Drug Compounding: FDA Issues Final Guidance on Section 503A’s Individually Identified Prescription Requirement – With At Least Three Noteworthy Changes

As the door was closing on 2016, FDA squeezed through three guidance documents on drug compounding: (1) Final guidance on Section 503A prescription requirement here; (2) Final guidance on electronic drug product reporting for outsourcing facilities here, and (3) Draft guidance on compounding of radiopharmaceuticals here. This blog post focuses on FDA’s final guidance addressing the prescription requirement under Section 503A (guidance document available here; see our coverage of the draft guidance here).

As a reminder, Section 503A of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) describes the conditions under which drug products compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician, are exempt from certain requirements of the FD&C Act (i.e., new drug, adequate directions for use, and FDA’s current good manufacturing practices (“cGMP”)). A condition to qualify for Section503A’s exemptions is that the drug product must be compounded for an identified individual patient based on the receipt of a valid prescription order or a notation for the patient or in limited quantities before receipt of a valid prescription order for an identified individual patient.  The final guidance issued on December 30, 2016 addresses the prescription requirement in Section 503A, including FDA’s policies regarding compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of such a prescription (referred to as “anticipatory compounding”), and compounding for office use (referred to as “office stock”).  The final guidance contains at least three noteworthy changes from FDA’s earlier draft:

1.    Documentation of the “Valid Prescription Order” Requirement for Purposes of Section 503A

In the draft guidance, FDA proposed that, to be a valid prescription order for a compounded drug product, the prescription order needed to state clearly that it is for a compounded drug and necessary for the treatment of the identified individual patient.  If the prescription did not contain this information, then the draft guidance recommended that the pharmacist consult with the prescriber to determine whether the patient needs a compounded drug, and that the compounder must make the appropriate notation on the prescription order or other appropriate documentation that the compounded preparation is necessary (including suggested language for the notification).  The final guidance no longer states that pharmacists should contact a prescriber for clarification concerning the individual patient who will receive the drug, and that the compounder document the same.

To the extent compounders believe FDA has softened its position concerning the necessity of documentation in the final guidance, however, please note the final guidance states that FDA intends to describe its policies regarding the documentation requirement in a future policy document (Guidance at 8 n.10).

The final guidance maintains the complementary requirement that, for a notation in a health record (i.e., patient chart) in an office or hospital setting to serve as the basis for compounding under Section 503A, this type of information should be recorded in the patient chart.

Importantly, the guidance recognizes (using an ophthalmologist as an example) that some drugs – for safety or emergency reasons – require immediate administration in a physician’s office. For example, if a patient presents with a fungal eye infection, “timely administration of a compounded antifungal medication may be critical to preventing vision loss.  In such a case, the ophthalmologist may need to inject the patient with a compounded drug product immediately, rather than writing a prescription and waiting for the drug product to be compounded and shipped to the prescriber.”  (Guidance at 3; 3 n.3).  Although FDA recognizes the importance of the availability of compounded medications for office use in exigent situations and as a matter of patient safety, FDA’s policy remains (at page 10-11) that these medications are only available from outsourcing facilities.  Otherwise, for compounding pursuant Section 503A, FDA requires a prescription for an individually identified patient.

2.    Clarification of “Interim” Compliance Policy for the “Limited Quantity” Condition

The final guidance clarifies that FDA’s draft guidance for considering whether a compounder has exceeded the “limited quantity” (i.e., 30-day supply) condition for anticipatory compounding in Section 503A(a)(2) is an interim policy.

Furthermore, FDA’s interim policy now explicitly contemplates that a drug compounded before receipt of a valid prescription might be distributed to any identified individual patient for the particular compounded drug.   The limited quantities policy also may not alter the beyond use dating on the product.  (Guidance at 9 n. 13).

Finally, the final guidance includes an illustrative example of anticipatory compounding that is consistent with the interim compliance policy, where compounders are allowed to adjust the number of units of a compounded product produced based on real-time changes in the historically highest number of valid patient-specific prescriptions (e.g., for the most recent 30-day period, even if not a calendar month).  FDA provides as an example that a compounder may consider a rolling 30-day period in a given year to determine the quantity it may compound in advance of receiving prescriptions. (Guidance at 9-10, 9 n. 16).

3.    Removing Recordkeeping Requirements to Demonstrate Compliance

To the (at least temporary) relief of prescribers and pharmacies, FDA’s final guidance dispenses with the draft’s section addressing onerous recordkeeping, including additional tracking and maintaining the documentation of compounding necessity, clarification of prescriptions, and quantities dispensed. The draft’s terms required pharmacists and physicians seeking to compound drugs under section 503A to maintain records to demonstrate compliance with the prescription requirement (e.g., valid prescription orders) and to document the basis for any anticipatory compounding (e.g., calculations performed to determine the limited quantities of drug products compounded before receipt of a valid prescription order).