Examination of import data: Chemical compounds in medicines commonly advertised to consumers

Executive summary

Active pharmaceutical ingredients (APIs) entering the United States from unregistered and uninspected facilities pose potential safety risks to consumers, including contamination, impurity control failures, incorrect potency, identity issues, sterility problems, and lack of traceability. These risks could lead to substandard or toxic treatment outcomes.

This study examines US Food and Drug Administration (FDA) import, registration, and inspection data from 2023 through 2025 to evaluate how much of the growing supply of APIs used in common therapeutic areas, including obesity, erectile dysfunction, hair loss, and hormone replacement, originates from facilities that have not been registered with or inspected by the FDA. The study focuses on drug substances from uninspected and unregistered facilities that are used for unapproved drugs, such as compounded medications or products mislabeled as “research use only,” rather than FDA-approved drugs, which must show that their APIs originate from a registered facility.

Key findings from our study of 2025 import data show that:

• 28 percent of shipments entering the US came from facilities not registered with the FDA, and 23 percent came from facilities that were both unregistered and uninspected.


• Shipment volumes have grown 30 percent since 2023, led by obesity treatment products (197-percent growth), which are predominantly APIs used in glucagon-like peptide-1 (GLP-1)-based therapies.


• The highest volume of unregistered, uninspected shipments came from India (22 percent) and China (12 percent). The highest rates of unregistered, uninspected shipments came from Brazil (86 percent), Colombia (84 percent), Mexico (64 percent), and the United Kingdom (52 percent).


• 93 percent of shipments from unregistered and uninspected facilities were released into the US market.


• Potential policy and enforcement responses may include 1) requiring verification of facility registration before releasing shipments, 2) issuing import alerts to detain products from facilities known to be unregistered, 3) requiring compounding pharmacies and sellers of products marketed as “research use only” to certify that they are using APIs from FDA-registered facilities, 4) prioritizing risk-based inspections by country and therapeutic area, and 5) strengthening enforcement and penalties for non-compliance by both foreign facilities and domestic entities that source APIs from unregistered facilities.

Inspecting imports of drug ingredient shipments commonly sold online in unapproved drugs

Methodology note: This study evaluates FDA import entry data from 2023 through 2025 for selected therapeutic categories commonly promoted online in non-FDA-approved formulations, including obesity, hair loss, hormone replacement, and erectile dysfunction products. Shipment-level records were compared to FDA Drug Establishments Current Registration Site (DECRS) data to determine facility registration status. They were also compared to FDA Inspections Dashboard data to identify whether the exporting facility had a recorded inspection. The unit of analysis is the quantity of shipments rather than the quantity of drug substance or finished product.

Introduction

To protect the safety and security of the US medicine supply, the FDA registers and periodically inspects foreign facilities that ship bulk drug substances, including APIs, and finished medicines into the US. However, as direct-to-consumer online promotion of unapproved medicines in certain therapeutic categories – such as obesity, hair loss, hormone replacement, erectile dysfunction, and unauthorized peptides – has expanded, so too have imports of the drug substances used to make these products.

APIs entering the US from unregistered and uninspected facilities pose potential safety risks to consumers. Registration and inspection are intended to protect consumers from products containing contaminated ingredients, ingredients of incorrect potency, or ingredients that do not match label claims, as well as related risks such as dosing errors. The importation of APIs from unregistered manufacturing facilities may create gaps in oversight that could increase risks related to contamination, impurity control, potency, identity, sterility, data integrity, and traceability.

Interlocking obligations recorded in approved applications, drug master files, registration databases, and import entry records create a traceable and enforceable chain of commitments for manufacturers of FDA-approved drugs. When seeking FDA approval, a required drug application identifies the API’s source and an independently registered manufacturing site. If the finished FDA-approved product is manufactured differently without seeking approval from the FDA for the change, the drug is considered misbranded as a matter of law. The FDA enforces these requirements with the manufacturers of FDA-approved drugs through import reviews and inspections. Non-FDA-approved treatments sold online to consumers are not subject to the same requirements.

FDA import, registration, and inspection records from 2023 through 2025 show 1) how much of that growing supply originates from facilities that were neither registered with the FDA nor documented to have been inspected by the FDA, 2) how denial and release rates vary across therapeutic categories and countries of origin, and 3) what these patterns may reveal about the risks associated with unauthorized versions of these medicines. This report provides information on the quantity of imported drug substances from uninspected and unregistered facilities that are used in unapproved drugs. FDA-approved drugs are outside the scope of this report.

