Ceutics Final

____________ is something physically wrong with the product (too strong, too weak, contaminated)

adulteration

adulteration is something physically wrong with the product (too strong, too weak, contaminated)

this can happen if the product violates ____________

CGMPs (503b must comply to these)

________________: strength accidentally labeled as too high or too low, or the product is mislabeled entirely, or not including necessary warning or potential SEs on the label

misbranding

describe reasons the FDA would need to visit a location

_______________ inspections: usually the companies do not know that the FDA is coming

routine

describe reasons the FDA would need to visit a location

_______________ inspections: d/t recalls, outbreaks, complaints from doctors, pharmacists, or patients (the companies probably have an idea of when they’ll come)

follow-up

503___ pharmacies compound for individual patients with a valid prescription

A

503A pharmacies compound for ____________ with a ____________

individual patients, valid prescription

503 A or B: which needs to comply to CGMPs?

B

Understand minimum requirements for nonsterile compounding as laid out in USP <795>

training: designated personnel must develop training to take place ______ _______

every year

Understand minimum requirements for nonsterile compounding as laid out in USP <795>

building and facilities: there needs to be a designated ____________ compounding area

non-sterile

Understand minimum requirements for nonsterile compounding as laid out in USP <795>

building and facilities: storage areas for CNSPs and components must be __________ __________

temperature monitored

a_w >0.60 (AQUEOUS dosage forms)

for non-preserved aqueous: __________ in the fridge

14 days (shortest)

a_w >0.60 (AQUEOUS dosage forms)

for preserved aqueous: __________ in the fridge or at controlled room temp

35 days

a_w <0.60 (NON-aqueous dosage forms)

Oral liquids (non-aqueous)= _________ in the fridge and controlled room temp

90 days

a_w <0.60 (NON-aqueous dosage forms)

other non-aqueous doses= _________ in the fridge and controlled room temp

180 days (longest)

The ____________________ Act is what differentiates between compounding pharmacies that compound prescriptions for individual patients vs. that compound large batches for resale (basically differentiates 503A from 503B)

Drug Quality and Security (DQSA)

503B pharmacies must be registered with _________

the FDA

in 503A pharmacies, compounding can be done by a pharmacist in a __________________ pharmacy or federal facility or by a licensed physician

state-licensed

in 503___ pharmacies, compounding can be done by a pharmacist in a state-licensed pharmacy or federal facility or by a licensed physician

A

in 503B pharmacies, compounding is by or under the direct supervision of a licensed pharmacist in a _____________ facility

outsourcing

in 503___ pharmacies, compounding is by or under the direct supervision of a licensed pharmacist in a outsourcing facility

B

503___ pharmacies can make copies if a drug is on shortage

B

503___ pharmacies: the label and container of compounded drugs must contain certain information (like the statement “this is a compounded drug”)

B

503___ pharmacies: bulk drug substance must be accompanied by a valid COA (Certificate of Analysis

B

503B pharmacies: bulk drug substance must be accompanied by a valid ________________

Certificate of Analysis (COA)

is filtration an approved method of sterilization

yes

Licensure is _______________

agency or government grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimal degree of competency necessary 

mandatory

___________ is mandatory

agency or government grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimal degree of competency necessary 

licensure

Licensure is mandatory

agency or government grants permission to a ____________ to engage in a given occupation upon finding that the applicant has attained the minimal degree of competency necessary 

individual

Licensure is mandatory

agency or government grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimal degree of competency necessary 

To ensure that the ______________, _________, and welfare are protected

public health, safety

Certification is _____________

Showing that you know/understand more than the minimal competencies

voluntary

____________ is voluntary

Showing that you know/understand more than the minimal competencies

certification

____________ establishes higher level credentials

certification

Accreditation is ______________

formal process by which an authorized body assesses and recognizes an organization, program or group as complying with requirements

voluntary (but its the only way youll get paid)

______________ is voluntary

formal process by which an authorized body assesses and recognizes an organization, program or group as complying with requirements

accreditation

Accreditation is voluntary

formal process by which an authorized body assesses and recognizes an ___________, __________or _________ as complying with requirements

organization, program, group (not for an individual person)

Accreditation is voluntary

formal process by which an authorized body assesses and recognizes an organization, program or group as complying with requirements

it’s not required, but it is necessary for organizations to be able to get ____________

paid (payment by third parties)

Explain the TJC on-site survey process and how often they are performed.

initial on-site surveys are scheduled

recertification every _________ is unannounced

3 years

what is the main reason to pursue accreditation

payment by third parties

payment by third parties is the main reason to pursue _____________

accreditation

List ways to Create Areas to Achieve Easily Cleanable Conditions in a clean room.

surfaces must have the following characteristics so they can be adequately cleaned: smooth, _____________ (meaning it can’t absorb liquids; easy to wipe off), free of cracks and crevices, and _____________ (do not use a paper towel)

impervious, non-shedding

Cleaning is the __________ __________ of __________

physical removal, particles

_________ is the physical removal of particles

cleaning

___________ can kill living organisms only

disinfectants

disinfectants can kill ________ organisms only

living

____________ can kill dormant organisms (like bacterial and fungal ________)

sporicidals, spores

Sporocidals can kill _________ organisms (like bacterial and fungal spores)

dormant

cleaning and disinfecting of PECS, pass-through chambers, work surfaces in and out of PECs, and floors must be done __________

daily (on days that compounding occurs)

sporocidals of PECs, work surfaces in and out the PECs, pass-through chambers, and floors in category 1 and 2 must be done __________, while it must be done ________ for category 3

monthly, weekly

___________ of PECs, work surfaces in and out the PECs, pass-through chambers, and floors in category 1 and 2 must be done monthly, while it must be done weekly for category 3

sporocidals

PECs certification must be performed initially, then re-certification must be performed every ___________

6 months

one disadvantage of automated compounding devices is their inability to pump very ________ volume medications

small (they can only do like 0.02mLs and up)

one advantage of automated compounding devices is that they can allow for ________ _________

remote verification

one advantage of IV robotics is that they can limit ______________ exposure

hazardous drug