IMPORTANT: READ ITEM 4 BELOW!!!!

PARTIAL OUTLINE OF THE GUIDANCE

1. What is Essentially a Copy
   1. Same Active Pharmaceutical Ingredient (API)
   2. Same, Similar or Easily Substitutable Strength
   3. Same Route of Administration
   4. Same Characteristics as Two or More Commercially Available Drug Products
2. Statement of Significant Difference
3. Documentation of Shortage
4. Regularly or in Inordinate Amounts
5. Recordkeeping

***

2. Statement of Significant Difference

The FDA does not require a particular format to document the determination, provided that the prescription makes clear that the prescriber identified the relevant change and the significant difference that the change will produce for the patient. The following are provided as examples:

• No Dye X, patient allergy
• Liquid form, patient can't swallow tablet
• 6 mg, patient needs higher dose

"Lower price" is not sufficient to establish that the drug product is not essentially a copy of the commercially available drug product.

If the prescription does not have a notation on it from the prescriber, the pharmacist can contact the prescriber and, if the prescriber confirms it, make a notation on the prescription that the compounded drug product contains a change that makes a significant difference for the patient.

3. Documentation of Shortage

If the approved drug product is not commercially available and is on the FDA drug shortage list, the prescriber or compounder should include a notationon the prescription that it was on the drug shortage list and the date the list was checked.

4. Regularly or in Inordinate Amounts

Consider the phrase: "regularly or in inordinate amounts (as defined by the Secretary)" any drug products that are that are essentially copies of a commercially available drug product.
The FDA interprets this to mean that a drug product that is essentially a copy of a commercially available drug product cannot be compounded regularly (i.e., it cannot be compounded at regular times or intervals, usually, or very often). This interpretation does NOT mean that one cannot compound copies of commercial products occasionally when a need arises�but it just cannot be done "regularly or in inordinate amounts."

The FDA further concludes that a drug product is compounded regularly or in inordinate amounts if it is compounded more frequently than needed to address unanticipated, emergency circumstances, or in more than the small quantities needed to address unanticipated, emergency circumstances.

The following are examples of factors (but it is not exhaustive) the FDA may use as the basis for concluding that a drug has been compounded regularly or in inordinate amounts:

• The compounded product amounts to more than a small number of prescriptions or a small percentage of the compounded drug products that a compounder prepares.
• The compounder routinely substitutes compounded drugs that are essentially copies of commercially available drugs upon receiving prescriptions for patients.
• The compounder offers pre-printed prescription pads that a prescriber can use to write a prescription for the drug product that is essentially a copy without making a determination that there is a change that will produce a significant difference for a patient.
• The compounded drug product is not compounded on an as-needed basis, but on a routine or pre-set schedule.

The FDA does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions for the relevant compounded drug product in a calendar month. (The FDA considers each refill of a prescription as an additional prescription.)

EDITOR'S NOTE: It appears that according to the Guidance, the FDA is okay if four or fewer prescriptions for each specific compounded preparation (that is commercially available) are prepared in a calendar month (including refills).

5. Recordkeeping

Records should be maintained to demonstrate compliance with section 503A. This includes notations on records for identified individual patients that a prescriber has determined that the compounded drug has a change that produces a significant difference for the patient.

Compounders should maintain records of the frequency in which they have compounded drug products that are essentially copies of commercially available drug products and the number of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products to document that such compounding has not been done regularly or in inordinate amounts.

Next week, a flowchart from the FDA Guidance! Please obtain a complete copy of this Guidance at the URL below and check all of this out.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM510154.pdf

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

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