - format slowly updated
What is a patient package insert (PPI)? When should it be given to the pt? Which drugs are required to have a PPI?
FDA-approved labeling written in pt friendly language that explains uses, risks and precautions
MUST be dispensed with drug both on new prescriptions and every 30 days thereafter (upon refills or every 30 days when in institution)
Required: oral estrogens (but manufacturers can make them if they believe it would benefit the patient)
Medication guide definition and when to give to pt
FDA-approved labeling written in pt friendly language that explains issues related to specific drug or class Must be given on new and refill prescriptions for pts not under direct supervision of HCP
When are medication guides required?
When FDA determines one or more of the following circumstances are met:
- Drug product is is one for which pt labeling could help prevent serious adverse effects
- Drug product has serious risks of which pt should be made aware b/c info concerning the risks could affect pt decision to use or continue to use
- Drug product is important to health and pt adherence to directions for use is crucial to drugs effectiveness
Purpose of prescription drug marketing act (PDMA)
Protect public health and to protect the public against drug diversion by establishing procedures, requirements, and minimum standards for the distribution of prescription drugs and prescription drug samples
What does the prescription drug marketing act (PDMA) say about reimportation of drugs?
Prohibits reimportation of rx drug into US unless reimported by manufacturer of drug or for emergency use after evaluation by FDA
What does the prescription drug marketing act (PDMA) say about selling, purchasing, or trading rx drugs purchase at a reduced price?
Cannot do or offer to sell, purchase, or trade rx drugs purchased by hospital or other healthcare facility as well as donated or suppied to charity at a reduced price
What does the prescription drug marketing act (PDMA) say about drug samples and drug coupons?
Bans sale, purchase, or trade drug samples and counterfeiting drug coupons
Requires practitioners to ask for drug samples in writing, prohibits retail pharmacies from having drug samples at any time, establishes record keeping, storage, and handling requirements for drug samples
What does the prescription drug marketing act (PDMA) say about record keeping?
Details how records should be kept and how to respond to record requests
Can be kept in electronic form if they are easily retrievable and resistant to tampering, modification, or unauthorized use and should be maintained for 3 years
What does the prescription drug marketing act (PDMA) say about “whistleblower” award
If you provide info on someone violating the PDMA and that info leads to conviction, you are entitled to one-half of the criminal fine imposed and collected for such violation, but not more than $125,000
What does the prescription drug marketing act (PDMA) say about wholesale distributors?
All states must license
Wholesalers must keep record of purchase of a product and provide a statement of origin if they are not an authorized distributor
Manufacturers must maintain a list of authorized distributors in their corporate office
5 parts of the federal anti-tampering act
1) Tampering or attempting to tamper with a product’s packaging or labeling
2) tainting a product
3) communicating false information that a product has been tainted
4) threatening to tamper with a product
5) conspiring to tamper with a product
What medications require tamper-evident packaging?
OTC drugs directly available to patients
What are requirements for tamper-evident packaging
- cannot be easily replicated (distinctive by design)
- one or more indicators or barriers to entry that use an identifying characteristic like a trademark, pattern, phrase, or picture
- capsules must be sealed to prevent opening
- prominently placed statement identifying all tamper-evident features must be on package in place that cannot be removed
The dietary supplement health and education act allows manufacturers to make statements about dietary supplements if they include any of what 4 things?
1) claims benefit related to a classical nutrient deficiency disease nad discloses prevalence of such disease in US
2) Describes role of nutrient or dietary ingredient intended to affect structure or function in humans
3) Characterizes documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function
4) Describes general well-being from consumption of a nutrient or dietary ingredient
Pharmaceutical equivalents vs therapeutic equivalents
Pharm - products with same active ingredients, same dosage form, and same strength
Therapeutic - pharmaceutical equivalents that likely have the same clinical and safety profile
What info does the orange book provide?
If pharmaceutical equivalents are also therapeutic equivalents
What do the following mean in the orange book A B AA BX AN
A - products are bioequivalent to RLD and therapeutically equivalent
B - not bioequivalent or therapeutically equivalent
AA - products in conventional dosage forms not presenting bioequivalence problems
BX - products for which data are insufficient to determine therapeutic equivalence
AN - bioequivalent solutions and powders for aerosolization
What is an investigational new drug (IND) application?
Application sent to FDA asking for exemption to NDA in order to investigate and conduct clinical trials on a new drug
What is a new drug application (NDA)?
Application sent to FDA after all clinical trials and data have been collected on a new drug in order to have the drug approved for marketing
AKA - drug registration process
When should a company submit an IND application to the FDA?
For each clinical trial phase (1-3)
Can apply for more than 1 phase in a single application
When can a company begin human trials?
If they have not received a rejection from the FDA within 30 days of submitting their IND
What does phase 1 of a clinical trial include?
First introduction of drug into human subjects
HEALTHY volunteers
Helps to understand PK, pharmacologic effects, and adverse effects of a drug
<100 patients
What does phase 2 of a clinical trial include?
First introduction of drug into pts with the disease
Evaluates effectiveness of a drug for a particular indication
Determines common short-term side effects and risks associated with the drug
<1000 pts
What does phase 3 of a clinical trial include?
Intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug to provide an adequate basis for physician labeling
Several thousand patients
When can a company submit a new drug application (NDA) to the FDA? How long does the FDA have to respond to the NDA?
Once phase 3 trials have been completed
FDA has 180 days to respond according to law but there are often lengthy delays
Can the manufacturers contest the FDA’s decision to not approve a drug?
Yes but FDA’s decision to not approve a drug has never been overturned
Purpose of REMS
Manage serious risks associated with the use of a medication
Who decides if a drug needs a REMS program? Who is responsible for creating the REMS program? Who approves it?
FDA decides
Manufacturer creates
FDA approves
What are the 4 types of REMS?
