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As of June 1, 2009, FDA no longer accepts FDA registrations for OTC drugs specifically, drug establishment registration and drug listing information in paper format unless FDA grants a waiver which must be accompanying with a reason as to why the company cannot conduct its FDA registration via the internet.

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to obtain FDA registration. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drug products that are not properly listed as required are misbranded and may be subject to regulatory action.

Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must obtain FDA registration from their OTC drugs and identify a U.S. agent. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent prior to importation. Any OTC drugs that arrive to the US border without the necessary labeler codes, establishment registration or drug listings will not be permitted into the US.

The FDA relies on registration, listing, and U. S. agent information for administering many key programs, including postmarketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application.

The new FDA registration online system requires many preliminary steps to ensure that the submitting company knows how to work the system and in fact has the authority to file the submissions on behalf of the company. Many companies do not have their FDA registrations simply because the company’s individuals do not understand the online system. Arrastia, Capote & Phang conducts the entire process from start to finish with minimal work on their client’s part, ensuring labeler codes, establishment registrations and NDC numbers are issued.

How Does FDA Identify a High-Risk (HR) Facility?

The agency is utilizing a decision-making process based on the risk factors identified in section 421(a)(1) of the FD&C Act, which are:

1. The known safety risks of the food manufactured, processed, packed, or held at the facility;
2. The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards;
3. The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls;
4. Whether the food manufactured, processed, packed or held at the facility meets the criteria for priority under section 801(h)(1) of the FD&C Act, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S.;
5. Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) (concerning imported food) or 806 (voluntary qualified importer program) of the FD&C Act, as appropriate;
6. Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

For the FY 2011-13 planning cycle for domestic facilities, the decision-making process is based primarily on the first two factors listed, as well as certain additional criteria identified as part of the sixth factor. There are not data available at this time to characterize the third factor for all industry types. It will be incorporated as the Preventive Controls regulation and the data collection develop. The fourth factor applies only to foreign facilities. While the fifth factor may apply to some domestic facilities, the relevant certification programs have not yet been established.

Two additional factors that have been identified pursuant to the sixth item are: establishment type / type of activity conducted at the facility (manufacturer/processor, repacker/packer, etc.) and years since last inspection.

The method utilized is through a software program that assesses the characteristics of each facility in the agency’s inventory. SAS® software provides data access, analysis, and reporting from the agency’s internal data systems. The current model is best depicted with a decision tree as shown in Diagram 1 resulting in facilities being categorized as HR or NHR.

Identification of HR facilities is based on the known safety risks of foods at the industry-wide level and compliance history, which is firm specific.

• The “known safety risks” of food are based on broad, industry-level food commodity categories, e.g., bakery, leafy vegetables, spices. If a facility manufactures food commodity categories associated with foodborne outbreaks AND class I recalls, then they are placed in the HR facility category. If a facility manufactures food commodities associated with foodborne outbreaks OR class I recalls and they have not been inspected within the previous five fiscal years, then they are placed in the HR facility category.
• The facility-specific factor of “compliance history” is based on inspection results for a facility from the previous five fiscal years. Facilities with a history of non-compliance with food safety requirements (a history of three or more VAI within the five year time period) and those with food safety violations of regulatory significance (one or more OAI in the five year time period) are placed in the HR facility category.

Under the proposed FDA law, FDA officials that have a reasonable belief that an article or any other food that may be affected in a similar manner will be permitted access to records to pertaining to these food products.

Under the current FDA law, an FDA official may request records of a specific food product where there is reason to believe it is adulterated. The new regulations will expand FDA’s powers to review records. As an example, an importer of papaya from Mexico will automatically be detained under an Import Alert currently in place. If in the same container a different fruit, say mangos, are being shipped there is the potential that FDA officials “reasonably believe” the mangos, simply for being shipped with the papayas, can be adulterated. At that point, FDA can request documentation from the importer or supplier to confirm the status and safety of the product. The FDA law requires that these documents must be made available as soon as possible, but not to exceed 24 hours from the time of receipt of the request.

Although the new FDA law is only a proposed law, there is a potential it will become regulation after the prescribed notice and comment period. Importers and suppliers, alike, need to be prepared to turn over any and all documentation related to their food products on a moment’s notice that establishes the safety of the product.

The new regulation will place responsibility and accountability for food safety on the importer bringing food products into this country.

Importers of food products will not be required to implement a foreign supplier verification program. The verification program will need to provide adequate assurance that the food products have been produced under risk-based preventive controls. Some importers may already have a verification program integrated into their food safety protocols, others may not. For those who do not have a verification program currently in place an FDA lawyer can assist with creating and implementing an adequate verification program. An adequate verification program needs to ensure that the importer’s suppliers have systems in place to produce and harvest safe food.

