Health

FDA Renews Pharmacy Compounding Advisory Committee for Two More Years

🇺🇸United States··Notice·Low Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This notice extends the FDA’s Pharmacy Compounding Advisory Committee through April 25, 2028. The committee advises FDA on drug compounding issues under sections 503A and 503B of the Food, Drug, and Cosmetic Act, so the main impact is continued expert input for compounding pharmacies, manufacturers, physicians, and patient groups. There is no change to the committee’s duties or the underlying FDA rules.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • FDA renews the Pharmacy Compounding Advisory Committee for another two years.
  • The committee remains in place until April 25, 2028.
  • No change is made to the committee’s name, duties, or FDA regulations.

Obligations

What this law requires

low

FDA must keep the Pharmacy Compounding Advisory Committee charter in effect through April 25, 2028, by renewing the committee for an additional two years beyond the prior expiration date.

Food and Drug Administration
April 25, 2028
operational
low

FDA must renew the Pharmacy Compounding Advisory Committee’s charter so the committee remains in effect until April 25, 2028.

Food and Drug Administration
April 25, 2028
operational
low

FDA must keep the Pharmacy Compounding Advisory Committee renewed and in effect through April 25, 2028.

Food and Drug Administration
through April 25, 2028
operational
low

The Commissioner or designee must continue to maintain a Pharmacy Compounding Advisory Committee with at least 10 voting members, including a Chair, selected from qualified experts in pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties.

Food and Drug Administration Commissioner or designee
operational
low

The Commissioner or designee must appoint and maintain a Committee with at least 10 voting members, including a Chair, selected from individuals knowledgeable in pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties.

Food and Drug Administration Commissioner or designee
ongoing during charter term
operational

Affected Parties

compounding pharmaciespharmaceutical manufacturers+1 more…

Tags

FDA,advisory committee,pharmacy compounding