In prior reports, we identified classes of medicines that were commonly promoted online in non-FDA-approved formulations, such as compounded drugs. These include medicines used to treat obesity, hair loss, hormone deficiencies, and erectile dysfunction. As online promotion of these non-FDA-approved medications has increased following the shortage of GLP-1 drugs in 2022, we consider whether the volume of API imports used to manufacture these drugs changed between 2023 and 2025, the most recent full year of data. We also examine inspection and registration records by country for 2025.

We recognize that the FDA import databases may not contain entirely complete records, and we note the potential limitations in our methodology. In addition, this report does not cover sources of APIs that are not recorded in the import databases, such as when smuggled into the US. Based on our study of the drugs or APIs commonly used to make non-FDA-approved drugs in the selected categories, we find the following for 2025:

• 28 percent of shipments entering the US came from facilities that were not registered with the FDA, and 23 percent of shipments entering the US came from facilities that were both unregistered with the FDA and had not been inspected.


• The share of unregistered, uninspected shipments imported into the US varied widely by country of origin, with percentages shown below representing the share of all shipments imported into the US in 2025 that were both unregistered and uninspected:
  
  
  • Largest exporters by shipping volume: India (22 percent) and China (12 percent).
  
  
  • Highest rates of unregistered, uninspected shipments relative to the total number of shipments imported: Brazil (86 percent), Colombia (84 percent), Mexico (64 percent), and the UK (52 percent).
  
  
  • Lowest rates of unregistered, uninspected shipments relative to the total number of shipments imported: Israel (zero percent), Spain (two percent), Denmark (three percent), Italy (three percent), and Sweden (four percent).


• 93 percent of shipments in our study that originated from unregistered, uninspected facilities were released into the US market in 2025, with seven percent denied entry.


• The proportion of shipments denied entry to the US increased from two percent in 2023 to 3.4 percent in 2025, driven by higher denial rates for API shipments related to obesity drugs (6.8 percent), which are predominantly APIs used in GLP-1-based therapies. Even with higher denial rates, 16 percent of API import shipments for obesity treatments originating from uninspected, unregistered facilities were released into the US in 2025.


• In a case study, we examine the country of origin for the unreleased, uninspected shipments of hair loss medicines entering the US, which is the therapeutic category with the highest rate of shipments from unregistered, uninspected facilities. We find that more than 70 percent of these unregistered shipments originated in two countries: India and Brazil.


• 23 percent of API shipments entering the US in 2025 – many of which are used in non-FDA-approved treatments, such as compounded drugs or drugs sold to the public in the form of “research use only” products – originated from facilities that were neither registered with nor documented to have been inspected by the FDA.


• Shipment volumes have grown 30 percent since 2023, led by obesity treatment products. Denial rates have risen in that same category, although many shipments are still allowed into the US. The highest volume of unregistered, uninspected shipments came from India and China; outside of these countries, Brazil, Colombia, Mexico, and the UK had the highest volumes.

Together, these data points potentially indicate gaps in oversight of the US medicine supply and identify therapeutic categories and countries that may warrant further examination of registration verification, inspection, and enforcement practices.

Background

The FDA generally requires foreign establishments that manufacture APIs for import into the US to register with the agency.[1] Facility registration and FDA inspection allow the FDA to track the facility’s history and manufacturing practices. They also allow the FDA to evaluate the control of raw materials, manufacturing operations, measurements of deviation in the quality of output, and laboratory testing.[2] The FDA does not inspect every facility regularly but instead relies on a risk-based model.[3] For FDA-approved drugs, manufacturers are required to register their facilities, whereas manufacturers of non-FDA-approved drugs are not. The absence of an FDA inspection generally indicates that the FDA has less information about a facility's manufacturing practices and compliance history, which may limit the agency’s ability to assess potential risks associated with importing its API.

