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FIXED: Guidance on Essentially a Copy for 503B Outsourcing Facilities
Guidance on Essentially a Copy for 503B Outsourcing Facilities
Learning Objectives
1. Describe the decision tree to evaluate if a compounded preparation is essentially a copy.
2. Identify, when given a preparation, if the drug shortage exclusion applies.
3. Recognize, when given a preparation, if the Clinical Need exclusion applies.
CE accredited for Pharmacists and Technicians. To get credits for this talk go https://compoundingce.com/courses/pharmasalon-guidance-on-essentially-a-copy-for-503b-outsourcing-facilities-evaluation/
To watch the accompanying slides go to: https://youtu.be/XYK4OtB3MAs
Self-Assessment Questions
1. Your facility compounds a succinylcholine 20 mg/ml syringe both from API powder and sterile sourced vials. Succinylcholine is not on the FDA drug shortage list.
a. The syringes made from either source are essentially a copy of the commercial product.
b. The syringes made from both sources are essentially a copy of the commercial product.
c. The syringes made from API powder are essentially a copy of the commercial product.
d. The syringes made from sterile sourced vials are essentially a copy of the commercial product.
2. An outsourcing facility compounds morphine 1 mg/ml syringes from API powder. These are available commercially in the same presentation. However, morphine is currently on the drug shortage list and the syringes are on backorder.
a. The syringes are not essentially a copy of the commercial product at this time.
b. The syringes are always essentially a copy of the commercial product regardless of the drug shortage list.
c. The syringes are not essentially a copy as long as there is a clinical need for Morphine.
d. Morphine is a controlled substance and therefore must not be sourced from API.
3. An outsourcing facility compounds preservative free rocuronium from API powder. Rocuronium is available in preservative free form commercially and is not on drug shortage. The facility asks you to check a box on its website stating that there is a clinical need for this product.
a. The product can be sourced commercially and hence there is no clinical need for the outsourced product.
b. The product is only available in vials, hence there is a clinical need for the product in syringes.
c. It is the responsibility of the outsourcing facility to determine clinical need, so if they state there is a clinical need, it is okay to check the box.
d. The box can only be checked by an OR physician.
#compoundingpharmacy #compoundingpharmacists #compoundingpharmacies #pharmacists #pharmacytechnicians #pharmacytechniciansCE #pharmasalon
#ACPE #pharmacyCEcredits #PharmacyCE #503b #essentialcopies
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By Vivian Juter FrankelGuidance on Essentially a Copy for 503B Outsourcing Facilities
Learning Objectives
1. Describe the decision tree to evaluate if a compounded preparation is essentially a copy.
2. Identify, when given a preparation, if the drug shortage exclusion applies.
3. Recognize, when given a preparation, if the Clinical Need exclusion applies.
CE accredited for Pharmacists and Technicians. To get credits for this talk go https://compoundingce.com/courses/pharmasalon-guidance-on-essentially-a-copy-for-503b-outsourcing-facilities-evaluation/
To watch the accompanying slides go to: https://youtu.be/XYK4OtB3MAs
Self-Assessment Questions
1. Your facility compounds a succinylcholine 20 mg/ml syringe both from API powder and sterile sourced vials. Succinylcholine is not on the FDA drug shortage list.
a. The syringes made from either source are essentially a copy of the commercial product.
b. The syringes made from both sources are essentially a copy of the commercial product.
c. The syringes made from API powder are essentially a copy of the commercial product.
d. The syringes made from sterile sourced vials are essentially a copy of the commercial product.
2. An outsourcing facility compounds morphine 1 mg/ml syringes from API powder. These are available commercially in the same presentation. However, morphine is currently on the drug shortage list and the syringes are on backorder.
a. The syringes are not essentially a copy of the commercial product at this time.
b. The syringes are always essentially a copy of the commercial product regardless of the drug shortage list.
c. The syringes are not essentially a copy as long as there is a clinical need for Morphine.
d. Morphine is a controlled substance and therefore must not be sourced from API.
3. An outsourcing facility compounds preservative free rocuronium from API powder. Rocuronium is available in preservative free form commercially and is not on drug shortage. The facility asks you to check a box on its website stating that there is a clinical need for this product.
a. The product can be sourced commercially and hence there is no clinical need for the outsourced product.
b. The product is only available in vials, hence there is a clinical need for the product in syringes.
c. It is the responsibility of the outsourcing facility to determine clinical need, so if they state there is a clinical need, it is okay to check the box.
d. The box can only be checked by an OR physician.
#compoundingpharmacy #compoundingpharmacists #compoundingpharmacies #pharmacists #pharmacytechnicians #pharmacytechniciansCE #pharmasalon
#ACPE #pharmacyCEcredits #PharmacyCE #503b #essentialcopies