3. TL:DR - Compounding

Question 1

Compounding areas shall have cleanable surfaces, including

Answer 1

walls, ceilings, and floors

Question 2

compounding areas will be designated and are required to be in

Answer 2

good repair for orderly compounding of prescriptions

Question 3

the area used for compounding must have

Answer 3

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

Question 4

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

Answer 4

reasonable amounts and labeled/documented with 4 specific elements

Question 5

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

Answer 5

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

Question 6

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

Answer 6

US Pharmacopeia-National Formulary (USP-NF)

Question 7

What is the definition of an outsourcing facility?

Answer 7

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

Question 8

503B outsourcing facilities must obtain what from the ALBOP?

Answer 8

annual permit

Question 9

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

Answer 9

biennally; expires Dec 31st of even numbered years

Question 10

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

Answer 10

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.

Question 11

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

Answer 11

outsourcing compounding facilities; must have an annual permit

Question 12

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

Answer 12

FDA modernization Act

Question 13

Can pharmacists compound drugs for animals?

Answer 13

yes, upon an order or prescription

Question 14

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

Answer 14

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.

Question 15

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

Answer 15

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

Question 16

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

Answer 16

no