The Government Accountability Office issued a report in 2008 recommending that the FDA implement better data management and more foreign inspections to strengthen the program. Since then, actions taken by the FDA have included sending letters to foreign manufacturers reminding them of their obligation to register, issuing import alerts intended to stop the importation of drugs from establishments that are not registered without physical inspection, and increasing staffing for inspections.[4] Foreign inspections significantly declined during the COVID-19 pandemic but have since resumed, although gaps from that period remain.[5]

The FDA Center for Drug Evaluation and Research maintains a catalog of manufacturing sites (Site Catalog) that includes 4,619 facilities as of 2024. Thirty-six percent of those sites are in the “no application sector,” meaning they solely manufacture for drugs that are not FDA-approved, such as compounded medicines. The remaining 64 percent of sites manufacture biologic, small-molecule, or generic drugs associated with an FDA drug approval. China and India, the second- and third-most common locations for manufacturing sites after the US, increased their number of sites by 18 percent and 27 percent, respectively, between 2020 and 2024. Inspection activity, however, remained stable in China and declined in India during the same period.[6]

From 2020 to 2024, 72 percent of global API manufacturing sites that were subject to FDA regulatory actions – including warning letters, import alerts, and regulatory meetings – were manufacturing sites that exclusively supplied compounding pharmacies. These API manufacturers represented 18 percent of API manufacturers in the Site Catalog, suggesting that they were involved in FDA regulatory actions at a rate approximately four times higher than API manufacturers overall.[7]

Methodology

We evaluate FDA imports data to 1) characterize the quantity of imports in each of our four therapeutic classes of interest (i.e., erectile dysfunction, hair loss, hormones, and obesity); 2) determine which countries are exporting APIs or finished drugs to the US and whether the facilities are registered with the FDA and have been inspected; and 3) evaluate the proportion of each shipment denied or granted entry to the US. To do this, we compare facility identifiers in the FDA imports data against the FDA Drug Establishments Current Registration Site (DECRS) database to determine whether the facilities exporting drugs or APIs to the US are registered with the FDA. Finally, we assess whether the registered facilities have been inspected using the FDA Inspections Dashboard, examining variation by country.

Products entering the US are declared to US Customs and Border Protection (CBP), which then refers all FDA-regulated products, including APIs and finished medicines, to the FDA for review. These entries are cataloged in the FDA Imports Entry database at the shipment level and indicate whether a shipment was allowed or denied entry into the US.[8] Our unit of analysis is the quantity of shipments, not the quantity of drugs or APIs.

The FDA maintains DECRS, which is a list of registered manufacturers of drugs distributed or marketed in the US. Registrations can be removed due to a compliance action, expiration, or withdrawal. For this study, we extracted registration and inspection data on December 5, 2025. Registration records may have been updated or withdrawn after that date. For that reason, this report evaluates only the percentage of registered entities in 2025. DECRS provides the FDA with visibility into facilities that are subject to oversight, inspection, and post-market surveillance. In addition, it allows the FDA to examine inspection and compliance records and track facilities by their establishment identifier number (FEI). Registration by a facility does not indicate that the FDA has approved or inspected the establishment; it indicates only that the facility can be identified and tracked.[9]

The FDA issued a Green List in September 2025, allowing imports from manufacturing facilities not on that list to be detained without inspection.[10] However, our study does not continue into 2026 and does not determine whether there was a decline in imports allowed into the US from those facilities.

The FDA Inspections Dashboard is a publicly available online database cataloging FDA inspections and listing the FEI number for the inspected facilities. Certain inspections are not included, such as pre-approval inspections, inspections awaiting a final enforcement action, and state-conducted inspections, which are outside the scope of this study of foreign imports. Finding that a facility has been inspected does not indicate that no action was taken; it indicates only that an inspection occurred.

Results

Growth in shipments: 2023 through 2025

We find that from 2023 through 2025, the number of shipments in our therapeutic categories of interest increased by 30 percent; other metrics, including the number of manufacturers exporting into the US (+32 percent), the number of countries shipping into the US (+26 percent), and the number of shipments allowed into the US (+28 percent), increased at approximately similar rates. The proportion of shipments denied increased by 103 percent in that same time period due to greater rates of denial for obesity-related shipments and growth in imports in that category. As of 2025, 6.8 percent of shipments of obesity treatments were denied entry compared to 3.4 percent across all therapeutic categories, with hormone replacement therapy having the lowest denied rate (1.7 percent) and erectile dysfunction (2.6 percent) the next lowest.