1) Medication guides
2) Communication plans for disseminating info to HCP about risks of drugs and REMS program in place
3) Elements to assure safe use (ETASU)
4) Implementation system where drugs sponsor may be required to take reasonable steps to monitor and evaluate those in the healthcare system who are responsible for implementing ETASU measures - this may limit or restrict access to a medication
What is the elements to assure safe use (ETASU)?
Required medical interventions or other actions HCPs need to execute prior to prescribing or dispensing the drug to the patient
Lab monitoring, pregnancy tests, etc
Which agencies may inspect a pharmacy?
FDA (only if the pharmacy manufacturers, prepares, or compounds drugs or devices - aka not retail)
DEA
BoP
When are pharmacies exempt from FDA inspections?
Always unless they manufacturer, prepare, or compound drugs or devices (aka retail won’t be inspected)
What must the FDA do in order to inspect? What happens if you refuse?
Show a notice of inspection and their credentials. They don’t need a warrant or to state a reason
Refusal could result in fines and imprisonment
***don’t usually inspect pharmacies but can
What can the DEA inspect? What can they not inspect?
Can: ANY place controlled substances are kept, all records and reports relating to controlled substances (may make copies), premises, take inventory of controlled substances without a warrant
CanNOT: review financial data, sales data, or pricing data unless given written consent by owner or pharmacist in charge or pursuant to a warrant
What must the DEA do in order to inspect? What happens if you refuse?
Must state purpose of inspection and provide their credentials with a written notice of inspection to the pharmacy owner or pharmacist in charge
You can refuse to give consent to an inspection and require agent to get an administrative inspection warrant (AIW)
Can withdraw consent at any time
What is an administrative inspection warrant?
Similar to search warrants
Can only be served during regular business hours
Can’t refuse to consent to search if presented with an AIW (fines/imprisonment)
When is an AIW not required?
If there is imminent danger to health and safety of the public
Emergency situations where obtaining one isn’t practical
Situations where warrant isn’t constitutionally required
What is the purpose of a board of pharmacy inspection? Can you refuse?
Verify compliance with laws and rules
Cannot refuse in Indiana
What does USP <797> cover?
Sterile compounding
What does USP <800> cover?
Handling of hazardous drugs in healthcare settings
Hazardous drugs meet at least one of what six criteria?
1) Carcinogenicity
2) Teratogenicity or developmental toxicity
3) Reproductive toxicity in humans
4) Organ toxicity at lower doses in humans or animals
5) Genotoxicity
6) New drugs that mimic existing hazardous drugs in structure or toxicity
Has Indiana adopted USP <800> as part of any statute or rule?
Not yet
What are the 8 factors that determine if a drug or substance should be added or removed from one of the 5 controlled substances schedules?
1) actual or relative potential for abuse
2) scientific evidence of pharmacologic effect, if known
3) State of current knowledge regarding the drug or other substance
4) hx and current pattern of abuse
5) scope, duration, and significance of abuse
6) what, if any risk there is to the public health
7) its psychic or physiological dependence liability
8) Whether the substance is an immediate precursor of a substance already controlled
What controlled substances drug schedules have US medical uses? Which don’t?
Do: II-V
Do NOT: I
What is the abuse potential for controlled substances in schedules I-V?
I: High II: High III: lower than I or II IV: lower than III V: lower than IV
What level of psychological and physical dependency is present for controlled substances in schedules I-V?
I: dependence not defined
II: Severe psych and physical dependence
III: High psych and moderate/low physical dependence
IV and V: limited psych and physical dependence
When can schedule I drugs be used?
if approved by DEA for investigation purposes
What is registration based on? What are the different types?
Schedule of drugs handled and activities engaged 1 - schedule I 2 - schedule II narcotics 2N - schedule II non-narcotics 3 - schedule III narcotics 3N - schedule III non-narcotics 4 - schedule IV 5 - schedule V
What are the Indiana registration types?
Manufacturing Distributing dispensing Research Instructional activities Research Research or instruction Chemical analysis
What does a DEA number consiste of?
2 letters followed by 7 numbers
What do the following first letters mean in a DEA number? A, B, F, G, M
A - physician B - dentist F - podiatrist G - vet M - mid-level (NP, PA, etc)
What does the second letter of a DEA number indicate?
First letter of last name during registration (may change d/t marriage)
OR
First letter of business name (if business name starts with number may also be a number)
How to verify DEA number?
Add 1, 3, 5
Add 2, 4, 6 and multiply by 2
Add both numbers - last digit of result should match seventh digit of DEA number
OR
Check on DEA’s list of registrants available as part of the NTIS
Exemptions from registration
- agent or employee of person/company who is registered (pharmacists, nurses)
- UPS, FEDEX, USPS, transport if within usual course of business
- Patient or guardian who received substance through prescription
- Officials from armed services, public health service, bureau of prisons, and other law enforcement officers - e.g. cops who confiscate drugs
How must scheduled drugs be stored?
CII-V can be dispersed throughout the pharmacy (e.g. alphabetically)
CI have to be stored in a securely locked, substantially constructed cabinet
If practitioner has supply of controlled substances in their office they must be in a locked cabinet
Who cannot be employed in a position that involves access to controlled substances?
Anyone convicted of a felony relating to controlled substances or who has had an application for registration with the DEA denied, revoked, or has surrendered their DEA registration
***Registrant can request an exemption from the DEA
How long to keep records and reports of controlled substances?
2 years
Do registrants need to maintain a perpetual inventory of controlled substances?
Nope
What information must pharmacies maintain about controlled substances dispensed?
Name and address of person to whom it was dispensed
Date of dispensing
Number of units or volume dispensed
Written or typewritten name or initials of individual who dispensed or administered substance
How to store records for schedule I-V?
