The Lachman Blog

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28
Oct

How Deep is FDA Diving in GMP Compliance for Compounding Pharmacies? Just Watch the Recalls and Warning Letters!

With Warning Letters (WLs) and significant FDA 483 observations continuing to confront the compounding pharmacy space, FDA is entering into rounds two and three of inspections to determine if corrective actions have been adequately and timely completed and if the compounding pharmacies understand compliance in this space

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27
Oct

Six Degrees of Shortage Prevention: ISPE Debuts New Gap Analysis Tool

Serving as a member of the pharmaceutical industry is a privilege that brings with it significant personal responsibility. In recent years, preventing and mitigating drug shortages has become a critical concern for every pharmaceutical professional. ISPE is leading an international effort to understand, assess, and educate patients, providers, regulators, and manufacturers on this critical topic.

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26
Oct

To Compound or Not to Compound? That is the Question!

To Compound or Not to Compound? That is the Question! FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use […]

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21
Oct

Single Patient Use – A New Label Term for Parenteral Products

FDA published a new draft Guidance entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”. This draft Guidance adds to the two specific terms that FDA has long use for parenteral products – single-dose container and multiple-dose container- but they have even tweaked those terms

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18
Oct

The Ying and Yang – CRLs vs IRs ECDs and Approvals

Complete Response Letters (CRLs) (remember those letters where FDA was going to respond all at once with Division level review and you were not going to get any more discipline specific letters?) are a harbinger of “approval issues that are too great to resolve through other means”. Yes, that’s right, expect a CRL if issues are complex or too vexing to permit approval.

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