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JP Exam 2 > Lecture 1 - 6/23/2022 > Flashcards

Lecture 1 - 6/23/2022 Flashcards

1
Q

USP Chapter 795 is for….

A

Non-sterile compounding

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2
Q

USP Chapter 797 is for….

A

Sterile compounding

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3
Q

USP Chapter 800 is for….

A

Handling of Hazardous Medications by Healthcare professionals

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4
Q

Manufacturing is….

A

the production of FDA approved drug products pursuant to current good manufacturing practices (CGMP)

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5
Q

Compound is….

A

production of a drug preparation that meets the unique needs of an individual patient when a commercial available drug does not meet those needs

Compounding is performed by/under the supervision of a licensed pharmacist pursuant to USP

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6
Q

4 Things we got from Kefauver-Harris Amendment of 1962

A
  1. Req evidence of effectiveness for intended use (drugs must be proven effective as well as safe to be approved)
  2. Established GMP requirement
  3. Transferred oversight of drug advertising from FTC to FDA
  4. Strengthened clinical trials by requiring informed consent of research subjects and adverse drug reaction reporting
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7
Q

FDA guidance documents….

A

Insanitary Conditions, Section 501(a)(2)(A )of FD&C Act

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8
Q

Insanitary conditions states that….

A

“shall be deemed to be adulterated if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess”

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9
Q

Do exemptions of 503A extend to provisions of 501(a)(2)(A)

A

Nah

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10
Q

What are the categories of insanitary conditions?

A

Staff Related = Aseptic Practices
Equipment and Facilities
Cleaning and Disinfecting

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11
Q

Examples of Staff Related (Aseptic Practices) considered insanitary conditions

A

Handling beta-lactam, hazardous drugs or hormones without providing controls to prevent contamination of the production area

Improper gowning

Failing to properly disinfect gloves

Exposed skin during compounding

Moving too quickly while performing aseptic manipulations

Blocking first pass air

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12
Q

Examples of Equipment and Facilities considered insanitary conditions

A

Actionable microbial contamination in ISO 5 area or adjacent

Unsealed ceiling tiles

Ante room and buffer room door open at the same time

HEPA filters not sealed around the perimeter to support frame

Construction in an area adjacent to compounding without adequate controls

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13
Q

Examples of Cleaning and Disinfecting considered insanitary conditions

A

Improper selection of cleaning agents

Improper use of cleaning agents or supplies (dedicated supplies)

No disinfection of equipment or supplies at each transition from areas of lower quality of air

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14
Q

Do we have to follow all Chapters of USP in MA?

A

Yea

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15
Q

Drug Quality and Security Act (DQSA) 2013

A

Amended FD&C Act with respect to human drug compounding and drug supply chain security

Title I & II

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16
Q

Title I DQSA

A

Drug compounding, Compounding Quality Act

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17
Q

Title II DQSA

A

Drug supply Chain Security Act (DSCSA)…Track n Trace

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18
Q

What is FD&C 503 A exemption

A

allows for pharmacy compounding

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19
Q

FD&C 503 A Exemption….

A

Describes conditions under which certain compounded human drug products are entitled to exemptions from 3 provisions of FD&C Act

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20
Q

Which 3 provisions of FD&C Act are exemptions for 503 A exemption

A

505: FDA approval prior to marketing (NDA)
501(a)(2)(B): cGMP requirements
502 (f)(1): adequate directions for use labeling requirement

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21
Q

Who primarily regulates pharmacies that fall under 503 A exemption

A

State, but some Federal requirements still apply

ie. No insanitary conditions

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22
Q

A compounding drug product will qualify for the exemption if the drug product is compounded….

A
  1. For ID patient = no office use
  2. Based on receipt of valid prescription or in limited quantities before receipt of valid prescription on history of receiving prescriptions
  3. Made by licensed pharmacist in state licensed pharmacy
  4. In compliance with USP
  5. Using bulk substances that are manufactured by FDA registered facilities & w/ Certificate of Analysis (shows where API from)
  6. Follow Memorandum of Understanding rules
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23
Q

Memorandum of Understanding rules…

A

can only ship 5% of product out of state if haven’t signed onto the Memorandum of Understanding

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24
Q

FDA Guidance on Essentially Copies

A
  1. prohibit copying of commercially available drug extends to essential copies, not just exact
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25
Q

When is a compounded product considered to be essentially a copy of a commercially available drug product….

A
  1. compounded product has same API as commercially available drug product
  2. API have same, similar or easily substitutable dosage strength
  3. commercially available drug product can be used by the same route of admin as prescribed for compounded drug
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26
Q

When can essentially copies be made?