The new FDA law will also allow for voluntary participation of an expedited importation program. Those importers choosing to participate must accompany all food shipments with safety certifications. The safety certifications will be issued by third-party accredited companies, however to date, FDA has not accredited any third-party companies. These third-party accreditation companies will do a site inspection, at the expense of the supplier, and assuming the supplier has the proper protocols in place and follows those protocols the third-party certification company will issue a certification. Customs and Border Protection and FDA will expedite those importations that are accompanied with these certification.

The new FDA law is and will continue to change the landscape of the food supply and those obligations for importers and food producers/harvesters alike. Consultation with an FDA lawyer can help ensure that you are up to date on the latest regulations as well as implementing the new regulations as they come to fruition.

Don’t Give the Gift of Food Poisoning; Keep Things Clean

• Wash hands with warm water and soap for 20 seconds before and after handling any food.
• Wash food-contact surfaces (cutting boards, dishes, utensils, countertops) with hot, soapy water before and after preparing each food item.
• Rinse fruits and vegetables thoroughly under cool running water and use a produce brush to remove surface dirt.
• Do not rinse raw meat and poultry before cooking in order to avoid spreading bacteria to areas around the sink and countertops.

Separate to Avoid Cross-Contamination

• Whether shopping in the store, storing food in the refrigerator at home, or while preparing meals, keep raw eggs, meat, poultry, seafood, and their juices away from foods that won’t be cooked.
• Consider using one cutting board only for foods that will be cooked, such as raw meat, poultry, and seafood, and another one for those that will not be cooked, such as raw fruits and vegetables.
• Keep fruits and vegetables that will be eaten raw separate from other foods such as raw meat, poultry or seafood—and from kitchen utensils used for those products.
• Do not put cooked meat or other food that is ready to eat on an unwashed plate that has held any raw eggs, meat, poultry, seafood, or their juices.

Cook to A Safe Internal Temperature

• Use a food thermometer to make sure meat, poultry, and fish are cooked to a safe internal temperature. To check a turkey for safety, insert a food thermometer into the innermost part of the thigh and wing and the thickest part of the breast. The turkey is safe when the temperature reaches 165ºF. If the turkey is stuffed, the temperature of the stuffing should also be 165ºF.
• Bring sauces, soups, and gravies to a rolling boil when reheating.
• Cook eggs until the yolk and white are firm. When making your own eggnog or other recipe calling for raw eggs, use pasteurized shell eggs, liquid or frozen pasteurized egg products, or powdered egg whites.
• Don’t eat uncooked cookie dough, which may contain raw eggs.

Chill Because Harmful Bacteria Grow Rapidly at Room Temperature

• Refrigerate leftovers and takeout foods—and any type of food that should be refrigerated, including pie—within two hours.
• Set your refrigerator at or below 40ºF and the freezer at 0ºF. Check both periodically with an appliance thermometer.
• Thaw safely in the refrigerator, under cold running water, or in the microwave—never at room temperature. Cook food that has been thawed in cold water or in the microwave immediately.
• Allow enough time to properly thaw food. For example, a 20-pound turkey needs four to five days to thaw completely in the refrigerator.
• Don’t taste food that looks or smells questionable. When in doubt, throw it out.
• Leftovers should be used within three to four days, unless frozen.

You’ve seen the turkey fryers and giant jugs of peanut oil. But you’re a little nervous. That’s a lot of hot oil! USDA’s Food Safety & Inspection Service has these tips to help you safely prepare a deep fat fried turkey.

Planning: Tips for Purchasing a Turkey

Before you purchase your turkey, check the instructions for your turkey fryer. Most fryers will accommodate a 12-16 lb. turkey. A larger turkey will not fit in the fryer and will take too long to cook. Don’t stuff a turkey that you’re going to fry!
Before you unwrap the turkey, take a minute to determine the amount of oil needed. Place the turkey in the fryer and add enough water to cover it. Do not fill the pot more than ¾ full; the oil level should be three inches to five inches from the top of the fryer. The turkey should be covered by about one to two inches. Remove the turkey and measure the amount of water – that’s how much oil you’ll need. Drain or pour out the water and dry the pot thoroughly.

Preparation: Check Your Food Safety Steps

Now for the turkey. As with all food preparation, remember to check your steps (clean, separate, cook and chill). As you prepare the bird, separate the raw turkey from fresh foods on your menu, and use separate cutting boards, plates, and utensils to avoid cross contamination.

