Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, June 23, 2016
Question of the Day July 23, 2016 61 Members of the House of Representatives signed a letter sent to the FDA urging FDA to Allow for Office-Use Drug Compounding in Pharmacies and claiming to know the intent of the full Congress and appearing to step in to the arena of judicial interpretation of legislation. If this was really the intent of the prior Congress who passed the DQSA why didn't every member who passed the legislation sign a letter to the FDA? Are the members of Congress who signed the letter violating separations of powers' principles? Why or why not?
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The parameters of lawful compounding originally defined and recodified under 503A have never reached beyond the tailoring medications to the individual patient. Exemptions to the FFDCA do not include tailoring to the individual doctor, or health clinic, or hospital--these entities are not trained, licensed or otherwise authorized to make judgements that the benefits of an unapproved therapy will outweigh its risks at a population level, for each and every patient that may be compelled to receive the non-FDA approved, compounded drug. Even if the responsible parties have been trained in population medicine and regulatory science, their representatives, who are often the persons engaged in compounded-drug sourcing transactions, may not be. Confounding these transactions further, potential risks necessary to inform an overall benefit-risk assessment for a standardized, compounded product may not be known with any degree of certainty in advance. Known risks, and the scope of uncertainty regarding other potential risks, are not disclosed as a material facts by pharmacies or formula and chemical suppliers to pharmacies.
Benefit-risk determinations for compounded drugs intended for populations have occurred during public health emergencies with FDA oversight, coordination and other expert input, for example, during pandemic flu for a pediatric dosage form experiencing shortages.
CQA Section 503B provides compounding exemptions to the FFDCA but adds certain public health protections, including FDA-GMP oversight and other requirements for sterile dosage forms intended for populations.
See IACP, the essence of compounding has always been tailoring to the individual patient, page 6: http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_02_02-TAB1.pdf
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