Over the weekend, the President signed the Drug Quality and Security Act, which deals with both Pharmacy Compounding and Track and Trace provisions for all prescription products.  The FDA was ready and issued three Draft Guidance documents covering various compounding issues.

First is the Guidance for Industry – Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food Drug and Cosmetic Act. (see here) That title is a mouthful for certain, but the draft Guidance actually provides that outsourcing facilities may register with the FDA and provide a list of all drugs compounded twice a year.  Outsourcing facilities that do register, “can qualify for exemptions from the FDA approval requirements in Section 505 of the FD&C Act (21 U.S.C. 355) and the requirement to label products with adequate directions for use in Section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) by meeting the requirements described in the rest of Section 503B.”  These facilities will be inspected by FDA and must comply with other sections of the Act, including meeting cGMPs.

The Guidance goes on to state that “Registered outsourcing facilities must report upon initial registration under Section 503B of the FD&C Act, and twice each year (once in June and once in December). FDA encourages companies wishing to compound as outsourcing facilities to register with FDA immediately. If a facility registers before June 2, 2014, FDA does not intend to immediately enforce the requirement to report product information at the time of initial registration, as long as the facility submits its report within 2 months after the date of that initial registration.”

Instructions on how to report electronically and what to report are also outlined in the Guidance document

The second document, Guidance for Industry – Registration for Human Drug Compounding Outsourcing Facilities Under Section 505B of the Federal Food, Drug, and Cosmetic Act (see here) addresses registration times, whether the facility plans to compound a drug on FDA’s drug shortage list in the following year, whether it compounds from bulk drug substance, and whether it intends on compounding sterile drug products.

The draft Guidance goes on to state that each separate location of an outsourcing facility must register, that the facility does not have to be a licensed pharmacy and may or may not obtain prescriptions from an individual patient.  The Guidance describes electronic registration methods, but also includes an interim method until electronic means are better understood by the facilities. Information collected will be posted on the internet as required by the new Act.

There are fees associated with registration of facilities “[U]nder the DQSA, an outsourcing facility is not considered registered until all registration fees owed by the facility have been paid (see Section 503B(g)(3)(A) of the FD&C Act). However, an outsourcing facility can register without paying a fee until October 1, 2014, because under the DQSA fees will not be assessed or owed until after that date.”

The third draft Guidance document is entitled, Guidance for Industry – Pharmacy Compounding of Human Drugs Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (see here) This Guidance addresses the compounding of drug products by licensed pharmacists and does not apply to outsourcing facilities. “Section 503A describes conditions that must be satisfied for drug products compounded by a licensed pharmacist or licensed physician to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (concerning current good manufacturing practice); (2) Section 502(f)(1) (concerning the labeling of drugs with adequate directions for use); and (3) Section 505 (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).”

Based on the Supreme Court decision relative to advertising and promotion of compounded drug products, the FDA revoked its previous Guidance and now revokes the 2002 Compliance Policy Guide that addressed pharmacy compounding.  This new draft Guidance sets FDA’s policy on pharmacy compounded products by exempting compounded drugs if:

  1. The drug product is compounded for an identified individual patient based on the receipt of a valid prescription order, or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient. (Section 503A(a) of the FD&C Act).
  2. The compounding of the drug product is performed:By a licensed pharmacist in a State licensed pharmacy or a Federal facility, or by a licensed physician on the prescription order for an individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or By a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patients when: – the licensed pharmacist or licensed physician has historically received valid prescription orders for the compounding of the human drug product and The orders have been generated solely within an established relationship between the licensed pharmacist or licensed physician and either the patient for whom the prescription order will be provided or the physician or other licensed practitioner who will write such prescription order (Sections 503A(a)(1) and (2) of the FD&C 102 Act).
  3. The product complies with the USP Monograph on Compounding, and if not, the guidance describes what is necessary.
  4. If bulk drug is used in the compounding, the bulk drug is manufactured by a facility registered with the FDA.
  5. Each bulk drug must be accompanied by a valid certificate of analysis.
  6. Other ingredients used in compounding the product are in compliance with an applicable USP or NF monograph.
  7. Is not for a drug that has been withdrawn for safety or efficacy reasons.
  8. Restrictions on commercially available drugs and qualities are a consideration.
  9. The compounded product does not appear on the FDA’s list of difficult to compound products.
  10. The product is compounded in a state that has entered into an MOU with the FDA (further described in the guidance document).

The remainder of the guidance discusses FDA’s enforcement approach for compounded products.      

There will be additional Guidance documents and policy decisions made regarding drug compounding as we move forward.  This is a good start for FDA and provides a window into the FDA’s initial thinking on the drug compounding issue.