I and II - kept separate from all others
III, IV, V - kept separate from all other records or in a way that information is readily retrievable from ordinary business records of the pharmacy
How to store prescriptions?
3 file system: Schedule II in one file, III-V in another and non-controlled in another
OR
2 file system: Schedule II in one file and all others in another file
***all must be readily retrievable
When is a prescription considered ““readily retrievable”?
Has a red C no less than 1 inch high stamped in the lower right corner of the front of the rx
OR
Pharmacy’s computer system identifies prescriptions by prescription number and can be retrieved by prescriber name, pt name, drug dispensed, and date filled
When can records be kept in a central location rather than in the pharmacy?
If the pharmacy notifies the DEA in writing. Must include:
- nature of records to be kept centrally
- exact location
- name, address, DEA registration number and type of DEA registration
- whether central records will be maintained in manual or computer readable form
- **Can start maintaining 14 days after DEA receives notification unless denied permission
What records can and cannot be maintained in a central location after approved by the DEA?
Can: financial info, shipping records, invoices
Cannot: DEA 222, executed DEA forms, inventories, prescriptions
How to order schedule III-V drugs? What do you use as a receipt?
Same way you order non-controlled drugs
Receipt: invoice
How to order schedule II drugs?
DEA 222 form
How to obtain DEA 222? Who can obtain?
Obtained by registrants who are registered to handle schedule II drugs
Come in books of 7 or 14 forms
Initial form: submit order form requisition (part of application for registration)
Subsequent forms: DEA form 222a (requisition form) or contact local DEA in writing
What is included on a DEA 222 form?
Name Address Registration number Authorized activities Schedules the registrant may handle
How many DEA 222 forms can a registrant have?
Max of 6 books at one time (books contain 7 or 14 forms)
What is a power of attorney (POA)? Can there be more than one?
Legal document that authorizes a designated individual to obtain and execute DEA222
Yes - but need POA for each person
Executed vs unexecuted DEA 222 form
Executed are filled out while unexecuted are blank
Difference between old and new DEA 222?
Old - triplicate carbon copies (keep copy 3 and send 1 and 2 back, supplier then sends form 2 to DEA)
New - one 222 with copies made (phasing in - mandatory after October, 2021)
If a supplier receives an order on a DEA 222 for a controlled substance and cannot fill the entire order, how long do they have to fill it? What happens after this time point?
60 days
Order form is no longer valid after 60 days and purchaser needs to re-order
Supplier must return copies 1 and 2 with reason why it wasn’t filled (must staple to copy 3 and keep in records)
What to do in the case of a lost or stolen DEA 222 form?
If form is filled out and lost in mail or by supplier before being filled - send new DEA 222 with statement saying it was lost - then staple statement and new copy 3 to copy 3 of lost paperwork
If unused form is lost - must notify DEA immediately (if found must also notify DEA immediately)
How long to keep DEA 222 form?
CSA says 2 years
Some states say longer
Must keep 222 forms that contain mistakes and were voided for same amount of time
How to cancel items on old DEA 222 form?
Notify supplier in writing
They will draw line through item not needed and write cancelled beside item
Can also be done if supplier cancels item or if item is unavailable
What is endorsing a DEA 222 form?
Done when a supplier cannot fill entire order
Entire order is signed over to second supplier to be filled (all or nothing)
Difference between electronic DEA 222 and paper ordering?
Electronic ordering isn’t automatically granted with a DEA registration like paper ordering
On electronic DEA 222s you can order any schedule of drug and non-controlled medications
What is the unique number assigned to track order when online DEA 222 is used?
Last 2 numbers of year, X, and six characters selected by the purchaser
What must an electronic DEA 222 contain?
Purchaser’s DEA number
Name, address, DEA of supplier
Date order signed
Name and strength of product or NDC number
Package size
Number of packages ordered
Signed with digital signature issued by DEA
What are the 3 inventory dates?
Initial - initial inventory the registrant has the day they first dispense controlled substances
Biennial - inventory at least every 2 years (may be more often based on company policy or state law)
Newly controlled substances - take inventory on date it becomes scheduled
Which controlled substances require an exact count during inventory, and which can have an estimate?
Exact: all CI, CII, CIII-V if 1000 or more units per bottle
Estimate: CIII-V if bottle contains <1000 units
***must include number of loose pills and number of full containers
When can an rx be issued for detoxification treatment or maintenance treatment?
Only if for schedule III-V drug approved by the FDA for use in maintenance or detox treatment
Exceptions:
- Practitioner is separately registered with DEA as a narcotic or opioid treatment program (they can administer or dispense directly but not prescribe - e.g. methadone treatment program)
- practitioner administers from own office supply, but not prescribe (max of 3 days with max of 1 day at a time)
- physician may administer or dispense narcotic drug to maintain or detoxify a hospitalized patient
-DATA 2000 - prescriber can prescribe schedule III-V narcotic drug approved by FDA for use in detox treatment (e.g. suboxone)
How many patients can a prescriber have once they become DATA waved?
30 or less in first year
Up to 100 after first year
Can apply to treat a max of 275 patietns
How can pharmacies dispose of controlled substances?
1) Sending to reverse distributor by contract carrier or by reverse distributor pickup
2) Destroying substance according to current laws
3) Sending controlled substance back to the person you received it from in case of return or recall
4) Promptly transport controlled substance by its own means to the registered location of a reverse distributor, the location of destruction, or registered location of any person authorized to receive that controlled substance for purpose of return or recall
What is DEA form 41 used for?
Destruction of controlled substances/sending back via reverse distributors
Who to notify in the case of theft or significant loss
DEA and Indiana BoP
How to notify DEA of significant loss?