If your turkey is frozen, make sure to thaw it before frying. You can thaw it in the refrigerator. It takes about 24 hours for every four to five pounds. Keep it refrigerated until about 30 minutes before cooking.

If you choose to marinade or to inject a flavor into the turkey, allow it to stand in the refrigerator for 24 to 48 hours before cooking. And always keep hands, utensils, and surfaces clean.

Cooking: Caution! Hot Oil!

Deep fat frying a turkey must be done OUTSIDE! Select a safe, flat outdoor location that is well-lit, well-ventilated and away from trees, shrubbery and buildings.

Heat the cooking oil to 350°F. Before lowering the turkey into the oil, turn the burner off. Do not just dunk the turkey in the oil. To avoid the oil bubbling over, gradually lower the turkey into the hot oil, pull it back out, and repeat until it is fully immersed. Turn the burner back on and bring the oil back to 350°F.

Monitor the temperature of the oil with a thermometer constantly during cooking. Never leave the hot oil unattended! Allow about three to five minutes per pound cooking time.

When the time is up, turn the burner off, and slowly lift the turkey out of the oil. Hold it over the fryer so the oil can drain. Check the temperature of the turkey with a food thermometer. The turkey is safely cooked when the food thermometer reaches a minimum internal temperature of 165°F in the innermost part of the thigh and wing and the thickest part of the breast.

Enjoy Your Meal

Cover the bird with foil and let it rest about 20 minutes before carving. After serving, refrigerate the leftovers within two hours in shallow containers. Refrigerate and use turkey leftovers for three to four days or freeze for three to four months.

Don’t forget about the oil! Once the turkey is out, remove the pot from the burner and move to a flat, safe place and allow the oil to cool, covered, overnight. Once the oil has cooled you can strain out the solids and use it again. Store in a cool, dry place for up to six months.

Safe Treats

• Give your child a good meal before trick-or-treating to prevent them from snacking on candy and treats. Urge them to wait until they get home before eating them and let you inspect the treats in their bags.
• Tell children not to accept – and especially not to eat – anything that isn’t commercially wrapped.
• Inspect all treats for signs of tampering, such as an unusual appearance or discoloration, tiny pinholes, or tears in wrappers. Throw away anything that looks suspicious.
• Parents of very young children should remove any choking hazards such as gum, peanuts, hard candies or small toys.
• Consider providing non-food treats for children that visit your home, such as coloring and activity books

Halloween Parties

• Unpasteurized juice or cider can contain harmful bacteria such as Salmonella. To stay safe, always serve pasteurized products at your parties.
• Don’t taste raw cookie dough or cake batter that contain uncooked eggs
• Keep all perishable foods chilled until serving time. These include finger sandwiches, cheese platters, fruit or tossed salads, cold pasta dishes with meat, poultry, or seafood, and cream pies or cakes with whipped-cream and cream-cheese frostings.
• Don’t leave perishable goodies out of the fridge for more than two hours (one hour in temperatures above 90°F).
• Bobbing for apples is a favorite Halloween game. Reduce the number of bacteria that might be present on apples and other raw fruits and vegetables by thoroughly rinsing them under cool running water. As an added precaution, use a produce brush to remove surface dirt.
• Try a different bobbing for apples game from FightBAC.org. Cut out apples from red construction paper. Write activities for kids to do on each apple, such as “say ABCs.” Place a paper clip on each apple and put them in a large basket. Tie a magnet to a string or make a fishing pole with a dowel rod, magnet and yarn. Let the children take turn “bobbing” with their magnet and doing the activity written on their apple. Give children a fresh apple for participating in your food-safe version of bobbing for apples.

FDA medical device classification involves placing items into certain categories according to how safe they are. This is very important to the health care industry because the lives of those affected by these devices should be protected. There are certain things that are looked at when placing these items into various categories.

The complexity of the design is one factor that is considered. Some items are designed in a very simple manner and are used for basic procedures while others are more complex, such as toothbrushes. Something that is simple in design might not cause much concern. This is classified as a Class I device But, it will still be subject to general controls, and this is a class I category.

These general controls include keeping an eye on items that are adulterated and devices that are banned. The devices which are placed under general controls are not used to support life and they are usually not a threat to one’s health. An example of this is gloves that are used for examination and bandages.

When there are general controls in addition to special controls, this is a class II category. These are devices that are subject to greater standards than those of a class I category. They have to perform in the way they are designed to perform without injuring the user or the patient. An example of this is a powered wheel chair. Class II medical devices require pre-market clearance from FDA. This clearance requires submission of an application referred to as a 510(k).

