This collaboration will allow for research into the development and administration of medicines to children, including the prevalence of extemporaneous compounding
of drug products for ease of administration to pediatric patients, and any safety and efficacy consequences.
The second is 'Starting Material For Extemporaneous Compounding
Only' whose supply in its original packaging is not allowed but which is intended to be compounded by a practitioner.
This, say Baxa, allows pharmacies to track oral dose prep, extemporaneous compounding
, telepharmacy and manual additions as well as IV dose prep.
Coverage extends to guidelines for the extemporaneous compounding
of ophthalmic solutions and information on systemic drugs affecting the eye and systemic medications used for ocular conditions.
Although the agency has attempted to alleviate the concerns of pharmacists (by stating that in its discretion it won't preclude extemporaneous compounding
of reasonable quantities of drugs by pharmacists), the coalition calls such assurances ambiguous.
The addition of the USP 797 Clean Room to Celerion's Phase I core capabilities, enables sterile extemporaneous compounding
in-house for microtracer studies.
The warning letter states that Pulmo-Dose's compounding of formulations of budesonide, albuterol/ipratropium, and formoterol/budesonide exceeds the scope of the practice of pharmacy and that Pulmo-Dose is operating as a pharmaceutical manufacturer and not a pharmacy engaged in extemporaneous compounding