DEA form 106
Include registrant info and pharmacy info, date of theft or loss if known or date discovered, type of theft or loss, how lost, drug lost, if police were notified, if someone was hurt
Which practitioners are identified by the following MD DO DDS DMD DVM DPM MSN DNP APRN PA OD
MD/DO - physicians DDS/DMD - dentists DVM - vet DPM - poditrists MSN/DNP/APRN - nurse practitioners PA - physician assistant OD - optometrists
***All have prescribing authority in Indiana
If you receive a prescription from which practitioners that practice in any state or jurisdiction in the US, they can be filled in the state of Indiana
MD/DO - physicians
DDS/DMD - dentists
DVM - vet
DPM - poditrists
Just need to be practicing within their scope
Can also fill for NP and PA if they are prescribers in the state in which they practice
Difference between scope and speciality
Scope of practice - optometry, can only prescribe for eye issues
Speciality - cardiology, still a medical doctor and can prescribe for full body issues
What things can a dentist prescribe for?
Mouth and maxillofacial (jaw and face)
Can prescribe meds for these areas, related structures, and conditions affecting these areas
What things can a podiatrist prescribe for?
Feet and ankles (sometimes hands in other jurisdictions but not Indiana)
Can you substitute a generic drug for a brand name drug when written by a vet for an animal?
No!
What is the scope of practice and speciality of an advance practicing registered nurse (APRN) (aka NP, midwives, and clinical nurse specialists) Can they prescribe controlled substances?
Whatever the scope of practice AND speciality of their supervising practitioner - if working under dermatologist, can only prescribe for dermatology related issues
- Can prescribe controlled substances if they have a DEA and CSR
Can APRN practice individually? PA?
APRN - yes
PA - no, must work directly under a supervising physician (directly supervised, or available via electronic method) and PA must be within a reasonable travel distance from the facility to personally ensure proper care of patients
What scope of practice and speciality can PA’s prescribe for?
Must prescribe according to protocol on file with board and are only allowed to prescribe within the physician’s scope of practice and speciality
Can PA’s prescribe controlled substances?
Yes after they receive a DEA number and indiana CSR and at least 1800 practice hours
What medications can optometrists prescribe?
Medications on a formulary that are either independently prescribe (can prescribe without consulting PCP), dependently prescribed by notification (must notify PCP), dependently prescribe by consult (must call and consult PCP before prescribing medication)
***If pt does not have PCP the OD may prescribe medications, as necessary
What controlled substances can optometrists (OD) prescribe?
ONLY TRAMADOL
***must have DEA number
What is required on a prescription per federal requirements
No real requirements
Indiana requirements for non-controlled medication prescriptions
Date issued Name and address of pt Drug name/strength Quantity Adequate SIG Name of prescriber Written or electronic signature of prescriber
Indiana requirements for controlled medication prescriptions
Date issued Name and address of pt Drug name/strength DOSAGE FORM Quantity Adequate SIG Name AND ADDRESS of prescriber DEA NUMBER Written or electronic signature of prescriber ***differences from non-controlled prescription noted in all caps
How can practitioners send in prescriptions? Agents?
Practitioner: written, telephoned, electronically, fax (schedule II: written or sent electronically)
Agent: Fax or telephoned (except schedule II)
Physical requirements for paper controlled substance prescriptions are written on
1) Written on security feature prescription (unless faxed, phoned, or transferred to pharmacy)
2) Manually signed in pen or indeilble pencil, or electronically
3) Cannot pre-print name of controlled substance
4) Can’t use stamp to put controlled substance information on a prescription
5) can’t use commercially printed form containing the name of a controlled substance
Requirements for drug orders in hospital setting
1) name and bed number of patient
2) name and strength/size of drug
3) amount to be dispensed, unless specified by institutional policy or guidelines
4) adequate directions for the proper use of the drug when administered to the patient
5) name of practitioner
How to fix missing info on non-controlled substance prescription?
Call prescriber and document on the face of the prescription for non-controlled medications
What changes can a pharmacist make to a schedule III-V prescription?
Add or correct pts address
Add or change dosage form, drug strength, quantity, directions for use, issue date after speaking to Dr and documenting on prescription
Can NOT change patient’s name, controlled substance prescribed, or prescribers signature
Can call Dr about other issues since controlled substances can be phoned in
What changes can a pharmacist make to a schedule II prescription?
In Indiana:
Adding/correcting pt address
Adding/changing dosage form, drug strength, drug quantity, directions for use, issue date after talking to Dr and documenting on face of prescription
Can NOT change: pts name, substance prescribed, or prescribers signature
Federal requirements for prescription labels
Date filled
Pharmacy name and address
Serial number of prescription
Name of patient (if stated on prescription)
Name of prescriber
Directions for use (if on prescription)
Cautionary statements (if on prescription)
CSA CII requirements for prescription labels
Date filled Pharmacy name and address Serial number of prescription Name of patient Name of prescriber Directions for use and cautionary statements *Quantity prescribed* *No transfer label*
CSA CIII-V requirements for prescription labels
Date of initial filling Pharmacy name and address Serial number of prescription Name of patient Name of prescriber Directions for use and cautionary statements Quantity prescribed No transfer label
Indiana requirements for prescription labels
Date of filling
Dispensing pharmacy name, address, and PHONE NUMBER
Serial number of the prescription
Name of patient or SPECIES OF ANIMAL AND OWNER NAME
Name of prescriber
Directions for use and cautionary statements
Quantity prescribed (unless determined by directions)
Name of drug
Prescription label requirements for category III pharmacies (e.g. nuclear, infusion, sterile compounding, not open to public)
Name, address, phone number of pharmacy Date Serial number Name of patient Name of drug and strength Directions for use by patient Route of administration Name of prescriber Precautionary info if on script
Non unit-dosed medication prescription label requirements for use in an institution (e.g. hospital)
Pt identification Pt location (room number) Brand name, generic name, or both Strength Route of administration (IV, oral, topical, etc) Quantity Pharmacist initials
Unit-dosed medication label requirements for use in an institution (e.g. hospital)
***Not prescription label, just unit dose packaging requirements
Brand name, generic name, or both
Strength
Control number and/or expiration date
In Indiana, how long can a prescription be refilled? Federally?
