Chapter 8: MPJE (Compounding Laws)
| Text | In addition to normal labeling requirements, a compounded prescription label must include: {{c1::-The names of the principal active ingredients of the compounded preparation- A statement that the preparation has been compounded by the pharmacy- A beyond-use date after which the compounded preparation should not be used }} |
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| Text | Nonsterile Compounding • Applies to {{c1::Class A (Community), Class C (Institutional), and Class E (Nonresident)}} pharmacies. • Covers compounding nonsterile preparations based on prescriptions or medication orders for patients.Distribution • Allows these pharmacies (Class A, C, E) to compound, dispense, and deliver a reasonable quantity of nonsterile compounded meds to a {{c2::practitioner’s office for office use.}}-A {{c3::written agreement is required with the practitioner/pharmacy. }}-Must be labeled “{{c3::For Institutional or Office Use Only}}”. • Allows a Class A pharmacy to compound and distribute nonsterile preparations to a {{c2::Class C pharmacy}}. • Allows Class C pharmacies {{c2::under common ownership}} to compound and distribute nonsterile preparations to other Class C pharmacies. |
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| Text | BUD for STERILE Compounding 797 Category 1 CSPs BUD (compounded in a segregated compounding area [SCA]): {{c1::12}} hours at room temperature {{c1::24}} hours in the fridge Category 2 CSPs BUD: {{c2::4}} Days at room temperature {{c2::10}} Days in the fridge -Maximum BUD (if undergone terminal sterilization): {{c2::60 days}} {{c2::45}} Days in the freezer Category 3 CSP BUD (prepared in a standard cleanroom with additional requirements met): -{{c3::90}} days at room temperature -{{c3::120}} fridge -{{c3::180}} freezer Note: These are the default BUDs if no sterility testing is done. If a compounder does sterility testing, longer BUDs may be justified. |
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