3. TL:DR - Compounding Flashcards
Compounding areas shall have cleanable surfaces, including
walls, ceilings, and floors
compounding areas will be designated and are required to be in
good repair for orderly compounding of prescriptions
the area used for compounding must have
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
products prepared in anticipation of a prescription prior to receiving a valid prescription shall be prepared in
reasonable amounts and labeled/documented with 4 specific elements
4 elements are required for compounded prescriptions prepared before a valid prescription
- preparation date
- BUD
- storage under conditions dictated by composition and stability, including storage in a clean, dry place or refrigerator
- bath/lot number
all pharmacies that engage in the compounding of drugs shall comply with all applicable regulations of the
US Pharmacopeia-National Formulary (USP-NF)
What is the definition of an outsourcing facility?
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
503B outsourcing facilities must obtain what from the ALBOP?
annual permit
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
biennally; expires Dec 31st of even numbered years
A pharmacy may prepare a compounded drug product for a prescriber’s office use; what is required?
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.
503B pertains to ____; they must have a(n) ____ permit from ALBOP
outsourcing compounding facilities; must have an annual permit
Which act prohibits pharmacists from compounding “essentially copies” of commercially available drug products
FDA modernization Act
Can pharmacists compound drugs for animals?
yes, upon an order or prescription
Can a pharmacy prepare compounded nonsterile drug products to be sold OTC without a prescription?
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.
What must be labeled on a product sold OTC compounded by a pharmacist
- name
- directions
- list of active ingredients
- any necessary warnings