Tuesday, March 17, 2015

So you are trying to decide whether to stay a traditional compounding pharmacy or register with the FDA as an outsourcing facility....

obviously you, your team of business advisors and consultants, and your attorney will need to consider a number of laws, regulations and factors before making this decision.  A good place to start might be to actually read 21 USC 353a and then to read the following section on the FDA website:
Traditional CompoundingDrugs produced by compounders that are not registered as outsourcing facilities must meet the conditions of section 503A to qualify for the exemptions specified in that section. Even if the conditions of section 503A are met, the compounded drugs are only exempt from those provisions of the FDCA listed above. All other applicable provisions of the FDCA remain in effect for compounded drugs, even if the conditions in section 503A are met. For example, a compounded drug cannot be contaminated or made under insanitary conditions (see sections 501(a)(1) and 501(a)(2)(A)). And if a compounded drug does not qualify for the exemptions under either section 503A or 503B of the FDCA, the compounded drug would be subject to all of the requirements of the FDCA that are applicable to drugs made by conventional manufacturers, including the new drug approval and adequate directions for use requirements.FDA has issued for public comment a draft guidance that
describes FDA’s intention with regard to the provisions of section 503A that require rulemaking or other action to implement. This draft guidance also describes the provisions of the law that are applicable to compounded drugs that do not qualify for the exemptions described above, and the other provisions of the FDCA applicable to compounded drugs regardless of whether they qualify for the exemptions under section 503A.FDA also has announced the withdrawal of CPG 460.200, Pharmacy Compounding, issued in 2002, and the guidance “Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act,” published in November 1998. Although we have withdrawn these guidance documents, under the DQSA, section 503A immediately applies nationwide. FDA plans to provide further information at a later date about how we intend to interpret certain provisions of section 503A.

quoted from here.  Also read the FDA Final Guidance :

7/2/2014
Final Guidance



 Are you in compliance or can you become compliant with what is now required to be a traditional compounding pharmacy? Can your pharmacy  or are you willing to meet the 5% rule if your state of residence does not sign the MOU? If your state of residence does sign the MOU, can you meet  or you willing to meet the 30% rule?. Note that even if you choose to comply with the traditional compounding laws and not register as an outsourcing facility, "compounded drug cannot be contaminated or made under insanitary conditions (see sections 501(a)(1) and 501(a)(2)(A))."  There are many factors to consider in making this important decision, and part of that decision requires a understanding of what the law actually says and not a misunderstanding based on what others are telling you the law says or what they think it says.

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