Indiana -
OTC and Rx non-controlled and CII: 1 year
CIII-V: 6 months
Federal-
OTC and Rx non-controlled: no rule
CIII-V: 6 months
CII: not defined
In Indiana, how many full refills are allowed on a prescription? Federally?
Indiana and Federal -
OTC and RX non-controlled: no rule
CIII-V: 5
CII: not refillable
In Indiana, when do prescriptions expire? Federally?
Indiana -
OTC, non-controlled, CII: 1 year from date issued
CIII-V: 6 months from date issued
Federal -
OTC and non-controlled RX: no rule
CIII-V: 6 months from date issued
CII: not defined
What is required for the record when refilling a prescription?
Date of refill
Quantity dispensed if DIFFERENT than original quantity
Pharmacist’s name or initials on back of original script or in another board approved, readily retrievable record
Can pharmacists change a script from 30 to 90 days?
Only if the patient has been on it for at least 30 days to make sure they tolerate it and if there is sufficient quantity remaining
***Cannot do for controlled substances
Do CII scripts have a limit to how many can be prescribed at one time?
Not really
Can only prescribe 90 days worth (in 3 scripts) but number of pills written for in those 90 days is not limited
Can you partial fill CIII-V substances?
Yes - can be partial filled more than 5 times with a max amount of however many pills they would have received with the original script + 5 refills
Can you partial fill CII substances?
Only if it is not prohibited by state law, it is requested by the patient or representative or practitioner who wrote the prescription, total quantity dispensed doesn’t exceed total amount prescribed, and remaining portions are filled no later than 30 days after the prescription was WRITTEN
If full amount cannot be provided can partial fill and provide remaining amount within 72 hours of partial filling
If pt is in LTCF or diagnosed with terminal illness - must document LTCF pt or terminally ill on prescription and can partially fill script for up to 60 days from ISSUE DATE - must document quantity dispensed, remaining quantity, and identification of dispensing pharmacist
Can CII script be taken over the phone?
Only in emergency situations
What is considered an emergency situation in which a CII can be given over the phone?
All 3 of the following must be met
1) immediate administration of controlled substance is necessary for proper treatment
2) No appropriate alternative available, including non-controlled medication
3) Not possible for prescriber to provide written prescription prior to dispensing the medication
How much can be dispensed from an emergency CII prescription given over the phone?
Quantity sufficient to treat patient during emergency period
***Dispensing beyond this period must be pursuant of a paper or electronic prescription
How long does a prescriber have to issue a covering prescription for an emergency prescription? What must this prescription contain? What if the pharmacy does not receive a prescription?
7 days
Must meet requirements of normal CII script and contain “Authorization for Emergency Dispensing”
If no prescription is received, pharmacist must notify the nearest DEA office and the Indiana BoP
When can pharmacists use faxes as original prescriptions?
1) non-controlled meds
2) CIII-V meds
3) CII narcotic to be compounded for direct administration to patient by parenteral, IV, IM, subcutaneous, or intraspinal infusion (aka injectable CII)
4) CII for pt in LTCF
5) CII narcotic for pt enrolled in hospice care program certified and/or paid for by medicare under title XVIII or hospice program licensed by the state
Can CII scripts be sent in a fax?
Only if
- Actual script is presented at time of pickup
- CII narcotic to be compounded for direct administration to patient by parenteral, IV, IM, subcutaneous, or intraspinal infusion (aka injectable CII)
3 - CII for pt in LTCF
4 - CII narcotic for pt enrolled in hospice care program certified and/or paid for by medicare under title XVIII or hospice program licensed by the state
How often can scripts be transferred?
Non-controlled: unlimited
CIII-V: once after it has been filled once
CII: never
When can a pharmacist refuse to transfer a prescription?
If it is against our professional judgement or meets one of the following
- Contrary to law
- Against best interest of patient
- Aid or abet an addiction or habit
- Contrary to the health and safety of the patient
***If it does not meet any of these criteria refusing to transfer is illegal!
What are the different types of sanctions?
Revocation Suspension Probation Letter of Reprimand and Censure Fine
What does it mean if a license is revoked
License is taken away permanently
If your license is revoked, how long until you can reapply for a license?
7 years from date of revocation
Will need to retake all exams and license will be issued under a new number
What does it mean if a license is suspended?
You can’t practice - usually suspended indefinately and board sets a minimum amount of time until it can be reinstated
Board can summarily suspend a practitioner’s license for up to 90 days if they are a clear and immediate danger to public health and safety (aka emergency suspension) - can be repeated as many times as needed
What does it mean if a license is placed on probation?
Can still practice but must meet conditions of their probation (community service, continuing education, refrain from certain acts, etc)
What does it mean if a letter of reprimand and censure has been issued?
Reprimand: License has been disciplined and includes what the board specifically found inappropriate
Mailed to practitioner and copy is kept in their permanent file
Censure: verbal expression of disapproval; still official record that a license has been disciplined
If a practitioner is fined and they don’t pay the amount in the time set by the board, what happens? How much can they be fined?
Fines are up to $1000 for each violation
They may suspend the practitioners license without a hearing
***Can’t suspend if practitioner cannot financially afford the fine
What happens if a practitioner surrenders their license?
Board can require a hearing for surrender
Board can impose sanctions after surrender
Do controlled substance prescriptions have to be sent electronically?
They did but the law was repealed in June 2021 - will be reinstated in January 2022
What is NOT included in the term telemedicine?
Audio-only communication Telephone call Electronic mail Instant messaging conversation Facsimile Internet questionnaire Telephone consultation Internet consultation
When can a prescriber issue a prescription through telemedicine without actually seeing the patient in person?