A

When the medication is on the FDA Back order list

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27
Q

Significant Difference

A

Prescriber must determine that the change made for an identified individual patient produces a significant difference from the commercial product

Determination must be documented on prescription

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28
Q

FDA Guidance: Inordinate amounts

A

Created Memorandum of understanding to address inordinate amounts of compounded products.

29
Q

If pharmacy located w/in state that doesn’t sign the MOU then….

A

distribution of compounded products in interstate commerce is restricted to not more than 5% of the total prescription orders dispensed / distributed by the pharmacy

30
Q

If pharmacy located w/in state that does sign the MOU then…

A

dont have to confirm to the 5% of total prescriptions

31
Q

What is considered “Complex Compounding”

A

making things like patches, troches, lollipops,etc

this requires a special license

32
Q

What are the examples of compounding

A
  1. removal of dye for medical reasons
  2. change in strength
  3. change in dosage
  4. change in form or delivery mechanism, provided that a price difference shall not be a significant difference to justify compounding
33
Q

What is the 503B exemption

A

Describes conditions under which certain human drug products compounded at a facility registered as an outsourcing facility are entitled to exemptions from 2 provision of FD&C Act

34
Q

Which 2 provisions are 503B exemptions….

A

505: FDA approval prior to marketing 9NDA)

502(f)(1) adequate directions for use labeling requirement

35
Q

What are 503B not exempt from?

A

Not exempt from CGMP requirements and inspected by FDA according to a risk-based schedule

36
Q

Massachusetts requires Outsourcing Facilities to be…

A

Registered with FDA + have FDA inspection

37
Q

Section 102 of DQSA (Title I)

A

exempts compounded drugs from new drug requirements, labeling requirements, track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements

38
Q

Mass regulations for Outsourcing facility?

A

247 CMR 21 Registration of Outsourcing Facilities

  1. Must register w/ FDA and be inspected by FDA prior to distributing compounded drugs
  2. may receive pt specific prescriptions but do not have to in order to distribute
39
Q

Section 105 of DQSA (Title I)

A

requires HHS to receive submissions from state boards of pharmacy for….

  1. describing any disciplinary actions taken against compounding pharmacies or any recall of a compounded drug
  2. expressing concerns that a compounding pharmacy maybe violating FDCA
40
Q

Section 103 of DSQA (Title I)

A

prohibits resale of compounded drug labeled “not for resale” or intentional falsification of a prescription for a compounded drug (OK if same hospital system)

** Deems compounded drug to be misbranded if its advertising or promotion is false or misleading in any particular way **

41
Q

Drugs exempt from Poison Prevention Packaging Act

A
  1. SL Nitroglycerin
  2. SL + chewable Isosorbide DN < 10mg
  3. Erythromycin Ethylsuccinate granules for oral suspension & oral suspensions in packages containing < 8g or equiv of Erythromycin
  4. Erythromycin ethysuccinate tab in package containing < 16mg Erythromycin
  5. Anhydrous Cholestyramine in powder
  6. Potassium Sup in unit dose forms, containing < 50mEq/dose
  7. Sodium Fluoride drug prep, containing < 264 mg/pcakge
  8. Betamethasone tab in manufacturers dispenser package containing < 12.6mg Betamethasone
  9. Mebendazole in Tab form in package containing < 600mg of drug
  10. Methylprednisolone in tab form in package contains < 84mg
  11. Colestipol in powder form in packages containing < 5g of drug
  12. Pancrelipase prep in tab, capsule, powder form
  13. Cyclically admin oral contraceptives in memory aid dispenser package which rely on activity of 1 or more progestogen or estrogen substances
  14. Prednisone in tab form dispensed in package w/ no more than 105mg of drug
  15. Conjugated estrogen tab when dispensed in mnemonic dispenser packages containing < 32mg of drug
  16. Norethindrone acetate tabs in mnemonic dispenser package containing < 50mg of drug
  17. Medroxyprogesterone acetate tabs
  18. Sacrosidase (sucrase) prep in solution of glycerol and water
  19. Hormone Replacement Therapy products that rely solely upon activity of one or more progestogen or estrogen substances
42
Q

Poison Prevention and Packaging Act 1970 requirements

A
  1. “special packaging” of household products and drugs to protect children from serious injury or illness.
  2. child-resistant packaging
  3. Manufacturers may market one size of an OTC product for the elderly or handicapped in noncompliant containers, provided that the package states, “This Package for Households Without Young Children.“
43
Q

PPPA Pharmacist Guidelines & Responsibilities

A
  1. The pharmacist is responsible to ensure packaging of required drugs is in child-resistant containers
  2. Institutionalized patients are not required to receive child-resistant containers (i.e. home-use only)
  3. Patient may provide a “blanket” waiver for child-resistant packaging
  4. Pharmacists should obtain patient waiver for child-resistant packaging in writing from the patient or their agent
  5. Provider may not provide a “blanket” waiver for child-resistant packaging for a patient (i.e., each prescription must direct the use of noncomplying packaging)
44
Q

What are Drug Pedigrees?

