3. TL:DR - Compounding Flashcards

1
Q

Compounding areas shall have cleanable surfaces, including

A

walls, ceilings, and floors

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2
Q

compounding areas will be designated and are required to be in

A

good repair for orderly compounding of prescriptions

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3
Q

the area used for compounding must have

A

ventilation and adequate lighting, as well as potable water supplied under continuous positive pressure in a plumbing system free of defects that could contribute to contamination to any compounded drug product

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4
Q

products prepared in anticipation of a prescription prior to receiving a valid prescription shall be prepared in

A

reasonable amounts and labeled/documented with 4 specific elements

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5
Q

4 elements are required for compounded prescriptions prepared before a valid prescription

A
  1. preparation date
  2. BUD
  3. storage under conditions dictated by composition and stability, including storage in a clean, dry place or refrigerator
  4. bath/lot number
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6
Q

all pharmacies that engage in the compounding of drugs shall comply with all applicable regulations of the

A

US Pharmacopeia-National Formulary (USP-NF)

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7
Q

What is the definition of an outsourcing facility?

A

a facility at 1 geographic location engaged in compounding of sterile drugs; has elected to register as an outsourcing facility; complies with all the requirements of 503B of the DQSA

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8
Q

503B outsourcing facilities must obtain what from the ALBOP?

A

annual permit

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9
Q

All pharmacies engaged in the compounding of sterile products shall be registered with ALBOP ____, which expires ___, and shall receive a permit as a parenteral sterile compounding pharmacy

A

biennally; expires Dec 31st of even numbered years

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10
Q

A pharmacy may prepare a compounded drug product for a prescriber’s office use; what is required?

A

an order by a prescriber indicating the formula and quantity ordered shall be filed in the pharmacy; the product shall be administered in the office and not dispensed to the patient.

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11
Q

503B pertains to ____; they must have a(n) ____ permit from ALBOP

A

outsourcing compounding facilities; must have an annual permit

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12
Q

Which act prohibits pharmacists from compounding “essentially copies” of commercially available drug products

A

FDA modernization Act

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13
Q

Can pharmacists compound drugs for animals?

A

yes, upon an order or prescription

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14
Q

Can a pharmacy prepare compounded nonsterile drug products to be sold OTC without a prescription?

A

yes, so long as the product shall not contain an ingredient which exceeds recommended strengths and doses for OTC drugs and cannot be for something a prescription is required.

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15
Q

What must be labeled on a product sold OTC compounded by a pharmacist

A
  1. name
  2. directions
  3. list of active ingredients
  4. any necessary warnings
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16
Q

Can pharmacists produce an OTC product to be sold in bulk to other pharmacies or vendors for resale?

A

no