Sterile Compounding Permit FAQs


Sterile Compounding Permit FAQs

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Who is required to apply for the new permit?

The only exceptions to this new permitting requirement are:

  1. Stand-alone Special Parenteral/Enteral pharmacies;
  2. Special Parenteral/Enteral Extended Scope pharmacies;
  3. Pharmacies that only perform non-sterile compounding;
  4. Non-resident pharmacies

(Note: Modified II B Institutional Pharmacies who are mixing/compounding strictly for immediate use are not required to obtain this permit.)

What is the deadline to obtain this permit?

The new Special Sterile Compounding Permit must be obtained on or before March 21, 2014 in order to continue sterile compounding.

Is there an online application available?

Online applications are available for new establishments only. Existing permits must submit a paper application found at http://floridaspharmacy.gov/licensing/

Can the pharmacy continue compounding sterile products during the application process?

Pharmacies that are compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014 in order to continue sterile compounding.

What is the fee for the Sterile Compounding Pharmacy permit?

There will be no fee required for existing licensees.  New establishments are required to submit $255.00 with the application.

Will the pharmacy be issued a new license number?

If you currently hold a combined Community/Special Parenteral & Enteral, or a combined Special Closed/Parenteral & Enteral permit you will also be required to apply for the Special Sterile Compounding Permit and maintain two separate permits.  Your current permit will become your Community Permit or your Special Closed Pharmacy Permit. Upon approval of your application, you will be issued a separate Special Sterile Compounding Permit. When you renew your existing permit it will be reprinted with just Community or Special Closed Pharmacy.

Can I submit a copy of the policy & procedure manual instead of answering the 36 questions listed in the application?

Do not send the policy and procedure manual to the board office.  The board office will approve the policy and procedure manual based upon answers submitted for the questions, where applicable, by using excerpts or summaries from the policy and procedure manual.

Is a separate pharmacy manger required for the new permit?

No, the existing pharmacy manager will be listed as PIC for both permits.

Is an inspection required in order for the permit to be issued?

An inspection is not required for pharmacies that currently hold a combined Community/Special Parenteral & Enteral or a combined Special Closed/Parenteral & Enteral permit. If applying for a new establishment an inspection is required and an inspector will contact you to set up an inspection date. Upon completion of a passing inspection a new permit number will be issued.

Will I need a new DEA permit for this license?

For information regarding DEA registration please contact the DEA at 1-800-667-9752 or 954-306-4654. You may also visit the DEA website at http://www.DEAdiversion.usdoj.gov