A

certain wholesalers provide a pedigree (chan of custody) prior to each wholesale distribution of prescription drugs

requirements set forth in 21 CFR Parts 203 & 205

45
Q

Product Tracing Info

A
  1. Includes transaction info, history, statement
    * * 2. Must be passed, received and maintained for 6 years by each trading partner**
  2. After 2023, info has to be electronically passed only
  3. Importation for personal use
46
Q

Importation for personal use

A

FDA instituted compassionate use policy

CSA also allows for limited personal importation

47
Q

Drug Supply Chain Security Act (DSCSA 2013)

A
  1. Established timeline for trading partners toward implementation of a track and trace system
  2. Full system of electronic track n trace must be in place by Nov 2023
  3. This applies to transactions where prescription drugs change ownership with some important exceptions
  4. Established uniform national licensing standards for wholesalers and 3PL providers
48
Q

What is a 3PL provider?

A

Virtual wholesaler

They don’t have product and are essentially middlemen

49
Q

USP 795 General Principles

A
  1. Personnel capable and qualified to perform duties
  2. compounding ingredients purchase from reliable sources
  3. all equip used is clean, properly maintained
  4. only authorized personnel allow in immediate vicinity of operations
  5. Assurance processes always carried out as intended + are reproducible
  6. compounding environment suitable for intended purpose to prevent errors
  7. adequate procedures and records exist for investigating an correcting errors
  8. provides general guidelines for BUD
50
Q

USP 795 Compounding Levels

A

Simple = magic mouthwash, combining 2 creams, etc. recon doesn’t count as compounding

Moderate = requires special calc or procedures, or stability data for specific formulation not available

Complex = req special training, environment, facilities, equipment, procedures

51
Q

USP 795 BUD

A

assigned by pharmacy for prep that they compound

52
Q

USP 797 General Principles

A
  1. aseptic technique
  2. compounding processes and BUD
  3. General facility design and layout
  4. Primary/secondary engineering controls
  5. Personnel Monitoring
  6. Environmental Monitoring.
53
Q

USP 797 Compounding lvls

A

Low = simple mixtures, involving 3 or fewer ingredients

Medium = combing 3+ products

High = sterilizing non sterile products to produce sterile product

54
Q

USP 797 Aseptic Technique & Practices

A

set of specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by pathogens

Basics
No Food and Drinks within ISO classified
No Cardboard boxes or particulate producing materials in any ISO classified areas or areas adjacent to an ISO classified area
Disinfecting of all supplies/equipment/drug components before moving from an unclassified area to classified area, and again before entering the ISO 5 DCA

Disinfects stoppers, injection ports, and ampule necks by wiping with sterile 70% IPA and allows sufficient time to dry.

Appropriate use of needles (filter)
Punctures vial stoppers and spikes infusion ports without contact contamination. (Coring)

55
Q

USP 800 NIOSH

A
  1. Makes recommendations for prevention of work related injury and illness
56
Q

USP 800 Definition of Hazardous Drugs

A
  1. carcinogenicity
  2. teratogenicity or developmental toxicity
  3. reproductive toxicity in humans, organ toxicity at low doses in humans or animals
  4. genotoxicity
  5. new drugs that mimic existing hazardous drugs in structure or toxicity
57
Q

USP 800 PPE

A 
N95
Non-permeable gown
Face Shield
Nitrile Gloves
Respirator = test fit
58
Q

Low Risk BUD

A

48hrs room temp
14 days fridge
45 days frozen

59
Q

Low risk w/ 12hrs or less BUD

A

12hrs room temp
12hrs fridge
N/A for frozen

60
Q

Medium Risk BUD

A

30hrs room temp
9 days fridge
45 days freezer

61
Q

High Risk BUD

A

24hrs room temp
3 days fridge
45 days freezer

62
Q

Immediate use BUD

A

1hr roomt temp

Fridge + Freezer = N/a

63
Q

MA examples of Complex 795 compounding

A

transdermal dosage forms
modified release preps
some inserts and suppositories for systemic efforts

64
Q

Ma examples of Moderate 795 compounding

A

morphine sulfate supp
Benadryl troches
mixing 2 creams when stability of mixture unknown

65
Q

795 BUD Non-aqueous formulation

A

6 months or earliest expiration of any of the API or componenets

66
Q

795 BUD water-containing oral formulations

A

14 days fridge

67
Q

796 BUD water containing topical/dermal and mucosal liquid and semi-solid formulations

A

30 days

68
Q

USP 800 activities requiring PPE

A 
receipt
storage
transport
compounding
admin
Deactivation, decontamination, cleaning, disinfecting
spill control

JP Exam 2 (5 decks)

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