When meeting the following criteria
1) Dr adequately treated the pt
2) Prescription is within the provider’s scope of practice
3) Rx is not an opioid (unless it is a partial agonist used to manage opioid dependence)
4) Rx is not for an abortion inducing drug
5) Rx is not for an ophthalmic device (e.g. glasses, contacts, or low vision devices)
***can issue opioid
When can an opioid prescription not exceed 7 days?
1) If the prescription is for an adult being prescribed an opioid for the first time
2) if the rx is for a child who is less than 18 years old
Under what circumstances can prescribers issue prescriptions for opioids for days supply >7 days without previous use?
When treating cancer
For palliative care
Medication-assisted treatment for substance use disorder
If the patient requires it based on the professional judgement of the provider
If a non-opioid medication is not appropriate
When can an opioid prescription be filled for a lesser amount than written on the script?
When requested by the
Patient
Pt representative
Guardian of pt
If an rx is written for a pt enrolled in IN medicaid, we must substitute generic product if it is cheaper - what must the prescriber do if they want the pt to have brand?
Write “Brand Medically Necessary”
If a generic is substituted for brand, what must be included on the prescription label?
_____ generic for _____
What must a pharmacist do when substituting a prescribed biologic?
- determine product is interchangeable with the prescribed biologic by the FDA
- Dr signed “may substitute”
- Pt is informed of substitution
- **must also notify prescribing Dr within 10 days of name and manufacturer of biologic product dispensed if substituted
What does “sale” mean in law?
- manufacturing, processing, transporting, repackaging
- exposure, offer
- holding, possession
- Dispensing, supplying
- Applying, administering
What are “unlawful acts” that apply to everyone (including pharmacy)
1) obtain or attempt to obtain a legend drug or procure by fraud, deceit, forgery of rx, concealment of material fact, use of false name or address
2) Communicate info to a physician in effort unlawfully to procure legend drug
3) make false statement in rx
4) falsely assume title of or represent oneself to be a manufacturer, RPh, Dr, etc
5) make a false or forged prescription
6) put a false or forged label on a drug
7) dispense legend drug unlawfully
When can anabolic steroids not be prescribed?
for enhancing performance in an exercise, sport, or game
Hormonal manipulation intended to increase muscle mass, strength, or weight without medical necessity
What are examples of mechanical storage devices?
Omnicell and Pyxis
Must be operated under the direct supervision and control of a pharmacy or practitioner
Definition of administering
Direct application of a drug to the body of a person by injection, inhalation, ingestion, or any other means
Definition of board
Indiana BoP
Definition of controlled drugs
Schedules I-V of the federal Controlled Substances Act or Schedules I-V of IC 35-48-2
Definition of investigational or new drug
any drug which is limited by state or federal law to use under professional supervision of a practitioner authorized by law to prescribe or administer such drug
What word is equivalent to “license”
permit
Definition of “qualifying pharmacist”
pharmacist who will qualify the pharmacy by being responsible to the board for the legal operations of the pharmacy under the permit
Difference between “powers” and “duties”
Powers: things an entity MAY do if it chooses
Duties: things an entity MUST do
What is the IPRP?
Indiana Professionals Recovery Program
Has a contract with the IPLA to monitor impaired pharmacists and student pharmacists
Requirements for pharmacist licensure
1) at least 18 years old
2) Haven’t been convicted of a crime that would have a direct bearing on your ability to practice competently
3) are a graduate of ACPE accredited college of pharmacy, Canadian council on pharmacy accreditation (CCPA) program and obtained the FPGEC certificate, or graduated outside the US and obtained the FPGEC certificate
How many hours of experience must you have under the supervision of a licensed pharmacist in order to become a licensed pharmacist?
1500
What does it mean if your license is “inactive”
fees are current but continuing education requirements of licensure haven’t been met
- **must ask to be made inactive by checking a box on the renewal form
- **Cannot practice pharmacy
What needs to be done to change license to active from inactive
Must complete all continuing education requirements you didn’t complete while license is inactive - if inactive for several years, must complete 30 hours for every 2 years inactive
When do pharmacist licenses expire?
June 30 of even number years
When can a pharmacist share confidential information
1) in the best interest of the patient
2) requested by the board, its representatives, or law enforcement officer
3) in connection with a criminal prosecution or proceeding or in connection with a proceeding in front of the board
When can a technician share confidential information?
When in connection with a criminal prosecution or proceeding
The person to whom the information relates is a party
When can a pharmacist refuse to fill a script
1) When in the best interest of the patient
2) When contrary to law
3) If it would aid or abet an addiction or habit
4) be contrary to the health and safety of the patient
Major difference between category I, II, and III pharmacy permits
I: dispense drugs to public (retail or outpatient)
II: institutional pharmacies (hospitals, clinics, nursing homes)
III: pharmacies that are not open to the public (central fill, mail order, nuclear, infusion)
***Types III, IV, V, and VI pharmacies are included in category III pharmacies
Each pharmacy must have their own qualifying pharmacist except for what situation?
A pharmacist can be a qualifying pharmacist for two category II pharmacies (hospital, clinic, nursing homes, etc) once it is proven that they tried to find another qualifying pharmacist without success
What is the pharmacist to tech/intern ratio?
1 pharmacist per 6 technicians, technicians in training, or interns
***No more than 3 can be technicians in training
Can security personnel know the combination to the alarm on the pharmacy?
Yes but they can’t go in without a pharmacist present
What must be done if a pharmacy changes ownership?
New owner must obtain a new pharmacy permit
Must submit application to transfer ownership no later than 10 days after the change of ownership is approved by the board (because old permit expires 10 days after transfer of ownership) and old permit must be returned by new owner
What must a pharmacy do if they are temporarily closed for 5 days or more?