The next category is class III and this means that in addition to general controls, there is a need for scientific review of these items. These devices are usually used to sustain life or support it in some way. This means that there is the potential to harm the patient if the item is misused. An example of this would be a pacemaker. Class III also requires pre-market clearance in the way of a PMA.

FDA Consultants, especially those welled versed in the regulations, such as attorneys, are best equipped to help maneuver the regulatory issues of FDA for medical devices. An FDA Consultant who has conducted 510(k) applications will be able to assist you in drafting the applications and ensuring that the necessary testing and paperwork is complete before submission.

OTC drugs are the most common forms of self-medication in the US. Since they are offered over the counter they do not require the client to present a doctor’s prescription. Some people argue that this might be a rather unsafe procedure since after all these products are still drugs which need to be taken with care. However there are a number of processes and systems which are used to make such a request legal and safe. One such procedure is the FDA registration for OTC drugs.

Basically the FDA oversees the types of drugs which are allowed to be purchased over the counter. This regulatory body ensures that the products which fall in this category are relatively safe and can be purchased without a prescription.

The regulatory structure for FDA registration of OTC drugs mainly depends on the type of ingredients, the quantity of the active ingredients, and the labeling the particular product is composed of. In fact a study is carried out for each product so as to come up with the drug monograph. This will govern the FDA’s decision as to whether to register that particular product as an OTC.

Furthermore, there are a number of other regulations which need to be complied with prior to filing FDA registration and while marketing the OTC drug.

An OTC drug which has a monograph requires that the manufacturer comply with all aspects of the monograph as well as filing FDA registration through FDA’s online system. In this application the manufacturer will delineate various aspects relating to the particular product, including active ingredients, inactive ingredients and labeling of the product.

FDA registration also requires annual renewal of registrations to keep track of which products are still in the US market. The regulatory framework for OTC drug FDA registration can be cumbersome and difficult to maneuver. Hiring an attorney well versed in the FDA registration process is vital to ensure compliance with FDA regulations.

When it comes to football, defense matters. When it comes to planning a tailgate party, a good defense against foodborne illness matters even more.
“This year, we’re urging fans to follow the food safety play book at the tailgate parties they host,” USDA Under Secretary for Food Safety Dr. Elisabeth Hagen said. “Large gatherings can increase the chance of becoming ill, but by following these rules all fans can enjoy the game and their food, safely.”

Illegal Use of Hands

Avoid penalties for “illegal use of hands.” Unclean hands are one of the biggest culprits for spreading bacteria, and finger foods are especially vulnerable. Chefs and guests should wash their hands with soap and warm water for 20 seconds before and after handling food. If running water is located far away from your tailgate, have sanitizing wipes available throughout the day. Also, be sure to clean eating surfaces often, and wash serving platters before replenishing them with fresh food.

Offsides

Think of your tailgate fare as two different teams—uncooked versus ready-to-eat foods. Prevent “encroachment” at all costs and keep each team in its own zone. The juices from raw meat can contain harmful bacteria that cross-contaminate other food. Use one cutting board for raw meat and poultry and another one for cutting veggies or foods that will not be cooked. If you use only one cutting board, wash it with hot soapy water after preparing each food item. As you take cooked meat off the grill, be sure to place it on a clean platter, not on the dish that held it while raw. The juices left on the plate from raw meat can spread harmful bacteria to safely cooked food.

Equipment violations and holding

Call a “time out” and use a food thermometer to be sure meat and poultry are safely cooked. Remember that internal temperature, not meat color, indicates doneness. To be sure harmful bacteria are killed, whole cuts of fresh beef and pork should be cooked to 145 °F followed by a three minute stand time, while ground beef and pork should be cooked to 160 °F (no rest time is necessary). Ground, whole, or pieces of poultry, as well as casseroles, should be cooked to 165 °F. Hotdogs and reheated deli meats should be cooked to 165 °F or until steaming hot.
“Holding” may be one of the most likely offenses your referee encounters during long football games. Never hold perishable foods out for more than two hours, or for more than one hour if the temperature is above 90 °F. Put leftovers back in the cooler promptly to block offensive bacteria from multiplying. When in doubt, throw it out of the game—and your tailgate.

False start

When it comes to foodborne illness, there is no opportunity for an instant replay. To avoid these infractions, make sure you understand the rules completely. One of the best resources available before kickoff is USDA’s virtual representative, “Ask Karen.” Food safety coaches are available Monday through Friday from 10 a.m. to 4 p.m. ET on the “Ask Karen Chat” and by phone at the USDA’s Meat and Poultry Hotline, 1-888-MPHotline (1-888-674-6854). Recorded messages are available 24 hours a day.