U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

January 5, 2024

Jason Weida, Secretary 

Florida Agency for Health Care Administration 

2727 Mahan Drive, Mailstop 1 

Tallahassee, FL 32308

Re: Letter of Authorization for Florida’s Section 804 Importation Program

Dear Secretary Weida:

FDA is committed to continuing to work with states, such as Florida, and Tribes that propose to 

develop Section 804 Importation Programs (SIP) in accordance with section 804 of the Federal 

Food, Drug, and Cosmetic Act (FD&C Act or the Act) and FDA’s implementing regulations. 

Numerous subject matter experts at FDA and other components of the Department of Health 

and Human Services (HHS) have carefully and thoroughly reviewed your revised SIP proposal. 

Based on FDA’s review of your most recent SIP proposal that was submitted on November 16, 

2023,1 and clarifying communications,2 FDA has determined that this SIP proposal meets the 

requirements of section 804 and 21 CFR part 251, and therefore Florida has demonstrated that 

it meets the statutory obligation to ensure that importation under section 804 will significantly 

reduce the cost of covered products to the American consumer without posing additional risk to 

the public’s health and safety. FDA is therefore authorizing, for a period of 2 years, Florida’s

Agency for Health Care Administration’s SIP with the labeling corrections specified in the 

attachment to this letter.3 

The Importer may now submit a Pre-Import Request to FDA. An eligible prescription drug may 

not be imported or offered for import under part 251 unless the Importer has filed a Pre-Import 

Request for that drug, in accordance with 21 CFR 251.5, and FDA has granted the Pre-Import 

Request. A list of items that “[a] complete Pre-Import Request must include, at a minimum” is 

specified at 21 CFR 251.5(c). Importation may not proceed until: 

1 The SIP proposal was initially submitted by the Florida Agency for Health Care Administration to the 

FDA on November 23, 2020, and subsequently revised on: April 19, 2021, September 15, 2021, 

November 15, 2021, April 21, 2023, and October 20, 2023.

2 The Florida Agency for Health Care Administration sent communications via email on October 27, 2023 

and November 16, 2023.

3 This time period begins when the Importer, or its authorized customs broker, files an electronic import 

entry for consumption for its first shipment of eligible prescription drugs under the SIP (21 CFR 251.6(b)). 

Authorization for the SIP will be terminated if the Importer, or its authorized customs broker, does not file 

an electronic import entry for consumption for a shipment of eligible prescription drugs under the SIP 

within 1 year of the date of this letter (21 CFR 251.6(c)).
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

1. The Importer submits a complete Pre-Import Request to FDA, by email to 

SIPDrugImportsandRFP@fda.hhs.gov, at least 30 calendar days before the scheduled date 

of arrival or entry for consumption of a shipment containing an eligible prescription drug 

covered by the SIP, whichever is earlier. Under 21 CFR 251.17(a) and 21 CFR 1.74(b), the 

entry for consumption, as defined in 19 CFR 141.0a(f), must be electronically filed in the 

Automated Commercial Environment (ACE) system for each eligible prescription drug 

imported or offered for import into the United States. These entries must be filed as formal 

entries. 

Entry and arrival of a shipment containing an eligible prescription drug is limited under 21 

CFR 251.17(b) to the U.S. Customs and Border Protection (CBP) port of entry authorized by 

FDA (currently the only authorized port is 3801—Detroit)4. Once the shipment arrives or is 

entered at the port of entry, it will be examined by a government agency. Be advised that 

this process may take longer than 30 calendar days.

FDA must grant your Pre-Import Request before products may be imported or offered for 

import. The timeframe necessary for FDA to grant your Pre-Import Request will vary 

depending on the circumstances of the request—such grant may take more than 30 

calendar days. Therefore, it is advisable to submit the Pre-Import Request sooner than the 

required 30 calendar days.

2. The manufacturer or the Importer conducts testing of the eligible prescription drugs for 

authenticity, degradation, and to ensure that the eligible prescription drugs are in 

compliance with established specifications and standards (i.e., Statutory Testing) in 

accordance with section 804(e)(1) of the FD&C Act. Unless the manufacturer has notified 

the Importer that it intends to conduct the required testing as provided in 21 CFR 251.16(e), 

the Pre-Import Request must contain, for each drug covered by the Pre-Import Request, a 

Statutory Testing plan that includes: (A) a description of how the samples will be selected 

from a shipment for the Statutory Testing; (B) the name and location of the qualifying 

laboratory in the United States that will conduct the Statutory Testing; and (C) a description 

of the testing method(s) that will be used to conduct the Statutory Testing (21 CFR 

251.5(c)(4)(xi)).