Table 1: Number of shipments – APIs or Medicines 2023 to 2025

Registration and inspection status counts: Shipments (allowed and denied entry), number of countries of origin, and number of registered manufacturers

FDA Imports Entry database
Number of	2023	2024	2025	Change from 2023 to 2025
Shipments	10,603	12,898	13,749	30%
Allowed	10,373	12,475	13,282	28%
Denied entry	230	423	467	103%
Manufacturer (FEI)	1,651	1,992	2,182	32%
Countries	66	75	83	26%

 

Next, we examine whether the facilities shipping APIs for medicines into the US were registered with the FDA and whether they had been inspected. In Chart 1, of the nearly 13,749 shipments evaluated, 28 percent (3,835 shipments) came into the US from facilities that were not registered with the FDA (i.e., had no FEI number). Of all shipments, 3.4 percent (467 shipments) were denied entry. Of the 9,914 shipments originating from registered facilities, 97 percent (9,639 shipments) came from facilities that were both registered and had been inspected. A small number of shipments (395 out of 3,835) originated from facilities that had been inspected but were unregistered, which may reflect post-inspection deregistration, administrative factors, or data limitations.

Denial rates were higher for shipments originating from unregistered facilities (ten percent, N=348) than for those from registered facilities (one percent, N=119). Twenty-three percent of all API shipments (N=3,102) entering the US in 2025 in these therapeutic areas originated from facilities that were neither registered with the FDA nor documented to have been inspected by the FDA.

Chart 1: Rates of entry of shipments from registered and inspected facilities 2025

 

Variation by therapeutic area

Next, we evaluate growth in imports by therapeutic area, where the greatest increase in shipments occurred in the obesity category (197 percent) from 2023 to 2025 (Appendix Table 1). We also observe variation by therapeutic area in the rate of unregistered, uninspected shipments: Hair loss had the highest rate, while obesity had the lowest.

Table 2: Released, unregistered, uninspected by therapeutic area in 2025

Status	Obesity	Erectile dysfunction	Hair loss	Hormone replacement
Not registered	24%	27%	35%	29%
Not inspected	24%	26%	30%	27%
Released, not registered or inspected	16%	23%	27%	25%
Shipments	4,000	1,644	1,379	6,726

 

Fifty-five percent of shipments originating from unregistered, uninspected facilities were for hormone replacement therapies. Hair loss had the highest rate of shipments released into the US that originated from unregistered, uninspected facilities.

Shipments by the exporting facility country of origin

Next, we examine shipments by the exporting facility’s country of origin. We study all shipments and separately report results for any countries with 100 or more shipments in 2025, which accounted for 91 percent of the total shipments imported into the US that year.

Half of all API shipments came from facilities based in China and India. Shipments from China had a lower-than-average rate (12 percent) of originating from uninspected, unregistered facilities. Shipments from Brazil, Colombia, Mexico, and the UK had the highest rates of originating from unregistered, uninspected facilities. Shipment volumes from Brazil (86 percent), Mexico (64 percent), and the UK (52 percent) also grew faster than the overall average between 2023 and 2025 (see Appendix Table 2).

Table 3: Rates of registration and inspection for shipments by country

Country	Shipments	Percent registered	Percent of unregistered, uninspected shipments released
India	5,821	74%	21%
China	1,119	87%	12%
Italy	917	97%	3%
Israel	636	100%	0%
Canada	558	30%	51%
Germany	553	73%	26%
Denmark	546	97%	3%
Spain	376	98%	2%
Brazil	371	3%	86%
France	326	56%	42%
Switzerland	291	90%	9%
Ireland	253	87%	13%
Mexico	225	23%	64%
Belgium	197	45%	13%
United Kingdom	131	21%	52%
Colombia	115	1%	84%
Sweden	100	96%	4%
Total	13,749	72%	23%

 

Chart 2: Distribution of shipments from unregistered and uninspected facilities released into the US, by country of origin of the exporting facility

 

Case study: Hair loss – finasteride and minoxidil

Hair loss APIs had the highest share of shipments released into the US that originated from unregistered and uninspected facilities. As a case study, we examine the countries that are the largest exporters of those drugs and APIs into the US and assess variation in registration and inspection rates. In this therapeutic category, there was greater concentration by country of origin, with five countries accounting for 90 percent of all shipments. India and Brazil had high rates of shipments from unregistered, uninspected facilities and together accounted for 72 percent of hair loss API shipments from unregistered, uninspected facilities.