Notify the board
Secure the drug stock
Take any additional steps instructed by the board to ensure the drugs are secure
What must a pharmacy do if they close permanently?
1) notify board 20 days before transfer of controlled substances and submit copy of inventory form required by DEA
2) Remove all legend drugs from stock by returning to wholesaler, transferring to another pharmacy, or destroying them in the presence of a representative appointed by the board
3) Remove any signs and symbols associated with a pharmacy
4) return pharmacy permit for cancellation within 10 days of all drugs being removed from premises
Can a pharmacist dispense a prescription after the demise of a practitioner?
No unless it is in the best interest of the patient’s health
Can a pharmacist dispense a prescription after the demise of a patient?
Not knowingly
How long must the expiration date be for epinephrine and glucagon when dispensed by the pharmacy?
12 months or more
***Unless pt consents to shorter expiration date
What can pharmacists prescribe?
Inhalation spacers
Nebulizers
Supplies for medical deices (CPAP) and insulin pumps
Normal saline and sterile water for irrigation for wound care
Diabetes blood sugar testing supplies
Pen needles
Syringes for medication use
**need advance beneficiary notice signed by pt stating they may not receive reimbursement for the device or supply - KEEP THIS INFO FOR 7 YEARS
**will write rx with our NPI and can bill insurance (some won’t cover)
What age can we administer vaccines to?
11 and older
***50 and older for pneumonia
What vaccines are pharmacists allowed to give?
Flu Shingles Pneumonia Tdap HPV Meningitis MMR Varicella Hep A Hep B H. influ type B
Are pharmacists required to be immunization certified?
Not by law, but some jobs may require it
When is the CE biennium?
January 1 of even year to Dec 31 of odd year (Jan 1 2020 - Dec 31 2021)
What are the CE requirements for pharmacists?
Must have at least 30 hours
- 6 or less from business, management, or computer courses
- 24 or more must be pharmacy practice related
- at least 15 hours must be from ACPE accredited/sponsored CE programs
Must keep record of CE for 4 years
If licensed after July (<6 mos from end of biennium) don’t have to do any CE
If we don’t complete CE, board can sanction us
In what situation can you use electronic data processing in place of a hardcopy prescription?
In the hospital/inpatient setting (Type II/Category II pharmacies)
What security features should a prescription for a controlled substance contain in Indiana?
- When photocopied: latent, repetitive “void” pattern screened at 5% in reflex blue must appear across the entire face of the document
- Custom artificial watermark printed on the backside of the base paper that can only be seen at a 45 degree angle
- Opaque Rx symbol must appear in the upper right-hand corner
- 6 check off boxes must be printed on the form and the appropriate quantity checked off
- No advertisements may appear on the prescription blank
- Logos for hospital, etc may appear on the prescription blank
- Only ONE prescription per prescription blank
- Dr and DEA/license/NPI
Can prescribers print the name of a controlled substance on a script? Can they stamp it?
Can print but can NOT pre-print before patient is there
Can NOT use a stamp
What does PDMP stand for and what is the name of Indiana’s PDMP? What drugs are reported here?
Prescription drug monitoring program
Indiana Scheduled Prescription Electronic Collection and Tracking (INSPECT) program
All scheduled drugs, pseudopehedrine, ephedrine, and gabapentin (b/c scheduled in some states)
What types of ID can be presented to pick up a controlled substance?
- Driver’s license (any state)
- Military ID card
- ID card issued by state’s BMV or DMV
- **Must be “valid” and NOT expired!
How much of a substance containing opium can be sold OTC? Any other schedule V substance? How often can these be sold?
240 ml (8 ounces) or 48 dosage units Any other schedule V: 120 ml (4 ounces) or 24 dosage units Must be over 18 and can only sell this much in a 48 hour period ***Can only be sold by pharmacist or intern
Who can buy syringes OTC? What info must be recorded?
Anyone
Can only be sold by pharmacist or intern
Must provide ID if not known to pharmacist
Must record: name and address of purchaser, name and quantity of syringes, date, name/initials of pharmacist
When can a pharmacist adjust drug therapy regimens of a patient in a hospital?
After the
1) written authorization of the admitting practitioner
2) according to hospital protocols
Ambulatory care pharmacists are allowed to adjust patient regimens under a protocol that includes what?
Name of patient, their doctor, and pharmacists allowed to adjust
Condition/disease state diagnosed by doctor
Statement regarding what medications can be used
Min/max doses
Duration of administration
Medication info (dose, forms, etc)
What is the max amount of ephedrine or pseudoephedrine that can be sold to 1 person on 1 day
- 6 grams
* Unless they have a script
What is the max amount of ephedrine or pseudoephedrine that can be sold to 1 person in 30 days?
- 2 grams
* Unless they have a script
What is the max amount of ephedrine or pseudoephedrine that can be sold to 1 person in 365 days?
- 2 grams
* Unless they have a script
If a pharmacy has 3 unusual thefts occur in a 30 day period (ephedrine and pseudoephedrine) - what must they do?
Move all products containing pseudoephedrine and ephedrine behind the counter for at least 180 days
Who can call in CII scripts? Fax?
Prescriber ONLY can call in - not an agent
***must be in emergency situation only
Prescriber and agent can fax in script
Which class of medical devices require premarket approval before marketing?
Class III
Who can require special packaging of “hazardous substances”?
Consumer Product Safety Commission (CPSC)
***Part of the poison prevention packaging act (PPPA)
Med guide vs PPI
Both are FDA-approved labeling written in patient-friendly language
Med guide: explains issues related to a specific drug or drug class
PPI: explains uses, risks, and precautions related to a particular drug
When should medguides be given to a patient?
On all new scripts and refills for an outpatient not under direct supervision of a HCP
***do NOT need inpatient like you do with PPI
What drugs require medication guides?
