Non-Controlled Substance State Laws

What are requirements for a pharmacy application?

complete form, fee, certified copies, fingerprints, PIC, address, self-inspection form, compounding services

What are the requirements for a remote pharmacy application?

parent pharmacy and proposed remote pharmacy must share a common ownership, show all pharmacies within 10 mile radius

How many licenses can a pharmacy have?

1 per address

How long is a pharmacy license good for?

2 years

How long is an accreditation for compounding pharmacy good for?

3 years

What are the requirements followed by compounding pharmacies?

USP 795 and 797

What is an outsourcing facility under compounding pharmacies?

located in state that dispenses, provides, distributes, or furnishes compounded pharmaceuticals in this state

What must licensed outsourcing facilities do for the board?

submit biannual report from FDA that identifies drugs compounded in last 6 months

What must a compounding pharmacy do for inspections?

submit a copy of most recent inspection performed in the last 2 years/18 months for sterile compounding, a new pharmacy needs an inspection prior to licensure

What are requirements of pharmacy housing?

suitable, well-lighted, well-ventilated, clean/sanitary

What is the working space requirement for a pharmacy?

> 150 sq ft space, prescription counter > 10 ft of free work space, each additional pharmacist = > 4 ft additional space, free movement/no obstacles, floor to ceiling substantially constructed/securable/lockable

What are specific terms only to pharmacies?

drugstore, apothecary, pharmacy

What must a pharmacy be equipped with?

necessary facility/equipment to provide prompt/efficient services + current editions of MI pharmacy laws/rules and 2 current pharmacy reference text

What is the requirement for closing a pharmacy?

notify the board 15 days before closing, records must be maintained for same amount of time as if pharmacy remained open

What are required learnings to become licensed?

opioid/CS awareness training, human trafficking awareness, implicit bias

What are the minimum and maximum hours for interns?

minimum 1600 hours, max 40 hours/week

What does prescription drug labeling and dispensing comply with?

FDC act

What information is required to be on medication label at a minimum?

pharmacy name/address, rx number, patient name, date dispensed, doc name, directions, med name/strength, quantity, manufacturer name

What is the expiration date for medications on the label?

1 year from dispensed, different than prescription expiration

What is the policy on returns of medication?

if left control of pharmacist = non returnable

What is the receipt?

price charged on receipt is price paid by customer

How long must receipt records be kept?

90 days

How long must acquisition/distribution records be kept?

5 years

What is the new law for prescriptions effective 1/1/2023?

all new rx should be electronic unless waiver/exempt

What are the requirements for a written rx?

dated, manually signed, patient name, doc address, drug name/dose/DF, quantity, directions, refills

What is needed if a script is written for an animal?

animal species and full name of owner

How many written scripts can be on the same form?

4

How many electronic scripts can be on the same form?

6

What is the expiration of a written script?

1 year

How long must a written script be kept?

5 years from last refill issued, after 2 years can make an electronic duplicate

How are prescription records held?

chronological order

What is the rule for readily retrievable records?

most current 2 years on site

What needs to be done in case of a power outage?

system in place to record information - record within 48 hours

What should not be filled under a pharmacist professional responsibility/professional judgement?

rx appears improperly written, susceptible to more than 1 interpretation, belief the rx can cause harm to patient, reason to believe rx is used for illegitimate medical purposes

What is the rule for counseling?

mandatory on all new to patient medications

What is considered a prescription drug?

dispensed pursuant to prescription, drug has rx only, designated by the board

What are requirements of a PIC?

no more than 3 pharmacies, 8 hours at each site, not more than 30D notice to board if there is a change

What must be determined before dispensing?

prescriber-patient relationship, authentic rx, scope of practice, appropriate/necessary, knowingly not dispensing after death of doc/patient

What are requirements to transfer a script?

original rx has refills remaining

What are the procedures for transferring a script?

cancellation record, duplicate of original, rx number, pharmacy name, date issued, refills remaining

What is the requirement when using an interchangeable biologic product?

notify doc within 5 days after dispensing

What is the PIC responsibilities with hospice ER boxes?

hospice has policies/procedures = inspection weekly, storage/control, who uses it, responsibility for ensuring rx removed are obtained from appropriate prescriber

What is required with hospice er boxes?

tamper evident seal/sealing system with color designation to open/closed, numbered boxes, permanent record maintained in pharmacy

What does the label outside the hospice er box contain?

pharmacy name/address, hospice name/address, pharmacist who inspected it last, date of restock, date needed to be returned, number of box

What is the storage requirements for hospice er boxes?

constructed, securely locked storage compartment when not under pharmacist/prescriber/RN/PA control, stored under conditions to maintain stability/integrity/effectiveness of drugs

Who are considered prescribers?

dentist, DM, DOMS, DPMS, optometrist, APRN, vets, licensed health professional working under delegation

What is the requirements with pricing?

posted notice, not obligated to purchase, must respond to per patient's request

What does the board of pharmacy consist of?

11 members = 6 pharmacist, 1 tech, 4 public

How many CE credits are required to renew pharmacist license?

30 hours/2 years

What are requirements with CE for pharmacist?

4 year retentions, 10 hours of live, 1 pain/symptom management, 1 ethics/jurisprudence, one time CD awareness/opioid training/human trafficking, implicit bias 2 hours each renewal

What is the expiration for customized patient medication packages?

60 days, no return to stock

What is not permitted with customized patient medication packages?

similar appearing products in package, incompatible = "original container"

What are label requirements for customized patient medication packages?

serial number for CPMP, separate serial number for each med, name/strength/physical description/total qty, doc name, directions, date prepared, expiration, name/address/phone of dispenser, patient information

What is considered a medical institution?

hospital, skilled nursing home, county medical care facility, nursing home, surgical outpatient facility, hospice, health facility licensed by state that includes pharmacy services

What is pharmacy services?

direct/indirect patient care services associated with practice of pharmacy

What are inspection requirements for medical institutes?

every 6 months at least

What is required for a remote pharmacy?

parent/remote relationship, > 10 mile radius, qualified pharm tech, surveillance/phone system, down time provisions, monthly inspection, 45 day video retention, signage requirements, patient counseling over audio/visual, average 150 rx/day during 90 day period

What is considered an authorized entity that a doc can write a script for epinephrine?

school board, governmental entity, law enforcement.

What is the storage/maintenance/oversight requirements of epinephrine?

readily accessible area, accordance to epi's instructions for use, designate trained employee to be responsible for storage/maintenance/general oversight

When is epi used?

believes in good faith the patient is experiencing anaphylaxis

What is the training requirements for epinephrine?

anaphylaxis training program every 2 years

When can a pharmacist dispense an emergency supply of insulin?

patient has qualified rx and no remaining refills + previously has rx for insulin dispensed at the pharmacy

What is an emergency supply of insulin?

up to 30 days, notify doc within 5 days, no more than 3 emergency supplies in 1 year

What is compounding?

preparation, mixing, assembling, packaging, and labeling of a drug/device by a pharmacist

What are examples of "not compounding"?

commercially available product, reconstitution, flavoring agents < 5%

Where can automated devices be used?

pharmacy, hospital, county medical care facility, hospice, nursing home, office of dispensing prescriber

What are automated devices policies and procedures?

accuracy, patient confidentiality, access, data retention/archive, downtime/emergency procedures, med security, quality assurance

What is continuous monitoring thermometers?

required for refrigerators

What is the requirement with dextromethorphan sales?

> 18, proof of age unless looks > 25, prescription = exception