Hair loss treatments are commonly promoted online in compounded formulations. Such treatments include finasteride, which is marketed in a topical format and is not FDA-approved. There are risks associated with dermal absorption of finasteride, including potential risks to pregnant women. FDA-approved tablets have a coating designed to prevent absorption through contact, but compounded finasteride treatments are not required to include such a coating.[11]

Table 4: Hair loss rates of registration and inspection for shipments by country

Country	Shipments	Percent registered	Percent of uninspected, unregistered shipments released
India	763	58%	31%
Israel	326	100%	0%
Italy	75	99%	1%
Brazil	51	0%	86%
Canada	40	68%	30%
Total	1,379	77%	27%

Conclusion

As consumer-facing online promotion of unapproved drugs in these therapeutic categories has increased, the volume of imported chemical inputs has also grown. Shipments in the studied categories increased 30 percent from 2023 to 2025, accompanied by comparable growth in the number of exporting manufacturers and countries of origin. For hair loss treatments (e.g., finasteride and minoxidil) – the therapeutic category with the highest rate of shipments released into the US from unregistered, uninspected facilities – country-of-origin concentration is particularly pronounced, with India and Brazil alone accounting for roughly 72 percent of those shipments. Additionally, topical compounded finasteride raises particular safety concerns. These trends may result in a greater share of imported APIs originating from facilities that are not registered with or documented to have been inspected by the FDA, which would likely limit traceability and oversight.

Our study of FDA import data from 2023 through 2025 indicates that 28 percent of shipments entering the US came from unregistered facilities, and 23 percent of shipments containing APIs used in medicines commonly advertised to US consumers in non-FDA-approved forms for obesity, hair loss, hormone replacement, and erectile dysfunction originated from facilities that were neither registered with the FDA nor documented to have been inspected by the FDA.

These findings highlight questions about the operation of the oversight framework intended to safeguard the US medicine supply. Registration with the FDA’s DECRS database allows the agency to identify which facilities are subject to inspection and post-market surveillance; when shipments are released from facilities that have neither registered nor been inspected, the FDA’s ability to trace, oversee, and act against substandard or adulterated products may be reduced.

The study points to variation across countries of origin. India and China, the two largest exporters of these chemicals to the US, recorded rates of 22 percent and 12 percent, respectively, for shipments originating from facilities that were both unregistered and uninspected. While at or below the average, these percentages translate into a comparatively large absolute number of unregistered, uninspected shipments given the volume of shipments from those countries. By country, Brazil (86 percent), Colombia (84 percent), Mexico (64 percent), and the UK (52 percent) had the highest rates of shipments from unregistered, uninspected facilities released into the US, while Denmark, Israel, Italy, Spain, and Sweden had rates at or below four percent.

Policy and enforcement considerations

 

In light of these findings, potential policy and enforcement responses may include:

• Requiring registration verification before release. The FDA may consider implementing a mandatory hold on any shipment from a facility without a valid FEI number in the DECRS database. In 2025, 93 percent of shipments originating from unregistered, uninspected facilities were released into the US market. Aligning CBP entry decisions with FDA registration records could help to close the gap that allows more than one quarter (28 percent) of API shipments to originate from facilities that are neither registered with the FDA nor documented to have been inspected by the FDA.


• Issuing import alerts for facilities known to be unregistered. FDA may place a product on an import alert after discovering a violation and detain future shipments of the product from that facility without testing or otherwise physically examining it. The FDA could issue an import alert and detain shipments without inspection for unregistered facilities that ship APIs into the US.


• Increasing inspections and verification requirements for sellers of unapproved medicines. Compounding pharmacies and sites selling for “research use only” could be required to demonstrate that they are using APIs from a facility registered with the FDA. Additionally, updates could be required if the source of the API changes, allowing for documentation and inspection of the sellers to ensure compliance.


• Prioritizing risk-based inspections by country and therapeutic area. FDA inspection resources could be concentrated on facilities in countries that account for the largest absolute volumes of shipments from unregistered, uninspected facilities entering the US, particularly India and China, as well as countries with the highest proportional rates of shipments from unregistered, uninspected facilities, particularly Brazil, Colombia, Mexico, and UK. Resources could also be focused on therapeutic categories driving shipment growth, such as obesity APIs, which increased 197 percent from 2023 to 2025. A tiered inspection priority system could allow the FDA to allocate inspection resources to the highest-risk facilities and shipments.


