Examples of moderate non-sterile compounding (non-inclusive): mixing two or more commercially manufactured creams, ointments, or liquids when the stability of mixture is unknown (i.e. Magic or Miracle Mouthwash) topical preparations intended for local effects omeprazole suspension when mixed from capsules or active pharmaceutical ingredients (API) since a pH meter is required preparations requiring special calculations (e.g. salt conversions like valproic acid to sodium valproate) Complex non-sterile compounding: compounding of drug preparations which require special training, a special environment or special facilities or equipment or the use of compounding techniques and procedures that may present an elevated risk to the compounder or the patient. (MGL 112 section 39D) Examples of complex non-sterile compounding (non-inclusive): NIOSH drug containing preparations or other hazardous agents (does not include simple reconstitution of commercially available FDA approved products if prepared as directed by the manufacturer) radiopharmaceutical preparations transdermal dosage forms capsules suppositories troches lollipops sublingual dosage forms tablets tablet triturates modified-release preparations other dosage forms intended to deliver systemic effects (inserts, nasal sprays, nasal irrigations, certain gels, etc.) Non-sterile compounding regulation 247 CMR 18.00: Compounding definition MGL c. 112 section 39D: https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter112/Section39D Adopted: June 15, 2017
Examples of moderate non-sterile compounding (non-inclusive): mixing two or more commercially manufactured creams, ointments, or liquids when the stability of mixture is unknown (i.e. Magic or Miracle Mouthwash) topical preparations intended for local effects omeprazole suspension when mixed from capsules or active pharmaceutical ingredients (API) since a pH meter is required preparations requiring special calculations (e.g. salt conversions like valproic acid to sodium valproate) Complex non-sterile compounding: compounding of drug preparations which require special training, a special environment or special facilities or equipment or the use of compounding techniques and procedures that may present an elevated risk to the compounder or the patient. (MGL 112 section 39D) Examples of complex non-sterile compounding (non-inclusive): NIOSH drug containing preparations or other hazardous agents (does not include simple reconstitution of commercially available FDA approved products if prepared as directed by the manufacturer) radiopharmaceutical preparations transdermal dosage forms capsules suppositories troches lollipops sublingual dosage forms tablets tablet triturates modified-release preparations other dosage forms intended to deliver systemic effects (inserts, nasal sprays, nasal irrigations, certain gels, etc.) Non-sterile compounding regulation 247 CMR 18.00: Compounding definition MGL c. 112 section 39D: https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter112/Section39D Adopted: June 15, 2017
Advisory-Non-Sterile.docx