Drug Quality and Security Act

what caused the DQSA

new england compounding center meningitis outbreak

compounding vs manufacturing

compounding must have triad (pharmacist, physician, patient) manufacturing is done without a specific patient in mine

agencies that regulate compounding vs manufacturing

USP, cGMP, state/federal regulations, guidance documents

agencies that enforce pharmacy compounding

FDA, state board of pharmacy, accreditation organizations, funding sources

normal FDA drug approval process

undergo premarket approval demonstrating safety and efficacy, be labeled to ensure safe use for intended purposes, be manufactured according to the cGMP

approval exemptions granted under DQSA 503A (traditional pharmacy compounding)

exempt from premarket approvals, exempt from labeling requirements, be compounded according to state/federal law and standards of practice

approval exemptions granted under DQSA 503B (outsourcing facilities)

exempt from premarket, approvals, exempt from labeling requirements, be compounded according to cGMP but exempt from DQSA Title II

3 parts to DQSA

503A, 503B, Title II

who does DQSA 503A apply to

all pharmacies engaged in both sterile and nonsterile compounding (not mixing)

requirements to get exemptions under DQSA 503A

requires individual RX, professional triad relationship, compounding is performed by a licensed practitioner, compounder follows USP 797 and 795

what quantity can 503A pharmacies not exceed

30 day supply

what can a 503A pharmacy not compound

a commercially available product (an essential copy) unless in short supply or clinical patient need, a demonstrably difficult product (ex. insulin pen)

503A pharmacies cannot exceed how much out of state distribution

5% of RX dispensed unless the state has entered into a MOU with FDA

activities temporarily allows during a pandemic under DQSA

compounding of hand sanitizers, repackaging/combining propofol, compounding of other drugs needed for COVID patients (very specific drugs with very specific BUD)

who does DQSA 503B apply to

sterile compounding outsourcing facilities, does not have to be a pharmacy but must have a direct supervising pharmacust

what is allowed under DQSA 503B

office use (no prescription needed) but cannot sell products wholesale, no limit on interstate distribution, can compound copies if in shortage, can compound “demonstrably difficult” products, must have specific labeling indicating it is a compounded product

DQSA 503A regulator

state boards of pharmacy

DQSA 503B regulator

FDA

503B registration

voluntary and requires payment of fees