General Rules in Lousiana Regarding Compounding Practices

§2535.  General Standards 
A. Compounding Practices.  Compounded medications may be prepared using prescription medications,
over-the-counter medications, chemicals, compounds, or other components.
1. A pharmacy shall have written procedures as necessary for the compounding of drug products
to assure that the finished products have the identity, strength, quality, and purity they are
represented to possess.
2. All compounding shall be accomplished utilizing accepted pharmacy techniques, practices,
and equipment.
3. Products or duplicates of products removed from the market for the purposes of safety shall
not be used to compound prescriptions for human use.
B.   Beyond Use Date.  Compounded medications shall be labeled with a beyond use date of no more than one hundred eighty (180) days, unless documentation on file supports a longer beyond use date.
January 2012 Page 188C. Records and Reports.  Any procedures or other records required to comply with this section shall be maintained for a minimum of two years.
D. Compounding for Prescriber’s Use.  Pharmacists may prepare practitioner administered compounds for a prescriber’s use with the following requirements:
1. an order by the prescriber indicating the formula and quantity ordered to be compounded by
the pharmacist;
2. the product is to be administered by the prescriber and not dispensed to the patient; and
3. the pharmacist shall generate a label and sequential identification number for the compounded
drug.
E. Anticipated Use Products.  The pharmacist shall label any excess compounded product so as to
reference it to the formula used and the assigned lot number and estimated beyond use date based on
the pharmacist’s professional judgment and/or other appropriate testing or published data.
F. Labeling of Compounded Products.
1. For patient-specific compounded products, the labeling requirements of R.S. 37:1225, or its
successor, as well as this Chapter, shall apply.
2. All practitioner administered compounds shall be packaged in a suitable container with a label
containing, at a minimum, the following information:
a. pharmacy’s name, address, and telephone number;
b. practitioner’s name;
c. name of preparation;
d. strength and concentration;
e. lot number;
f. beyond use date;
g. special storage requirements, if applicable;
h. assigned identification number; and
i. pharmacist’s name or initials.
AUTHORITY NOTE:  Promulgated in accordance with R.S. 37:1182.
HISTORICAL NOTE:  Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708
(October 1988), effective January 1, 1989, amended LR 23:1316 (October 1997), amended LR 29:2105 (October 2003), effective January 1, 2004.

 

There are also additonal rules regarding compounding in Lousiana. Rules are found here.