Section 1330.640  Pharmaceutical Compounding Standards

The minimum standards and technical equipment considered adequate for compounding drugs shall include:

a)         A storage area separate for materials used in compounding.

b)         Scales and balances for the compounding done in the pharmacy.

c)         An area of the pharmacy used for compounding activities.

d)         A heating apparatus.

e)         A logbook or record keeping system to track each compounded prescription and the components used.

f)         A book or reference containing formulas with directions for compounding.  The books and references may be in electronic format and/or available via the Internet.

g)         The pharmacy operations manual shall contain the policies and procedures pertinent to the level of complexity and the size of the compounding operations of the practice at that specific pharmacy.  Electronic versions are acceptable.

h)         Consumable materials, as appropriate to the pharmacy services provided at that specific pharmacy, such as filter paper, powder papers, empty capsules, ointment jars, bottles, vials, safety closures, powder boxes, labels and distilled water.

i)          The pharmacy may compound drug products to be used by practitioners in their office for administration to patients. 

j)          Sales of compounded drugs to other pharmacies not under common ownership, or to clinics, hospitals or manufacturers are not allowed, except for sales provided by pharmacies contracted to provide centralized prescription filling services pursuant to Section 25.5 of the Act, including compounding in anticipation of receiving a prescription or order based on routine, readily observed dispensing patterns.