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Diving into DQSA: Getting in Deep – RX Repackaging

Diving into DQSA: Getting in Deep – RX Repackaging

Diving into DQSA: Getting in Deep – RX Repackaging

David G. Miller, R.Ph.
David G. Miller, R.Ph.
on behalf of Texas Pharmacy Association

$70.00 $ 70.00 $ 70.00

$70.00 $ 70.00 $ 70.00

$ 70.00 $ 70.00 $ 70.00
$ 70.00 $ 70.00 $ 70.00
Normal Price: $70.00 $70.00

Review:

Launch date: 13 Mar 2017
Expiry Date:

Last updated: 15 Mar 2017

Reference: 172136

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This course is only available to trainees days after purchase. It would need to be repurchased by the trainee if not completed in the allotted time period. This course is no longer available. You will need to repurchase if you wish to take the course again.

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Description

One major change to §503A was the removal of the word “repackaging” from the definition of compounding! That enabled the FDA to align this very traditional role for compounders with their control over federally registered repackagers and relabelers. Do you know whether what you’re doing is repackaging? Compliant with federal and state law? Whether you need an additional permit or registration? Get the answers!

Objectives

Objectives
At the completion of this activity, the pharmacists and technicians will be able to:
1.List the six types of lists specified in 503A and 503B of DQSA.
2.Explain why repackaging of manufactured products is not covered under sections 503A and 503B of DQSA.
3.Contrast the labeling requirements and record keeping requirements for repackaged products by 503A compounders and 503B outsourcing facilities.
4.Describe the record keeping requirements under federal oversight for repackaged sterile and non-sterile products.
5.Identify three resources for remaining up to date on changes to repackaged requirements.
David G. Miller, R.Ph.

Author Information Play Video Bio

David G. Miller, R.Ph.
on behalf of Texas Pharmacy Association

David G. Miller, R.Ph. David G. Miller, R.Ph. is the former Executive Vice President and Chief Executive Officer of the International Academy of Compounding Pharmacists. IACP represents more than 4,000 practitioners and 163,000 consumers who recognize the value of customized medication solutions provided by the art and science of pharmacy compounding. After receiving his bachelor of science in pharmacy degree from the University of Maryland School of Pharmacy in 1985, he joined the staff of the National.David G. Miller, R.Ph. is the former Executive Vice President and Chief Executive Officer of the International Academy of Compounding Pharmacists. IACP represents more than 4,000 practitioners and 163,000 consumers who recognize the value of customized medication solutions provided by the art and science of pharmacy compounding. After receiving his bachelor of science in pharmacy degree from the University of Maryland School of Pharmacy in 1985, he joined the staff of the National Community Pharmacists Association (formerly NARD) as Director of Professional Affairs. In 1988, he accepted a position as Director of Professional Affairs for the Maryland Pharmacists Association and was promoted to serve as that organization’s Executive Director three years later. Miller left the pharmacy association world in 1996 to become the Director of Pharmacy Affairs at Merck where he was responsible for corporate relations with the profession at the national and state level as well as with the academic community.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • Accreditation Council for Pharmacy Education (ACPE)
  • 1.00 Hours -
    Exam Pass Rate: 75
    -
    Reference: 0201-9999-15-108-H04-P/0201-9999-15-108-H04-T

Faculty and Disclosures

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