• Strengthening enforcement and penalties for non-compliance. Congress could authorize increased civil monetary penalties for 1) individuals operating foreign facilities that fail to register and 2) domestic entities, including compounding pharmacies and direct-to-consumer platforms, that knowingly source APIs from unregistered facilities. Additionally, platforms that promote unapproved medicines manufactured from uninspected APIs could face liability for inducing importation of adulterated or misbranded drugs. Stronger deterrence mechanisms could help enforcement efforts keep pace with the 30-percent growth in shipments and the increasing online promotion of these products.

Further research could examine the downstream pathways of these imported APIs, including the extent to which they enter compounded or non-FDA-approved formulations marketed directly to consumers.

Appendix

For the selected products in our study, we evaluated the number of shipments entering the US by distinct manufacturers and country of origin. We examined 37,250 shipments from 224 countries of origin, representing 5,381 distinct manufacturer names and 5,825 distinct FEI numbers, from January 1, 2023 through December 31, 2025. Our study spanned 30 products.[12]

Appendix Table 1: Growth in shipments by therapeutic area

Therapeutic area	N=Shipments 2025	Change from 2023 to 2025
Obesity	4,000	197%
Erectile dysfunction	1,644	-8%
Hair loss	1,379	1%
Hormone replacement	6,726	10%

 

Appendix Table 2: Growth in shipments by country 

Country	Shipments in 2025	Change from 2023 to 2025
India	5,832	12%
China	1,124	76%
Italy	928	334%
Denmark	605	240%
Germany	548	141%
Canada	516	7%
Netherlands	384	280%
Spain	377	62%
Brazil	376	121%
Israel	339	-36%
France	311	51%
Switzerland	284	-1%
Mexico	220	36%
Ireland	192	-10%
United Kingdom	188	96%
Belgium	159	38%
Colombia	120	-12%
All countries	13,749	30%

 

Appendix Table 3: List of drug types studied 

For this list of drug types and source, one drug type may account for multiple drugs. For example, estradiol includes estradiol, estradiol benzoate, estradiol cypionate, estradiol enanthate, estradiol valerate, and ethinyl estradiol.

Product types to select	Molecule name	Brand name	Source
Obesity	Orlistat Phentermine-topiramate Naltrexone-bupropion Liraglutide Semaglutide Tirzepatide	Xenical Qsymia Contrave Saxenda Wegovy or Ozempic Zepbound or Mounjaro	Weight loss medications guide
Hormone replacement	Estradiol Conjugated estrogens Progesterone Medroxyprogesterone acetate		FDA menopause medicines guide
Erectile dysfunction	Sildenafil Tadalafil Alprostadil Vardenafil hydrochloride	Viagra Cialis Caverject Levitra	FDA SPL label database
Hair loss	Finasteride Minoxidil	Propecia Rogaine	FDA SPL label database Hair loss medication guide

 

_{[1] FDA, “Importing Active Pharmaceutical Ingredients,” https://www.fda.gov/drugs/human-drug-imports/importing-active-pharmaceutical-ingredients.}

_{[2] FDA, “Facts About the Current Good Manufacturing Practice (CGMP),” https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practice-cgmp.} 

_{[3] FDA, “Types of FDA Inspections,” https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-basics/types-fda-inspections#risk-based-approach.} 

_{[4] Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program, GAO-08-970, Published: September 22, 2008.} 

_{[5] Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog GAO-21-409T, Published: March 4, 2021.}

_{[6] FDA and Center for Drug Evaluation and Research (CDER), Report on the State of Pharmaceutical Quality, Fiscal Year 2024 https://www.fda.gov/media/193320/download.} 

_[7] Id.

_{[8] Released shipments included those with the following final disposition statuses: MPro Issued, OASIS MPro Issued, OGA Referral Closed/No Further Actn, Rel after Detain, Rel w/Cmnt after Detain, Released, Released w/Comment, and Rel/IB.}

• _{OASIS MPro Issued and MPro Issued both indicate that the shipment has been authorized for release.}
• _{OGA Referral Closed/No Further Actn indicates that another government agency was consulted for review or inspection, but the referral case has been closed.}

 

_{[9] We identified instances in which a facility missing an FEI number had a name resembling that of a registered facility; however, only facilities with an FEI number were included in the final study.} 

_{[10] FDA, Import Alert 66-80, https://www.accessdata.fda.gov/CMS_IA/importalert_1186.html.}

_{[11] FDA, “FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products,” https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded.} 

_{[12] FDA, “FDA Imports Entry Data Search,” https://datadashboard.fda.gov/oii/cd/impentry-table.htm.}