3. You make the labeling corrections specified in the attachment to this letter. To facilitate the 

importation process and ensure that the requirements of the FD&C Act and 21 CFR part 251 

are met, you should submit the corrected labeling by email to

SIPDrugImportsandRFP@fda.hhs.gov for FDA’s review prior to the submission of a PreImport Request. 

In accordance with 21 CFR 251.17(g), after an eligible prescription drug has been shown by 

testing and relabeling to meet the requirements of section 804 and 21 CFR part 251, the 

Importer or the manufacturer must provide to FDA the written certification described in section 

804(d)(1)(K). 

4 See U.S. Customs and Border Protection Cargo Systems Messaging Service bulletin, Nov. 9, 2020, at 

https://content.govdelivery.com/accounts/USDHSCBP/bulletins/2aabc2f. See also FDA Supplemental 

Guide for the Automated Commercial Environment/International Trade Data System (ACE/ITDS), 

https://www.cbp.gov/document/guidance/fda-supplemental-guide.
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

FDA also notes the following, this is not an exhaustive list of all relevant ongoing requirements,

and you should consult 21 CFR part 251 for more information:

A Foreign Seller must review and update its registration information in accordance with 

21 CFR 251.10. 

A SIP Sponsor must submit a report to FDA each quarter in electronic format by email to 

SIPDrugImportsandRFP@fda.hhs.gov containing the information set forth in FDA’s 

regulations, beginning after the SIP Sponsor files an electronic import entry for 

consumption for its first shipment of drugs under the SIP (21 CFR 251.19).

A SIP Sponsor may request that FDA extend the authorization period of an authorized 

SIP (21 CFR 251.8(f)). To be eligible for an extension, a SIP must be up to date on all of 

the information and records-related requirements of section 804 of the FD&C Act and 

FDA’s regulations. FDA may extend the authorization period for up to 2 years at a time. 

Such a request must be submitted at least 90 calendar days before the SIP's

authorization period will expire. 

Additionally, a SIP Sponsor may propose to modify an authorized SIP (21 CFR 251.8). 

In reviewing a proposal to modify a SIP, among other things, FDA may consider

information learned subsequent to authorization of the SIP (21 CFR 251.8(b)). A SIP

Sponsor must not make or permit any changes to a SIP without FDA’s authorization (21 

CFR 251.8(e)). If FDA authorizes changes to a SIP, the Importer must submit a new 

Pre-Import Request in accordance with 21 CFR 251.5 (21 CFR 251.8(d)).

FDA may suspend or revoke a SIP, in whole or in part, including with respect to one or 

more drugs in the SIP, at any time, under any circumstances set forth in the FD&C Act

and FDA’s regulations, including circumstances in FDA’s discretion (21 CFR 251.7, and 

251.18). An eligible prescription drug cannot be shipped into the United States under 

section 804 and FDA’s regulations, and is subject to refusal of admission into the United 

States, if FDA has suspended the SIP or revoked its authorization.

We recommend that you stay up-to-date on relevant FDA requirements, including those that are 

referenced in 21 CFR part 251, and any associated FDA guidance on such requirements. 

An article that is imported or offered for import into the United States in violation of section 804 

of the FD&C Act or 21 CFR part 251 is subject to refusal under section 801 of the FD&C Act (21 

CFR 251.21(a)). The importation of a prescription drug in violation of section 804 of the FD&C

Act; the falsification of any record required to be maintained or provided to FDA under section 

804; or any other violation of 21 CFR part 251 is a prohibited act under section 301(aa) of the 

FD&C Act (21 CFR 251.21(b)).
U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

We encourage you to bring any questions you may have to FDA’s Office of Drug Security,

Integrity and Response, Division of Global Drug Distribution and Policy via the mailbox at:

SIPDrugImportsandRFP@fda.hhs.gov. 

Sincerely,

S. Leigh Verbois, PhD 

Director

Office of Drug Security, Integrity & Response

Office of Compliance

Center for Drug Evaluation and Research 

Sandi L. Verbois 

-S

Digitally signed by Sandi L. 

Verbois -S 

Date: 2024.01.05 07:41:16 

-05'00'