Just days after the Drug Quality and Security Act (DQSA)1 was signed into law on November 27, 2013, the Food and Drug Administration (FDA) issued a Draft Guidance2 outlining the agency’s compliance policies related to pharmacy compounding. This article describes the Draft Guidance’s effect on traditional pharmacy compounding.
The Draft Guidance mirrors provisions in the law and clearly identifies the now rather narrowed boundaries of traditional drug compounding. Comments on the Draft Guidance may be submitted until the end of January 2014.
Under the statute and the Draft Guidance, FDA retains authority over adulterated or misbranded compounded drugs and over any false or misleading advertising of compounded drugs that violates federal law. However, state boards of pharmacy will provide the day-to-day oversight of pharmacies that compound drugs, as long as the drugs are compounded within the context of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA).3 Drug products compounded by a licensed pharmacist or licensed physician in accordance with section 503A will be exempt from current drug good manufacturing practices, from adequate directions for use labeling, and from the New Drug Approval (NDA) or Abbreviated New Drug Approval (ANDA) requirements.
To qualify as “traditional compounding,” the compounded drug product MUST BE:
- Compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility;
- For an identified individual patient with a valid prescription order made by a licensed physician or other licensed practitioner authorized by State law to prescribe; or
- In limited quantities before the receipt of a valid prescription when the licensed pharmacist or licensed physician has historically received valid prescription orders for compounding the human drug product within an established relationship between the licensed pharmacist or physician and either the patient with the prescription or the prescriber.
The compounded drug product MUST NOT BE:
- Identified by FDA regulation as a drug that presents difficulties for compounding that results in an adverse effect on the drug’s safety and effectiveness.
- A copy of a commercially available drug product (unless changed to accommodate the special needs of an identified patient).
- Advertised or promoted as a particular drug, class or type of drug by the physician or pharmacist.
- On the list, published at 21 C.F.R. § 216.24, that includes drug products that have been withdrawn or removed from the market because they have been found to be unsafe
Out of State Shipping and Dispensing
The drug product must be compounded in a State that has entered into a Memorandum of Understanding (MOU) with FDA to provide for State investigation of complaints related to shipment of “inordinate” amounts of compounded drugs outside the State or if no such MOU exists, shipments outside of the State of compounded drugs must comprise no more than 5% of the total prescription orders dispensed or distributed by the pharmacy or physician.
Compounded Drug Materials
Further, a compounded drug must be made in accordance with the United States Pharmacopoeia (USP) using bulk drug substances that:
- comply with the standards of an applicable existing USP or National Formulary (NF) monograph and be accompanied by valid certificates of analysis for each bulk drug substance;
- be a component of an FDA-approved human drug product; or
- be on an FDA-developed list (in the making) of bulk drug substances for use in compounding made in a registered drug facility.
If the drug product is compounded using ingredients (other than bulk drug substances), it must comply with the standards of an applicable USP or NF monograph, if one exists, and the USP chapters on pharmacy compounding.
Finally, the licensed pharmacist or physician compounding the drug must not compound regularly or in inordinate amounts any drug products that are essentially copies of commercially available drug products.