For 503A and 503B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions?

  • Do you know the Federal and State laws you are required to follow?
  • Do you have the right enabling documentation (procedures, policies, records, etc., in place and in use, to meet all the requirements of DQSA and USP)?
  • Are you organized effectively to execute the requirements?
  • Do you have the right people in place?
  • Are they effectively trained and can you produce the training records?
  • Is the role of your pharmacist-in-charge and your Quality Unit well defined (roles, responsibilities, and authorities)?
  • Do you have the right infrastructure (people, facilities, computer systems, space, etc.)?
  • Do you have master plans for Facilities, Validations, Cleaning and Sanitizing, Training, and Document and Record Control?
  • Do you have an internal or external compliance audit/assessment program and effective metrics of performance to regulatory requirements?

There are more of these types of business questions that can be asked by regulators and if you can’t say yes to at least the ones above, you will likely have little chance of being in compliance with Federal and State laws, and therefore, your firm will be at high risk of regulatory interventions.  These interventions can be triggered by routine inspections, sterility events/failures, customer complaints to the regulators, and other matters.

One of the first premises of compliance is to be knowledgeable of the Federal and State laws. FDA routinely publishes Guidances in which they cover their interpretations of law.

FDA has posted a list of 101 new and revised draft Guidances in 16 categories it plans to publish in FY 2017.  Categories, followed by the number of planned Guidances, are as follows: advertising (1), biopharmaceutics (3), biosimilarity (2), clinical/antimicrobial (1), clinical/medical (11), clinical pharmacology (8), clinical/statistical (3), drug safety (3), electronic submissions (4), generics (13), labeling (6), pharmaceutical quality/CMC (11), pharmaceutical quality/manufacturing standards (CGMP) (4), pharmacology/toxicology (1), procedural (28), and user fees (2).

How many of these apply to compounding pharmacies? Most of the Guidances are found under Drug Safety, Labeling, and Pharmaceutical Quality/Manufacturing Standards and Procedural Categories. Some examples that apply to compounding are:

  • Visual Inspection of Injectable Drug Products
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft
  • Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
  • Container Closure Systems for Packaging Human Drugs and Biologics; Revised Draft
  • Use of the FDA Inactive Ingredient Software (IID)
  • Field Alert Report Submission
  • Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
  • Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
  • Enforcement Policy Regarding Ingredients Nominated for Inclusion on the Bulk Drug Substances List Pursuant to Section 503B
  • National Drug Code (NDC) Assignment of CDER-Regulated Products
  • REMS Assessment: Planning and Reporting

But what’s not on the 2017 list that would add clarity to the compounding practice?

There is no mention of a final Guidance for Memorandum of Understanding (between States and FDA) and GMPs for 503Bs. Will FDA publish these, despite them not appearing on the 2017 list?  Will the new administration support the FDA efforts or will they scale back on the issuance of both regulations or guidance documents?

Hold onto your hats (or sterile garbs), we are likely in for a wild ride.