Import unapproved medicine into American Samoa

Importing medicines into American Samoa

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Fa'atonuga mo le Fa'aulufaleina atu o Vaila'au e le'i Fa'amaonia mo Fa'aoga Patino i Amerika Samoa

O le Federal Food, Drug, and Cosmetic Act (FD&C Act) o le tulafono autu lea e fa'atonutonuina ai le saogalemu ma le lelei o vaila'au, mea'ai, ma mea teuteu i totonu o le Iunaite Setete ma ona teritori, e aofia ai Amerika Samoa. Mo i latou o lo'o mana'omia vaila'au e le'i fa'amaonia pe le maua i Amerika Samoa, aemaise lava pe a fa'asaoina ai le soifua, e tele ni mana'oga e tatau ona usita'ia ina ia mafai ai ona fa'aulufaleina lelei nei vaila'au mo fa'aoga patino.

Malamalama i le FD&C Act ma lona A'afiaga

O le FD&C Act e fa'asa le fa'aulufaleina mai o vaila'au fou e le'i fa'amaonia i totonu o le Iunaite Setete. Peita'i, o le Food and Drug Administration (FDA) e iai le fa'atanaga e fa'aoga ai le fa'autauta fa'aletulafono i tulaga ta'itasi. O lona uiga, e mafai e le FDA ona fa'atagaina le fa'aulufaleina mai o vaila'au e le'i fa'amaonia mo fa'aoga patino pe afai e fa'amalieina nisi tu'utu'uga.

Mana'oga mo le Fa'aulufaleina atu o Vaila'au mo Fa'aoga Patino

Mo Fa'aoga Patino na'o: E tatau ona manino o le vaila'au o lo'o fa'aogaina e le tagata lava ia ma e le mo fa'amoemoega fa'apisinisi pe toe fa'atau atu.
Fa'amaoniga Fa'afoma'i: E mana'omia se tusi mai se foma'i fa'amaonia o lo'o fa'ailoa ai le mana'omia o le vaila'au mo le soifua maloloina o le tagata, aemaise lava pe a leai se isi togafitiga avanoa.
Aofa'i Fa'atapula'a: E le tatau ona sili atu i le tolu masina le aofa'i o le vaila'au o lo'o aumai.
E Leai se Fa'asalalauga: E le tatau ona fa'alauiloaina pe fa'asalalauina le vaila'au i totonu o le Iunaite Setete.
Saogalemu o le Vaila'au: E tatau ona fa'amaonia e le FDA e le'o lamatia ai le saogalemu o le tagata le fa'aogaina o le vaila'au.

La'asaga mo le Fa'aulufaleina atu

1. Fa'afeso'ota'i Lau Foma'i

Fa'afeso'ota'i lau foma'i ina ia maua se tusi fa'amaonia o lo'o fa'amaonia ai le mana'omia o le vaila'au. E tatau ona fa'amatalaina manino le mafua'aga e le maua ai le vaila'au i Amerika Samoa ma pe fa'apefea ona a'afia ai lou soifua maloloina.

2. Fa'afeso'ota'i le FDA

O le aoga o le fa'afeso'ota'i sa'o lea i le FDA e ala i le upega tafa'ilagi a le FDA po'o le latou ofisa fa'alotoifale, pe afai e iai, i Amerika Samoa. E mafai ona e talosagaina fa'amatalaga e uiga i le fa'aulufaleina mai o vaila'au mo fa'aoga patino.

3. Fa'atulaga le Fa'aulufaleina atu

Fa'atalanoa ma le kamupani va'aia po'o le fale talavai o lo'o tu'uina mai le vaila'au ina ia mautinoa o lo'o latou iloa o mana'oga fa'aletulafono. E tatau ona fa'ailoga manino le talone o lo'o fa'atasi ai le tusi a le foma'i ma fa'amatalaga talafeagai.

4. Fa'amautinoa le Usita'ia o Tulafono a le U.S. Customs

O le U.S. Customs and Border Protection (CBP) e aiaia fo'i le fa'aulufaleina mai o vaila'au. Ia mautinoa o lo'o fa'amaoni au fa'amatalaga uma ma o lo'o usita'ia tulafono a le CBP.