SSRI, NSAIDs, some opioids
What can a dietary supplement not make claims about?
A disease
Can make claims about diseases resulting from essential nutrient deficiencies (scurvy, pellagra)
Which medications have the new pregnancy categories?
Meds approved after June 30, 2015
What are the old pregnancy categories?
A - data suggests safe
B - no human data, animal data suggests safe
C - no human data and either no animal data or animal data suggests potential fetal risk
D - data shows risk to human fetus
X - risk to fetus outweighs benefit - DO NOT USE
What is the drug registration process?
Process of sending in an IND to the FDA to investigate a new drug and then sending an NDA to the FDA to get a drug approved for marketing
How often should registrations be renewed?
Every year for most
Every 3 years for dispensing/instructing registrations
Which providers can prescribe CIII-V for detox for opioid-dependent patients? (e.g. suboxone)
PA, NP, or physician
Need DEA number for maintenance and detox treatment (starts with X and must be added to any script written for maintenance and detox)
If a script is partial filled and then expires, can you complete the fill?
No
Who can transfer prescriptions?
Non-control: pharmacist or intern to pharmacist or intern
Control: pharmacist to pharmacist
What prescribers can practice telemedicine?
Physicians PA APRN Optometrists Podiatrists
How long does the board have to grant a pharmacy permit after submitting all the requirements?
120 days
When can a pharmacist fill a drug without a prescription?
- If they tried to reach the doctor
- RPh believes that failure to provide this medication would be detrimental to pt health
- Script is expired or all refills have been dispensed
- Original script had refills
- Last filled at your pharmacy or pharmacy in the same chain (and was never out of your chain)
- Not a PRN med
- Only 30 days dispensed or less if the script was written for less
- Can only do once in 6 month period per script
- Not a controlled medication
- RPh notifies prescriber
***Cannot do if dr writes “no emergency refill” on script
When can a pharmacy reuse returned medications?
- If dispensed to individual residing in an institutional facility or in a hospice program in a county jail or department of correction facility
- Properly stored and securely maintained
- Returned unopened and was dispensed in original stock bottle or unit dose package
- Dispensed at same pharmacy accepting return
- Not expired
- Not a controlled substance, compound, biological product
When can a pharmacy reuse returned medical devices or supplies?
- If dispensed to individual in county jail or department correction facility
- Not expired
- Returned unopened and in original sealed packaging
When can a pharmacist change (quantity, dosage form, etc) on a script?
- If prescribed quantity is not commercially available
- The change in quantity is related to change in dosage form
- Change in quantity reflects intended days supply
- Change dosage form if best interest of patient (tablet to liquid, tab to cap, etc)
- Can complete missing information on a script if sufficient evidence to support the change
- Extend maint drug for limited quantity necessary to coordinate a patient’s refills in a med synchronization program
How can someone access a cabinet that stores drugs?
Security code
Password
Other method positively identifying individual
How can medications be accessed in an institution when a pharmacist is not present?
- Locked cabinet (RPh must review every 24 hours)
- Supervisory nurse may access pharmacy and remove drugs - must be needed to treat immediate needs of patient
- Emergency boxes/kits, drug carts, crash carts, etc
- Pharmacist can come in and dispense something
If a nurse removes a drug from an emergency kit, what must they document?
Pt name
Drug name, strength
Quantity remove
Date and time of removal
Can pharmacies with category II permits dispense prescriptions for a patient being discharged?
Nope, only category III
When can a patient self-administer medication when in an institutional facility?
- When dr said it’s ok
- No risk of harm to pt from self-administration
- Someone has evaluated their knowledge or pt has received training on how to do it
- Nurse witnesses self-administration
What happens if an inpatient has a home med and they die?
Must be delivered to the pharmacy for appropriate destruction
***Can NOT be given to pt representative
What happens if an inpatient is discharged and they forget their home meds?
Store at nursing station for 7 days then send to pharmacy for destruction
What additional information is required for sterile product labels?
Date of preparation
Expiration date
Who prepared it
Who checked it
What counts as an offer to counsel
- RPh counseling pt
- Intern counseling pt if allowed by pharmacist and followed with offer for RPh counseling
- Written notice with pharmacy’s phone number and bona fide offer if pt not present or if drug is sent via mail
What does not count as an offer to counsel
- Asking if the pt has questions
- Any method shifting responsibility to pt for initiating counseling
- Relaying info through intermediary (unless translator)
- Using signs or notes
Do you have to counsel an inpatient?
Nope!
How do we document a patient’s acceptance or declination to be counseled? How long do we keep this info?
Electronically or written
Keep for 2 years
Qualifications to be a pharmacy technician
- Apply to BoP for licensure
- Be 18 years old (may be waived by the board)
- High school graduate or have GED
- Not be convicted of a crime that has direct bearing on their ability to practice or a felony relating to controlled substances
- Be certified within 12 months of being hired
What is a temporary variance? How long does it last?
Change or exception to a rule or regulation
Must be submitted to BoP in writing
Can last 6 months and be renewed up to 5 times
What does therapeutic alternative mean?
Drug that has different chemical structure, is in the same drug class, and can be expected to have similar therapeutic effects and SE when given at therapeutically equivalent doses
What does convenience package mean?
Package that contains a drug having 60mg or less of ephedrine or pseudoephedrine or both
Who can sell pseudoephedrine or ephedrine?
A pharmacy or NPLEx retailer
If a pharmacist determines there is not a medical need to ephedrine or pseudoephedrine, the pharmacist can only allow a person to buy what?
ONE PACKAGE OF
Extraction resistant or conversion resistant form
Product that contains <720mg per package or 30mg per tablet
When do new pharmacy laws go into effect?
July 1 of every year
What does DSHEA stand for?
Dietary Supplement Health and Education Act
