Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 15 - Pharmacy › Part 1 - Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors › Section 216-RICR-40-15-1.7 - Compounding of Pharmaceuticals

Current through June 14, 2024
A. General
				  Requirements: Non-sterile and Sterile Compounding
1. A pharmacist/patient/prescriber
				  relationship shall exist in order for a pharmacist to prepare compounds that
				  are not commercially available, except as applied to Outsourcing
				  Facilities.
2. Pharmacists,
				  interns, or Technician IIs engaged in compounding shall operate in conformity
				  with all applicable State and Federal laws and Regulations regulating the
				  practice of pharmacy.
3. The
				  requirements in §
											1.7   of this Part shall not
				  apply to the preparation of medications by licensed healthcare professionals in
				  emergency situations for immediate administration to patients.
4. A practitioner's prescription shall be
				  required for the compounding of all pharmaceuticals except as applied to
				  Outsourcing Facilities.
5. Retail
				  pharmacies shall only prepare compounded preparations in limited quantities
				  (i.e., stock preparation, batch processing) prior to receiving a valid
				  prescription based on a history of receiving valid prescriptions that have been
				  generated solely within an established pharmacist/patient/practitioner
				  relationship, provided that the prescriptions are maintained on file for all
				  such products prepared at the pharmacy.
a.
				  Hospital and institutional pharmacies shall only prepare compounded
				  preparations in limited quantities (i.e., batch compounding) in anticipation of
				  receiving a valid practitioner order/prescription or as part of an established
				  hospital or institutionally approved protocol/procedure. Such anticipated
				  compounding shall be based upon a history of receiving valid practitioner
				  orders/prescriptions/protocol/procedure that have been generated solely within
				  an established pharmacist/patient/practitioner relationship provided that the
				  practitioner order/prescription/protocol/procedure is maintained on file in the
				  pharmacy or in the patient's medical record for all such products prepared at
				  the pharmacy.
6. All
				  compounded products shall be labeled with the following information:
a. Complete list of active ingredients
				  (components) (Abbreviations may be included);
b. The assigned beyond-use date.
7. All compounded products shall
				  be stored under conditions dictated by composition and stability
				  characteristics (e.g., in a clean, dry place, on a shelf, or in the
				  refrigerator) to ensure strength, quality, and purity.
8. Pharmacists shall not offer
				  pharmaceutically prepared compounded preparations to other State-licensed
				  persons or commercial entities for subsequent resale, except as applied to
				  Outsourcing Facilities.
9.
				  Compounding personnel shall be responsible for ensuring that compounded
				  preparations are accurately identified, measured, diluted, and mixed; are
				  correctly packaged, sealed, labeled, stored, dispensed, and distributed.
				  Ingredients shall be of the correct identity, quality, and purity. Appropriate
				  cleanliness shall be maintained. Proper labeling and supplementary instructions
				  for the clinical administration of CSPs shall be provided by a pharmacist.
				  Beyond-use dates shall be determined based upon current USP standards and
				  documented testing or literature and professional judgment.
10. Bulk and active ingredients used in the
				  preparation of compounded sterile products (CSPs), and non-sterile compounded
				  products shall be USP or National Formulary (NF) certified or shall be
				  accompanied by a certificate of analysis for inspection by the Department upon
				  request.