Tapula'a ma Mata'ituina

E taua le malamalama e ui lava e mafai e le FDA ona fa'aalia le fa'autauta i nisi tulaga, e leai se mautinoa o le a talia ai lau talosaga. O vaila'au e ono lamatia ai le saogalemu o tagata pe afai e le'i fa'amaonia e ala i faiga fa'aletulafono. O le taofia poo le saisai o au vaila'au i le taimi o le fa'aulufaleina mai e ono tula'i mai.

Mataupu Tau Tulafono ma A'afiaga

O le solia o le FD&C Act e ono i'u ai i fa'asalaga fa'aletulafono, e aofia ai sala tupe ma fa'asalaga fa'afalepuipui. O le mea lea, e tatau ona faia lau taumafaiga sili ina ia usita'ia tulafono uma ma faiga fa'avae.

Fa'ai'uga

O le fa'aulufaleina mai o vaila'au e le'i fa'amaonia mo fa'aoga patino i Amerika Samoa e aofia ai ni la'asaga lelei ma le usita'ia o tulafono a le FD&C Act. E ala i le galulue fa'atasi ma lau foma'i ma le malamalama i mana'oga fa'aletulafono, e mafai ona e taumafai e maua le vaila'au e mana'omia mo lou soifua maloloina.

Mau Fa'asinomaga

Wersja angielska

Guidelines for Importing Unapproved Medications for Personal Use into American Samoa

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the primary law regulating the safety and efficacy of drugs, food, and cosmetics within the United States and its territories, including American Samoa. For individuals requiring medications that are unapproved or unavailable in American Samoa, particularly life-saving drugs, there are specific requirements that must be adhered to in order to legally import these medications for personal use.

Understanding the FD&C Act and Its Implications

The FD&C Act prohibits the importation of new unapproved drugs into the United States. However, the Food and Drug Administration (FDA) has the discretion to exercise regulatory discretion on a case-by-case basis. This means the FDA may allow the importation of unapproved medications for personal use if certain conditions are met.

Requirements for Importing Medications for Personal Use

For Personal Use Only: The medication must be intended solely for the individual's personal use and not for commercial distribution or resale.
Medical Documentation: A valid prescription or a letter from a licensed physician is required, stating the necessity of the medication for the individual's health, especially when no alternative treatment is available in American Samoa.
Quantity Limitations: Generally, only a supply sufficient for no more than three months is permitted.
No Promotional Activities: The medication must not be advertised or promoted to U.S. residents.
Safety Assurance: The FDA must determine that the medication does not pose an unreasonable risk to the individual.

Steps for Importation

1. Consult Your Physician

Contact your healthcare provider to obtain a prescription or a detailed medical letter that explains the necessity of the medication. The documentation should clarify why the medication is essential and why it cannot be substituted with an approved alternative available in American Samoa.

2. Contact the FDA

It is advisable to reach out directly to the FDA through their official website or local office, if available, in American Samoa. You can request information regarding the importation of medications for personal use and any specific procedures you must follow.

3. Arrange for Importation

Coordinate with the foreign supplier or pharmacy to ensure they are aware of U.S. laws and regulations. Ensure that all shipments include the required medical documentation and are properly labeled to facilitate the customs process.

4. Comply with U.S. Customs Regulations

The U.S. Customs and Border Protection (CBP) oversees the importation of goods into the United States. You must ensure all declarations are accurate and comply with CBP regulations to prevent delays or seizure of your medication.

Limitations and Monitoring

It's important to note that even if all conditions are met, there is no guarantee that your medication will be allowed entry. The FDA and CBP have the authority to detain or refuse shipments that they determine may violate the FD&C Act or pose a health risk.

Legal Considerations and Consequences

Violations of the FD&C Act can result in legal penalties, including fines and imprisonment. Therefore, it's crucial to make every effort to comply with all legal requirements and to be forthright in all declarations and documentation.

Wnioski

Importing unapproved medications for personal use into American Samoa involves careful adherence to the FD&C Act and FDA regulations. By working closely with your healthcare provider and understanding the legal requirements, you can navigate the process to obtain necessary medications for your health.

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