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In its latest to bid to set parameters around compounding, the US Food and Drug Administration last week issued a pair of draft guidelines to clarify when compounding pharmacies are permitted to make versions of commercially available medicines.

Although federal law currently states that a compounder generally shouldn’t make copies of drugs that are approved for sale, the agency is getting more specific and wants to ensure that a true clinical need exists before a compounded version of an approved medicine drug is made for a patient.

“The FDA is making a policy statement that you can’t just compound a copy and then market it,” said Elizabeth Jungman, director of public health at Pew Charitable Trusts, a nonprofit that studies health care issues. “There has to be a patient need. And it’s important from a safety perspective.”

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Indeed, there are ongoing safety concerns surrounding compounding pharmacies ever since a scandal erupted four years ago. That’s when injectable steroids made by a compounder in the Boston area were linked to 64 deaths and more than 750 cases of fungal meningitis around the country.

The episode cast a harsh spotlight on compounders, as well as FDA and state oversight. In response, a federal law called the Drug Quality and Security Act was passed to beef up FDA authority to inspect facilities and enforce regulations.

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A key issue has been the extent to which compounders can make medicines for patients in ways that may cross the line into more conventional drug manufacturing. The new law attempts to create boundaries, although the latest guidelines are designed to refine the FDA interpretation.

For instance, the guidelines would permit compounders to make versions of brand-name drugs when a shortage exists or the brand-name medicine has been discontinued. Another example meeting the threshold of patient need might be a required change in formulation, such as different dosage strengths.

But safety is not the only issue in play here. For instance, pointing to a lower price — in other words, a compounded version would be cheaper than a brand-name drug — is not justification for compounding an FDA-approved medicine.

Brand-name drug makers would be less likely to invest in innovative medicines if a compounder — especially compounders that make large quantities of a medicine — is otherwise allowed to make and sell versions of treatments approved by the FDA, Jungman explained.

Similarly, generic drug makers may avoid seeking approval of copycat medicines if compounders can make copies of approved drugs, according to Robert Pollock, a former acting deputy director of the FDA Office of Generic Drugs, who now works at Lachman Consultants and advises drug makers.

Of course, these are only draft guidelines — guidances in regulatory parlance — and are not set in stone. Manufacturers and others have an opportunity to comment. To date, the compounding industry has bristled at some restrictions contained in the new law.

A spokeswoman for the International Academy of Compounding Pharmacists, an industry trade group, told us the guidelines are still being reviewed and that there is no comment at this time.

  • Ed, It looks like this will effectively put an end to the big batch compounders who are advertising their compounds in a branded way. Many of these products have sales forces behind them. Additionally, many of them currently exceed the proposed dating guidance that was floated out last year but has not been issued as final guidance yet. Hard to see, short of stripping the teeth of this language, that would leave much room for many of the nationwide compounders to stay in business. The publicly held ones are already losing money, in some cases a lot of money. Do you have any thoughts on the viability of the entire industry based the meat of these guidelines becoming final? It really looks to me to be the end of the line for the handful of large multi-state compounders who appear to have been operating beyond their registration anyway.

    • Hi Old Sport,

      Thanks for writing and it’s a good question. The guidance shouldn’t crimp compounders that are not making identical copies, even when using the same active ingredient. Maybe there’s a need for a different dosage or different administration. I suppose this will affect some folks, yes, but hard to know right now.
      ed

  • Ed–This sounds like it comes down on KV’s side on Makena compounding. Is that how you read it?

    • Hi NJ Biologist,
      Yeah, I would largely agree with that interpretation, although the pricing in that situation was such a contentious issue – and got red hot so quickly – that it also grew political quickly. So never say never, I guess.
      Best
      ed

  • Are the guidances likely to have any deterrent effect on the compounding of drugs for lethal injection in my home state of Texas, or elsewhere?

    • Hi Ray,
      To be honest, I’m not entirely sure so I’ve ask for some clarity and hope to hear back tomorrow. I’ll let you know.

      ed

    • Hi Ray,

      So I asked the FDA for a little clarity and got this: “FDA would need to evaluate whether the compounding of a particular drug is restricted or prohibited by the copies provisions in the Act under the law and the relevant facts.”
      Not much help, but getting back to your question, I can imagine that it won’t make it easier.

      Best
      ed

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