U.S. Pharmacist eNewsletter
July 2022

The Importance of Compounding in Pediatric Hypertension
The American Academy of Pediatrics has updated its guidelines for diagnosing, screening, and treating pediatric hypertension. Blood pressure ranges have been updated, and different hypertensive stages in pediatrics and adolescents have been described. Although dosage forms may serve as a barrier of care, compounding pediatric hypertension medication may provide more therapy alternatives for these individuals. Read more.


Addition of Bulk Drug Substances to 503B Bulk List
The FDA added four bulk drug substances into the 503B Bulk List under the Federal Drug, Food and Cosmetic Act. With the intention to allow optimal treatment access for all patients, the FDA enforced an interim policy for compounding drugs using the bulk substances. Three categories of bulk drug substances were described for use in compounding. Read more.

MOU Addresses Certain Distribution of Compounding Medications
The FDA suspended the earlier Memorandum of Understanding (MOU) covering specific distribution of compounded pharmaceuticals in February 2022. With the suspension, the 5% limit on interstate distribution of compounded prescriptions is not in effect. The suspension is intended to allow for adequate notice-and-comment rules on the distribution of certain compounds, and these measures are intended to support the public health system. Read more.

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